Biorelevant Dissolution: Methodology and Application in Drug Development

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Dissolution testing can play an important role in several areas for drug products as a quality control
tool to monitor batch-to-batch consistency of drug release from a dosage form and as an in vitro surrogate
for in vivo performance that can guide formulation development and ascertain the need for bioequivalence
tests. The possibility of substituting dissolution tests for clinical studies has been revealed by the development
of the Biopharmaceutics Classification System, and dissolution tests that can predict the in vivo performance
of drug products (usually called “biorelevant” dissolution tests) could serve this purpose (1, 2). In terms of media and hydrodynamics, biorelevant dissolution testing should provide a baseline for drug and dosage-form performance and should be used to guide formulation development, to identify food effects on the dissolution and bioavailability of orally administered drugs, and to identify solubility limitations and stability issues. The importance of the development of predictive dissolution testing is increased by the fact that the majority of drugs currently in development are poorly soluble drugs and by the challenges for new dosage-form approaches.

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Dicari Distribution Planning Officer untuk PT AAM

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PT Anugrah Argon Medica anggota Dexa Group, mencari kandidat untuk Distribution Planning Officer.

selengkapnya klik disini

Rumah Sakit Dr. OEN SOLO BARU membutuhkan tenaga-tenaga profesional

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... DIBUTUHKAN SEGERA ...

Rumah Sakit Dr. OEN SOLO BARU membutuhkan tenaga-tenaga profesional untuk menjadi karyawan / karyawati Rumah Sakit.

Kualifikasi :

* Lulusan S-1 Farmasi profesi.
* Laki-laki / perempuan.
* Usia maximal 30 tahun.
* Sebagai tenaga full timer Rumah Sakit.
* Penempatan di SOLO.

Surat Lamaran dilampiri :
1.Daftar Riwayat Hidup.
2.Fotocopy Ijazah terakhir, Fotocopy Transkrip Nilai.
3.Pas photo ukuran 4 x 6 sebanyak 2 lembar.
4.Foto Copy KTP.
5.Surat Pengalaman Kerja (kalau ada).

Surat lamaran dapat dikirimkan melalui pos ke :

Direktur Utama

RS Dr. OEN SOLO BARU
Kompleks Perumahan Solo Baru
Grogol – Sukoharjo

Atau melalui e-mail ke : rumah_sakit@droensolobaru.com

Lowongan kerja MR

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Medical Representatives

Requirements :

* Syarat mutlak pengalaman kerja min 1 tahun sebagai Medical Representative
* Min D3 (Pharmacy, Medical, etc).
* Ada bonus untuk yang memiliki sertifikat PEDFI

Bagi Anda yang berminat dan sesuai persyaratan di atas mohon membawa

CV ke : hr.indonesia@spcorp.com

selengkapnya klik disini

Job Vacancy for PT Soho Industri Pharmasi

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I.Export Administration

Requirements:

* Female, max 28 years old
* Hold Diplom (D3) degree from any subject
* Fluent in English, Oral and Writing
* Honest, Precise and Agile
* Computer literacy skill and able to handle secretary’s role
* Willing to learn new things

II.Brand Executive

Requirements:

* Male, max 30 years old
* Pharmacist / Business / Industrial Engineering
* Minimum 2 years experience as Product / Brand Executive / Supervisor at Pharmaceutical or FMCG industries
* Will representing the company in Africa

Please send your CV to:
soho.recruitment@gmail.com
Kawasan Industri Pulogadung Jl Pulogadung No 6 Jakarta 13011

Job Vacancy for PT Soho Industri Pharmasi

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I.Mechanical Technician
(Jakarta Raya - Kawasan Industri Pulogadung, Jakarta Timur)

Requirements:

* Candidate must possess at least a Diploma in Engineering (Mechanical) or equivalent.
* At least 1 year(s) of working experience in the related field is required for this position.
* Applicants should be Indonesian citizens or hold relevant residence status.
* Preferably Senior Staffs specializing in Engineering - Mechanical/Automotive or equivalent. Job role in Technician/Support or Mechanical Engineer.
* Full-Time positions available.

II.Training Analyst
(Jakarta Raya - Kawasan Industri Pulogadung)

Requirements:

* Candidate must possess at least a Bachelor’s Degree in Psychology or equivalent.
* Applicants should be Indonesian citizens or hold relevant residence status.
* Fresh graduates/Entry level applicants are encouraged to apply.
* Full-Time positions available.

III.Validation Engineer
(Jakarta Raya)

Requirements:

* Candidate must possess at least a Bachelor’s Degree, Engineering (Chemical), Engineering (Electrical/Electronic), Engineering (Industrial), Engineering (Mechanical), Pharmacy/Pharmacology or equivalent.

* Preferably has experience in at least 1 (one) year in qualification/validation in the pharmaceutical facility

* Interested in engineering work in pharmaceutical manufacturing site
* Familiar with qualification/validation approach of GMP (any standard)
* Fresh graduates/Entry level applicants are encouraged to apply.
* Full-Time positions available.

IV.HVAC & Utility Engineering Section Head
(Jakarta Raya)

Requirements:

* Man, Age max. 30 yearsold
* Candidate must possess at least a Bachelor’s Degree, Engineering (Electrical/Electronic)
* At least 2 year(s) of working experience in the related field is required for this position.
* Preferably Senior Staffs specializing in Engineering - Electrical or equivalent.
* Full-Time positions available.

Email: soho.recruitment@gmail.com

Lowongan kerja PT ETHICA Industri Farmasi

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We’re one of the growing fast Pharmaceutical Company, looking for a highly potential candidate to reach our vision together as:

I.Marketing Service Administrator (Adm) - (Jakarta Raya)

Responsibilities:

* Main Job:
- Handling administration; data input

Requirements:

* Female, max 28 years old
* D3 from related field
* Computer Literate

II.Medical Representative (MR) - (Jakarta Raya)

Responsibilities:
* Main Job:
- Handling medicine promotion to doctor

Requirements:

* Male/Female, max. 28 years old
* Diploma/ Bachelor degree from any major
* Have own motorcycle and C driving license
* Willing to be located in big cities In Indonesia

III.Engineering Staff (ES) - (Jakarta Raya)

Responsibilities:

* Main Job:
- Handling machine maintenance

Requirements:

* Male, max. 28 years old
* Bachelor degree from engineering, min GPA 2.75
* 1 year experience is preferable

IV.Accounting Staff (AS)- (Jakarta Raya)

Responsibilities:

* Main Job:
- Handling journal and financial report

Requirements:

* Male/Female, max 30 years old
* Bachelor degree in Accounting from reputable University
* Min GPA 2,75
* 2 Years experience is preferable, Fresh graduate are welcome to apply

V.Bank Custodian / Finance Staff (FS) - (Jakarta Raya)

Responsibilities:

* Main Job:
- Handling Bank transaction

Requirements:

* Male/Female, max 30 years old
* Bachelor degree in Economic (Finance/ Accounting) from reputable University
* Min GPA 2,75
* 2 Years experience is preferable, Fresh graduate are welcome to apply

Please send your application letter with CV, recent photograph, and copy of ID card, not later than 2 weeks after the advertising date to:
POBOX 1049-JAT 13010
Or
recruitment@ethica.co.id
Note: Please state the code of the position on the envelope / e-mail subject

Dokter dispensing

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Kontroversi dan perdebatan mengenai dokter dispensing sudah berjalan cukup lama.. Hal tersebut ternyata tidak saja menjadi perdebatan di dalam negri ini, tapi juga di luar negri.

Profesi apoteker dan dokter adalah profesi yang telah menjalani pendidikan khusus sesuai dengan kompetensinya masing-masing. Apoteker memiliki kompetensi dalam hal obat-obatan sementara dokter memiliki kompetensi dalam hal penyakit dan diagnosanya. Pemisahan antara dokter dan apoteker merupakan konsep pengobatan modern yang berlaku saat ini, dimana dokter menulis resep dan apoteker menyiapkan obat dan menyerahkannya pada pasien. Pada zaman dahulu praktek penyembuhan dilakukan dalam satu paket. Setelah menentukan penyakit yang diderita pasien, penyembuh kemudian meracik sendiri obat dan menyerahkannya. Seiring perkembangan ilmu pengetahuan, praktek layanan kesehatan pun mengalami perubahan. Jenis obat-obatan semakin meningkat dan cara pembuatannya semakin rumit sehingga membutuhkan para ahli yang dapat mencurahkan segenap perhatiannya pada pekerjaan ini. Maka bidang farmasi dipisahkan secara resmi dari bidang kedokteran sejak tahun 1240 dengan dikeluarkannya dekrit Two Sicilies oleh raja Jerman Frederick II. Dekrit itu antara lain menyatakan bahwa seorang tabib tidak boleh menguasai tempat penyimpanan obat atau melakukan bentuk eksploitasi apapun terhadap penderita melalui hubungan bisnis penjualan obat. Kini sebagaimana berlaku di berbagai negara di dunia, pekerjaan kefarmasian dipisahkan dari pekerjaan kedokteran. Pasien diperiksa oleh dokter, lalu dokter akan menulis resep yang kemudian diserahkan ke apoteker untuk diracik dan diserahkan pada pasien.

Dalam posting saya sebelumnya (klik disini), di UK juga terdapat perbedaan pendapat antara praktisi dokter dan farmasi. Namun demikian, ada kalimat yang menarik dalam posting tersebut diakhirnya, bahwa ada kualifikasi khusus untuk dokter yang diperbolehkan melakukan dispensing. Bagaimana dengan kondisi negri tercinta ini, akan seperti apa kontrol dan kebijakan pemerintah mengenai hal ini??

Fife pharmacy plans threaten dispensing doctor

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Permission for a rural pharmacy to be opened in a village post office in Fife has caused controversy among locals.

Residents in Leuchars have held a public meeting on the issue, as it is feared that the new pharmacy will have a detrimental effect on the region's dispensing doctor surgery.

If the pharmacy is opened, the village's GPs surgery could lose its lucrative medication dispensing contract, which accounts for half of its income.

Dr Bryan Johnston, who runs two dispensaries from his Leuchars and Balmullo practices, told STV that the money raised through dispensing medication is re-invested in the surgery and helps the practice improve its services.

However, James Semple, who will open the new pharmacy, said: "Community pharmacies such as this one are being established in retail premises in villages and towns all over Scotland.

"Losing a dispensing facility couldn't possibly impact on the surgery as general medical services are funded separately and not dependent on money raised from dispensing."

Meanwhile, the UK's Commission for Employment and Skills recently introduced a new range of dispensing doctor qualifications.

Adopted from Actavis.co.uk

Film Coating Technology: An Overview

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Abstract

Tablet coating is perhaps one of the oldest pharmaceutical processes still in existence. The sugar-coating process was a skilled manipulative operation and could last for even five days. The operator must be highly skilled for such coating. In the last 25 years tablet coating has undergone several fundamental changes. Many modifications were advocated to improve the basic process and film coating chosen in place of sugar coating. Coating solution composition may affect the quality of final coated tablets. Some coating process parameters are affect the final quality of coated tablets so it is necessary to optimize the coating process parameters for particular equipment and particular film former. Optimization of composition of film coating solution is also required.

Keywords : Film coating, Coating Process parameters, Coating composition

Introduction

All drugs have their own characteristic, like some drugs are bitter in taste or has an unpleasant odor, some are sensitive to light or oxides, some are hygroscopic in nature.1,2,3 Because of this reason tablet coating is the choice of option to solve such problems in conventional dosage form.

In the past sugar coating was mostly borrowed from the confectionary industry. But now a days it is replaced with film coating, because the sugar coating process was a skilled manipulative process and could last for even five days. The operator must be highly skilled for such coating. Hence film coating is preferred over sugar coating.

Tablet film coating is performed by two types, one is aqueous film coating (generally water is used as a solvent) and non aqueous film coating (generally organic solvent are used.) Some problems are associated with the non aqueous film coating like employee safety (it’s dangerous, it smells, and it’s not good to breathe.) atmosphere pollution etc. But key problem is with the approval of the regulatory authority4. High quality aqueous film coating must be smooth, uniform and adhere satisfactorily to the tablet surface and ensure chemical stability of a drug.
“ Why Tablet Coating is Required ? ” 1, 2, 3

A number of reasons can be suggested:

§ The core contains a material which has a bitter taste in the mouth or has an unpleasant odour.

§ Coating will protect the drug from the surroundings with a view to improve its stability.

§ Coating will increase the ease by which a tablet can be ingested by the patient.

§ Coating will develop the mechanical integrity, means coated products are more resistant to mishandling (abrasion, attrition etc.)

§ The core contains a substance which is incompatible in the presence of light and subject to atmospheric oxidation, i.e. a coating is added to improve stability.

§ The core alone is inelegant.

§ The active substance is coloured and migrates easily to stain hands and clothes.

§ The coated tablets is packed on high-speed packaging machine. Coating reduces friction and increases packaging rate.

§ Coating can modify the drug release profile, e.g., enteric coating, osmotic pump, pulsatile delivery.

Introduction to Film Coating Materials

A film coating is a thin polymer-based coat applied to a solid dosage form such as a tablet. The thickness of such a coating is usually between 20-100 µm. Under close inspection the film structure can be seen to be relatively non- homogenous and quite distinct in appearance, from a film forming, from casting a polymer solution on a flat surface.5, 6

Film coating formulations usually contain the following components


Polymer,

Plasticizer,

Colourants / Opacifiers,

Solvent / Vehicle.

Polymers


Amongst the vast majority of the polymers used in film coating are cellulose derivatives or acrylic polymers and copolymers.5, 6, 7

Non-enteric polymers8


·Hypromellose

·Hydroxyethyl cellulose

·Hydroxyethylmethyl cellulose

·Carboxymethylcellulose sodium

·Hydroxypropyl cellulose

·Polyethylene glycol

·Ethylcellulose

Enteric polymers

Some examples of enteric coating polymers

·Hypromellose phthalate

·Polyvinyl acetate phthalate

·Cellulose acetate phthalate

·Polymethacrylates

·Shellac

Plasticizers


Plasticizers are simply relatively low molecular weight materials which have the capacity to alter the physical properties of the polymer to render it more useful in performing its function as a film-coating material.7, 8, 9 It is generally considered to be mechanism of plasticizer molecules to interpose themselves between individual polymer strands thus breaking down polymer-polymer interactions. Thus polymer is converted in to more pliable materials. Plastisizers are classify in three groups. Polyos type contain glycerol, propylene glycol, PEG( Polyethylene glycol ). Organic esters contain phthalate esters, dibutyl sebacete, citrate esters, triacetin. Oils/glycerides contain castor oil, acetylated, monoglycerides, fractionated coconut oil.

Solvents/Vehicles


The key function of a solvent system is to dissolve or disperse the polymers and other additives. All major manufactures of polymers for coating give basic physicochemical data on their polymers. These data are usually helpful to a formulator. Some important considerations for solvent are as follows:6

The major classes of solvents being used are


·Water

·Alcohols

·Ketones

·Esters

·Chlorinated hydrocarbons

Because of environmental and economic considerations, water is the solvent of choice; however organic coating is totally cannot be avoided.

Colourants / opacquants


The sematerials are generally used as ingredients in film-coating formulae to contribute to the visual appeal of the product, but they also improve the product in other ways7,8,9:

Identification of the product by the manufacturer and therefore act as an aid for existing GMP procedures.

- Reinforcement of brand imaging and reduction in product counterfeiting.

- Identification of the product by patients by using colourants.

Colourants for film coating are having, in more or less amount, property of opacifier. So they would give protection to active ingredients in presence of light. Colourants are mainly classified in to three part. Sunset yellow, tartrazine, erythrosine are examples of Organic dyes and their lakes. Iron oxide yellow, red and black, titanium dioxide, talc are the examples of Inorganic colours. Anthrocyanins, ribofloavine and carmine are the examples of natural colours.

Miscellaneous coating solution components


To provide a dosage form with a single characteristic, special materials may be incorporated into a solution6.

Flavours and sweeteners are added to mask unpleasant odours or to develop the desired taste. For example, aspartame, various fruit spirits (organic solvent), water soluble pineapple flavour (aqueous solvent) etc.

Surfactants are supplementary to solubilize immiscible or insoluble ingredients in the coating. For example, Spans,Tweens etc.

Antioxidants are incorporated to stabilize a dye system to oxidation and colour change. For example oximes, phenols etc.

Antimicrobials are added to put off microbial growth in the coating composition. Some aqueous cellulosic coating solutions are mainly prone to microbial growth, and long-lasting storage of the coating composition should be avoided. For example alkylisothiazloinone, carbamates, benzothiazoles etc.

Coating Process


Film-coating of tablets is a multivariate process, with many different factors, such as coating equipment, coating liquid, and process parameters which affect the pharmaceutical quality of the final product10-13.

Coating equipment14


Before few years different types of coating pans are used for coating like conventional coating pans, manesty accelacota, driam ( driacoater ), butterfly coater etc. Now a days the side-vented, perforated pan-coater is the most commonly used coating device of tablets. In equipment spray nozzle, number of spray nozzle, pan size, etc may also affect the quality of final product. Its air flow system through a perforated pan ensures rapid and continuous drying conditions. The low evaporation capacity of water requires high drying efficiency of aqueous film-coating equipment.

Coating liquid


Coating liquid may affect the final quality of the tablets. Different film former have different chemical nature and different charesteristic. Viscosity may affect the spreading of coating liquid across surface of substrate. Surface tension may affect in wetting of surface. % Solid content generally affect the tablet surface and coating efficiency.15

Process parameters


Spray rate


The spray rate is an significant parameter since it impacts the moisture content of the formed coating and, subsequently, the quality and uniformity of the film.16,17,18 A low coating liquid spray rate causes incomplete coalescence of polymer due to insufficient wetting, which could effect in brittle films16. A high coating liquid spray rate may result in over wetting of the tablet surface and subsequent problems such as picking and sticking.16,17 If the spray rate is high and the tablet surface temperature is low, films are not formed during the spraying but the post drying phase, and rapid drying often produces cracks in the films16.

Atomizing air pressure


In general, increasing the spraying air pressure decreases the surface roughness of coated tablets and produces denser and thinner films.19,20,21 If spraying air pressure is excessive, the spray loss is great, the formed droplets are very fine and could spray-dry before reaching the tablet bed, resulting in inadequate droplet spreading and coalescence21. If spraying air pressure is inadequate, the film thickness and thickness variation are greater possibly due to change in the film density and smaller spray loss. In addition, with low spraying air pressure big droplets could locally over wet the tablet surface and cause tablets to stick to each other.

Inlet air temperature


The inlet air temperature affects the drying efficiency (i.e. water evaporation) of the coating pan and the uniformity of coatings19. High inlet air temperature increases the drying efficiency of the aqueous film coating process and a decrease in the water penetration into the tablet core decreases the core tablet porosity, tensile strength and residual moisture content of coated tablets.19,22 Too much air temperature increases the premature drying of the spray during application and, subsequently, decreases the coating efficiency.18,23 Measuring the pan air temperature helps to manage the optimum conditions during the coating process and, consequently, enables predicting possible drying or over wetting problems which may result in poor appearance of the film or may have unfavorable effects on the moisture and heat sensitive tablet cores.24

Rotating speed of pan


It is well documented that increasing the rotating speed of the pan improves the mixing of tablets.23-27 The pan speed affects the time the tablets spend on the spraying zone and, subsequently, the homogeneous distribution of the coating solution on the surface of each tablet throughout the batch. Increasing the pan speed decreases the thickness variation and increase the uniformity of coatings.16,23,26 Too much rotating speed of the pan will cause the tablet to undergo unnecessary attrition and breakage.

Conclusion


Film coating technology is now a days very important in the field of pharmacy particularly in formulation development. Process parameters and coating composition play an important in coating of tablets. So for getting good final quality of coated tablet it would be necessary to optimize the parameters.

References


1. Cole G. Pharmaceutical Coating Technology,Taylor and Francis Ltd, 1998;1-5.

2.Porter C. Coating of Pharmaceutical Solid-dosage forms, Pharm. Tech., 1980,4(3), 66.

3.Libermen H, Lachman L, Pharmaceutical Dosage Forms: Tablets, Vol. I to III, Marcel Dekker Inc., N.Y, 85-143.

4.Hinkes T, Solvent film coating: aqueous vs. Organic, Wisconsin Alumni Research Foundation Madison, Wisconsin.

5.Nyamweya N, Mehta K. Film Coating with Aqueous Latex Dispersions, Pharmaceutical Technology Yearbook 2001.

6.Hogan J. Pharmaceutical Coating Technology, Taylor and Francis Ltd 1998; 6-52.

7.Rowe R, Sheskey P, Owen S. Pharmaceutical Excipients.

8.Martini L, Ford J, Roberts M. The use of hypromellose in oral drug delivery, J Pharm Pharmacol. 2005,57,533-546.

9. Porter S. Coating of Pharmaceutical Dosage forms, Remington’s book of science,volume 1, Ch 46; 894-902.

10.Rowe R. The effect of some formulation and process variables on the surface roughness of film-coated tablets. J. Pharm. Pharmacol 1978a,30,669-672.

11. Elaine S, Celine V, Dawn Z, Xiaohua L, Anthony J, Paul W. Study of Coat Quality of Tablets Coated by an On-line Supercell Coater, AAPS PharmSciTech 2007,8(3), Article 63.

12. Tobiska S, Peter K. Coating uniformity and coating efficiency in a Bohle Lab-Coater using oval tablets European Journal of Pharmaceutics and Biopharmaceutics. 2003,56,3-9.

13. Philip A, Rowe R, York P, Doherty C. The effect of experimental design on the modeling of a tablet coating formulation using artificial neural networks;European Journal of Pharmaceutical Sciences. 2002,16,281-288.

14.Heinamaki. J, Ruotsalainen M, Lehtola V, Antikainen O, Yliruusi J. Optimization of Aqueous-Based Film Coating of Tablets Performed by a Side-Vented Pan- Coating System. Pharmaceutical Development and Technology. 1997,2(4),357-364.

15.Optimal Coating Process Parameters for a New, Fully-Formulated, Acrylic-based, Enteric, Film-Coating System,Poster ReprintAmerican Association ofPharmaceutical Scientists,November 2000.

16. Obara S, McGinity J. Influence of processing variables on the properties of free films prepared from aqueous polymeric dispersions by a spray technique. Int. J. Pharm.1995,126,1-10.

17. Franz R, Doonan G. Measuring the surface temperature of tablet beds using infrared thermometry. Pharm Technol. 1983,7,55-67.

18.Porter S, Verseput R, Cunningham C. Process optimization using design of experiments. Pharm. Technol. 1997,21,60-70.

19. Twitchell A, Hogan J, Aulton M. The behaviour of film coating droplets on the impingement onto uncoated and coated tablet. S.T.P. Pharm. Sci. 1995a,5,190-195.

20. Twitchell A, Hogan J, Aulton M. Assessment of the thickness variation and surface roughness of aqueous film coated tablets using a light-section microscope. Drug Dev.Ind.Pharm. 1995b,21,1611-1619.

21.Tobiska S, Kleinbudde P. Coating Uniformity: Influence of atomizing air pressure. Pharm. Dev. Tech. 2003,8,39-46.

22. Poukavoos N, Peck G. Effect of aqueous film coating conditions on water removal efficiency and physical properties of coated tablet cores containing superdisintegrants. Drug Dev. Ind. Pharm. 1994,20,1535-1554.

23. Rege B, Gawel J, Kou H. Identification of critical process variables for coating actives onto tablets via statistically designed experiments, International Journal of Pharmaceutics. 2002,237,87-94.

24. Okutgen E, Jordan M, Hogan J, Aulton, M. Effects of tablet core dimensional instability of the generation of internal stresses within film coats. Part II: Temperature and relative humidity variation within a tablet bed during aqueous film coating in an Accela-Cota. Drug. Dev. Ind. Pharm. 1991b,17,1191-1199.

25. Tobiska S, Kleinbudde P. A simple method for evaluating the mixing efficiency of a new type of pan coater. Int. J. Pharm. 2001,224,141-149.

26. Wilson K, Crossman E. The influence of tablet shape and pan speed on intra-tablet film coating uniformity. Drug Dev. Ind. Pharm. 1997,23,1239-1243.

27.Skultety P, Rivera D, Dunleavy J, Lin C. Quantification of the amount and uniformity of aqueous film coating applied to tablets in a 24" Accela-Cota. Drug Dev.Ind. Pharm. 1988,14,617-631.

Authors:

Anand Shah, Navin Sheth, Sunny Shah, Ashok Suthar, Sanjay Patel, and Arvind Desai

Dry Granulation and Compression of Spray-Dried Plant Extracts

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The purpose of this research was to evaluate the influence of dry granulation parameters on granule and tablet properties of spray-dried extract (SDE) from Maytenus ilicifolia, which is widely used in Brazil in the treatment of gastric disorders. The compressional behavior of the SDE and granules of the SDE was characterized by Heckel plots. The tablet properties of powders, granules, and formulations containing a high extract dose were compared. The SDE was blended with 2% magnesium stearate and 1% colloidal silicon dioxide and compacted to produce granules after slugging or roll compaction. The influences of the granulation process and the roll compaction force on the technological properties of the granules were studied. The flowability and density of spray-dried particles were improved after granulation. Tablets produced by direct compression of granules showed lower crushing strength than the ones obtained from nongranulated material. The compressional analysis by Heckel plots revealed that the SDE undergoes plastic deformation with a very low tendency to rearrangement at an early stage of compression. On the other hand, the granules showed an intensive rearrangement as a consequence of fragmentation and rebounding. However, when the compaction pressure was increased, the granules showed plastic deformation. The mean yield pressure values showed that both granulation techniques and the roll compaction force were able to reduce the material’s ability to undergo plastic deformation. Finally, the tablet containing a high dose of granules showed a close dependence between crushing strength and the densification degree of the granules (ie, roll compaction force).

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Author(s):
Luiz Alberto Lira Soares, George González Ortega, Pedro Ros Petrovick, Peter Christian Schmidt
Journal:
American Association of Pharmaceutical Scientists.
Copyright:
© All Rights Reserved. ISSN 1550-7416

Process Validation: How Much to Do and When to Do It

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The trick to process validation, these industry experts argue, is to understand that it is a process that stretches through the whole product life cycle. Some secrets of success: Take a team approach; focus o­n the timing of the various stages of validation; avoid some common mistakes; and build your documentation as you go.

For full article Click Here

Author(s):
Anurag S. Rathore, Joseph F. Noferi, and Edward R. Arling from Pharmacia Corporation, and Gail Sofer, Bioreliance; Peter Watler, Amgen, Inc.; and Rhona O'Leary, Genentech, Inc
Journal:
BioPharm International, October 2002
Copyright:
BioPharm International

Methods and Tools for Process Validation

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ABSTRACT
by : Dr. Wayne A. Taylor

There are many statistical tools that can be used as part of validation. Control charts, capability studies, designed experiments, tolerance analysis, robust design methods, failure modes and effects analysis, sampling plans, and mistake proofing are but a few. Each of these tools will be summarized and their application in validation described.



1. INTRODUCTION

Validation requires documented evidence that a process consistently conforms to requirements. It requires that you first obtain a process that can consistently conform to requirements and then that you run studies demonstrating that this is the case. Statistical tools can aid in both tasks.



2. USES OF THE TOOLS

This section describes the many contributions that statistical tools can make to validation. Each tool appearing in bold is further described in Section 4.

One tool that is particularly useful in organizing the overall validation effort is a failure modes and effects analysis (FMEA) or a closely related fault tree analysis (FTA). An FMEA involves listing out the potential problems or failure modes and evaluating their risk in terms of their severity, likelihood of occurring and ease of detection. Where potential risks exists, the FMEA can be used to document which failure modes have been addressed and which still need to be addressed. As each failure mode is addressed, the controls established are documented. The end result is a control plan. Addressing the individual failure modes will require the use of many different statistical tools.

Failures or nonconformities occur because of errors made and because of excessive variation. Obtaining a process that consistently conforms to requirements requires a balanced approach using both mistake proofing and variation reduction tools. When a nonconformance occurs because of an error, mistake proofing methods should be used. Mistake proofing attempts to make it impossible for the error to occur or at least to go undetected.

However, many nonconformities are not the result of errors, instead they are the result of excessive variation and off-target processes. Reducing variation and proper targeting of a process requires identifying the key input variables and establishing controls on these inputs to ensure that the outputs conform to requirements. Strategies and tools for reducing variation and optimizing the process average are described in Section 3.

The end result is a control plan. The final phase of validation requires demonstrating that this control plan works, i.e., that it results in a process that can consistently conform to requirements. One key tool here is a capability study. A capability study measures the ability of the process to consistently meet the specifications. It is appropriate for measurable characteristics where nonconformities are due to variation and off-target conditions. Testing should be performed not only at nominal, but also under worst-case conditions. When pass/fail data is involved, acceptance sampling plans can be used to demonstrate conformance to specifications. Finally, in the event of potential errors, challenge tests should be performed to demonstrate that mistake proofing methods designed to detect or prevent such errors are working.

Depending of circumstances, not all tools need be used, other tools could be used instead and the application of the tools can vary.



3. STRATEGIES AND TOOLS FOR REDUCING VARIATION AND OPTIMIZATION

Each unit of product differs to some small degree from all other units of product. These differences, no matter how small, are referred to as variation. Variation can be characterized by measuring a sample of the product and drawing a histogram. For example, one operation involves cutting wire into 100 cm lengths. The tolerance is
100 ± 5 cm. A sample of 12 wires is selected at random and the following results obtained:

98.7 99.3 100.4 97.6 101.4 102.0

100.2 96.4 103.4 102.0 98.0 100.5

A histogram of this data follows. The width of the histogram represents the variation.


Histogram of Lengths

Of special interest is whether the histogram is properly centered and whether the histogram is narrow enough to easily fit within the specification limits. The center of the histogram is estimated by calculating the average of the 12 readings. The average is 99.99. The width of the histogram is estimated by calculating either the range or standard deviation. The range of the above readings is 7.0 cm. The standard deviation is 2.06 cm. The standard deviation represents the typical distance a unit is from the average. Approximately half of the units are within ± 1 standard deviation of the average and about half of the units are more than one standard deviation away from the average. On the other hand, the range represents an interval containing all the units. The range is typically 3 to 6 times the standard deviation, depending on the sample size.

Frequently, histograms take on a bell-shaped appearance that is referred to as the normal curve as shown below. For the normal curve, 99.73% of the units fall within ± 3 standards deviation of the average.

For measurable characteristics like wire length, fill volume, and seal strength, the goal is to optimize the average and reduce the variation. Optimization of the average may mean to center the process as in the case of fill volumes, to maximize the average as is the case with seal strengths, or to minimize the average as is the case with harmful emissions. In all cases, variation reduction is also required to ensure all units are within specifications. Reducing variation requires the achievement of stable and capable processes. The figure below shows an unstable process. The process is constantly changing. The average shifts up and down. The variation increases and decreases. The total variation increases due to the shifting.

Instead, stable processes are desired as shown below. Stable processes produce a consistent level of performance. The total variation is reduced. The process is more predictable.


However, stability is not the only thing required. Once a consistent performance has been achieved, the remaining variation must be made to safely fit within the specification limits. Such a process is said to be stable and capable. Such a process can be relied on to consistently produce good product.


A capability study is used to determine whether a process is stable and capable. It involves collecting samples over a period of time. The average and standard deviation of each time period is estimated and these estimates plotted in the form of a control chart. These control charts are used to determine if the process is stable. If it is, the data can be combined into a single histogram to determine its capability. To help determine if the process is capable, several capability indices are used to measure how well the histogram fits within the specification limits. One index, called Cp, is used to evaluate the variation. Another index, Cpk, is used to also evaluate the centering of the process. Together these two indices are used to decide whether the process passes. The values required to pass depend on the severity of the defect (major, minor, critical).

While capability studies evaluate the ability of a process to consistently produce good product, it does little to help achieve such processes. Reducing variation and the achievement of stable processes requires the use of numerous variation reduction tools. Variation of the output is caused by variation of the inputs. Consider a pump. An output is flow rate. Suppose the pump uses a piston to draw solution into a chamber through one opening and then pushes it back out another opening. Valves are used to keep the solution moving in the right direction. Flow rate will be affected by piston radius, stroke length, motor speed and valve backflow to name a few. Flow rate varies because piston radius, stroke length, etc. varies. Variation of the inputs is transmitted to the output as shown below.

Reducing variation requires identifying the key input variables affecting the outputs and then establishing controls on these inputs to ensure that the outputs conform to their established specifications. In general, one must identify the key input variables, understand the effect of these inputs on the output, understand how the inputs behave and finally, use this information to establish targets (nominals) and tolerances (windows) for the inputs. One type of designed experiment called a screening experiment can be used to identify the key inputs. Another type of designed experiment called a response surface study can be used to obtain a detailed understanding of the effects of the key inputs on the outputs. Capability studies can be used to understand the behavior of the key inputs. Armed with this knowledge, robust design methods can be used to identify optimal targets for the inputs and tolerance analysis can be used to establish operating windows or control schemes that ensure the output consistently conforms to requirements.

The obvious approach to reducing variation is to tighten tolerances on the inputs. This improves quality but generally drives up costs. The robust design methods provide an alternative. Robust design works by selecting targets for the inputs that make the outputs less sensitive (more robust) to the variation of the inputs as shown below. The result is less variation and higher quality but without the added costs. Several approaches to robust design exist including Taguchi methods, dual response approach and robust tolerance analysis.

Another important tool is a control chart. A control chart can be used to help determine whether any key input has been missed and if so to help identify them. Many other tools also exist for identifying key inputs and sources of variation including component swapping studies, multi-vari charts, analysis of means (ANOM), variance components analysis, and analysis of variance (ANOVA).

When studying variation, good measurements are required. Many times an evaluation of the measurement system should be performed using a gage R&R or similar study.



4. DESCRIPTIONS OF THE TOOLS

A brief description of each of the cited tools follows:

1. Acceptance Sampling Plan – An acceptance sampling plan takes a sample of product and uses this sample to make an accept or reject decision. Acceptance sampling plans are commonly used in manufacturing to decide whether to accept (release) or to reject (hold) lots of product. However, they can also be used during validation to accept (pass) or to reject (fail) the process. Following the acceptance by a sampling plan, one can make a confidence statement such as: "With 95% confidence, the defect rate is below 1% defective."

2. Analysis of Means (ANOM) – Statistical study for determining if significant differences exist between cavities, instruments, etc. It has many uses including determining if a measurement device is reproducible with respect to operators and determining if differences exists between fill heads, etc. Simpler and more graphical alternative to Analysis of Variance (ANOVA)
.
3. Analysis of Variance (ANOVA) – Statistical study for determining if significant differences exist between cavities, instruments, etc. Alternative to Analysis of Means (ANOM).

4. Capability Study – Capability studies are performed to evaluate the ability of a process to consistently meet a specification. A capability study is performed by selecting a small number of units periodically over time. Each period of time is called a subgroup. For each subgroup, the average and range is calculated. The averages and ranges are plotted over time using a control chart to determine if the process is stable or consistent over time. If so, the samples are then combined to determine whether the process is adequately centered and the variation is sufficiently small. This is accomplished by calculating capability indexes. The most commonly used capability indices are Cp and Cpk. If acceptable values are obtained, the process consistently produces product that meets the specification limits. Capability studies are frequently towards the end of the validation to demonstrate that the outputs consistently meet the specifications. However, they can also be used to study the behavior of the inputs in order to perform a tolerance analysis.

5. Challenge Test – A challenge test is a test or check performed to demonstrate that a feature or function is working. For example, to demonstrate that the power backup is functioning, power could be cut to the process. To demonstrate that a sensor designed to detect bubbles in a line works, bubbles could be purposely introduced.

6. Component Swapping Study – Study to isolate the cause of a difference between two units of product or two pieces of equipment. Requires the ability to disassemble units and swap components in order to determine if the difference remains with original units or goes with the swapped components.

7. Control Chart – Control charts are used to detect changes in the process. A sample, typically consisting of 5 units, is selected periodically. The average and range of each sample is calculated and plot. The plot of the averages is used to determine if the process average changes. The plot of the ranges is used to determine if the process variation changes. To aid in determining if a change has occurred, control limits are calculated and added to the plots. The control limits represent the maximum amount that the average or range should vary if the process does not change. A point outside the control limits indicates that the process has changed. When a change is identified by the control chart, an investigation should be made as to the cause of the change. Control charts help to identify key input variables causing the process to shift and aid in the reduction of the variation. Control charts are also used as part of a capability study to demonstrate that the process is stable or consistent.

8. Designed Experiment – The term designed experiment is a general term that encompasses screening experiments, response surface studies, and analysis of variance. In general, a designed experiment involves purposely changing one or more inputs and measuring the resulting effect on one or more outputs.

9. Dual Response Approach to Robust Design – One of three approaches to robust design. Involves running response surface studies to model the average and variation of the outputs separately. The results are then used to select targets for the inputs that minimize the variation while centering the average on the target. Requires that the variation during the study be representative of long term manufacturing. Alternatives are Taguchi methods and robust tolerance analysis.

10. Failure Modes and Effects Analysis (FMEA) – An FMEA is systematic analysis of the potential failure modes. It includes the identification of possible failure modes, determination of the potential causes and consequences and an analysis of the associated risk. It also includes a record of corrective actions or controls implemented resulting in a detailed control plan. FMEAs can be performed on both the product and the process. Typically an FMEA is performed at the component level, starting with potential failures and then tracing up to the consequences. This is a bottom up approach. A variation is a Fault Tree Analysis, which starts with possible consequences and traces down to the potential causes. This is the top down approach. An FMEA tends to be more detailed and better at identifying potential problems. However, a fault tree analysis can be performed earlier in the design process before the design has been resolved down to individual components.

11. Fault Tree Analysis (FTA) – A variation of a FMEA. See FMEA for a comparison.

12. Gauge R&R Study – Study for evaluating the precision and accuracy of a measurement device and the reproducibility of the device with respect to operators. Alternatives are to perform capability studies and analysis of means on measurement device.

13. Mistake Proofing Methods – Mistake proofing refers to the broad array of methods used to either make the occurrence of a defect impossible or to ensure that the defect does not pass undetected. The Japanese refer to mistake proofing as Poka-Yoke. The general strategy is to first attempt to make it impossible for the defect to occur. For example, to make it impossible for a part to be assembled backwards, make the ends of the part different sizes or shapes so that the part only fits one way. If this is not possible, attempt to ensure the defect is detected. This might involve mounting a bar above a chute that will stop any parts that are too high from continuing down the line. Other possibilities include mitigating the effect of a defect (seat belts in cars) and to lessen the chance of human errors by implementing self-checks.

14. Multi-Vari Chart – Graphical procedure for isolating the largest source of variation so that further efforts concentrate on that source.

15. Response Surface Study – A response surface study is a special type of designed experiment whose purpose is to model the relationship between the key input variables and the outputs. Performing a response surface study involves running the process at different settings for the inputs, called trials, and measuring the resulting outputs. An equation can then be fit to the data to model the affects of the inputs on the outputs. This equation can then be used to find optimal targets using robust design methods and to establish targets or operating windows using a tolerance analysis. The number of trials required by a response surface study increases exponentially with the number of inputs. It is desirable to keep the number of inputs studied to a minimum. However, failure to include a key input can compromise the results. To ensure that only the key input variables are included in the study, a screening experiment is frequently performed first.

16. Robust Design Methods – Robust design methods refers collectively to the different methods of selecting optimal targets for the inputs. Generally, when one thinks of reducing variation, tightening tolerances comes to mind. However, as demonstrated by Taguchi, variation can also be reduced by the careful selection of targets. When nonlinear relationships between the inputs and the outputs, one can select targets for the inputs that make the outputs less sensitive to the inputs. The result is that while the inputs continue to vary, less of this variation is transmitted to the output causing the output to vary less. Reducing variation by adjusting targets is called robust design. In robust design, the objective is to select targets for the inputs that result in on-target performance with minimum variation. Several methods of obtaining robust designs exist including robust tolerance analysis, dual response approach and Taguchi methods.

17. Robust Tolerance Analysis – One of three approaches to robust design. Involves running a designed experiment to model the output’s average and then using the statistical approach to tolerance analysis to predict the output’s variation. Requires estimates of the amounts that the inputs will vary during long-term manufacturing. Alternatives are Taguchi methods and the dual response approach.

18. Screening Experiment – A screening experiment is a special type of designed experiment whose primary purpose is to identify the key input variables. Screening experiments are also referred to as fractional factorial experiments or Taguchi L-arrays. Performing a screening experiment involves running the process at different settings for the inputs, called trials, and measuring the resulting outputs. From this, it can be determined which inputs affect the outputs. Screening experiments typically require twice as many trials as input variables. For example, 8 variables can be studied in 16 trials. This makes it possible to study a large number of inputs in a reasonable amount of time. Starting with a larger number of variables reduces the chances of missing an important variable. Frequently a response surface study is performed following a screening experiment to gain further understanding of the affects of the key input variables on the outputs.

19. Taguchi Methods – One of three approaches to robust design. Involves running a designed experiment to get a rough understanding of the effects of the input targets on the average and variation. The results are then used to select targets for the inputs that minimize the variation while centering the average on the target. Similar to the dual response approach except that while the study is being performed, the inputs are purposely adjusted by small amounts to mimic long-term manufacturing variation. Alternatives are the dual response approach and robust tolerance analysis.

20. Tolerance Analysis – Using tolerance analysis, operating windows can be set for the inputs that ensure the outputs will conform to requirements. Performing a tolerance analysis requires an equation describing the effects of the inputs on the output. If such an equation is not available, a response surface study can be performed to obtain one. To help ensure manufacturability, tolerances for the inputs should initially be based on the plants and suppliers ability to control them. Capability studies can be used to estimate the ranges that the inputs currently vary over. If this does not result in an acceptable range for the output, the tolerance of at least one input must be tightened. However, tightening a tolerance beyond the current capability of the plant or supplier requires that improvements be made or that a new plant or supplier selected. Before tightening any tolerances, robust design methods should be considered.

21. Variance Components Analysis – Statistical study used to estimate the relative contributions of several sources of variation. For example, variation can on a multi-head filler could be the result of shifting of the process average over time, filling head differences and short-term variation within a fill head. A variance components analysis can be used to estimate the amount of variation contributed by each source.

New Health Miracle -- Pharmaceutical Grade Fish Oil (by: Bev Storer)

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“High-dose pharmaceutical-grade fish oil is as close to a medical miracle as we will see in the 21st century.” – Dr. Barry Sears

Dr. Barry Sears revolutionized nutritional thinking around the world with his 1995 landmark #1 New York Times best seller The Zone. With The Zone, and his subsequent bestselling Zone books, Dr. Sears describes how a scientifically proven plan of moderate carbohydrate consumption balanced with appropriate amounts of protein and fat may help you live a longer and better life.

In his latest best seller, The Omega Rx Zone, Dr. Sears greatly expands the potential of the Zone to alter how we think about optimal health in general. Drawing upon his own research, as well as recently published studies, he reveals how a revolutionary new technological advance in fish oil manufacturing, never before available to the general public, may be the magic bullet...

This new high-dose, pharmaceutical-grade fish oil is very rich in omega-3 fatty acids. Scientific evidence reveals a diet rich in long-chain Omega-3 fatty acids helps support:

* a healthy brain
* a healthy heart
* a healthy immune system
* healthy joint movement
* healthy kidneys
* balanced mood and sense of well being
* and, helps maintain cholesterol levels that are already within the normal range.

This new generation of fish oil is much different from the historical, impure, terrible-tasting cod-liver oil. As Dr. Sears points out, the fish oil doled out by our mothers and grandmothers, and currently sold at health food stores, has never been pure enough to be used in the quantities it takes to realize its potential benefits. The new pharmaceutical-grade fish oil is more concentrated, free of dangerous toxins, and has been clinically tested with spectacular results.

By following the Zone Diet and adding pharmaceutical grade fish oil to your daily routine, Dr. Sears believes that each of us will reach our maximum potential for optimal health.

For more information about pharmaceutical grade fish oil, please visit http://www.omega3zone.biz or call 503-244-5941.

Exploring Stress Management Options (by: James Pendergraft)

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Managing your stress effectively make take on many different forms. While there are women who choose expensive and more complicated ways to help deal with stress, there are others who employ simpler and less costly means that are no less effective. It just takes commitment and willingness to be able to get rid of stress in the best possible ways available.

Here are some of the practical options on how women can achieve stress management.

Feeling Better at the Exact Moment You Want To

There are times when you may recognize that you are already under a lot of stress. When you need to decrease your stress level at the soonest time possible, there are a number of techniques that you can take on. Known to act considerably fast, these methods can be used so that you would feel better in a less amount of time. Doing these techniques regularly will also bring about better long term benefits.

These techniques include:

* Meditation
* Listening to music
* Breathing exercises
* Yoga
* Reframing your mind with some sense of humor
* Exercise
* Keeping a journal
* Finding perspective in your life
* Doing visualizations

Sustaining the Proper Attitude in Your Daily Life

The stress that you are experiencing could be linked directly to the attitude that you take on daily. Your perception of the daily happenings in your life also brings on added pressure. So here are some good attitude reminders that could help you relieve stress.

* Be optimistic
* Be happy
* Stop feeling like you always need to be in control
* Stop being a perfectionist
* Always maintain positive affirmations in life
* Cultivate a sense of humor
* Let go of your anger
* Have fun
* Let go of thoughts that can cause you stress

Taking Proper Care of Yourself

In moments when we are stressed, women tend to forget to take proper care of their own bodies. This could result in added stress. However, there are ways that can reduce stress levels such as the following:

* Getting proper rest and adequate hours of sleep
* Eating well-balanced and nutritious meals
* Getting plenty of exercise regularly
* Maintaining a healthy sex life
* Indulging in a number of hobbies

Creating the Proper Atmosphere for Daily Living

The emotional and physical environment that you are in could also affect your stress level. Although the effects that your surroundings bring may be subtle, they can become significant in the long run. Here are some ways to alter your atmosphere so that it can bring about stress relief:

* Get rid of the clutter, as too much can affect your sense of calm
* Create a soothing environment by choosing light shades for the colors of your home
* Add some music as this could really soothe the soul and bring more relaxation
* Make your own spa at home
* Use some aromatherapy through the use of scented oils and candles

Lowongan Kerja PT Pharos

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JOB OPPORTUNITY

PT. PHAROS INDONESIA

Finance Manager

1. Male or female, maximal 37 years old
2. Bachelor degree in Finance or any major
3. Minimal 2 years working experience in related field

Analytical Development Supervisor

1. Male or female, maximal 30 years old
2. Pharmacist / Bachelor Degree in Pharmacy / Chemical / Biology
3. Minimal 1 year working experience in Research & Development Pharmaceutical Company

Packaging Supervisor

1. Male or female, maximal 29 years old
2. Bachelor degree in Industrial Engineering / Mechanical Engineering / Management

Finance & Internal Control Staff

1. Male or female, maximal 27 years old
2. Bachelor degree in any major

PPIC Staff

1. Male or female, maximal 28 years old
2. Bachelor degree in Industrial Engineering / Management

Accounting & Tax Officer

1. Male or female, maximal 24 years old
2. Bachelor degree in accounting or finance

Product Training Executive

1. Male or female, maximal 28 years old
2. Bachelor degree in Pharmacy / Medical / Biology

Bioanalisa Staff

1. Male or female, maximal 26 years old
2. Pharmacist / Bachelor Degree in Chemical

Send your CV, recent photograph and copy of certificate to:

PT. Pharos Indonesia
Jl. Limo No. 40 Permata Hijau
Kebayoran Lama, Jakarta Selatan 12220
Email: recruitment@pharos.co.id

(put the title as the subject)

Lowongan Kerja PT Novell

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PT Novell Pharmaceutical - We are one of top twenty pharmaceutical company in Indonesia. We are supported with high-tech plant which awarded TGA’s Australia in Gunung Putri, Bogor. To achieve our ambition, we require a performance oriented people with excellent qualification :

ASSOCIATE R&D MANAGER (ARDM-A)

Requirements:

- Having experience minimum 2 years of R&D in pharmaceutical manufacturing, in Managerial level
- Max 33 years old with education in Pharmacist
- Excellent in English with good communication skills.
- Management skill, excellent leadership in all of job aspect and human aspect

PPIC MANAGER (PPICM-A)

Requirements:

- Having experience minimum 2 years of PPIC in pharmaceutical manufacturing, in Managerial level
- Max 35 years old, bachelor degree in Technique
- Excellent in English with communication skills.
- Management skill, excellent leadership in all of job aspect and human aspect

QUALITY CONTROL MANAGER (QCM-A)

Requirements :

- Having experience minimum 2 years of Quality Control in pharmaceutical manufacturing, in Managerial level
- Max 35 years old with education in Pharmacist.
- Excellent in English with good communication skills.
- Management skill, excellent leadership in all of job aspect and human aspect

Excellent remuneration and benefits package commensurate with qualification and experience will be provided. Please send your complete application letter, CV, and recent photograph not later than 17 September 2009 to :

dwina_a@novellpharm.com

Please indicate on the envelope & CV the code of position applied for.
Only selected excellent candidates will be processed and notified.

Lowongan Kerja PT Bayer

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Bayer Schering Pharma in Indonesia is under the legal entity of PT. Bayer Indonesia. It is part of the worldwide operations of Bayer HealthCare AG, a subsidiary of Bayer AG. The Pharmaceuticals Division is primarily organized in a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Women HealthCare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology, General Medicines and Oncology. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets and by using new ideas, Bayer Schering Pharma aims its contribution to medical progress and strives to improve the quality of life. We are looking to appoint top notch individuals for this key position:

PLANT ASSISTANT CONTROLLER

The incumbent will be responsible for management accounting, including cost accounting, ensures proper process of recording, monitoring and analyzing the cost associated with manufacturing and related activities, proper implementation and compliance of cost center accounting, consolidates information required for planning, as well as maintains proper inventory management.

On daily basis this person will be responsible for providing management with accurate and timely reporting and analysis of the plant’s operations.

Job Qualifications:

* Bachelor Degree from a reputable university, majoring in Accounting and/or Finance
* Having 2 years or more experience in reputable Public Accounting Firm , particularly handling assignment in manufacturing industry, preferably from Pharmaceutical industries; experience as cost accountant will be advantage
* Excellent interpersonal skill and good communication skill both Indonesian and English
* Age is below 28 years.

An attractive compensation package and career development opportunity will be offered commensurate with the qualification and experience of the successful candidate.

In strictest confidence, please forward your comprehensive resumes immediately to the address below. Only short listed candidates will be notified.

PT. TEMPINDO JASATAMA
Mid Plaza II, 12th Floor, Jl. Jend. Sudirman Kav. 10-11, Jakarta 10220
Ph. 021-573TEMP(8367) / Fax.021-5733791
Email: hc_yenna@tempindo.com

Sumber http://bilaboong-kerja.blogspot.com

Lowongan Kerja Kalbe Farma

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PT Kalbe Farma Tbk, Kalbe International - We, one of the biggest pharmaceutical company in South East Asia is looking for high talented, motivated, independent and agile person to be posted in this following position:

Legal Staff

Requirements and Abilities:

- Male or Female, max 27 years
- S1 Graduate from Law School
- Proficiency in English
- Able to communicate well (writing & verbal)
- Able to work with computer applications
- Have experience in Legal matters would be an advantage, especially in
- Corporate matters, Drafting & Intellectual Property Rights ( 2-3 years)
- Able to work independently and in a team
- Result oriented, willing to learn, good team work, hard worker, reliable, self motivated, and self determine.

Trading Senior Supervisor / Junior Manager

Requirements and Abilities:

- Male, Age max. 35 years old
- At least 2 year(s) of working experience in the related field is required for this position
- Required skill(s): Have an advance understanding on international trading transaction (negotiation, contracting, reporting).
- English is a must (oral & written)
- Willing to work hard and self initiative
- Able to work independent and also in a team
- Can work under pressures

If you meet the above requirements and wish to join with us, please send your Comprehensive Resume, CV and Current Photograph to the email address:

recruitment.kalbeinternational@kalbe.co.id

We encourage only for those who meet all the qualifications to apply
Applications will be closed on 22 September 2009

Urgently Required for Rohto Laboratories Indonesia

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We are an established Pharmaceutical, Health Care Products and Cosmetics Company is seeking qualified and motivated candidate as:

Research and Development Specialists

Requirement:
• Max. 30 years old
• Licensed pharmacist from reputable university
• 2 – 5 years experiences in R&D in consumer product/ pharmaceutical/cosmetic company
• Experienced in liquid and semi solid formulation
• Strong analytical skill and self-starter
• Proficient in English
• Computer literate
• Stationed in Padalarang, Bandung
Please send complete application and recent photograph within 10 days to:

HRD PT. ROHTO LABORATORIES INDONESIA
Bank Resona Perdania Building, 7th Fl.,
Jl. Jend. Sudirman Kav. 40-41 Jakarta 10210
Email : recruitment-rli@rohtolab.com

Sumber JobSDB.com

Urgently Required for Rohto Laboratories Indonesia

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We are an established Pharmaceutical, Health Care Products and Cosmetics Company is seeking qualified and motivated candidate as:

Product Specialist
The incumbent will be responsible to handle OTC product.

Requirement:
• Female, max. 25 years old
• Hold S1 degree in any field from reputable university
• Able to operate design related computer applications like Freehand, Photoshop, Illustrator, etc is an advantage
• 1 year experience in handling product management in OTC pharmacies/ cosmetics/ consumer product/media field or advertising field is preferable
• Good appearance, communication skill and presentation skill
• Proficient in English

Please send complete application and recent photograph within 10 days to:

HRD PT. ROHTO LABORATORIES INDONESIA
Bank Resona Perdania Building, 7th Fl.,
Jl. Jend. Sudirman Kav. 40-41 Jakarta 10210
Email : recruitment-rli@rohtolab.com

Sumber JobSDB.com

Urgently Required for Rohto Laboratries Indonesia

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We are an established Pharmaceutical, Health Care Products and Cosmetics Company is seeking qualified and motivated candidate as:
Area Sales & Promotion Coordinator

The incumbent will be based in Jakarta with frequent travel to other city. Report to CHC Marketing Manager, this position will be responsible to conduct, oversee and coordinate sales and promotion effort to outlet and wholesaler. Coordinate and motivate sales and promotion team in Jabotabek and Sumatra.

Requirement:
• Male, max. 35 years old
• Hold S1 degree in any field from reputable university
• Min 2 years at the same capacity in Distribution/Consumer Product/OTC with sales and promotion experience
• Good knowledge about modern and traditional oulet
• Know well about Jabotabek and Sumatra area
• Good communication skill and negotiation skill
• Proficient in English
• Computer literate
• Having SIM C

Please send complete application and recent photograph within 10 days to:

HRD PT. ROHTO LABORATORIES INDONESIA
Bank Resona Perdania Building, 7th Fl.,
Jl. Jend. Sudirman Kav. 40-41 Jakarta 10210
Email : recruitment-rli@rohtolab.com

Sumber JobSDB.com

PT Sritunggal Sinarjaya membutuhkan karyawan untuk R&D (Research & Development)

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Ingin penghasilan yang fantastik ???
Anda pribadi inovatif dengan kreasi hasil kerja yang unik ???
Perusahaan kosmetik nasional yang sudah eksis & berkembang menantang Anda sebagai :
R&D (Research & Development)

Kualifikasi:
• S1 Apoteker dan sudah ambil profesi apoteker, Teknik kimia.
• GPA min 3.00
• Mengerti mengenai Bahan Baku kosmetika (dekoratif dan skin care) serta formulanya
• Bersedia kerja di daerah Sunter
• Usia 25-35 tahun
• Pengalaman kerja min 1 tahun
• Mau belajar
• Bisa bekerja sama dalam tim, dan mengedepankan komunikasi
• Berintegritas tinggi (jujur, loyal, dan disiplin)
• Inovatif dan kreatif (mau mencoba yang baru dan berbeda)
• Mempunyai sifat tanggung jawab, dapat diandalkan, dan rasa memiliki
• Tekun, pantang menyerah, berpikir logis dan analitikal
• Berkomitmen 100% pada perusahaan
• Mengerti peraturan CPKB (cara produksi kosmetika yang baik dan penerapannya)

Untuk keterangan & pengiriman lamaran, selengkapnya buka di JobSDB.com

Required Pharmacist (Production / Marketing - Based in Malaysia)

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Responsibilities of Marketing Pharmacist:
• Provide training and technical support to the medical sales teams.
• Devise product brochures, training notes and any other detailing aids targeted at medical professionals.
• Source for new products locally and abroad, working closely with the R&D team and company's business partners.
• Carry out market research and analysis of pharmaceutical products and plan for
• Plan and implement marketing and sales strategies for assigned product(s) towards achieving company goals.

Responsibilities of Production Pharmacist:
• Execute and coordinate process validation.
• To ascertain the manufacturing activities produce with consistent quality.
• To monitor production schedule & progress.
• Ensure GMP standards and other operations standards are followed.
• To review and improve on the work method and work safety.
• To support Regulatory & Quality compliance requirement.
• Attend to achoc assignment from time to time.

Requirements:
• Bachelor of Degree in Pharmacy.
• At least 5 years working experience in the related field.
• Pleasant personality with good command in English.
• Highly independent and good working attitude.

Interested candidates are invited to apply via e-mail or fax with detailed resume stating current and expected salaries and a recent passport-sized photograph (n.r.) to:

Fax: +603-7727 6701

Email: recruit.indo@yspsah.com
Sumber JobsDB.com
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Propofol, penyebab kematian Michael Jackson

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Tragis benar kisah hidup sang Raja Pop Dunia Michael Jackson. Penyebab kematiannya dipertanyakan banyak orang. Dan inilah hasil investigasinya. Petugas Los Angeles County menetapkan Michael tewas karena dibunuh. Penyebabnya, Michael menerima suntikan 25 miligram propofol beberapa jam sebelum meninggal.

Polisi menyelidiki kematian Michael dan merujuk pada tindakan dokter pribadi Michael, Dr Conrad Murray, yang secara rutin menyuntikkan propofol. Kepada LAPD, Murray mengaku, merawat King of Pop dari penyakit susah tidur yang dideritanya sejak enam minggu terakhir.

Murray setiap malam rutin menyuntikkan 50 miligram propofol. Namun, kepada polisi Murray bersumpah sudah berusaha menghentikan ketergantungan Michael terhadap obat-obatan. Demikian dikutip okezone dari The Sun, Selasa (25/8/2009).

Murray menurunkan dosis propofol menjadi 25 miligram dan mencampurnya dengan dua obat penenang lain, lorazepam dan midazolam. Dua hari sebelum Michael meninggal, Murray memberinya dua obat tersebut tanpa propofol.

Pagi hari sebelum Michael meninggal pada 25 Juni 2009, Murray masih belum memberi Michael propofol meski sulit tidur. Pada pukul 02.00 pagi, Murray menyuntikkan lorazepam.

Namun, Michael masih saja kesulitan tidur. Murray pun memberi midazolam. Akhirnya, karena tak kunjung tidur, Murray memberi Michael 25 miligram propofol sekira pukul 10.40. Michael pun tidur.

Melihat Michael pulas, Murray beranjak ke toilet. Kurang dari dua menit kemudian, Murray kembali ke kamar Michael. Betapa terperanjatnya dia tatkala menemukan mantan suami Lisa Marie Presley itu sudah tak bernapas.

Detak jantung Michael berhenti. Murray lalu melakukan bantuan pernafasan (CPR). Sekira pukul 11.18, Murray menyerah dan meminta bantuan pengawal pribadi Michael untuk menghubungi 911.

Sambil menunggu paramedis tiba, Murray terus melakukan CPR. Upaya itu tak membuahkan hasil. Setiba di UCLA Medical Center, pemilik album Thriller itu dinyatakan meninggal.

Meski Murray mengakui memberi Michael propofol, petugas tidak menemukan bukti kuat Murray memesan obat tersebut melalui resep yang ditulisnya maupun melalui file DEA (Drug Enforcement Administration).

Saat menggeledah rumah pelantun Ben itu, petugas menemukan delapan botol propofol, juga botol kecil dan pil yang diresepkan oleh Murray dan dua dokter lainnya, termasuk Dr Arnold Klein. Sumber : okezone.com

Obat Tamiflu Tak Cocok Buat Orang Dewasa Sehat

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Obat flu Tamiflu dan Relenza mungkin tak cocok untuk mengobati influenza musiman pada orang dewasa yang sehat, kata beberapa peneliti Inggris.

"Merekomendasikan penggunaan obat anti-virus bagi perawatan orang yang memiliki beberapa gejala tampaknya bukan jalur tindakan yang paling cocok," tulis Jane Burch dari University of York, dan rekannya.

Studi mereka, yang disiarkan di dalam "Lancet Infectious Diseases", mendukung saran dari Organisasi Kesehatan Dunia (WHO) --yang menyatakan pasien sehat yang terserang flu babi H1N1 tanpa menderita komplikasi tak memerlukan pengobatan anti-virus.

Tamiflu, yang dibuat oleh perusahaan Swiss, Roche, berdasarkan lisensi dari Gilead Sciences Inc., adalah pil yang dapat mengobati dan mencegah segala jenis virus influenza A.

Zanamivir, yang dibuat oleh GlaxoSmithKline, berdasarkan lisensi dari perusahaan Australia, Biota, dan dijual dengan merek Relenza, adalah obat hirup di klas yang sama.

WHO sangat menyarankan penggunaan kedua obat itu buat perempuan hamil, pasien dengan kondisi medis yang mendasari dan anak-anak yang berusia di bawah 5 tahun, karena mereka menghadapi resiko yang meningkat terhadap penyakit yang lebih parah.

Tim Burch mengkaji beragam studi yang diterbitkan mengenai Tamiflu dan Relenza. "Kami menyajikan hasilnya buat orang dewasa yang sehat dan orang yang menghadapi resiko komplikasi yang berkaitan dengan influenza," tulis mereka.

Mereka mendapati kedua obat tersebut, rata-rata, memangkas setengah hari hari saat pasien sakit. Influenza biasanya mempengaruhi orang selama sekitar satu pekan.

Obat itu memberi hasil sedikit lebih baik pada orang yang memiliki resiko komplikasi, seperti pasien yang menderita diabetes atau asme, sementara Relenza mengurangi rasa sakit hampir satu hari dan Tamiflu sebanyak tiga-perempat per hari.

Itu menunjukkan obat tersebut mesti diberikan kepada orang yang paling memerlukannya, kata para peneliti tersebut.

Banyak negara telah menimbun kedua obat itu. Flu babi H1N1 telah dinyatakan sebagai wabah dan menyebar ke seluruh dunia. Para pejabat kesehatan AS, Jumat, mengatakan penyakit tersebut masih bertambah parah di Jepang, kondisi membaik di Inggris dan masih aktif di Amerika Serikat.

Flu jarang menyerang di semua ketiga negara itu pada Agustus.

Pabrik global menduga tak dapat menyediakan vaksin tersebut sampai akhir September atau Oktober.(*)

Disadur dari antaranews

Menyikapi Kontroversi Autisme dan Imunisasi MMR

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Dalam waktu terakhir ini kasus penderita autisme tampaknya semakin meningkat pesat. Autisme tampak menjadi seperti epidemi ke berbagai belahan dunia. Dilaporkan terdapat kenaikan angka kejadian penderita Autisme yang cukup tajam di beberapa negara. Keadaan tersebut di atas cukup mencemaskan mengingat sampai saat ini penyebab autisme multifaktorial, masih misterius dan sering menjadi bahan perdebatan diantara para klinisi.

Autisme adalah gangguan perkembangan pervasif pada anak yang ditandai dengan adanya gangguan dan keterlambatan dalam bidang kognitif, bahasa, perilaku, komunikasi dan interaksi sosial. Perdebatan yang terjadi akhir-akhir ini berkisar pada kemungkinan hubungan autisme dengan imunisasi MMR (Mumps, Measles, Rubella). Banyak orang tua menolak imunisasi karena mendapatkan informasi bahwa imunisasi MMR dapat mengakibatkan autisme. Akibatnya anak tidak mendapatkan perlindungan imunisasi untuk menghindari penyakit-penyakit justru yang lebih berbahaya seperti hepatitis B, Difteri, Tetanus, pertusis, TBC dan sebagainya. Banyak penelitian yang dilakukan secara luas ternyata membuktikan bahwa autism tidak berkaitan dengan imunisasi MMR. Tetapi memang terdapat penelitian yang menunjukkan bahwa Autism dan imunisasi MMR berhubungan.

Imunisasi MMR adalah imunisasi kombinasi untuk mencegah penyakit Campak, Campak Jerman dan Penyakit Gondong. Pemberian vaksin MMR biasanya diberikan pada usia anak 16 bulan. Vaksin ini adalah gabungan vaksin hidup yang dilemahkan. Semula vaksin ini ditemukan secara terpisah, tetapi dalam beberapa tahun kemudian digabung menjadi vaksin kombinasi. Kombinasi tersebut terdiri dari virus hidup Campak galur Edmonton atau Schwarz yang telah dilemahkan, Componen Antigen Rubella dari virus hidup Wistar RA 27/3 yang dilemahkan dan Antigen gondongen dari virus hidup galur Jerry Lynn atau Urabe AM-9.

Pendapat yang mendukung autism berkaitan dengan imunisasi :
Terdapat beberapa penelitian dan beberapa kesaksian yang mengungkapkan Autisme mungkin berhubungan dengan imunisasi MMR. Reaksi imunisasi MMR secara umum ringan, pernah dilaporkan kasus meningoensfalitis pada minggu 3-4 setelah imunisasi di Inggris dan beberapa tempat lainnya. Reaksi klinis yang pernah dilaporkan meliputi kekakuan leher, iritabilitas hebat, kejang, gangguan kesadaran, serangan ketakutan yang tidak beralasan dan tidak dapat dijelaskan, defisit motorik/sensorik, gangguan penglihatan, defisit visual atau bicara yang serupa dengan gejala pada anak autism.

Andrew Wakefielddari Inggris melakukan penelitian terhadap 12 anak, ternyata terdapat gangguan Inflamantory Bowel disesase pada anak autism. Hal ini berkaitan dengan setelah diberikan imunisasi MMR. Bernard Rimland dari Amerika juga mengadakan penelitian mengenai hubungan antara vaksinasi terutama MMR (measles, mumps rubella ) dan autisme. Wakefield dan Montgomery melaporkan adanya virus morbili (campak) dengan autism pada 70 anak dari 90 anak autism dibandingkan dengan 5 anak dari 70 anak yang tidak autism. Hal ini hanya menunjukkan hubungan, belum membuktikan adanya sebab akibat.

Jeane Smith seorang warga negara Amerika bersaksi didepan kongres Amerika : kelainan autis dinegeri ini sudah menjadi epidemi, dia dan banyak orang tua anak penderta autisme percaya bahwa anak mereka yang terkena autisme disebabkan oleh reaksi dari vaksinasi. Sedangkan beberapa orang tua penderita autisme di Indonesiapun berkesaksian bahwa anaknya terkena autisme setelah diberi imunisasi

Pendapat yang menentang bahwa imunisasi menyebabkan autisme :
Sedangkan penelitian yang mengungkapkan bahwa MMR tidak mengakibatkan Autisme lebih banyak lagi dan lebih sistematis. Brent Taylor, melakukan penelitian epidemiologik dengan menilai 498 anak dengan Autisme. Didapatkan kesimpulan terjadi kenaikkan tajam penderita autism pada tahun 1979, namun tidak ada peningkatan kasus autism pada tahun 1988 saat MMR mulai digunakan. Didapatkan kesimpulan bahwa kelompok anak yang tidak mendapatkan MMR juga terdapat kenaikkan kasus aurtism yang sama dengan kelompok yang di imunisasi MMR.

Dales dkk seperti yang dikutip dari JAMA (Journal of the American Medical Association) 2001, mengamati anak yang lahir sejak tahun 1980 hingga 1994 di California, sejak tahun 1979 diberikan imunisasi MMR. Menyimpulkan bahwa kenaikkan angka kasus Autism di California, tidak berkaitan dengan mulainya pemberian MMR.

Intitute of medicine, suatu badan yang mengkaji keamanan vaksin telah melakukan kajian yang mendalam antara hubungan Autisme dan MMR. Badan itu melaporkan bahwa secara epidemiologis tidak terdapat hubungan antara MMR dan ASD. The British Journal of General Practice mepublikasikan penelitian De Wilde, pada bulan maret 2001. Meneliti anak dalam 6 bulan setelah imunisasi MMR dibandingkan dengan anak tanpa Autisme. Menyimpulkan tidak terdapat perubahan perilaku anak secara bermakna antara kelompok control dan kasus. Pada jurnal ilmiah Archives of Disease in Childhood, September 2001, The Royal College of Paediatrics and Child Health, menegaskan bahwa tidak ada bukti ilmiah yang mendukung adanya hipoteda kaitan imunisasi MMR dan Autisme. Para profesional di bidang kesehatan tidak usah ragu dalam merekomendasikan imunisasi MMR pada pasiennya..

Makela A, Nuorti JP, Peltola H tim peneliti dari Central Hospital Helsinki dan universitas Helsinky Finlandia pada bulan Juli 2002 telah melakukan penelitian terhadap 535.544 anak yang mendapatkan imunisasi MMR sejak 1982 hingga 1986, yang dilakukan pengamatan 3 bulan setelah di Imunisasi. Mereka menyimpulkan bahwa tidak menunjukkan hubungan yang bermakana antara imunisasi MMR dengan penyakit neurologis (persrafan) seperti ensefalitis, aseptik meningitis atau autisme. Kreesten Meldgaard Madsen dkk bulan November 2002, melakukan penelitian sejak tahun 1991 - 1998 terhadap 440.655 anak yang mendapatkan imunisasi MMR. Hasilnya menunjukkan tidak terbukti hipotesis hubungan MMR dan Autisme.

Rekomendasi Intitusi atau Badan Kesehatan Dunia
Beberapa institusi atau badan dunia di bidang kesehatan yang independen dan sudah diakui kredibilitasnya juga melakukan kajian ilmiah dan penelitian tentang tidak adanya hubungan imunisasi dan autisme. Dari hasil kajian tersebut, dikeluarkan rekomendasi untuk tenaga profesional untuk tetap menggunakan imunisasi MMR dan thimerosal karena tidak terbukti mengakibatkan Autisme.

The All Party Parliamentary Group on Primary Care and Public Health pada bulan Agustus 2000, menegaskan bahwa MMR aman. Dengan memperhatikan hubungan yang tidak terbukti antara beberapa kondisi seperti inflammatory bowel disease (gangguan pencernaan) dan autisme adalah tidak berdasar.

WHO (World Health Organisation), pada bulan Januari 2001 menyatakan mendukung sepenuhnya penggunaan imunisasi MMR dengan didasarkan kajian tentang keamanan dan efikasinya.

Beberapa institusi dan organisasi kesehatan bergengsi di Inggris termasuk the British Medical Association, Royal College of General Practitioners, Royal College of Nursing, Faculty of Public Health Medicine, United Kingdom Public Health Association, Royal College of Midwives, Community Practitioners and Health Visitors Association, Unison, Sense, Royal Pharmaceutical Society, Public Health Laboratory Service and Medicines Control Agency pada bulan januari tahun 2001 setelah mengadakan pertemuan dengan pemerintahan Inggris mengeluarkan pernyataan bersama yaitu MMR adalah vaksin yang sangat efektif dengan laporan keamanan yang sangat baik. Secara ilmiah sangat aman dan sanagat efektif untuk melindungi anak dari penyakit. Sangat merekomendasikan untuk memberikan MMR terhadap anak dan tanpa menimbulkan resiko.

The Committee on Safety of Medicine (Komite Keamanan Obat) pada bulan Maret 2001, menyatakan bahwa kesimpulan dr Wakefield tentang vaksin MMR terlalu premature. Tidak terdapat sesuatu yang mengkawatirkan. The Scottish Parliament�s Health and Community Care Committee, juga menyatakan pendapat tentang kontroversi yang terjadi, yaitu Berdasarkan pengalaman klinis berbasis bukti, tidak terdapat hubungan secara ilimiah antara MMR dan Autisme atau Crohn disease. Komite tesebut tidak merekomendasikan perubahan program imunisasi yang telah ditetapkan sebelumnya bahwa MMR tetap harus diberikan.

The Irish Parliament�s Joint Committee on Health and Children pada bulan September 2001, melakukan review terhadap beberapa penelitian termasuk presentasi Dr Wakefield yang mengungkapkan AUTISM berhungan dengan MMR. Menyimpulkan tidak ada hubungan antara MMR dan Autisme. Tidak terdapat pengalaman klinis lainnya yang mebuktikan bahan lain di dalam MMR yang lebih aman dibandingkan kombinasi imunisasi. MMR.

The American Academy of Pediatrics (AAP), organisasi profesi dokter anak di Amerika Serikat pada tanggal 12 � 13 Juni 2000 mengadakan konferensi dengan topik "New Challenges in Childhood Immunizations" di Oak Brook, Illinois Amerika Serikat yang dihadiri para orang tua penderita autisme, pakar imunisasi kesehatan anak dan para peneliti. Pertemuan tersebut merekomendasikan bahwa tidak terdapat huibungan antara MMR dan Autisme. Menyatakan bahwa pemberian imunisasi secara terpisah tidak lebih baik dibandingkan MMR, malahan terjadi keterlambatan imunisasi MMR. Selanjutnya akan dilakukan penelitian l;ebih jauh tentang penyebab Autisme.

BAGAIMANA SIKAP KITA SEBAIKNYA ?
Bila mendengar dan mengetahui kontroversi tersebut, maka masyarakat awam bahkan beberapa klinisipun jadi bingung. Untuk menyikapinya kita harus cermat dan teliti dan berpikiran lebih jernih. Kalau mengamati beberapa penelitian yang mendukung adanya autisme berhubungan dengan imunisasi, mungkin benar sebagai pemicu. Secara umum penderita autisme sudah mempunyai kelainan genetik (bawaan) dan biologis sejak awal. Hal ini dibuktikan bahwa genetik tertentu sudah hampir dapat diidentifikasi dan penelitian terdapat kelainan otak sebelum dilakukan imunisasi. Kelainan autism ini bisa dipicu oleh bermacam hal seperti imunisasi, alergi makanan, logam berat dan sebagainya. Jadi bukan hanya imunisasi yang dapat memicu timbulnya autisme. Pada sebuah klinik tumbuh kembang anak didapatkan 40 anak dengan autism tetapi semuanya tidak pernah diberikan imunisasi. Hal ini membuktikan bahwa pemicu autisme bukan hanya imunisasi.

Penelitian yang menunjukkan hubungan keterkaitan imunisasi dan autism hanya dilihat dalam satu kelompok kecil (populasi) autism. Secara statistik hal ini hanya menunjukkan hubungan, tidak menunjukkan sebab akibat. Kita juga tidak boleh langsung terpengaruh pada laporan satu atau beberapa kasus, misalnya bila orang tua anak autism berpendapat bahwa anaknya timbul gejala autism setelah imunisasi. Kesimpulan tersebut tidak bisa digeneralisasikan terhadap anak sehat secara umum (populasi lebih luas). Kalau itu terjadi bisa saja kita juga terpengaruh oleh beberapa makanan yang harus dihindari oleh penderita autism juga juga akan dihindari oleh anak sehat lainnya. Jadi logika tersebut harus dicermati dan dimengerti.

Bila terpengaruh oleh pendapat yang mendukung keterkaitan autism dan imunisasi tanpa melihat fakta penelitian lainnya yang lebih jelas, maka kita akan mengabaikan imunisasi dengan segala akibatnya yang jauh lebih berbahaya pada anak. Penelitian dalam jumlah besar dan luas secara epidemiologis lebih bisa dipercaya untuk menunjukkan sebab akibat dibandingkan laporan beberapa kasus yang jumlahnya relatif tidak bermakna secara umum. Beberapa institusi atau badan kesehatan dunia yang bergengsi pun telah mengeluarkan rekomendasi untuk tetap meneruskan pemberian imunisasi MMR. Hal ini juga menambah keyakinan kita bahwa memang Imunisasi MMR memang benar aman.

Kontroversi itu terus berlanjut terus, namun kita bisa mengambil hikmah dan jalan yang terbaik anak kita harus imunisasi atau tidak ? Untuk meyakinkan hal tersebut mungkin kita bisa berpedoman pada banyak penelitian yang lebih dipercaya validitasnya secara statistik dengan populasi lebih banyak dan luas yaitu Autisme tidak berhubungan dengan MMRl. Demikian pula kita harus percaya terhadap rekomendasi berbagai badan dunia kesehatan yang independen dan terpercaya setelah dilakukan kajian ilmiah terhadap berbagai penelitian yang dilakukan oleh beberapa pakar kesehatan anak di berbagai dunia maju.

Dari beberapa hal tersebut diatas, tampaknya dapat disimpulkan bahwa Imunisasi MMR tidak mengakibatkan Autisme, bila anak kita sehat dan tidak berbakat autisme. Tetapi diduga imunisasi dapat memicu memperberat timbulnya gangguan perilaku pada anak yang sudah mempunya bakat autisme secara genetik sejak lahir.

Tetapi tampaknya teori, penelitian atau pendapat beberapa kasus yang mendukung keterkaitan autisme dengan imunisasi, tidak boleh diabaikan bergitu saja. Meskipun laporan penelitian yang mendukung hubungan Autisme dan imunisasi hanya dalam populasi kecil atau bahkan laporan perkasus anak autisme. Sangatlah bijaksana untuk lebih waspada bila anak kita sudah mulai tampak ditemukan penyimpangan perkembangan atau perilaku sejak dini, memang sebaiknya untuk mendapatkan imunisasi MMR harus berkonsultasi lebih jelas dahulu dengan dokter anak. Bila anak kita sudah dicurigai ditemukan bakat kelainan Autism sejak dini atau beresiko terjadi autisme, mungkin bisa saja menunda dahulu imunisasi MMR sebelum dipastikan diagnosis Autisme dapat disingkirkan. Meskipun sebenarnya pemicu atau faktor yang memperberat Autisme bukan hanya imunisasi. Dalam hal seperti ini kita harus memahami dengan baik resiko, tanda dan gejala autisme sejak dini.

Tetapi bila anak kita sehat, tidak beresiko atau tidak menunjukkan tanda dini gejala Autisme maka kita tidak perlu kawatir untuk mendapatkan imunisasi tersebut. Kekawatiran terhadap imunisasi tanpa didasari pemahaman yang baik dan pemikiran yang jernih akan menimbulkan permasalahan kesehatan yang baru pada anak kita. Dengan menghindari imunisasi maka akan timbul permasalahan baru yang lebih berbahaya dan dapat mengancam jiwa terutama bila anak terkena infeksi yang dapat dicegah dengan imunisasi.

Artikel ini ditulis oleh dr. Widodo Judarwanto, Rumah Sakit Bunda Jakarta.