Japanese Perspectives on Pharmaceutical Product Release Rate Testing
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Drug Informarion Journal,Vol. 36. pp. 407-415, 2002
F’rinted in the USA. All rights reserved.
JAPANESE PERSPECTIVES ON PHARMACEUTICAL PRODUCT RELEASE RATE TESTING NAHOKO KANIWA,PHD Section Chief of the Third Section, Division of Drugs, National Institute of Health Sciences, Tokyo, Japan
The current recommendations for dissolution testing in the Japanese Pharmacopeia are discussed. The use of dissolution tests and bioequivalence studies in the Japanese drug regulatory process is also briefly introduced. The Japanese Pharmacopeia is unique in stating that a major purpose of dissolution testing is to prevent significant bioinequivalence. To achieve this, and to allow for the high incidence of achlorhydria in Japan, the Japanese Pharmacopeia recommends testing in a buffer solution at pH 6.8 or in water; especially for sugar-coated andjlm-coated tablets. These are ofren tested in O.IM HCI in the United States Pharmacopeia Parallel dissolution and disintegration tests using p H 1.2 and pH 6.8 solutions are also recommended by the Japanese Phannacopeiafor enteric-coated tablets due to the high in vitroin vivo correlation compared with sequential tests. Adopting rational acceptance criteria, developing calibrators, and the application of release testing to semi-solid nonoral dosage forms are future issues for the Japanese Pharmacopeia Key Words: Dissolution testing; Bioinequivalence; Acceptance criteria; Test medium;
Achlorhydria
INTRODUCTION DISSOLUTION TESTS ARE becoming an increasingly important aspect of drug development, bioequivalence tests, and quality control, although it is difficult to establish dissolution tests that correlate well with in vivo results. This paper puts forward the Japanese viewpoint on pharmacopeial dissolution testing. Presented at the DIA Workshop, “Drug Dissolution Testing: Current Status and Future Challenges,” June 18-19.2001, London, United Kingdom. Reprint address: Nahoko Kaniwa, PhD, Section Chief of the Third Section, Division of Drugs, National Institute of Health Sciences, Tokyo, 1-18-1 Kamiyoga, Setagayu-ku, Tokyo 158-8501, Japan. E-mail: nkaniwa Onihs.go.jp.
THE USE OF DISSOLUTION TESTING IN JAPAN Before describing the dissolution tests contained in the Japanese Phannacopeia, it might be useful to explain briefly how dissolution tests are used in the Japanese drug regulatory process. Dissolution testing is used in a unique way in Japan. The Guideline f o r Bioequivalence Studies of Generic Products (1) recommends that applicants perform dissolution tests before carrying out a bioequivalence study in humans, and select the subject population for the in vivo study according to the results. When a specific and significant difference in dissolution is observed between the test and reference products at a neutral pH, subjects with achlorhy-
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dria should be recruited into the bioequivalence study because the two drug products may show a large difference in bioavailability depending on the gastric acidity level (interaction between a formulation and gastrointestinal physio
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