Japanese Perspectives on Pharmaceutical Product Release Rate Testing

Abstract

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 and film-coated tablets. These are often tested in 0.1M HCI in the United States Pharmacopeia. Parallel dissolution and disintegration tests using pH 1.2 and pH 6.8 solutions are also recommended by the Japanese Pharmacopeia for enteric-coated tablets due to the high in vitro-in 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