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 0.1 M HCl 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
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Guideline for Bioequivalence Studies of Generic Products. Japan: December 22, 1997.
Guideline for Bioequivalence Studies for Formulation Changes of Oral Solid Dosage Forms. Japan: February 14, 2000.
Guideline for Bioequivalence Studies for Different Strengths of Oral Dosage Forms. Japan: February 14, 2000.
Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation.
Modified-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation.
Morihara M, Aoyagi N, Kaniwa N, Kojima S, Ogata H. Assessment of gastric acidity of Japanese subjects over the last 15 years. Biol Pharm Bull. 2001;24(3): 313–315.
Ogata H, Aoyagi N, Kaniwa N, Ejima A, Suzuki K, Ishioka T, Morishita M, Ohta K, Takagishi Y, Doi Y, et al. Development and evaluation of a new peroral test agent GA-test for assessment of gastric acidity. J Pharmacobiodyn. 1984;7(9):656–664.
Ogata H, Aoyagi N, Kaniwa N, Shibazaki T, Ejima A, Talagishi T, Ogura T, Tomita K, Inoue S, Zaizen M. Bioavailability of metronidazole from sugar coated tablets in humans Part I: Effect of gastric acidity and correlation with in vitro dissolution rate. Int J Pharmaceutics. 1985,23:277.
Aoyagi N, Ogata H, Kaniwa N, Koibuchi M, Shibazaki T, Ejima A, Mizobe M, Kohno K, Samejima M. Bioavailability of sugar-coated tablets of thiamine disulfide in humans. I. Effect of gastric acidity and in vivo-in vitro correlation. Chem Pharm Bull (Tokyo). 1986;34(1):281–291.
Kaniwa N, Ogata H, Aoyagi N, Koibuchi M, Shibazaki T, Ejima A, Takanashi S, Kamiyama H, Suzuki H, Hinohara Y, et al. Bioavailability of pyridoxal phosphate from enteric-coated tablets. III. Correlations between bioavailability in humans and beagle dogs and between bioavailability in humans and in vitro dissolution rates. Chem Pharm Bull (Tokyo). 1985;33(9);3906–3914.
Kaniwa N, Ogata H, Aoyagi N, Koibuchi M, Shibazaki T, Ejima A, Takanashi S, Kamiyama H, Suzuki H, Hinohara Y, et al. Bioavailability of pyridoxal phosphate from enteric-coated tablets. I. Apparent critical dissolution pH and bioavailability of commercial products in humans. Chem Pharm Bull (Tokyo). 1985;33(9):4045–4049.
Katori N, Kaniwa N, Aoyagi N, Kojima S. Contro-versey on acceptance criteria for dissolution tests. JP Forum. 1998;7(1): 17–24.
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Kaniwa, N. Japanese Perspectives on Pharmaceutical Product Release Rate Testing. Ther Innov Regul Sci 36, 407–415 (2002). https://doi.org/10.1177/009286150203600220
- Dissolution testing
- Acceptance criteria
- Test medium