Use of the “dissolution” test for evaluation of the pharmaceutical equivalence of tablet formulations of phenazepam
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Studies of the dissolution of tablet medicinal formulations of phenazepam are reported. The dissolution profiles of these medicinal forms are compared. Comparative evaluation of their pharmaceutical equivalence is presented.
KeywordsDissolution Medium Dissolution Profile Direct Compression Dissolution Kinetic Ground Substance
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- 1.V. P. Zherdev, G. B. Kolyvanov, and A. A. Litvin, Farmateka, No. 3, 66 (2003).Google Scholar
- 2.Note for Guidance on the Investigation of Bioavailability and Bioequivalence, European Agency for the Evaluation of Medicinal Products, London, CPMP / EWP / 1401 / 98:18 (2001).Google Scholar
- 3.V. L. Bagirova, G. S. Kiseleva, and A. I. Tentsova, Farmateka, No. 1, 39–40 (1997).Google Scholar
- 4.The United States Pharmacopoeia 26th revision (2003).Google Scholar
- 5.Guidance for Industry: Immediate Release Solid Oral Dosage Forms. Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, in Vivo Dissolution Testing, and in Vivo Bioequivalence Documentation, Center for Drug Evaluation and Research (CDER) (1995).Google Scholar
- 6.M. D. Mashkovskii, Therapeutic Substances, Novaya Volna, Moscow (2002), Vol. 1, pp. 76–79.Google Scholar
- 7.Methodological Specifications of the Ministry of Health and Social Development of the Russian Federation for Studies of the Dissolution Kinetics of Therapeutic Agents [in Russian], Moscow (2004).Google Scholar
- 8.Guidance for Industry. Dissolution Testing of Immediate Release Solid Oral Dosage Forms. Office of Training and Communications. Division of Communications Management, Drug Information Branch, HFD-210, 5600 Fishers Lane, Rockville, MD 20857 (1997).Google Scholar
- 9.G. S. Kiseleva, Farmats. Vestnik, No. 8, 21 (1988).Google Scholar