Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium
Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either diclofenac potassium and diclofenac sodium. Within the biopharmaceutics classification s...
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Published in | Journal of pharmaceutical sciences Vol. 98; no. 4; pp. 1206 - 1219 |
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Main Authors | , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Hoboken
Elsevier Inc
01.04.2009
Wiley Subscription Services, Inc., A Wiley Company |
Subjects | |
Online Access | Get full text |
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Summary: | Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either diclofenac potassium and diclofenac sodium. Within the biopharmaceutics classification system (BCS), diclofenac potassium and diclofenac sodium are each BCS class II active pharmaceutical ingredients (APIs). However, a biowaiver can be recommended for IR drug products of each salt form, due to their therapeutic use, therapeutic index, pharmacokinetic properties, potential for excipient interactions, and performance in reported BE/bioavailability (BA) studies, provided: (a) test and comparator contain the same diclofenac salt; (b) the dosage form of the test and comparator is identical; (c) the test product contains only excipients present in diclofenac drug products approved in ICH or associated countries in the same dosage form, for instance as presented in this paper; (d) test drug product and comparator dissolve 85% in 30min or less in 900mL buffer pH6.8, using the paddle apparatus at 75rpm or the basket apparatus at 100rpm; and (e) test product and comparator show dissolution profile similarity in pH1.2, 4.5, and 6.8. |
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Bibliography: | ArticleID:JPS21525 istex:3C3786F5A0046B720212B7FB818458763F658F17 ark:/67375/WNG-0TGB9QZL-8 A project of the International Pharmaceutical Federation FIP, Groupe BCS, www.fip.org/bcs. This article reflects the scientific opinion of the authors and not the policies of regulating agencies, the International Pharmaceutical Federation (FIP) and the World Health Organization (WHO). This article reflects the scientific opinion of the authors and not the policies of regulating agencies, the International Pharmaceutical Federation (FIP) and the World Health Organization (WHO). www.fip.org/bcs A project of the International Pharmaceutical Federation FIP, Groupe BCS |
ISSN: | 0022-3549 1520-6017 |
DOI: | 10.1002/jps.21525 |