Biowaiver monographs for immediate release solid oral dosage forms: diclofenac sodium and diclofenac potassium

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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Bibliographic Details
Published in:Journal of pharmaceutical sciences Vol. 98; no. 4; p. 1206
Main Authors: Chuasuwan, B, Binjesoh, V, Polli, J E, Zhang, H, Amidon, G L, Junginger, H E, Midha, K K, Shah, V P, Stavchansky, S, Dressman, J B, Barends, D M
Format: Journal Article
Language:English
Published: United States 01-04-2009
Subjects:
Administration, Oral
Animals
Anti-Inflammatory Agents, Non-Steroidal - administration & dosage
Anti-Inflammatory Agents, Non-Steroidal - adverse effects
Anti-Inflammatory Agents, Non-Steroidal - chemistry
Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics
Biological Availability
Chemical Phenomena
Diclofenac - administration & dosage
Diclofenac - adverse effects
Diclofenac - chemistry
Diclofenac - pharmacokinetics
Excipients - chemistry
Humans
Solubility
Tablets
Therapeutic Equivalency
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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 30 min or less in 900 mL buffer pH 6.8, using the paddle apparatus at 75 rpm or the basket apparatus at 100 rpm; and (e) test product and comparator show dissolution profile similarity in pH 1.2, 4.5, and 6.8.
ISSN:1520-6017
DOI:10.1002/jps.21525