Polymorphism in Commercial Sources of Fusidic Acid: A Comparative Study of the In Vitro Release Characteristics of Forms I and III from a Marketed Pharmaceutical Cream

Journal of Analytical Methods in Chemistry
Jonathan ByrneTrinidad Velasco-Torrijos

Abstract

A comparison of the polymorphic forms of 3 commercial sources of fusidic acid using FTIR and XRPD techniques has been performed in this study. It has been demonstrated that polymorphic Forms I and III are currently available on the commercial market. The influence of the observed polymorphism on the stability of the drug substance in bulk form has been investigated through stability and stress testing according to current ICH guidelines. Significant differences were detected between commercial sources with regard to the stability of the bulk substance under photolytic and humidity stress conditions. When properly packaged in an inert atmosphere, fusidic acid from all 3 manufacturers showed a comparable stability. The effects of the observed polymorphic differences on the intrinsic dissolution rate of the drug substance and its in vitro release from the marketed drug product Fusicutan® plus Betamethasone cream have been investigated. Results indicated that the release rate of the drug substance is similar for polymorphic Forms I and III, allowing both forms to be used during manufacture without affecting the safety or efficacy of the drug product.

References

Feb 1, 1990·The Journal of Antimicrobial Chemotherapy·L Verbist
Mar 10, 1972·Biochemical and Biophysical Research Communications·E Cundliffe
Jan 1, 1966·Journal of Medicinal Chemistry·W O GodtfredsenS Vangedal
Jul 1, 1967·Journal of Pharmaceutical Sciences·A J AguiarJ C Samyn
Dec 1, 1983·The Journal of Antibiotics·M J PerryW C Noble
Jul 1, 1995·Pharmaceutical Research·S ByrnG Poochikian
Oct 21, 1999·International Journal of Antimicrobial Agents·D Spelman
Oct 21, 1999·International Journal of Antimicrobial Agents·M Whitby
Mar 10, 1962·Nature·W O GODTFREDSENL TYBRING
Jan 8, 2004·Archives of Disease in Childhood·D Dobie, J Gray
Feb 14, 2004·Advanced Drug Delivery Reviews·Dharmendra Singhal, William Curatolo
Jan 5, 2006·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Benjamin P Howden, M Lindsay Grayson
May 13, 2011·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Sandrine LemairePaul M Tulkens
Nov 22, 2011·International Journal of Pharmaceutics·Samuel E GilchristHelen M Burt
Apr 9, 2013·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Ming ZhaoChun-Tao Che
May 4, 2013·Journal of Controlled Release : Official Journal of the Controlled Release Society·Samuel E GilchristHelen M Burt

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BETA
X-ray

Software Mentioned

Shimadzu LCsolution
Bruker Diffrac Plus XRD
Shimadzu Class - VP

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