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Related Experiment Videos

Are all aciclovir cream formulations bioequivalent?

L Trottet1, H Owen, P Holme

  • 1GlaxoSmithKline, Weybridge, Surrey, UK. lionel.x.trottet@gsk.com

International Journal of Pharmaceutics
|September 6, 2005
PubMed
Summary

Generic acyclovir (ACV) creams may not be bioequivalent to the innovator product due to lower propylene glycol (PG) content, potentially impacting herpes labialis treatment efficacy.

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Area of Science:

  • Pharmacology
  • Dermatology
  • Pharmaceutical Sciences

Background:

  • Topical acyclovir (ACV) cream (Zovirax Cream) with 40% propylene glycol (PG) is clinically effective for herpes labialis.
  • Analysis revealed 80% of generic ACV creams contain less than 20% PG, raising concerns about bioequivalence.

Purpose of the Study:

  • To investigate potential bioinequivalence between innovator ACV cream and generic formulations.
  • To assess the impact of varying propylene glycol (PG) concentrations on ACV skin permeation.

Main Methods:

  • In vitro skin permeation studies using human skin.
  • Analysis of ACV content via LC-MS-MS.
  • Comparison of innovator cream, generic creams (0-15% PG), and a PG dose-ranging study.

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Main Results:

  • Innovator cream delivered 7.5-fold more ACV than two generics in a pilot study.
  • All 10 tested generic ACV creams showed lower ACV delivery compared to the innovator.
  • A positive correlation between PG content and ACV skin permeation was observed.

Conclusions:

  • Significant differences in ACV skin permeation exist between innovator and generic creams.
  • Lower PG content in generics may lead to reduced ACV delivery.
  • Concerns regarding therapeutic inequivalence of generic ACV creams are warranted.