Complying with the Guideline for Quality and Equivalence for Topical Semisolid Products: The Case of Clotrimazole Cream.

ABSTRACT: Semisolids constitute a significant proportion of topical pharmaceutical dosage forms available on the market, with creams being considered profitable systems for releasing active substances into the skin. This work aimed at the development of a generic Clotrimazole topical cream, based on the assumptions that assist the development of such formulations. First, the critical parameters to obtain a final formulation as similar as possible to the reference product were defined. Then, the percentages of cetyl palmitate and octyldodecanol were identified as critical variables and chosen for optimization in further studies. A "quality by design" approach was then used to identify the effect of process variability on the structural and functional similarity (Q3) of the generic product qualitative

SUBMITTER: Alves T 

PROVIDER: S-EPMC8071103 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature