Mupirocin ointments: In vitro x In vivo bioequivalence evaluation
Braz. J. Pharm. Sci. (Online)
;
58: e19426, 2022. tab, graf
Article
in English
| LILACS
| ID: biblio-1383978
ABSTRACT
Abstract Bioequivalence (BE) assessment of topical drug products is a long-standing challenge. Agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published several drafts in recent years suggesting different approaches as alternative to evaluate the BE. A proposed Topical Classification System (TCS) has even been discussed. Given the above, the objective of this research was to use in vitro and in vivo BE approaches to evaluate Brazilian marketed mupirocin (MPC) ointments, previously classified as TCS class The in vitro permeation test (IVPT) was performed by applying formulations to pig skin by Franz cells. The in vivo methodology was dermatopharmacokinetic (DPK). These approaches (in vivo tape stripping and IVPT) demonstrated capability of distinguishing among different formulations, thus making them useful methodologies for BE evaluation.
Full text:
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Index:
LILACS (Americas)
Main subject:
Ointments
/
In Vitro Techniques
/
Therapeutic Equivalency
/
Mupirocin
Language:
English
Journal:
Braz. J. Pharm. Sci. (Online)
Journal subject:
Farmacologia
/
Teraputica
/
Toxicologia
Year:
2022
Type:
Article
Affiliation country:
Brazil
Institution/Affiliation country:
Federal University of Pernambuco/BR
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