Drug intelligence / Profile preview

Cream vehicle for Mupirocin Calcium Cream, 2% (Sun Pharmaceutical Industries)

Development stage
Unknown
Lead developer
Taro
Administration
Topical
01

Overview

This substance is a vehicle control (placebo) used in clinical trials to evaluate the safety and bioequivalence of a generic mupirocin calcium cream (2%) compared to the reference listed drug, Bactroban® Cream. Developed by Sun Pharmaceutical Industries (via its subsidiary Taro Pharmaceuticals), the vehicle is an oil-and-water-based emulsion containing inactive ingredients such as benzyl alcohol, cetomacrogol 1000, cetyl alcohol, mineral oil, phenoxyethanol, purified water, stearyl alcohol, and xanthan gum. It lacks the active antibiotic ingredient mupirocin calcium and serves as a negative control in randomized, double-blind studies for the treatment of secondarily infected traumatic skin lesions (SITSL). Its primary role is to demonstrate that the therapeutic efficacy of the active generic and reference treatments is superior to the vehicle alone.

Other names
Cream vehicle of test product

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