Mise au point d’une crème pharmaceutique à base de naftifine hydrochloride

Abstract

This work is part of the development of a dermatological form based on naftifine HCl, an antifungal from the allylamine class, indicated for the treatment of superficial dermatomycoses. The aim of this work was to formulate a stable topical cream that complies with pharmaceutical requirements. A bibliographic research was conducted on the qualitative composition of the reference product to study the role of each excipient. On this basis, a series of preliminary tests were subsequently conducted, followed by a formulation step that allowed the development of six creams based on Naftifine HCl, by varying the composition of the oily phase as well as the method of introducing the actif ingredient. These creams were controlled (visual appearance, pH, viscosity), dosed (by HPLC), and subjected to stability testing for 30 days at 40 °C and 50 °C. The results of this work were conclusive, the majority of the formulations remained stable and presented a homogeneous appearance without signs of phase separation.