TRIALS OF DERMATOLOGICAL CREAM AND OINTMENT FORMULATIONS BASED ON REFINED SHEA BUTTER AND BETAMETHASONE DIPROPIONATE

Formulation trials of dermatological creams and ointments based on refined shea butter and betamethasone dipropionate

Abstract

Introduction : Local production of medicines using natural raw materials such as shea butter (SB) could help to promote local resources and expand the range of treatments available in dermatology. The aim of this study was to evaluate the potential for using refined SB as an excipient in the manufacture of dermatological creams and ointments based on betamethasone dipropionate.

Method : Various cream formulations were produced using BK. Three of these formulations were selected for further testing with betamethasone dipropionate as the active ingredient: it was incorporated at a concentration of 0.064% m/m. The prepared dermatological creams and ointments were tested and their stability was monitored for six months of storage at room temperature.

Results : The dermatological creams obtained had compliant organoleptic characteristics. The other physicochemical parameters (pH, viscosity, content) also complied with the standards of the 10th edition of the European Pharmacopoeia. At the end of the stability study, no significant changes in the pharmaceutical quality of the creams were observed.

Discussion : After six months of storage at room temperature, the organoleptic characteristics remained unchanged. An increase in the viscosity of the creams and a decrease in pH were noted. All changes were within acceptable limits. The betamethasone dipropionate content remained within specifications.

Conclusion : Locally produced refined BK can be used to make dermatological preparations.