Evaluation of Galenic Bases developed in a University Compounding Pharmacy

Abstract

Compounding pharmacies have galenic bases to produce topical medicines, and the non-ionic and Lanette® creams are examples of galenic bases widely used. It is necessary to standardize and monitor the minimum quality parameters to ensure a stable and homogeneous product. This study aimed to evaluate the characteristics of non-ionic cream and Lanette® cream through viscosity, density, pH, occlusion factor, spreadability, and microbiological safety, and to perform stability studies through pH, viscosity, density, and microbiological purity tests, 30, 60, and 90 days after preparing the formulation. The non-ionic cream and Lanette® cream proved to be semi-solid, odorless, and white. The pH of the formulations was between 5.4 and 6.1, compatible with the pH of the skin and within the range recommended by Anvisa. The formulations presented a density above 0.85 g/mL, which is recommended by Anvisa. The non-ionic cream showed an occlusion factor (F) greater than 50%, favoring the occlusion and hydration effects on the skin. All developed formulations presented viscosity values between 1.00-1.85 x 103 cP, for 90 days after preparation of the formulations, at 25 oC and 40 oC. The microbiological test proved that both the non-ionic cream and the Lanette® cream containing the preservative did not show microbiological growth for 90 days after the preparation of the formulations. The galenic bases can be considered stable from the physicochemical and microbiological aspects and follow the parameters indicated by the Brazilian Pharmacopoeia.