Title : Stability of Semisolid Extemporaneous Topical Formulations of Cocoa Butter
The aim of this study is focused on the reproduction of a routinely used individual preparation, its physicochemical, accelerated and real-time stability testing to predict the rate of change at a proposed storage temperature. Five variations of the chosen ointment were freshly prepared and subjected to accelerated stability testing at 40°C; 75±5% relative humidity and 25°C; 60±5% relative humidity. The preparations were monitored, and few units of the reference material were taken at 1, 3 and 6 month intervals. During the stability testing process the following experiments and tests were conducted according to the Hungarian and European Pharmacopoeias: Dropping point and freezing point measurements, extensometric test, microscopic examination, pH measurements of the aqueous phase, rheometric, dissolution and diffusion tests. The study revealed that the choice of an optimal method of preparation results in a more stable pharmaceutical product than the original preparation. Even similar production methods resulted in ointments with significantly different physicochemical parameters. Based on the study, we can recommend a good manufacturing practice, expiry date, packaging material and storage conditions regarding the chosen formulation. These results confirmed that the physical and chemical stability of the ointments were achieved with the appropriate choice of the preparing conditions.