Preformulation studies of progesterone: an instrumental approach

Abstract Progesterone is a cholesterol-derived human hormone utilized in the treatment of endometrial hyperplasia. Besides its well-known role in the reproductive system (i.e., initiation and maintenance of pregnancy.), it contributes significantly to the cardiovascular system, mammary gland, bones and central nervous system. The aim of this study was to evaluate the compatibility of progesterone with various pharmaceutical excipients used in the development of solid formulations. To assess the compatibility of the active principle, binary mixtures were prepared with a mass ratio of 1:1 (progesterone: excipient). The analytical methods employed were thermal analysis (TG/DTG, DSC), FTIR spectroscopy, and PXRD analysis. For a more accurate interpretation of the results of the infrared spectroscopy, the value of Pearson’s correlation for each spectral region was determined. At ambient temperature no chemical interaction was observed between progesterone and the selected excipients. Under thermal stress chemical interactions were observed for the following excipients: aspartame, colloidal silicon dioxide, methocel, stearic acid, adipic acid and magnesium stearate. Precautions during the heating process should be considered for the binary mixtures containing sodium lauryl sulfate, polyvinylpyrrolidone and sodium bicarbonate.