Physicopharmaceutical Approach for Hospital Preparation of Mianserin Hydrochloride Suppositories

Abstract

We tried to optimize the formulation for the hospital preparation of mianserin hydrochloride (MS) suppositories. MS as the raw material for the preparation was obtained from Tetramide tablets (MS-T), which were ground. The physicopharmaceutical properties of MS suppositories with bases of Witepsol H15 (H15), Witepsol W35 (W35) and Witepsol S55 (S55) were compared to choose the optimal base for the suppositories. The preparation strength correlated negatively among the three bases. The heat of fusion of MS-H15 suppositories was significantly low relative to MS-W35 and MS-S55 suppositories. The average drug release rate of MS-H15 suppositories exhibited the highest level on moment analysis. Comprehensive evaluation of the properties of MS suppositories, including the heat of fusion due to the solubility of the preparation and the drug release rate indicated that H15 was the optimal base for MS suppositories. Additionally, we examined the optimal mixing rate of ground MS-T and H15. The preparation strength positively correlated with an increased mixing rate of ground MS-T. The mean dissolution time (MDT) of suppositories was reduced with an increased mixing rate of ground MS-T. These results suggested that 0.10 g ground MS-T combined with 0.8 g H15 as the base was the optimal formulation for the hospital preparation of MS suppositories.