Release Property of Progesterone from a Mixed-Base Suppository Consisting of Witepsol® W35 and Witepsol® E85

Abstract

The mechanism of drug release from progesterone suppositories that consist of two types of hard fat (Witepsol® W35 and Witepsol® E85) was investigated. The strength, the thermodynamic characteristics, the surface structures, the drug release property, methylene blue penetration into suppositories, and change of surface structure after the dissolution test were employed for detecting characteristics of progesterone suppositories. The formulation with a mixing ratio of Witepsol W35 and Witepsol E85 at a 1:1 ratio showed the maximum strength value. The peak temperature of the suppositories showed a tendency to increase with increases in the ratio of Witepsol E85. The maximum height of the profiles measured with laser microscopy, from 20.8 μm to 29.2 μm, reached a maximum after 3 h of the dissolution test. When the suppositories were immersed in pH 7.4 phosphate buffer containing 0.5% methylene blue at 37°C, the penetrating area increased with time. The weight of the suppositories also increased with time. According to these findings, it was suggested that the release of drug from a mixed type of suppository containing progesterone was via the matrix and pores.

Key Words:

• Drug release
• Hospital preparation
• Progesterone
• Suppositories
• Witepsol