Quality of Progesterone Suppositories Prepared by FIRST-Progesterone Vaginal Suppository 50 Kit or Traditional Compounding Method: In Vitro Comparison.

The objective of this study was to compare the quality of progesterone suppositories prepared by using the FIRST-Progesterone Vaginal Suppository Kit to that of progesterone suppositories compounded extemporaneously by using the traditional method. The comparison parameters were weight variation, content uniformity, pH, yield, and compounding time. Each of five compounders prepared two batches, one batch using each method. The results indicate that the quality of the suppositories prepared by both methods including weight variation and content uniformity, fell within the United States Pharmacopeial accepted limits (+/- 10% of the label concentration). However, preparation time and yield were significantly different. The time spent compounding the suppositories with the FIRST-Progesterone Vaginal Suppository 50 kit was significantly shorter (five times shorter) than spent compounding the suppositories by the traditional method (P-less than 0.05). Although all compounders were advised to use an extra 10% during traditional compounding, three of the compounders failed to fill the prescribed number and ended with fewer suppositories than required. The reasons for this deficiency were either conventional mold leakage or spilling during mold filling.