Abstract
Indomethacin (IM) slow-release suppositories were prepared using hydrogenated soybean lecithin (HL) as an additive. The suppositories were prepared by the fusion method with IM, HL and Witepsol H-15. The suppositories were evaluated by in vitro release testing, X-ray diffractometry, differential scanning calorimetry and penetrometry. IM existed in an amorphous state in the suppositories.The melting point and hardness of the suppositories increased with increasing HL content. Slow release from suppositories in which the IM content was 10 mg was obtained when the HL content was over 300 mg. When the IM content was 20 mg, the HL content required to obtain the slow-release profile was more than 600 mg. The slow-release suppositories did not melt or disintegrate entirely in the test solution in the cylindrical cell of the releasing apparatus in the course of testing. It was considered that IM dissolved gradually from the surface of the suppositories, because HL at the levels giving slow release of IM made the suppositories hard.
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