中空坐剤の製剤学的評価(第2報)中空部へのIndomethacinの添加形態と放出特性

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The hollow cavities of suppositories made from oily-base material (Witepsol H-15) were filled up with indomethacin (IDM) in the following 4 forms : IDM fine powder (I), IDM physically mixed powder with lactose (II), IDM in propylene glycol (PG) suspension (III) and IDM in macrogol 300 solution (IV). The dissolution percentage of IDM and their releasing aspects were observed in vitro. By using I, after melting the base material of hollow type suppositoty, the released powder did not become wet easily and was difficult to diffuse into the solution. Therefore, IDM dissolved into the solution very slightly. By the use of II, IDM mixture powder dissolved into the aqueous solution a little faster than that by the case I, but no considerable improvement could be found. The difficulty in wetting was improved in III, but the dissolution was not perfect. In the case of IV, IDM dissolved more quickly and almost completely. Plasma concentration of IDM was measured in rabbits after the rectal administration of the suppositories including 50 mg of IDM in two kinds of hollow types, one of which had fine powder (I) and the other included macrogol 300 solution (IV) and two kinds of conventional types, one was prepared from oily-base material (V) and the other was made of water soluble base material (VI), with IDM. These data on bioavailability suggested that the hollow type suppository was superior to the conventional one made of the same kind of oily-base material. Furthermore, compared to the conventional type suppository made of water soluble base material (VI), the hollow type one including macrogol 300 solution (IV) could be expected to have an immediate effect, because its t_<max> was smaller than VI.
1985-03-25

中空坐剤の製剤学的評価(第2報)中空部へのIndomethacinの添加形態と放出特性

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