Solid pharmaceutical formulation

摘要

This invention provides a solid pharmaceutical formulation having high physical strength and further having excellent drug release properties and digestibility of excipients when administered, which comprises (a) an active medical ingredient and (b) a pre-gelatinized starch in an amount of 10 to 90% by weight, said pre-gelatinized starch being prepared by pre-gelatinizing a cheap and stable usual starch during the procedure for formulation. This invention also provides a method for preparing the solid pharmaceutical formulation.

主权项

1. A solid pharmaceutical formulation which is in the form of a sustained release preparation comprising (a) cilostazol, (b) crystalline cellulose, and (c) a pre-gelatinized starch,
which is prepared by the following steps: (i) mixing cilostazol, crystalline cellulose, starch, and water to prepare a starting composition, wherein the starch is selected from the group consisting of corn starch and potato starch; (ii) granulating the starting composition by an extrusion granulation technique to obtain wet granules; (iii) subjecting the wet granules to pre-gelatinization of the starch by heating with steam, wherein the heating temperature is 75 to 100° C.; and (iv) drying the heated granules to obtain the solid pharmaceutical formulation; wherein the solid pharmaceutical formulation contains pre-gelatinized starch in an amount of 10-90% by weight based on the weight of the solid pharmaceutical formulation.