| 摘要 |
PCT No. PCT/EP92/01953 Sec. 371 Date Mar. 4, 1994 Sec. 102(e) Date Mar. 4, 1994 PCT Filed Aug. 25, 1992 PCT Pub. No. WO93/04676 PCT Pub. Date Mar. 18, 1993.A process for the preparation of a pharmaceutical composition in the form of agglomerates comprising 70-97% by weight of 2-(4-isobutylphenyl)propionic acid or a pharmaceutically acceptable salt thereof and 3-30% by weight of a starch component, said process comprising the steps of a) forming an emulsion comprising 1) 70-97% by weight of 2-(4-isobutylphenyl)propionic acid or a salt thereof 2) a solvent system 3) 3-30% by weight of the starch component 4) water and optionally 5) a surfactant b) crystallising to produce a suspension comprising crystals of 2-(4-isobutylphenyl)propionic acid or the salt thereof in intimate contact with the starch component c) agitating said suspension to form agglomerates comprising an evenly distributed mixture of 2-(4-isobutylphenyl)propionic acid or a salt thereof and the starch component d) collecting said agglomerates and optionally e) drying said agglomerates. Pharmaceutical formulations comprising 90-99.98% by weight of such a composition together with 0.02-10% of a pharmaceutically acceptable excipient are also described, which are suitable for direct compression into tablets. |
