HIGH CONTENT IBUPROFEN AGGLOMERATES AND PROCESS TO PREPARE THEM

摘要

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. Preferably the starch component comprises a mixture of maize starch and pregelled maize starch.