Process for preparing pharmaceutical formulations for inhalation comprising a high-dosage strength active ingredient

摘要

Cohesive high-dosage strength micronized active ingredients may be dispersed in dry powder formulations for inhalation comprising carrier particles, by use of the apparatus described herein.

主权项

1. A process for dispersing a cohesive, high-dosage strength micronized active ingredient in a dry powder formulation comprising carrier particles, said process comprising:
(i) loading said active ingredient and a portion of said carrier particles in a dispersion capsule comprising a cylindrical room (1) with a lateral boundary made of a sieving mesh (2), said room (1) containing grinding balls (3), which can be closed by a screw cap (4) on the top, two longitudinal roads (6), and a disk (5), wherein the capsule is connected to said disk by said two longitudinal rods; (ii) fitting said capsule to a drum, filled with the remaining part of the carrier; (iii) inserting said drum into a rotating body mixer apparatus; and (iv) operating said rotating body mixer to mix the whole powder.