Process for dry powder formulations

摘要

The present invention relates to a process developed for production of a dry powder medicament used in respiratory tract diseases such as asthma and COPD.

主权项

1. A process for producing a dry powder formulation, comprising the steps of:
a) dividing an excipient into two fractions, wherein each fraction of the excipient is micronized separately and the average particle size of each excipient fraction is different; b) placing the finer excipient fraction into empty capsules, wherein the capsules containing the finer excipient fraction is subjected to vibration ensuring that the particles of the finer excipient fraction cover the inner surfaces of the capsules; c) mixing the coarser excipient fraction and an active agent formulation to obtain a mixture; and d) filing the mixture into the capsules, wherein the inner surfaces of the capsules are covered with the finer excipient particles, wherein the empty capsules are subjected to at least 75% relative humidity at a temperature in the range of 30° C. to 50° C. for at least 1 hour before the finer excipient fraction is placed in the capsules.