| 摘要 |
A process for the sterilization of water insoluble solid medicinal substances is described. The process provides the sterilization of drug substances, which are suitable for pulmonary administration. In particular, the process is used in industrial plants for the production of formulations of sterile glucocorticoids for inhalation delivery, so as to avoid any modifications in particle size distribution and in the impurities profile of the drug. the process is carried out by heating a mixture of micronized glucocorticoid and purified water only, preferably at a temperature of about 120° C. for 20 minutes. The process is particularly efficient and economic for the steam sterilization of beclomethasone dipropionate in formulations for pulmonary delivery.
|
