公开(公告)号：WO2004078102A3

公开(公告)日：2004-11-18

申请号：PCT/EP2004050235

申请日：2004-03-02

Applicant: DOMPE SPA ,  GENTILE MARCO ,  DRAGANI MARIA CONCETTA ,  DELL UOMO MARCO

Inventor： GENTILE MARCO ,  DRAGANI MARIA CONCETTA ,  DELL UOMO MARCO

IPC: A61K9/00 ,  A61K31/56 ,  A61K31/57 ,  A61K31/573 ,  A61L2/00 ,  A61L2/04 ,  A61L2/07 ,  C07J5/00 ,  C07J7/00 ,  C07J51/00 ,  C07J75/00

CPC classification number: C07J7/00 ,  A61K9/0078 ,  A61K31/56 ,  A61K31/57 ,  A61K31/573 ,  A61L2/0005 ,  A61L2/0011 ,  A61L2/0023 ,  A61L2/04 ,  A61L2/07 ,  C07J5/0015 ,  C07J5/0061 ,  C07J51/00 ,  C07J75/00

Abstract: A process for the sterilization of water insoluble solid medicinal substances is described.The process provides the sterilization of beclomethasone, which is suitable for pulmonary administration. In particular, the process is used in industrial plants for the production of formulations of sterile beclomethasone 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 beclomethasone 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.

Abstract translation: 描述了对水不溶性固体药物灭菌的方法。该方法提供了适用于肺部给药的倍氯米松的灭菌方法。 特别地，该方法用于生产用于吸入输送的无菌倍氯米松配方的工业装置中，以避免药物的粒度分布和杂质分布的任何修改。 该方法通过仅加热微粉化的倍氯米松和纯化水的混合物，优选在约120℃的温度下加热20分钟来进行。 该方法对于用于肺部输送的制剂中的丙酸倍氯米松的蒸汽灭菌是特别有效和经济的。