公开(公告)号：US20060140816A1

公开(公告)日：2006-06-29

申请号：US10544832

申请日：2004-03-02

申请人： Marco Gentile ,  Maria Dragani ,  Marco Dell'uomo

发明人： Marco Gentile ,  Maria Dragani ,  Marco Dell'uomo

IPC分类号： A61L2/08

CPC分类号： 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

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.

摘要翻译： 描述了对水不溶性固体药物进行灭菌的方法。 该过程提供了适用于肺部给药的药物物质的灭菌。 特别地，该方法用于生产用于吸入递送的无菌糖皮质激素制剂的工业装置中，以避免药物的粒度分布和杂质分布的任何修改。 该方法仅通过加热微粉化糖皮质激素和纯化水的混合物进行，优选在约120℃的温度下加热20分钟。 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。

公开(公告)号：US20060058386A1

公开(公告)日：2006-03-16

申请号：US10531579

申请日：2003-10-22

申请人： Marco Gentile ,  Maria Dragani

发明人： Marco Gentile ,  Maria Dragani

IPC分类号： A61K31/205

CPC分类号： A61K31/192

摘要： Pharmaceutical compositions are described, containing an alkylammonium salt of a 2-arylpropionic acid, which are suitable for parenteral administration and do not generate pain upon injection. The compositions contain preferably ketoprofen, ibuprofen, naproxen or tiaprofenic acid in aqueous solution at pH in the range between 8 and 9. The alkylammonium salt is preferably a L-lysine salt. Compositions at pH=8,5 have shown to cause less pain upon injection than other known compositions.

摘要翻译： 描述了含有2-芳基丙酸的烷基铵盐的药物组合物，其适用于肠胃外给药，并且在注射时不产生疼痛。 所述组合物优选在pH为8至9的范围内，在水溶液中含有酮洛芬，布洛芬，萘普生或噻吗啡。烷基铵盐优选为L-赖氨酸盐。 pH = 8,5的组合物已显示注射时疼痛少于其他已知组合物。