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Lyophilised salmeterol xinafoate formulations
专利权人:
INC.;LITHERA
发明人:
JOHN DANIEL DOBAK,CHRIS KEMMERER,KENNETH WALTER LOCKE
申请号:
GB201207749
公开号:
GB2487868A
申请日:
2011.01.14
申请国别(地区):
GB
年份:
2012
代理人:
摘要:
A pharmaceutical formulation comprises lyophilised salmeterol (a long-acting beta adrenergic receptor agonist) or a pharmaceutically acceptable salt thereof, a bulking agent and a non-ionic surfactant. Preferably the salmeterol is salmeterol xinafoate present in an amount of about 0.001% to about 0.1% by weight of the total combined dry weight of the lyophile. Preferably, the bulking agent is lactose monohydrate and the non-ionic surfactant is preferably polysorbate 80. A method of preparing a lyophilised sterile salmeterol (a long-acting beta adrenergic receptor agonist) composition comprises (i) solubilising salmeterol or a pharmaceutically acceptable salt thereof, a bulking agent, and a non-ionic surfactant with a solvent or co-solvent to form a bulk solution; (ii) sterilising the bulk solution; and (iii) lyophilizing the sterilised bulk solution to provide a lyophilised sterilised salmeterol composition. A pharmaceutical formulation for use in the treatment of regional adiposity, abdominal adiposity or exophthalmos due to thyroid eye disease comprising administering a reconstituted formulation that has been reconstituted from a lyophilized composition comprising lyophilised salmeterol or a pharmaceutically acceptable salt thereof, a bulking agent and a non-ionic surfactant is outlined. A method of cosmetic treatment comprising administering subcutaneously or otherwise a reconstituted formulation that has been reconstituted from a lyophilized composition comprising lyophilised salmeterol or a pharmaceutically acceptable salt thereof, a bulking agent and a non-ionic surfactant is also provided.
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