| 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. |
