Method for producing a pharmaceutical composition comprising rotigotine
View Patent ↗Pharmaceutical compositions are provided for administration of rotigotine in depot form. Pharmaceutical compositions of the invention can provide therapeutically significant plasma levels of rotigotine over a period of at least 24 hours after administration to a patient. Preferred pharmaceutical compositions of the invention include oily suspensions that contain rotigotine in solid form as well as anhydrous pharmaceutical compositions that comprise rotigotine.
1. A method for producing an injectable pharmaceutical composition, comprising
preparing an oily suspension of solid-phase rotigotine or a pharmaceutically acceptable salt thereof in a pharmaceutically acceptable hydrophobic liquid phase that comprises a wetting agent free of phosphatides; and
thermally treating said oily suspension to provide a sterile depot suspension of said rotigotine or salt thereof.
2. The method of claim 1 , wherein less than 1% by weight of the rotigotine or salt thereof decomposes during the thermal treatment.
3. The method of claim 1 , wherein the solid-phase rotigotine or salt thereof is in crystalline form.
4. The method of claim 3 , wherein the crystalline rotigotine is in a form of a hydrochloride salt.
5. The method of claim 1 , wherein over 95% by weight of rotigotine in the composition is in solid phase.
6. The method of claim 1 , wherein less than 0.5% by weight of the rotigotine decomposes while thermally treating said oily suspension of rotigotine.
7. The method of claim 1 , wherein said thermally treating comprises autoclaving the composition.
8. The method of claim 1 , wherein said thermally treating is performed in a nitrogen atmosphere.
9. The method of claim 1 , wherein the oily suspension contains less than 3% water.