FREMGANGSMAADE TIL FREMSTILLING AF EN SOLUBILISERET OG STABILISERET OPLOESNING INDEHOLDENDE 2-CHLOR-11-(4-METHYL-1-PIPERAZINYL)-DIBENZ(B,F)(1,4)OXAZEPIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF

Process for obtaining solubilisable and stabilized solutions of 2-chloro-ll-84-methyl-i-piperizanyl) 9dibenz [b, f] [1,4] oxazepine or a pharmaceutically acceptable salt thereof, characterized in that it comprises dissolving said oxazepine or its salt in about 50% and 80% volumes of aqueous propylene glycol solution, adjust the ph to about 5.0 to about 7.0 with 10% hydrochloric acid, heat the solution to 60ºC for 30 minutes, cool the solution at room temperature, readjust the ph between approximately 5.0 and 7.0 with 10% hydrochloric acid, dilute the solution 100% with water, filter the solution to remove the solid particles, sterilize the solution with refiltered through a solvent resistant membrane of 0.2 to 1.2 microns to obtain a final solution having a potency of 2.0% to 5.0% active ingredient. (Machine-translation by Google Translate, not legally binding)