A PROCESS OF PREPARING LORATADINE AND MONTELUKAST SODIUM NASAL SPRAY

摘要

A process for preparing nasal spray composition of loratidine and montelukast sodium comprises the following steps: a. mixing 0.05-5% w/v loratidine in purified water to make a slurry; b. adding 1M Hydrochloric acid under stirring to the slurry of step (a) and continuing stirring until clear solution is obtained; c. dissolving either 0.005-0.5% w/v butylated hydroxy anisole or butylated hydroxy toulene in 2-25% w/v in propylene glycol at 50°C to 60°C temperature; d. mixing solution of step (c) with solution of step (b); e. adding 2-30% w/v polyoxyl-35-castor oil in solution of step (d); f. dissolving 0.5-10% w/v glycerin and 0.01-0.5% w/v disodium edetate in purified water and adding to it under stirring 0.05-5% w/v phenyl ethyl alcohol and 0.01-0.04% v/v 50% solution of Benyalkonium chloride, thereafter transferring the whole to solution of step (e); g. dissolving 0.05-5% w/w montelukast sodium in purified water; h. adding solution of step (g) to the solution of step (f) under continues stirring; i. adjusting pH of solution of step (h) either with 20% w/v solution of tromethamine or 5% w/v solution of sodium hydroxide in the range of 4.0 to 7.0; and j. finally making the volume of solution of step (i) with purified water. Dated this 14th day of May, 2003 (RAMU) Agent of the Applicant