Patent ID: 6391452
Filing Date: 2002-05-21
Classification: A61K,C07K,Y10T

Abstract:
A process for making an intranasal drug delivery system comprising gelatin microspheres in combination with a drug intended for intranasal delivery, said process comprising:a) preparing a low-salt or salt-free aqueous solution of gelatin and the drug to be delivered, at a temperature above the gelation temperature of the gelatin; b) preparing a solution of a suitable oil and a suitable surfactant; c) emulsifying a mixture of the solution of step (a) and the solution of step (b) to generate a water-in-oil emulsion wherein the volume ratio of (a):(b) is between 1:2 and 1:10; d) continuing emulsification until the target droplet size is achieved; e) reducing the temperature of said emulsion to below the gelation temperature of the gelatin at a controlled rapid rate to achieve gelation before droplet coalescence, thus allowing the formation of gelatin microspheres associated with drug at the desired particle size; the emulsion in steps (c, d) and (e) above being mixed at the maximum rate consistent with a low-vortex or vortex-free circulation pattern;f) separating the drug-containing microspheres from the oil/surfactant phase; and g) dehydrating the drug-containing microspheres to produce a dry powder.