Patent ID: 6607748
Filing Date: 2003-08-19
Classification: A61K,A61P,C08B

Abstract:
A process for manufacturing, in an aqueous medium, a controlled release excipient consisting primarily of cross-linked high amylose starch, for use in preparation of tablets, said process comprising(a) cross-linking high amylose starch thereby forming a reaction medium containing a reaction product consisting of a cross-linked high amylose starch slurry; (b) subjecting said cross-linked high amylose starch slurry from step (a) to chemical modification at a temperature of about 10 to about 90Â° C. for about 1 to about 72 hours; (c) neutralizing said reaction medium obtained in step (b) with an acid, washing the slurry formed and optionally dewatering or to form a starch cake or a dry powder; (d) diluting said slurry or re-slurrifying said starch cake or said dry powder from step (c) with water to form a slurry at a concentration of about 2% to about 40% w/w, adjusting pH to a desired value between about 3 and about 12, and gelatinizing said slurry at a temperature of about 80 to 180Â° C. for about 1 second to about 120 minutes; and (e) drying the thermally treated product obtained in step (d) to obtain said controlled release excipient consisting mainly of chemically modified and cross-linked high amylose starch in form of a powder.