Patent ID: 11602507

Abstract:
The present invention relates to oral extended release composition, comprising memantine or its pharmaceutically acceptable salt as an active ingredient, resin complexation ingredient, release retardant, extended release coating system and the composition further comprising diluents, viscosity increasing agents, glidants, sweeteners, stabilizing agents, preservatives and other pharmaceutically acceptable excipients, wherein the drug-resin complex and drug-resin complex matrix particulates and coated drug-resin complex particulates have the specific particle size range. The present invention also relates to a process for the preparation of memantine or its salt oral extended release composition comprising the steps of drug-resin complexation, matrix resinate/particulates preparation process followed by extended release coating. The present invention also relates to oral extended release composition comprising memantine or its pharmaceutically acceptable salt as an active ingredient and pharmaceutically acceptable excipients using extended release resin-complexation technology, further comprising additional active ingredient is in its immediate release form.