Patent ID: 8481060
Filing Date: 2013-07-09
Classification: A61K

Abstract:
1. A process for producing a solid, coated fast-release pharmaceutical composition, said process comprising the steps of: (i) providing a core containing one or more pharmaceutically active ingredients and optionally one or more pharmaceutically acceptable excipients, (ii) providing at least one coating composition comprising at least one taste-masking compound having a melting point of at least 40° C. and an HLB value of 10 or less, wherein the at least one coating composition comprising the taste-masking compound is heated to a temperature of at least 40° C. so that the taste-masking compound is in melt phase, (iii) providing at least one release compound that, in the gastrointestinal tract, either causes disruption or disintegration of the taste-masking layer or improves the permeability of the taste-masking layer for the one or more pharmaceutically active ingredients, and (iv) spray-coating the core of step (i) with the at least one coating composition of step (ii) and the release compound of step (iii) to yield a solid, coated fast-release pharmaceutical composition having a dissolution profile measured according to the European Pharmacopoeia in a USP type 2 paddle apparatus at 75 rpm in 900 ml aqueous buffer at 37° C. for 30 minutes under acidic conditions (pH=1) and then under conditions at which the active ingredients are soluble, wherein after 45 minutes at least 60% of the one or more active ingredients is dissolved, wherein the taste-masking compound is present in the at least one coating composition of step (ii) in an amount in the range of 70% to 95%, based on the weight of the coating composition, and wherein the release compound is present in the at least one coating composition of step (ii) or in a seperate coating composition in an amount in the range of 5% to 30%, based on the weight of the respective coating composition.