Controlled release and taste masking oral pharmaceutical composition

摘要

Controlled release and taste masking compositions containing one or more active principles inglobated in a three-component matrix structure, i.e. a structure formed by successive amphiphilic, lipophilic or inert matrices and finally inglobated or dispersed in hydrophilic matrices. The use of a plurality of systems for the control of the dissolution of the active ingredient modulates the dissolution rate of the active ingredient in aqueous and/or biological fluids, thereby controlling the release kinetics in the gastrointestinal tract.

主权项

1. An oral pharmaceutical composition administered to a human, wherein said oral pharmaceutical composition is in the form of a tablet, said tablet comprising:
(a) a tablet core comprising:
(i) 9 mg of budesonide; and(ii) a macroscopically homogenous composition comprising stearic acid and/or salt thereof, lecithin, and hydroxypropyl cellulose, wherein said budesonide is dispersed in said macroscopically homogeneous composition; and (b) a coating on said tablet core consisting essentially of a gastro-resistant film, wherein said gastro-resistant film consists essentially of a mixture of 8 mg of a first methacrylic acid copolymer and 8 mg of a second methacrylic acid copolymer, and wherein said oral pharmaceutical composition provides a Tlag of said budesonide in said human of about 6.79±3.24 hours following said administration of said oral pharmaceutical composition to said human.