Details for Patent: 8,784,888

Title:	Controlled release and taste masking oral pharmaceutical composition
Abstract:	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.
Inventor(s):	Villa; Roberto (Lecco, IT), Pedrani; Massimo (Gignese, IT), Ajani; Mauro (Milan, IT), Fossati; Lorenzo (Milan, IT)
Assignee:	Cosmo Technologies Limited (Dublin, IE)
Filing Date:	Sep 14, 2012
Application Number:	13/617,138
Claims:	1. A controlled release oral pharmaceutical composition consisting essentially of: (1) a tablet core consisting essentially of: a) budesonide in an amount effective to treat intestinal inflammatory disease; and b) a macroscopically homogeneous composition comprising at least one lipophilic excipient, at least one amphiphilic excipient, and at least one hydrogel-forming hydrophilic excipient other than a gum, wherein said budesonide is dispersed in said macroscopically homogeneous composition; and (2) a coating on said tablet core, said coating consisting essentially of a gastro-resistant film. 2. A controlled release oral pharmaceutical composition according to claim 1, wherein said at least one hydrogel-forming hydrophilic excipient comprises at least one hydroxyalkyl cellulose. 3. A controlled release oral pharmaceutical composition according to claim 1, wherein said gastro-resistant film consists essentially of at least one methacrylic acid polymer. 4. A controlled release oral pharmaceutical composition according to claim 3, wherein said at least one hydrogel-forming hydrophilic excipient comprises at least one hydroxyalkyl cellulose. 5. A controlled release oral pharmaceutical composition according to claim 1, wherein said at least one lipophilic excipient comprises stearic acid or magnesium stearate. 6. A controlled release oral pharmaceutical composition according to claim 5, wherein said at least one hydrogel-forming hydrophilic excipient comprises at least one hydroxyalkyl cellulose. 7. A controlled release oral pharmaceutical composition according to claim 1, wherein said at least one amphiphilic excipient comprises lecithin. 8. A controlled release oral pharmaceutical composition according to claim 7, wherein said at least one hydrogel-forming hydrophilic excipient comprises at least one hydroxyalkyl cellulose. 9. A controlled release oral pharmaceutical composition according to claim 7, wherein said at least one lipophilic excipient comprises stearic acid or magnesium stearate.