|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) |
1. A controlled release oral pharmaceutical composition comprising: (1) a tablet core comprising: a) budesonide in an amount effective for treatment of inflammatory
bowel disease in the gastrointestinal tract, b) stearic acid; c) lecithin; and d) hydroxypropyl cellulose; and (2) a gastro-resistant coating on said tablet core, said coating comprising at least one methacrylic acid polymer.
2. The composition of claim 1, wherein said tablet core further comprises microcrystalline cellulose, lactose, and magnesium stearate.
3. The composition of claim 1, comprising 9 mg of budesonide.
4. The composition of claim 2, comprising 9 mg of budesonide.