Controlled release and taste masking oral pharmaceutical composition
AssigneeCosmo Technologies Limited
InventorsRoberto VILLA, Massimo PEDRANI, Mauro AJANI, Lorenzo FOSSATI
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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.
Claims22
An oral dosage form consisting essentially of (1) a core, and (2) a gastro-resistant film on said core, wherein said core comprises:
- (a) 9 mg of budesonide;
- (b) hydroxypropyl cellulose;
- and
- (c) magnesium stearate, stearic acid, or a mixture thereof;
- and wherein following oral administration of the oral dosage form to a human, the oral dosage form provides an AUC0-infinity of said budesonide in said human of about 16431.2±10519.8 (pg)×(h)/mL, wherein said oral dosage form is in the form of a tablet and provides extended release of budesonide in the colon of said human effective to treat ulcerative colitis in said human.
An oral dosage form consisting essentially of (1) a core, and (2) a gastro-resistant film on said core, wherein said core comprises:
- (a) 9 mg of budesonide;
- (b) hydroxypropyl cellulose;
- (c) magnesium stearate, stearic acid, or a mixture thereof;
- and wherein following oral administration of the oral dosage form to a human, the oral dosage form provides a Cmax of said budesonide in said human of about 1348.8±958.8 pg/mL, wherein said oral dosage form is in the form of a tablet and provides extended release of budesonide in the colon of said human effective to treat ulcerative colitis in said human.
A method of treating a human subject with ulcerative colitis, comprising administering to said human subject an oral dosage form consisting essentially of (1) a core, and (2) a gastro-resistant film on said core, wherein said core comprises:
- (a) 9 mg of budesonide;
- (b) hydroxypropyl cellulose;
- and
- (c) magnesium stearate, stearic acid, or a mixture thereof;
- and wherein following oral administration of the oral dosage form to a human, the oral dosage form provides an AUC0-infinity of said budesonide in said human of about 16431.2±10519.8 (pg)×(h)/mL, wherein said oral dosage form is in the form of a tablet and provides extended release of budesonide in the colon of said human effective to treat ulcerative colitis in said human.
A method of treating a human subject with ulcerative colitis, comprising administering to said human subject an oral dosage form consisting essentially of (1) a core, and (2) a gastro-resistant film on said core, wherein said core comprises:
- (a) 9 mg of budesonide;
- (b) hydroxypropyl cellulose;
- (c) magnesium stearate, stearic acid, or a mixture thereof;
- and wherein following oral administration of the oral dosage form to a human, the oral dosage form provides a Cmax of said budesonide in said human of about 1348.8±958.8 pg/mL, wherein said oral dosage form is in the form of a tablet and provides extended release of budesonide in the colon of said human effective to treat ulcerative colitis in said human.
Dependencies are inferred from the claim text.