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Claims for Patent: 8,895,064

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Claims for Patent: 8,895,064

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)
Application Number:13/226,758
Patent Claims: 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 T.sub.lag of said budesonide in said human of about 6.79.+-.3.24 hours following said administration of said oral pharmaceutical composition to said human.

2. An oral pharmaceutical composition administered to a human according to claim 1, wherein said oral pharmaceutical composition administered to said human further provides a C.sub.max of said budesonide of about 1768.7.+-.1499.8 pg/mL in said human following administration of said oral pharmaceutical composition to said human.

3. 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 (T.sub.max-T.sub.lag) of said budesonide in said human of about 7.21.+-.5.49 hours following said administration of said oral pharmaceutical composition to said human.

4. An oral pharmaceutical composition administered to a human according to claim 3, wherein said oral pharmaceutical composition administered to said human further provides a C.sub.max of said budesonide of about 1768.7.+-.1499.8 pg/mL in said human following administration of said oral pharmaceutical composition to said human.

5. An oral pharmaceutical composition administered to a human, wherein said oral pharmaceutical composition is in the form of a tablet, said tablet consisting essentially of: (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 T.sub.lag of said budesonide in said human of about 6.79.+-.3.24 hours following said administration of said oral pharmaceutical composition to said human.

6. An oral pharmaceutical composition administered to a human according to claim 5, wherein said oral pharmaceutical composition administered to said human further provides a C.sub.max of said budesonide of about 1768.7.+-.1499.8 pg/mL in said human following administration of said oral pharmaceutical composition to said human.

7. An oral pharmaceutical composition administered to a human, wherein said oral pharmaceutical composition is in the form of a tablet, said tablet consisting essentially of: (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 (T.sub.max-T.sub.lag) of said budesonide in said human of about 7.21.+-.5.49 hours following said administration of said oral pharmaceutical composition to said human.

8. An oral pharmaceutical composition administered to a human according to claim 7, wherein said oral pharmaceutical composition administered to said human further provides a C.sub.max of said budesonide of about 1768.7.+-.1499.8 pg/mL in said human following administration of said oral pharmaceutical composition to said human.

9. 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 T.sub.lag of said budesonide in said human of from about 1 hour to about 12 hours following said administration of said oral pharmaceutical composition to said human.

10. An oral pharmaceutical composition administered to a human according to claim 9, wherein said oral pharmaceutical composition administered to said human further provides a C.sub.max of said budesonide of about 1768.7.+-.1499.8 pg/mL in said human following administration of said oral pharmaceutical composition to said human.

11. An oral pharmaceutical composition administered to a human, wherein said oral pharmaceutical composition is in the form of a tablet, said tablet consisting essentially of: (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 T.sub.lag of said budesonide in said human of from about 1 hour to about 12 hours following said administration of said oral pharmaceutical composition to said human.

12. An oral pharmaceutical composition administered to a human according to claim 11, wherein said oral pharmaceutical composition administered to said human further provides a C.sub.max of said budesonide of about 1768.7.+-.1499.8 pg/mL in said human following administration of said oral pharmaceutical composition to said human.
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