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Claims for Patent: 9,132,093

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Claims for Patent: 9,132,093

Title:Controlled release and taste making 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:13/585,190
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: granules comprising 9 mg of budesonide, lipophilic or inert matrix, and at least one amphiphilic matrix, wherein said granules are dispersed in a composition comprising a hydrophilic matrix; and (b) a tablet coating comprising a gastro-resistant film, wherein said gastro-resistant film comprises: a plasticizer and at least one methacrylic acid copolymer, and wherein said oral pharmaceutical composition provides a mean C.sub.max of said budesonide in said human of about 1348.8.+-.958.8 pg/mL following said administration of said oral pharmaceutical composition to said human.

2. The oral pharmaceutical composition administered to a human according to claim 1, wherein said oral pharmaceutical composition further provides a mean T.sub.max of said budesonide in said human of about 13.3.+-.5.9 hours following administration of said oral pharmaceutical composition to said human.

3. The oral pharmaceutical composition administered to a human according to claim 1, wherein said oral pharmaceutical composition further provides a mean AUC.sub.0-infinity of said budesonide in said human of about 16431.2.+-.10519.8 (pg)(hr)/mL following said administration of said oral pharmaceutical composition to said human.

4. The oral pharmaceutical composition administered to a human according to claim 1, wherein said oral pharmaceutical composition further provides a mean AUC.sub.0-t of said budesonide in said human of about 13555.9.+-.7816.9 (pg)(hr)/mL in 36 hours following said administration of said oral pharmaceutical composition to said human.

5. The oral pharmaceutical composition administered to a human according to claim 1, wherein said gastro-resistant film comprises methacrylic acid copolymer type A.

6. The oral pharmaceutical composition administered to a human according to claim 1, wherein said oral pharmaceutical composition is in the form of a tablet that is swallowed whole without chewing by said human.

7. The oral pharmaceutical composition administered to a human according to claim 1 wherein said oral pharmaceutical composition further provides following administration of said oral pharmaceutical composition to said human: (1) a mean T.sub.max of said budesonide in said human of about 13.3.+-.5.9 hours; and (2) a mean AUC.sub.0-infinity of said budesonide in said human of about 16431.2.+-.10519.8 (pg)(hr)/mL.

8. The oral pharmaceutical composition administered to a human according to claim 1, wherein said gastro-resistant film further comprises talc.

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: granules comprising 9 mg of budesonide, stearic acid, and lecithin, wherein said granules are dispersed in a composition comprising hydroxypropyl cellulose; and (b) a tablet coating comprising a gastro-resistant film, wherein said gastro-resistant film comprises: a plasticizer and at least methacrylic acid copolymer, and wherein said oral pharmaceutical composition provides a mean Cmax of said budesonide in said human of about 1348.8.+-.958.8 pg/mL 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 further provides a mean T.sub.max of said budesonide in said human of about 13.3.+-.5.9 hours following said administration of said oral pharmaceutical composition to said human.

11. An oral pharmaceutical composition administered to a human according to claim 9, wherein said oral pharmaceutical composition further provides a mean AUC.sub.0-infinity of said budesonide in said human of about 16431.2.+-.10519.8 (pg)(hr)/mL following said administration of said oral pharmaceutical composition to said human.

12. The oral pharmaceutical composition administered to a human according to claim 9, wherein said oral pharmaceutical composition further provides a mean AUC.sub.0-1 of said budesonide in said human of about 13555.9.+-.7816.9 (pg)(hr)/mL in 36 hours following said administration of said oral pharmaceutical composition to said human.

13. The oral pharmaceutical composition administered to a human according to claim 9, wherein said gastro-resistant film comprises methacrylic acid copolymer type A.

14. The oral pharmaceutical composition administered to a human according to claim 9, wherein said oral pharmaceutical composition is in the form of a tablet that is swallowed whole without chewing by said human.

15. The oral pharmaceutical composition administered to a human according to claim 9, wherein said gastro-resistant film further comprises talc.

16. 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: granules comprising 9 mg of budesonide, at least one lipophilic or inert matrix, and at least one amphiphilic matrix, wherein said granules are dispersed in a composition comprising at least one hydrophilic matrix; and (b) a tablet coating comprising a gastro-resistant film, wherein said gastro-resistant film comprises: a plasticizer and at least one methacrylic acid copolymer, and wherein said oral pharmaceutical composition provides a C.sub.max of said budesonide in said human of from about 485 pg/mL to about 4227 pg/mL following said administration of said oral pharmaceutical composition to said human.

17. The oral pharmaceutical composition administered to a human according to claim 16, wherein said oral pharmaceutical composition provides a T.sub.max of said budesonide in said human of from about 6 hours to about 24 hours following said administration of said oral pharmaceutical composition to said human.

18. The oral pharmaceutical composition administered to a human according to claim 16, wherein said oral pharmaceutical composition further provides a mean AUC.sub.0-infinity of said budesonide in said human of about 16431.2.+-.10519.8 (pg)(hr)/mL following said administration of said oral pharmaceutical composition to said human.

19. The oral pharmaceutical composition administered to a human according to claim 16, wherein said oral pharmaceutical composition further provides a mean AUC.sub.0-1 of said budesonide in said human of about 13555.9.+-.7816.9 (pg)(hr)/mL in 36 hours following said administration of said oral pharmaceutical composition to said human.

20. The oral pharmaceutical composition administered to a human according to claim 16, wherein said gastro-resistant film comprises methacrylic acid copolymer type A.

21. The oral pharmaceutical composition administered to a human according to claim 16, wherein said oral pharmaceutical composition is in the form of a tablet that is swallowed whole without chewing by said human.

22. The oral pharmaceutical composition administered to a human according to claim 16, wherein said gastro-resistant film further comprises talc.

23. 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: granules comprising 9 mg of budesonide, stearic acid, and lecithin, wherein said granules are dispersed in a composition comprising hydroxypropyl cellulose; and (b) a tablet coating comprising a gastro-resistant film, wherein said gastro-resistant film comprises: a plasticizer and at least one methacrylic acid copolymer, and wherein said oral pharmaceutical composition provides a C.sub.max of said budesonide in said human of from about 485 pg/mL to about 4227 pg/mL following said administration of said oral pharmaceutical composition to said human.

24. The oral pharmaceutical composition administered to a human according to claim 23, wherein said oral pharmaceutical composition provides a T.sub.max of said budesonide in said human of from about 6 hours to about 24 hours following said administration of said oral pharmaceutical composition to said human.

25. The oral pharmaceutical composition administered to a human according to claim 23, wherein said oral pharmaceutical composition further provides a mean AUC.sub.0-infinity of said budesonide in said human of about 16431.2.+-.10519.8 (pg)(hr)/mL following said administration of said oral pharmaceutical composition to said human.

26. The oral pharmaceutical composition administered to a human according to claim 23, wherein said oral pharmaceutical composition further provides a mean AUC.sub.0-1 of said budesonide in said human of about 13555.9.+-.7816.9 (pg)(hr)/mL in 36 hours following said administration of said oral pharmaceutical composition to said human.

27. The oral pharmaceutical composition administered to a human according to claim 23, wherein said gastro-resistant film comprises methacrylic acid copolymer type A.

28. The oral pharmaceutical composition administered to a human according to claim 23, wherein said oral pharmaceutical composition is in the form of a tablet that is swallowed whole without chewing by said human.

29. The oral pharmaceutical composition administered to a human according to claim 23, wherein said gastro-resistant film further comprises talc.
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