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Last Updated: March 29, 2024

Claims for Patent: 10,307,375


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Summary for Patent: 10,307,375
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:16/139,793
Patent Claims: 1. A tablet for the treatment of ulcerative colitis consisting essentially of (1) a tableted core, and (2) a coating on said tableted core, wherein said tableted core consists of a dispersion of ingredients, said ingredients comprising: (a) 9 mg of budesonide; (b) hydroxypropyl methylcellulose; and (c) magnesium stearate; wherein said coating on said tableted core comprises methacrylic acid copolymer type A and methacrylic acid copolymer type B in a weight to weight ratio of from 1:5 to 5:1; wherein following oral administration of the tablet to a human, the tablet provides an AUC of said budesonide in said human of about 16.43.+-.10.52 (ng).times.(h)/mL; and wherein said tablet provides extended release of budesonide in the colon of said human effective to treat ulcerative colitis in said human.

2. The tablet of claim 1, wherein said ingredients further comprise all of hydroxypropyl cellulose, silicon dioxide, lactose, microcrystalline cellulose, and lecithin.

3. The tablet of claim 1, wherein said ingredients further comprise starch or a starch derivative.

4. The tablet of claim 2, wherein said ingredients further comprise starch or a starch derivative.

5. The tablet of claim 1, wherein said ingredients do not comprise stearic acid.

6. The tablet of claim 2, wherein said ingredients do not comprise stearic acid.

7. The tablet of claim 3, wherein said ingredients do not comprise stearic acid.

8. The tablet of claim 4, wherein said ingredients do not comprise stearic acid.

9. The tablet of claim 1, wherein the weight to weight ratio of said methacrylic acid copolymer type A to said methacrylic acid copolymer type B in said coating on said tableted core is 1:1.

10. The tablet of claim 1, wherein said coating on said tableted core further comprises triethylcitrate.

11. The tablet of claim 1, wherein following oral administration of the tablet to a human, the tablet provides a C.sub.max of said budesonide in said human of about 1.35.+-.0.96 ng/mL.

12. The tablet of claim 4, wherein following oral administration of the tablet to a human, the tablet provides a C.sub.max of said budesonide in said human of about 1.35.+-.0.96 ng/mL.

13. The tablet of claim 5, wherein following oral administration of the tablet to a human, the tablet provides a C.sub.max of said budesonide in said human of about 1.35.+-.0.96 ng/mL.

14. The tablet of claim 1, wherein following oral administration of the tablet to a human, the tablet provides a T.sub.max of said budesonide in said human of about 13.3.+-.5.9 hours.

15. The tablet of claim 4, wherein following oral administration of the tablet to a human, the tablet provides a T.sub.max of said budesonide in said human of about 13.3.+-.5.9 hours.

16. The tablet of claim 5, wherein following oral administration of the tablet to a human, the tablet provides a T.sub.max of said budesonide in said human of about 13.3.+-.5.9 hours.

17. The tablet of claim 8, wherein following oral administration of the tablet to a human, the tablet provides a T.sub.max of said budesonide in said human of about 13.3.+-.5.9 hours.

18. The tablet of claim 11, wherein following oral administration of the tablet to a human, the tablet provides a T.sub.max of said budesonide in said human of about 13.3.+-.5.9 hours.

19. A tablet consisting essentially of (1) a tableted core, and (2) a gastro-resistant coating on said tableted core, wherein said tableted core consists of a dispersion of ingredients, said ingredients comprising: (a) 9 mg of budesonide; (b) hydroxypropyl methylcellulose; (c) magnesium stearate; (d) hydroxypropyl cellulose; (e) silicon dioxide; (f) lactose; (g) starch or starch derivative; (h) microcrystalline cellulose; and (i) lecithin; wherein said gastro-resistant coating comprises methacrylic acid copolymer type A, methacrylic acid copolymer type B and triethylcitrate, wherein said methacrylic acid copolymer type A and said methacrylic acid copolymer type B are present in said gastro-resistant coating in a weight to weight ratio of from 1:5 to 5:1; wherein following oral administration of the tablet to a human, the tablet provides an AUC of said budesonide in said human of about 16.43.+-.10.52 (ng).times.(h)/mL; and wherein said tablet provides extended release of budesonide in the colon of said human effective to treat ulcerative colitis in said human.

20. The tablet of claim 19, wherein following oral administration of the tablet to a human, the tablet provides a C.sub.max of said budesonide in said human of about 1.35.+-.0.96 ng/mL.

21. The tablet of claim 19, wherein following oral administration of the tablet to a human, the tablet provides a T.sub.max of said budesonide in said human of about 13.3.+-.5.9 hours.

22. A tablet consisting essentially of (1) a tableted core, and (2) a gastro-resistant coating on said tableted core, wherein said tableted core consists of a dispersion of ingredients, said ingredients comprising: (a) 9 mg of budesonide; (b) hydroxypropyl cellulose; and (c) magnesium stearate; wherein said gastro-resistant coating comprises methacrylic acid copolymer type A, methacrylic acid copolymer type B and triethylcitrate, wherein said methacrylic acid copolymer type A and said methacrylic acid copolymer type B are present in said gastro-resistant coating in a weight to weight ratio of from 1:5 to 5:1; wherein following oral administration of the tablet to a human, the tablet provides an AUC of said budesonide in said human of about 16.43.+-.10.52 (ng).times.(h)/mL, a C.sub.max of said budesonide in said human of about 1.35.+-.0.96 ng/mL, and a T.sub.max of said budesonide in said human of about 13.3.+-.5.9 hour; and wherein said tablet provides extended release of budesonide in the colon of said human effective to treat ulcerative colitis in said human.

23. The tablet of claim 22, wherein said ingredients further comprise starch or a starch derivative.

24. The tablet of claim 2, wherein the weight to weight ratio of said methacrylic acid copolymer type A to said methacrylic acid copolymer type B in said coating on said tableted core is 1:1.

25. The tablet of claim 3, wherein the weight to weight ratio of said methacrylic acid copolymer type A to said methacrylic acid copolymer type B in said coating on said tableted core is 1:1.

26. The tablet of claim 5, wherein the weight to weight ratio of said methacrylic acid copolymer type A to said methacrylic acid copolymer type B in said coating on said tableted core is 1:1.

27. The tablet of claim 11, wherein the weight to weight ratio of said methacrylic acid copolymer type A to said methacrylic acid copolymer type B in said coating on said tableted core is 1:1.

28. The tablet of claim 19, wherein the weight to weight ratio of said methacrylic acid copolymer type A to said methacrylic acid copolymer type B in said coating on said tableted core is 1:1.

29. The tablet of claim 22, wherein the weight to weight ratio of said methacrylic acid copolymer type A to said methacrylic acid copolymer type B in said coating on said tableted core is 1:1.

30. The tablet of claim 1, wherein the weight to weight ratio of said methacrylic acid copolymer type A to said methacrylic acid copolymer type B in said coating on said tableted core is 1:1.

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