IP Library Granted Patent US 7,338,942
Granted Patent B2
US 7,338,942 · App. 10/865,404 · Granted Mar 4, 2008

Composition and method for maintaining healthy mobile joints and cartilage

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Quick Facts
Patent No.
US 7,338,942
App. No.
10/865,404
Granted
Mar 4, 2008
Kind
B2
Abstract

Compositions and methods for maintaining healthy mobile joints and cartilage in humans and animals are disclosed. The composition comprises glucosamine and chondroitin dispersed in a controlled-release matrix system capable of releasing the glucosamine and chondroitin over a designated time period. In another aspect, the invention provides compositions and methods for maintaining health mobile joints and cartilage in humans and animals without adversely affecting glucose regulation.

Claims (43)

1. A controlled-release composition for maintenance of healthy mobile joints and cartilage, comprising a therapeutically effective amount of glucosamine and chondroitin dispersed in a controlled-release matrix system, said matrix system comprising a continuum of material and a controlled-release component finely dispersed throughout said matrix system and capable of releasing said glucosamine and chondroitin in an amount and at a rate sufficient to maintain healthy mobile joints and cartilage over a designated time period, said controlled-release component comprising at least one water soluble high molecular weight cellulose polymer selected from the group consisting of hydroxypropyl methyl cellulose (HPMC), hydroxy ethyl cellulose (HEC), hydroxy propyl cellulose (HPC), carboxy methyl cellulose (CMC), and mixtures thereof.

2. A controlled-release composition of claim 1 , wherein said glucosamine is selected from the group consisting of N-acetyl-D-glucosamine, glucosamine hydrochloride, glucosamine sulfate and mixtures thereof.

3. A controlled-release composition of claim 1 , wherein said matrix system further comprises at least one material selected from the group consisting of microcrystalline cellulose, calcium silicate, stearic acid, magnesium stearate and mixtures thereof.

4. A controlled-release composition of claim 2 , wherein said glucosamine is present in an amount sufficient to provide a daily dosage of from about 250 mg to about 3000 mg.

5. A controlled-release composition of claim 4 , wherein said daily dosage is from about 1000 mg to about 2000 mg.

6. A controlled-release composition of claim 5 , wherein said daily dosage is about 1500 mg.

7. A controlled-release composition of claim 1 , wherein said chondroitin is chondroitin sulfate.

8. A controlled-release composition of claim 7 , wherein said chondroitin sulfate is present in an amount sufficient to provide a daily dosage of from about 100 mg to about 2400 mg.

9. A controlled-release composition of claim 8 , wherein said daily dosage of chondroitin sulfate ranges from about 200 mg to about 1800 mg.

10. A controlled-release composition of claim 9 , wherein said daily dosage of chondroitin sulfate is about 1200 mg.

11. A controlled-release composition of claim 1 , wherein said daily dosage of glucosamine is about 1500 mg and said daily dosage of chondroitin is about 1200 mg.

12. A controlled-release composition of claim 1 wherein said water soluble high molecular weight cellulose polymer is HPMC.

13. A controlled-release composition of claim 12 wherein said HPMC has a molecular weight of at least about 85,000.

14. A controlled-release composition of claim 13 , wherein said HPMC is present in an amount from about 4 to about 24 wt %, based upon total weight of the composition.

15. A controlled-release composition of claim 14 , wherein said HPMC is present in an amount from about 4 to about 20 wt %, based upon the total weight of the composition.

16. A controlled-release composition of claim 1 , wherein said composition is in a form suitable for oral administration.

17. A controlled-release composition of claim 1 , wherein said controlled-release matrix system is capable of releasing said glucosamine at a substantially constant rate over a designated time.

18. A controlled-release composition of claim 17 , wherein said designated time period is selected from the group consisting of about 1, 2, 4, 6, and 8 hours.

19. A controlled-release composition of claim 18 , wherein said designated time period is about 4 hours.

20. A controlled-release composition of claim 18 , wherein said designated time period is about 6 hours.

21. A controlled-release composition of claim 18 , wherein said designated time period is about 8 hours.

22. A unit dosage for controlled delivery of glucosamine and chondroitin comprising glucosamine and chondroitin dispersed in a controlled-release matrix system, said matrix system comprising a continuum of material and a controlled-release component finely dispersed throughout said matrix system and capable of providing a release profile which results in a substantially constant glucosamine and chondroitin release rate over a designated time period, wherein said controlled-release component comprises HPMC.

23. The unit dosage of claim 22 , wherein said matrix system further comprises at least one other controlled-release component selected from the group consisting of a polymeric coating and a biodegradable coating.

24. The unit dosage of claim 23 , wherein said glucosamine is coated with said polymeric or biodegradable coating.

25. The unit dosage of claim 23 , wherein said chondroitin is coated with said polymeric of biodegradable coating.

26. The unit dosage of claim 23 , wherein said unit dosage is coated with said polymeric or biodegradable coating.

27. The unit dosage of claim 22 , wherein said HPMC has a molecular weight of at least about 85,000, and wherein said designated time period is at least about 4 hours.

28. The unit dosage of claim 22 , wherein said glucosamine is present in an amount sufficient to provide a daily dosage of about 1500 mg and said chondroitin is present in an amount sufficient to provide a daily dosage of about 1200 mg.

29. The unit dosage of claim 22 wherein said unit dosage is a tablet.

30. A method for maintaining healthy mobile joints and cartilage in a mammal, said method comprising:

administering to said mammal a composition which comprises glucosamine and chondroitin dispersed in a controlled-release matrix system, said matrix system comprising a continuum of material and a controlled-release component finely dispersed throughout said matrix system and capable of releasing said glucosamine and chondroitin in an amount and at a rate sufficient to maintain healthy mobile joints and cartilage, over a designated time period, wherein said composition is administered in an amount to provide a daily dosage of glucosamine of about 250 mg to about 3000 mg and a daily dosage of chondroitin of about 100 mg to about 2400 mg.

31. A method for maintaining healthy mobile joints and cartilage of claim 30 , wherein said glucosamine component is selected from the group consisting of N-acetyl-D-glucosamine, glucosamine hydrochloride, glucosamine sulfate and mixtures thereof.

32. A method for maintaining healthy mobile joints and cartilage of claim 30 , wherein said daily dosage of glucosamine is from about 1000 mg to about 2000 mg.

33. A method for maintaining healthy mobile joints and cartilage of claim 30 , wherein said daily dosage of glucosamine is about 1500 mg.

34. A method for maintaining healthy mobile joints and cartilage of claim 30 , wherein said chondroitin is chondroitin sulfate.

35. A method for maintaining healthy mobile joints and cartilage of claim 34 , wherein said daily dosage of chondroitin sulfate ranges from about 200 mg to about 1800 mg.

36. A method for maintaining healthy mobile joints and cartilage of claim 34 , wherein said daily dosage of chondroitin sulfate is about 1200 mg.

37. A method for maintaining healthy mobile joints and cartilage of claim 30 , wherein said composition is in a tablet form.

38. A method for maintaining healthy mobile joints and cartilage of claim 37 , wherein said tablet releases said glucosamine at a substantially constant rate over a designated time period ranging at least about 1, 2, 4, 6, and 8 hours.

39. A method for maintaining healthy mobile joints and cartilage of claim 38 , wherein said tablet comprises a high molecular weight HPMC having a molecular weight of at least about 85,000, in an amount from about 4 to about 24 wt %.

40. A method for maintaining healthy mobile joints and cartilage of claim 39 , wherein said designated time period is approximately 4 hours.

41. A method for maintaining healthy mobile joints and cartilage of claim 39 , wherein said designated time period is approximately 6 hours.

42. A method for maintaining healthy mobile joints and cartilage of claim 41 , wherein said designated time period is approximately 8 hours.

Assignments (11)
RELEASE OF SECURITY INTEREST Recorded Aug 11, 2021
From: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH, AS COLLATERAL AGENT
To: NBTY ACQUISITION, LLC; NBTY MANUFACTURING, LLC; REXALL SUNDOWN, INC.; THE ESTER C COMPANY; THE NATURE'S BOUNTY CO.
Reel/Frame 057145/0410 →
RELEASE OF SECURITY INTEREST Recorded Aug 11, 2021
From: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH, AS COLLATERAL AGENT
To: NBTY ACQUISITION, LLC; NBTY MANUFACTURING, LLC; REXALL SUNDOWN, INC.; THE ESTER C COMPANY; THE NATURE'S BOUNTY CO.
Reel/Frame 057145/0544 →
RELEASE OF SECURITY INTEREST Recorded Aug 11, 2021
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: NBTY ACQUISITION, LLC; NBTY MANUFACTURING, LLC; REXALL SUNDOWN, INC.; THE ESTER C COMPANY; THE NATURE'S BOUNTY CO.
Reel/Frame 057145/0656 →
RELEASE (REEL 038698 / FRAME 0788) Recorded Sep 27, 2017
From: BANK OF AMERICA, N.A.
To: NBTY, INC.; NBTY ACQUISITION, LLC; NBTY MANUFACTURING, LLC; THE ESTER C COMPANY
Reel/Frame 044027/0269 →
RELEASE (REEL 038697 / FRAME 0846) Recorded Sep 27, 2017
From: BANK OF AMERICA, N.A.
To: NBTY, INC.; NBTY ACQUISITION, LLC; NBTY MANUFACTURING, LLC; THE ESTER C COMPANY
Reel/Frame 044027/0444 →
SECURITY INTEREST Recorded Sep 26, 2017
From: NBTY ACQUISITION, LLC; NBTY MANUFACTURING, LLC; REXALL SUNDOWN, INC.; THE ESTER C COMPANY; THE NATURE'S BOUNTY CO.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 043706/0591 →
SECURITY INTEREST Recorded Sep 26, 2017
From: NBTY ACQUISITION, LLC; NBTY MANUFACTURING, LLC; REXALL SUNDOWN, INC; THE ESTER C COMPANY; THE NATURE'S BOUNTY CO.
To: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH, AS COLLATERAL AGENT
Reel/Frame 043698/0122 →
SECURITY INTEREST Recorded Sep 26, 2017
From: NBTY ACQUISITION, LLC; NBTY MANUFACTURING, LLC; REXALL SUNDOWN, INC.; THE ESTER C COMPANY; THE NATURE'S BOUNTY CO.
To: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH, AS COLLATERAL AGENT
Reel/Frame 043704/0560 →
SECURITY AGREEMENT Recorded May 13, 2016
From: NBTY, INC.; NBTY, ACQUISITION, LLC; NBTY MANUFACTURING, LLC; THE ESTER C COMPANY
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 038698/0788 →
SECURITY AGREEMENT Recorded May 12, 2016
From: NBTY, INC.; NBTY ACQUISITION, LLC; NBTY MANUFACTURING, LLC; THE ESTER C COMPANY
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 038697/0846 →
RELEASE (REEL 025192 / FRAME 0096) Recorded May 11, 2016
From: BARCLAYS BANK PLC; BARCLAYS BANK PLC ADMINISTRATIVE TRUSTEE
To: NBTY, INC.; NBTY ACQUISITION, LLC; NBTY MANUFACTURING, LLC; THE ESTER C COMPANY
Reel/Frame 038679/0167 →