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Claims for Patent: 6,875,445

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Claims for Patent: 6,875,445

Title: Encapsulated calcium acetate caplet and a method for inhibiting gastrointestinal phosphorous absorption
Abstract:A composition for inhibiting gastrointestinal absorption of phosphorous in an individual. The composition includes a quantity of calcium acetate sufficient to bind the phosphorous in the gastrointestinal tract of the individual. The calcium acetate has a bulk density of between 0.50 kg/L and 0.80 kg/L and is dimensioned to form a caplet for fitting within a capsule in a manner that optimizes the volume of the capsule. Also provided is a method for administering the calcium acetate composition of the present invention to an individual to reduce phosphorous absorption by binding with the phosphorous in their gastrointestinal tract.
Inventor(s): Dennett, Jr.; Edmund V. (Milton, MA), Raleigh, Jr.; Robert M. (Pembroke, MA), Aronson; Bruce H. (Sharon, MA)
Assignee: Nabi Biopharmaceuticals (Boca Raton, FL)
Application Number:10/279,598
Patent Claims: 1. A drug delivery vehicle for a composition for binding phosphorous within the gastrointestinal tract of an individual, the drug delivery vehicle comprising: an outer capsule defining an inner volume; and an inner caplet comprising a quantity of calcium acetate sufficient to bind to and reduce absorption of phosphorous in the gastrointestinal tract of the individual; the calcium acetate having a bulk density between about 0.55 kg/L and 0.75 kg/L and being compressed to a caplet form dimensioned for fitting within and optimizing the inner volume of said capsule.

2. The drug delivery vehicle of claim 1, wherein the quantity of calcium acetate is a dosage amount equivalent to 667 mg of calcium acetate, anhydrous basis.

3. The drug delivery vehicle of claim 1, wherein the quantity of calcium acetate is a dosage amount equivalent to 333.5 mg of calcium acetate, anhydrous basis.

4. The drug delivery vehicle of claim 1, where in the quantity of calcium acetate is a dosage amount equivalent to 708 mg of monohydrous calcium acetate.

5. The drug delivery vehicle claim 1, wherein the quantity of calcium acetate is a dosage amount equivalent to 354 mg of monohydrous calcium acetate.

6. The drug delivery vehicle of claim 1, wherein the calcium acetate, after being compressed to the caplet form, dissolves by at least 85% in not more than 15 minutes USP #24 at 50 to 100 rpm, apparatus 1 or 2.

7. The drug delivery vehicle of claim 1, wherein said capsule is a #0 size capsule and said calcium acetate caplet is dimensioned for fitting within and optimizing the inner volume of the #0 size capsule.

8. The drug delivery vehicle of claim 1, wherein said capsule is a #2 size capsule and said calcium acetate caplet is dimensioned for fitting within and optimizing the inner volume of the #2 size capsule.

9. The drug delivery vehicle of claim 1, wherein said capsule is a #0 size capsule and wherein said calcium acetate caplet contains a dosage amount equivalent to 667 mg of calcium acetate, anhydrous basis, dimensioned for fitting within and optimizing the inner volume of the #0 size capsule.

10. The drug delivery vehicle of claim 1, wherein said capsule is a #2 size capsule and wherein said calcium acetate caplet contains a dosage amount equivalent to 333.5 mg of calcium acetate, anhydrous basis, dimensioned for fitting within and optimizing the inner volume of the #2 size capsule.

11. The drug delivery vehicle of claim 1, wherein said capsule is a #0 size capsule and wherein said calcium acetate caplet contains a dosage amount equivalent to 708 mg of monohydrous calcium acetate dimensioned for fitting within and optimizing the inner volume of the #0 size capsule.

12. The drug delivery vehicle of claim 1, wherein said capsule is a #2 size capsule and wherein said calcium acetate caplet contains a dosage amount equivalent to 354 mg of monohydrous calcium acetate dimensioned for fitting within and optimizing the inner volume of the #2 size capsule.

13. A drug delivery vehicle for a composition for binding phosphorous within the gastrointestinal tract of an individual, the drug delivery vehicle comprising: an outer capsule defining an inner volume; and an inner caplet comprising a quantity of calcium acetate sufficient to bind to and reduce absorption of phosphorous in the gastrointestinal tract of the individual; the calcium acetate: a. having a bulk density between about 0.55 kg/L and about 0.75 kg/L; b. being compressed to a caplet form dimensioned for fitting within and optimizing the inner volume of said capsule; and c. after being compressed to the caplet form, dissolving by at least 85% in not more than 15 minutes USP #24 at 50 to 100 rpm, apparatus 1 or 2.

14. The drug delivery vehicle of claim 13, wherein said capsule is a #0 size capsule and wherein said calcium acetate caplet contains a dosage amount equivalent to 667 mg of calcium acetate, anhydrous basis, dimensioned for fitting within and optimizing the inner volume of the #0 size capsule.

15. The drug delivery vehicle of claim 13, wherein said capsule is a #2 size capsule and wherein said calcium acetate caplet contains a dosage amount equivalent to 333.5 mg of calcium acetate, anhydrous basis, dimensioned for fitting within and optimizing the inner volume of the #2 size capsule.

16. The drug delivery vehicle of claim 13, wherein said capsule is a #0 size capsule and wherein said calcium acetate caplet contains a dosage amount equivalent to 708 mg of monohydrous calcium acetate dimensioned for fitting within and optimizing the inner volume of the #0 size capsule.

17. The drug delivery vehicle of claim 13, wherein said capsule is a #2 size capsule and wherein said calcium acetate caplet contains a dosage amount equivalent to 354 mg of monohydrous calcium acetate dimensioned for fitting within and optimizing the inner volume of the #2 size capsule.

18. A method of making a drug delivery vehicle for a composition for binding phosphorous in the gastrointestinal tract of an individual, the method comprising at least the steps of: providing an outer capsule defining an inner volume; providing a quantity of calcium acetate sufficient to bind to and reduce absorption of phosphorous in the gastrointestinal tract of the individual, the calcium acetate having a bulk density between about 0.55 kg/L and about 0.75 kg/L; compressing the quantity of calcium acetate to a caplet form dimensioned for fitting within and optimizing the inner volume of the capsule; and inserting the compressed calcium acetate caplet within the outer capsule.

19. The method of claim 18, wherein the quantity of calcium acetate provided is a dosage amount equivalent to 667 mg of calcium acetate, anhydrous basis.

20. The method of claim 18, wherein the quantity of calcium acetate provided is a dosage amount equivalent to 333.5 mg of calcium acetate, anhydrous basis.

21. The method of claim 18, wherein the quantity of calcium acetate provided is a dosage amount equivalent to 708 mg of monohydrous calcium acetate.

22. The method of claim 18, wherein the quantity of calcium acetate provided is a dosage amount equivalent to 354 mg of monohydrous calcium acetate.

23. The method of claim 18, wherein the calcium acetate, after being compressed to the caplet form, dissolves by at least 85% in not more than 15 minutes USP #24 at 50 to 100 rpm, apparatus 1 or 2.

24. The method of claim 18, wherein the capsule is a #0 size capsule and the calcium acetate caplet is dimensioned for fitting within and optimizing the inner volume of the #0 size capsule.

25. The method of claim 18, wherein the capsule is a #2 size capsule and the calcium acetate caplet is dimensioned for fitting within and optimizing the inner volume of the #2 size capsule.

26. The method of claim 18, wherein the capsule is a #0 size capsule and wherein the calcium acetate caplet contains a dosage amount equivalent to 667 mg of calcium acetate, anhydrous basis, dimensioned for fitting within and optimizing the inner volume of the #0 size capsule.

27. The method of claim 18, wherein the capsule is a #2 size capsule and wherein the calcium acetate caplet contains a dosage amount equivalent to 333.5 mg of calcium acetate, anhydrous basis, dimensioned for fitting within and optimizing the inner volume of the #2 size capsule.

28. The method of claim 18, wherein the capsule is a #0 size capsule and wherein the calcium acetate caplet contains a dosage amount equivalent to 708 mg of monohydrous calcium acetate dimensioned for fitting within and optimizing the inner volume of the #0 size capsule.

29. The method of claim 18, wherein the capsule is a #2 size capsule and wherein the calcium acetate caplet contains a dosage amount equivalent to 354 mg of monohydrous calcium acetate dimensioned for fitting within and optimizing the inner volume of the #2 size capsule.

30. A method of making a drug delivery vehicle for a composition for binding phosphorous within the gastrointestinal tract of an individual, the method comprising at least the steps of: providing an outer capsule defining an inner volume; providing an inner caplet comprising a quantity of calcium acetate sufficient to bind to and reduce absorption of phosphorous in the gastrointestinal tract of the individual, the calcium acetate having a bulk density between about 0.55 kg/L and about 0.85 kg/L before being compressed; compressing the calcium acetate to caplet form dimensioned for fitting within and optimizing the inner volume of the capsule; the calcium acetate, after being compressed to the caplet form, dissolving by at least 85% in not more than 15 minutes USP #24 at 50 to 100 rpm, apparatus 1 or 2; and inserting the compressed calcium acetate caplet within the outer capsule.

31. The method of claim 30, wherein the capsule is a #0 size capsule and wherein the calcium acetate caplet contains a dosage amount equivalent to 667 mg of calcium acetate, anhydrous basis, dimensioned for fitting within and optimizing the inner volume of the #0 size capsule.

32. The method of claim 30, wherein the capsule is a #2 size capsule and wherein the calcium acetate caplet contains a dosage amount equivalent to 333.5 mg of calcium acetate, anhydrous basis, dimensioned for fitting within and optimizing the inner volume of the #2 size capsule.

33. The method of claim 30, wherein the capsule is a #0 capsule and wherein the calcium acetate caplet contains a dosage amount equivalent to 708 mg of monohydrous calcium acetate dimensioned for fitting within an optimizing the inner volume of the #0 size capsule.

34. The method of claim 30, wherein the capsule is a #2 size capsule and wherein the calcium acetate caplet contains a dosage amount equivalent to 354 mg of monohydrous calcium acetate dimensioned for fitting within and optimizing the inner volume of the #2 size capsule.

35. A drug delivery vehicle for orally administering calcium acetate to a patient, said drug delivery vehicle comprising: an outer capsule defining an inner volume; an inner caplet comprising the calcium acetate, the calcium acetate having a bulk density such that the calcium acetate can be compressed to form a tablet dimensioned for fitting within and optimizing inner volume of said capsule.

36. A drug delivery vehicle for administering a granulated or powdered calcium acetate to a patient comprising: an outer capsule defining an inner volume; an inner caplet comprising a desired quantity of the granulated or powdered calcium acetate; wherein the calcium acetate is compressed into a caplet dimensioned to fit in and optimizing the volume of said capsule.
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