Encapsulated calcium acetate caplet and a method for inhibiting gastrointestinal phosphorous absorption
View Patent ↗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.
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.