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Claims for Patent: 7,829,595

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Claims for Patent: 7,829,595

Title:Rapid dissolution formulation of a calcium receptor-active compound
Abstract:The present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of a calcium receptor-active compound and at least one pharmaceutically acceptable excipient, wherein the composition has a controlled dissolution profile. The present invention further relates to a method of manufacturing the pharmaceutical composition, as well as a method of treating a disease using the pharmaceutical composition.
Inventor(s): Lawrence; Glen Gary (Thousand Oaks, CA), Alvarez; Francisco J. (Newbury Park, CA), Lin; Hung-Ren H. (Oak Park, CA), Ju; Tzuchi R. (Vernon Hills, IL)
Assignee: Amgen Inc. (Thousand Oaks, CA)
Application Number:10/937,870
Patent Claims: 1. A pharmaceutical composition comprising (a) from about 10% to about 40% by weight of cinacalcet HCl; (b) from about 40% to about 75% by weight of microcrystalline cellulose; (c) from about 1% to about 5% by weight of povidone; (d) from about 5% to about 35% by weight of starch; (e) from about 1% to about 10% by weight of crospovidone; (f) from about 0.05% to about 1.5% by weight of colloidal silicon dioxide; and (g) from about 0.05% to about 1.5% by weight of magnesium stearate; wherein the percentage by weight is relative to the total weight of the composition.

2. The composition according to claim 1 further comprising at least one ingredient chosen from lubricants and clear and color coating materials.

3. The composition according to claim 1 further comprising from about 1% to about 6% by weight of at least one coating material chosen from clear and color coating materials relative to the total weight of the composition.

4. The composition according to claim 1, wherein the cinacalcet HCl in a form chosen from amorphous powders, crystalline particles, matrix particles, and mixtures of any of the foregoing.

5. The composition according to claim 1, wherein the cinacalcet HCl is in a form chosen from needle-shape particles, rod-shape particles, plate-shaped particles, and mixtures of any of the foregoing.

6. The composition according to claim 1, wherein the particle D.sub.50 of the cinacalcet HCl particles is less than or equal to about 50 .mu.m.

7. The composition according to claim 1, wherein the composition is in the form of granules.

8. The composition according to claim 1, wherein the composition is in a form chosen from tablets, capsules, and powders.

9. The composition according to claim 7, wherein the granules have a granule D.sub.50 measured using a sieve analysis ranging from about 50 .mu.m to about 150 .mu.m.

10. The composition according to claim 9, wherein the granules have a granule D.sub.50 measured using a sieve analysis ranging from about 80 .mu.m to about 130 .mu.m.

11. The composition according to claim 1, wherein the cinacalcet HCl is present in a therapeutically effective amount for the treatment of at least one of hyperparathyroidism, hyperphosphonia, hypercalcemia, and elevated calcium phosphorus product.

12. The composition according to claim 1, wherein the cinacalcet HCl is present in an effective dosage amount for the treatment of at least one of hyperparathyroidism, hyperphosphonia, hypercalcemia, and elevated calcium phosphorus product.

13. The composition according to claim 11, wherein the hyperparathyroidism is chosen from primary hyperparathyroidism and secondary hyperparathyroidism.

14. The composition according to claim 12, wherein the hyperparathyroidism is chosen from primary hyperparathyroidism and secondary hyperparathyroidism.

15. The composition according to claim 1, wherein the cinacalcet HCl is present in an amount ranging from about 10% to about 30% by weight relative to the total weight of the composition.

16. The composition according to claim 15, wherein the cinacalcet HCl is present in an amount ranging from about 15% to about 20% by weight relative to the total weight of the composition.

17. The composition according to claim 1, wherein crospovidone is present intergranularly, intragranularly, or a combination thereof.

18. The composition according to claim 1, wherein crospovidone is present intergranularly.

19. The composition according to claim 1, wherein crospovidone is present intragranularly.

20. The composition according to claim 1, wherein the microcrystalline cellulose and starch are present in a weight ratio ranging from about 1:1 to about 15:1.

21. The composition according to claim 20, wherein the weight ratio is about 10:1.

22. The composition according to claim 20, wherein the weight ratio ranges from about 1:1 to about 10:1.

23. The composition according to claim 22, wherein the weight ratio is about 5:1.

24. A method for the treatment of at least one disease chosen from hyperparathyroidism, hyperphosphonia, hypercalcemia, and elevated calcium phosphorus product, comprising administering to a patient in need thereof a pharmaceutical composition according to claim 1.

25. The method according to claim 24, wherein the patient is human.
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