Multi-use vessels for vitamin D formulations

• US 20040053895A1
• Filed: 09/18/2002
• Published: 03/18/2004
• Est. Priority Date: 09/18/2002
• Status: Abandoned Application

• Current Assignee: Bone Care International Inc (Sanofi )
• Original Assignee: Bone Care International Inc (Sanofi )
• Inventors: LeVan, Leon W., Goldensoph, Creighton Reed, Driscoll, Jeffrey W., Mazess, Richard B.
• Application Number:
  US10/247,766
• Publication Number:
  US 20040053895A1
• Time in Patent Office: Days
• US Class Current: 514/167
• CPC Class Codes: A61K 31/59 Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems

Abstract

This invention relates to multi-use dispensing vessels containing pharmaceutical formulations of active vitamin D compounds, and also to plastic blow fill containers containing active vitamin D formulations.

Claims

1. A multi-use vessel comprising a pharmaceutical formulation and a package insert including instructions for use and governmental regulatory agency approval for multi-use, the formulation comprising an active vitamin D compound, a non-ionic solubilizer, a lipophilic antioxidant and an aqueous vehicle.

2. A vessel as set forth in claim 1 further comprising a needleless access vial.

3. A vessel as set forth in claim 2, wherein the vial has a volume greater than 2 mL and the formulation has a volume of greater than 2 mL.

4. A vessel as set forth in claim 3, wherein the vitamin D includes an active vitamin D which includes a vitamin D precursor or a vitamin D metabolite.

5. A vessel as set forth in claim 4, wherein the vitamin D includes doxercalciferol, seocalcitol, maxacalcitol, falecalcitriol, calcitriol, calcipotriol and paricalcitol.

6. A vessel as set forth in claim 5, wherein the vitamin D compound includes doxercalciferol.

7. A vessel as set forth in claim 5, wherein the vitamin D compound includes seocalcitol.

8. A vessel as set forth in claim 5, wherein the vitamin D compound includes calcitriol.

9. A vessel as set forth in claim 5, wherein the vitamin D compound includes paricalcitol.

10. A vessel as set forth in claim 5, wherein the vitamin D compound includes calcipotriol.

11. A vessel as set forth in claim 5, wherein the vitamin D compound includes maxacalcitol.

12. A vessel as set forth in claim 5, wherein the vitamin D compound includes falecalcitriol.

13. A vessel as set forth in claim 1, wherein the non-ionic solubilizer includes polyoxyalkylenes, polysorbates, fatty acid esters of glycerol, cyclodextrins, dextrans, fatty alcohol ethers of oligoglucosides and polyoxyethylene type compounds.

14. A vessel as set forth in claim 13, wherein the non-ionic solubilizer is a polysorbate.

15. A vessel as set forth in claim 1, wherein the lipophilic antioxidant includes butylated hydroxytoluene (BHT), lipoic acid, lycopene, lutein, lycophyll, xanthophyll, carotene, zeaxanthin or vitamin E and esters thereof.

16. A vessel as set forth in claim 15, wherein the lipophilic antioxidant is BHT.

17. A vessel as set forth in claim 13, wherein the non-ionic solubilizer is present at a concentration of about 0.05% to about 5% w/w.

18. A vessel as set forth in claim 15, wherein the lipophilic antioxidant is present at a concentration of about 20 to about 2000 ppm.

19. A vessel as set forth in claim 3, wherein the vitamin D is administered in a dose of about 2 μ

g to about 100μ

/dose.

20. A vessel as set forth in claim 3, wherein the formulation is suitable for patenteral administration.

21. A vessel as set forth in claim 3, wherein the formulation is administered on an episodically.

22. A vessel as set forth in claim 21, wherein the formulation is administered one to three times per week.

23. A vessel as set forth in claim 3, wherein the formulation is administered on a daily basis.

24. A vessel as set forth in claim 3, wherein the formulation further comprises an optional agent.

25. A vessel as set forth in claim 24, wherein the optional agent includes an alcohol.

26. A vessel as set forth in claim 25, wherein the alcohol is present at a concentration of 0% to about 30% w/w.

27. A vessel as set forth in claim 25, wherein the alcohol includes ethanol.

28. A vessel as set forth in claim 25, wherein the alcohol includes benzyl alcohol.

40. A method of treating diseases or disorders which include hyperproliferative diseases, disorders of calcium metabolism, and hyperparathyroidism, comprising parenterally administering to a mammal in need thereof a dosage form comprising the multi-use vessel of claim 1.

41. A method as set forth in claim 40, wherein the hyperproliferative diseases are cancers of the breast, colon, prostate and pancreas.

42. A method as set forth in claim 40, wherein the hyperproliferative disease is psoriasis.

43. A method as set forth in claim 40, wherein the hyperparathyroidism is secondary hyperparathyroidism.

44. A method as set forth in claim 40, wherein the disease or disorder is disorders of calcium metabolism.

29. A multi-use vessel comprising a needleless access vial and a vitamin D formulation, the formulation comprising an active vitamin D compound, a non-ionic solubilizer, a lipophilic agent, an organic solvent and an aqueous vehicle, the vial and formulation having volumes greater than 2 mL.

30. A vessel comprising a greater than 2 mL, multi-use, needleless access vial containing a vitamin D formulation, and a package insert including instructions for use and approval from a regulatory agency for multi-use.

31. A vessel as set forth in claim 30, wherein the formulation includes doxercalferol.

32. A vessel as set forth in claim 30, wherein the formulation includes paricalcitol.

33. A vessel as set forth in claim 30, wherein the formulation includes calcitriol.

34. A vessel as set forth in claim 30, wherein the formulation includes seocalcitol.

35. A vessel as set forth in claim 30, wherein the formulation includes calcipotriol.

36. A vessel as set forth in claim 30, wherein the formulation includes maxacalcitol.

37. A vessel as set forth in claim 30, wherein the formulation includes falecalcitriol.

38. A vessel as set forth in claim 30, wherein the formulation includes about 0.05% to about 5% w/w non-ionic solubilizer, about 20 to about 2000 ppm lipophilic antioxidant, and 0% to about 30% organic solvent.

39. A vessel as set forth in claim 38, wherein the formulation includes about 0.5% to about 5% w/w/TWEEN™

-20, 20 ppm BHT, and 2.5% w/w benzyl alcohol.

45. A vessel comprising a plastic, blow-fill vial containing a vitamin D formulation, and a package insert including instructions for use and marketing approval from a governmental regulatory agency.

46. A vessel as set forth in claim 45 further comprising a luer lock.

47. A vessel as set forth in claim 45, wherein doses of the formulation are administered episodically.

48. A vessel as set forth in claim 47, wherein the formulation is administered once per week to three times per week.

50. A method of treating a subject with an active vitamin D compound, comprising administering parenterally to the subject a dosage form comprising the vessel of claim 45.

49. A vessel as set forth in 45, wherein doses of the formulation are administered on a daily basis.

51. A multi-use vessel comprising a pharmaceutical formulation and a package insert including instructions for use and governmental regulatory agency approval for multi-use, the formulation comprising an active vitamin D compound.