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Last Updated: May 10, 2024

Claims for Patent: 5,496,801

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Summary for Patent: 5,496,801

Title:	Parathyroid hormone formulation
Abstract:	Described herein are preparations containing parathyroid hormone that has been stablized with an excipient and buffering agent. Preferred preparations incorporate human PTH(1-84), mannitol as excipient and citrate as buffering agent, and are incorporated in vials as a freeze-dried powder for reconstitution to treat osteoporosis.
Inventor(s):	Holthuis; Josephus J. M. (AJ Leiden, NL), Mekking; Albert (CR Woerden, NL), Voetman; Alwinus A. (DT Zwanenburg, NL)
Assignee:	Allelix BioPharmaceuticals Inc. (Ontario, CA)
Application Number:	08/172,206
Patent Claims:	1. A parathyroid hormone preparation, comprising: a medically useful amount of parathyroid hormone (1-84); a polyol excipient that co-lyophilizes with said hormone to yield an amorphous cake; a non-volatile buffering agent in an amount sufficient to adjust the pH of the preparation to within a physiologically acceptable pH range; and water. 2. A parathyroid hormone preparation according to claim 1, wherein said excipient is mannitol. 3. A parathyroid hormone formulation according to claim 1, wherein the buffering agent is a citrate source. 4. A parathyroid hormone formulation according to claim 3, wherein said excipient is mannitol. 5. A parathyroid hormone preparation according to claim 1, in the form of a freeze-dried powder containing not more than 2% water by weight. 6. A parathyroid hormone preparation according to claim 5, wherein the hormone is human PTH(1-84). 7. A parathyroid hormone preparation according to claim 6, wherein said excipient is mannitol. 8. A parathyroid hormone preparation according to claim 7, wherein the buffering agent is a citrate source. 9. A parathyroid hormone preparation according to claim 8, wherein said excipient is mannitol. 10. A parathyroid hormone preparation comprising parathyroid hormone (1-84) in a concentration within the range from 25 to 250 .mu.g/mL; mannitol in a concentration in the range from 3 to 7% (w/v); citrate buffer in an amount sufficient to adjust the pH of the preparation to within the range from pH 3.5 to pH 6.5; and water. 11. A parathyroid hormone preparation according to claim 10, wherein the parathyroid hormone is human PTH(1-84). 12. A parathyroid hormone preparation according to claim 11, in the form of a freeze-dried powder containing not more than 2% water by weight. 13. A parathyroid hormone preparation according to claim 12, wherein mannitol is present in a concentration within the range from 4 to 6%. 14. A parathyroid hormone preparation according to claim 13, wherein the citrate buffer is present in an amount sufficient to adjust the pH of the preparation to pH 6.+-.0.4. 15. A vial containing a parathyroid hormone preparation according to claim 1. 16. A vial containing a parathyroid hormone preparation according to claim 5. 17. A vial containing a parathyroid hormone preparation according to claim 9. 18. A vial containing a parathyroid hormone preparation according to claim 12. 19. A kit useful to formulate an injectable PTH solution, comprising at least one first vial containing a parathyroid hormone preparation as defined in claim 5, at least one second vial containing sterile water for reconstituting said preparation, and a sheet instructing preparation of a formulation therefrom. 20. The kit according to claim 19, further comprising a device for injection of the reconstituted PTH solution. 21. A parathyroid hormone preparation as claimed in claim 1, consisting of: a medically useful amount of parathyroid hormone (1-84); an excipient that co-lyophilizes with said hormone to yield an amorphous cake; a non-volatile buffering agent in an amount sufficient to adjust the pH of the preparation to within a physiologically acceptable pH range; and water. 22. A parathyroid hormone preparation as claimed in claim 1, consisting of: parathyroid hormone (1-84) in a concentration within the range from 25 to 250 .mu.g/mL; mannitol in a concentration in the range from 3 to 7% (w/v); citrate buffer in an amount sufficient to adjust the pH of the preparation to within the range from pH 3.5 to pH 6.5; and water. 23. A parathyroid hormone preparation as claimed in claim 1, wherein the polyol excipient and the non-volatile buffering agent are the only substances added to render the composition stable during storage. 24. A parathyroid hormone preparation as claimed in claim 10, wherein D-mannitol and citrate buffer are the only substances added to render the composition stable during storage.

Details for Patent 5,496,801

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006	⤷ Try a Trial	2039-03-29
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015	⤷ Try a Trial	2039-03-29
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

International Patent Family for US Patent 5,496,801

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	9517207	⤷ Try a Trial
Slovakia	82896	⤷ Try a Trial
Portugal	735896	⤷ Try a Trial
Poland	315158	⤷ Try a Trial
New Zealand	277463	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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