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Last Updated: September 24, 2020

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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

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Merck Sharp & Dohme Corp. ZOSTAVAX zoster vaccine live INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 125123 001 2006-05-25   Start Trial Allelix BioPharmaceuticals Inc. (Ontario, CA) 2039-03-29 search
Merck Sharp & Dohme Corp. ZOSTAVAX zoster vaccine live INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 125123 1 2006-05-25   Start Trial Allelix BioPharmaceuticals Inc. (Ontario, CA) 2039-03-29 search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 001 2015-01-23   Start Trial Allelix BioPharmaceuticals Inc. (Ontario, CA) 2039-03-29 RX Orphan company
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 002 2015-01-23   Start Trial Allelix BioPharmaceuticals Inc. (Ontario, CA) 2039-03-29 RX Orphan company
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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