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Last Updated: October 16, 2019

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Claims for Patent: 4,692,433

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Summary for Patent: 4,692,433
Title: Method and composition for regulating serum calcium levels of mammals
Abstract:Method for regulating serum calcium levels in mammals by orally administering a composition which includes a polypeptide hormone such as parathyroid hormone (PTH) or calcitonin. The polypeptide hormone is protected from destruction in the digestive tract by encapsulation in liposomes. The liposome preferably includes a cationic amphiphilic agent so that the surface of the liposome has a net positive charge. Agents for enhancing the action of the liposome encapsulated hormones are also disclosed.
Inventor(s): Hostetler; Karl Y. (Del Mar, CA), Deftos; Leonard J. (Del Mar, CA)
Assignee: The Regents of the University of California (Berkeley, CA)
Application Number:06/761,751
Patent Claims:1. A method for regulating blood calcium levels in a mammal which comprises: orally administering to said mammal a blood calcium-regulating effective amount of a composition consisting essentially of an aqueous solution of a polypeptide hormone selected from the group consisting of parathyroid hormone and calcitonin, said polypeptide hormone being encapsulated in a liposome.

2. A method according to claim 1 wherein said polypeptide hormone is parathyroid hormone.

3. A method according to claim 2 wherein said polypeptide hormone is the hPTH 1-34 fragment of parathyroid hormone.

4. A method according to claim 1 wherein said polypeptide hormone is calcitonin.

5. A method according to claim 1 wherein said liposome contains from about 1 to 20 molar percentage of an alkylamine having the general formula C.sub.n H.sub.2n+1 NH.sub.2, where n is 12 to 20.

6. A method according to claim 5 wherein said alkylamine is stearylamine.

7. A method according to claim 1 including the additional step of administering salicylate, salicylamide, acetylsalicylate or methylsalicylate to said mammal to improve the blood calcium-regulating action of said polypeptide hormone encapsulated in said liposome.

8. A method according to claim 1 wherein said liposome is made from phospholipids selected from the group consisting of phosphatidylcholine, dimyristoylphosphatidylcholine and dipalmitoylphosphatidylcholine.

9. A composition for use in oral administration in mammals to regulate blood calcium levels, said composition consisting essentially of a polypeptide hormone selected from the group consisting of parathyroid hormone and calcitonin, said polypeptide hormone being encapsulated in a liposome, said liposome containing from about 1 to 20 molar percentage of an alkylamine having the general formula C.sub.n H.sub.2n+1 NH.sub.2,where n is 12 to 20.

10. A composition according to claim 9 wherein said polypeptide hormone is parathyroid hormone.

11. A composition according to claim 9 wherein said polypeptide hormone is calcitonin.

12. A composition according to claim 9 wherein said polypeptide hormone is the hPTH 1-34 amino acid fragment of parathyroid hormone.

13. A composition according to claim 9 wherein said alkylamine is stearylamine.

14. A composition according to claim 9 wherein said liposome is made from phospholipids selected from the group consisting of phosphatidylcholine, dimyristoylyphosphatidylcholine and dipalmitoylphosphatidylcholine.

15. A method according to claim 1 including the additional step of administering aprotinin to said mammal to improve the blood calcium-regulating action of said polypeptide hormone encapsulated in said liposome.

16. A method according to claim 4 wherein said polypeptide hormone is salmon calcitonin.

17. A composition according to claim 11 wherein said polypeptide hormone is salmon calcitonin.

18. A composition for oral administration in mammals to regulate blood calcium levels, said composition comprising:

a polypeptide hormone selected from the group consisting of parathyroid hormone and calcitonin, said polypeptide hormone being encapsulated in a liposome, said liposome containing from about 1 to 20 molar percentage of an alkylamine having a general formula C.sub.n H.sub.2n+1 NH.sub.2, where n is 12 to 20; and

a pharmaceutically acceptable aqueous buffer solution have a pH of between about 4.0 and 8.0.

19. A composition for oral administration according to claim 18 wherein cysteine is added to said buffer solution as a preservative.

20. A composition for oral administration according to claim 18 wherein aprotinin, salicylate, salicylamide, acetylsalicylate or methylsalicylate is added to said buffer solution in an amount sufficient to improve the calcium-regulating action of said polypeptide hormone encapsulated in said liposome.

21. A composition for oral administration according to claim 18 wherein said polypeptide hormone is calcitonin.

22. A composition for oral administration according to claim 18 wherein said alkylamine is stearylamine.

Details for Patent 4,692,433

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 001 2015-01-23   Request a Trial The Regents of the University of California (Berkeley, CA) 2004-09-08 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 002 2015-01-23   Request a Trial The Regents of the University of California (Berkeley, CA) 2004-09-08 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 003 2015-01-23   Request a Trial The Regents of the University of California (Berkeley, CA) 2004-09-08 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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