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Last Updated: April 23, 2024

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

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bayer Healthcare Pharmaceuticals Inc.	TRASYLOL	aprotinin	Injection	020304	12/29/1993	⤷ Try a Trial	2004-09-08
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015	⤷ Try a Trial	2004-09-08
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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