Claims for Patent: 5,164,181

Summary for Patent: 5,164,181

Title:	Enzyme castration of animals
Abstract:	Male animals may be chemically castrated by injecting both testes and/or both spermatic cords with a castratingly effective amount of a protease enzyme such as a chymopapain-rich enzyme preparation.
Inventor(s):	Silver; Jules (Niantic, CT), Hopkins, II; Robert E. (Scituate, MA)
Assignee:	Robert E. Hopkins, II, D.V.M., Inc. (Scituate, MA)
Application Number:	07/820,272
Patent Claims:	1. A method of chemically castrating male animals which comprises injecting into the testes or into the spermatic cords a castratingly effective amount of a protease enzyme preparation which does not effectively break down the outer collagen membrane of the testes to permit substantial and toxic release of the enzyme into the body of the animal and which is substantially free of collagenase activity. 2. A method of chemically castrating male animals which comprises injecting into the testes or into the spermatic cord a castratinly effective amount of a protease enzyme preparation which does not effectively break down the outer collagen membrane of the testes to permit substantial and toxic release of the enzyme into the body of the animal and which comprises chymopapain. 3. The method of claim 2 in which said enzyme preparation has a buffered pH of about 7.2 to 8.2. 4. The method of claim 2 in which said enzyme preparation comprises a chymopapain activity-stabilizing amount of EDTA and cysteine. 5. The method of claim 2 in which said enzyme preparation comprises a fluorescent marker material in effective concentration to be detactable in the animal's urine if the enzyme preparation escapes from the region of the testes. 6. The method of claim 2 in which said enzyme preparation comprises an effective concentration of a loca anesthetic. 7. The method of claim 2 in which said enzyme preparation comprises a vasoconstrictor in sufficient concentration to cause constriction of precapillary arterioles in the testes upon injection of said preparation into the testes, whereby migration of said enzyme from the testes is further inhibited. 8. The method of claim 7 in which said vasoconstrictor comprises epinephrine. 9. The method of claim 2 in which at least a portion of said enzyme preparation is injected into the epididymis of the testes. 10. The method of claim 2 in which said enzyme preparation comprises a chymopapain activity-stabilizing amount of EDTA and cysteine, said enzyme preparation also comprising a vasoconstrictor in sufficient concentration to cause constriction of precapillary arterioles in the testes upon injection of said preparation into the testes, whereby migration of said enzyme from the testes is inhibited. 11. The method of claim 10 in which said enzyme preparation has a buffered pH of about 7.2 to 8.2. 12. The method of claim in which said enzyme preparation comprises a fluorescent marker material in effective concentration to be detectable in the animals's urine if the enzyme preparation escapes from the region of the testes. 13. The method of claim 12 in which said enzyme preparation comprises an effective concentration of a local anesthetic. 14. The method of claim 13 in which said vasoconstrictor comprises epinephrine. 15. An injectable preparation which comprises a pharmaceutically acceptable, aqueous suspension of essentially 150 to 400 units per ml. of a protease enzyme preparation which does not effectively break down the outer collagen membrane of the testes to permit substantial and toxic release of the enzyme into the body of the animal and substantially free of collagenase activity, and a vasoconstrictor in sufficient concentration to cause constriction of nearby precapillary arterioles upon injection of said preparation into an animal in a clinically effective amount. 16. The preparation of claim 15 in which said protease enzyme preparation comprises chymopapain. 17. The preparation of claim 16 which comprises from 0.2 to 20 mg. of a fluorescent marker material per ml. of said preparation, to be detectable in the urine of an animal after injection of said preparation if the enzyme preparation escapes from the region of injection. 18. The preparation of claim 16 which comprises an effective concentration of a local anesthetic when a castratingly effective amount of such preparation is injected into a testicle. 19. The preparation of claim 16 in which said vasoconstrictor comprises epinephrine. 20. The preparation of claim 16 which comprises a chymopapain activity-stabilizing amount of EDTA and cysteine. 21. The preparation of claim 16 which has a buffered pH of about 7.2 to 8.2.

Details for Patent 5,164,181

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Discure Medical, Llc	CHYMODIACTIN	chymopapain	For Injection	018663	11/10/1982		2039-02-26
Discure Medical, Llc	CHYMODIACTIN	chymopapain	For Injection	018663	08/21/1984		2039-02-26
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2039-02-26