Claims for Patent: 6,565,897

Summary for Patent: 6,565,897

Title:	Extract of nerium species, pharmaceutical composition thereof and methods for preparation thereof
Abstract:	A substantially sterile extract of Nerium species is described, together with a method for production thereof. A pharmaceutical composition comprising the extract is also described, together with a method for production thereof. The pharmaceutical composition is useful for the treatment of cell-proliferative and immune deficient diseases in mammals, including cancer and AIDS, respectively.
Inventor(s):	Selvaraj; Ulagaraj (San Antonio, TX), Singh; Chandra U. (San Antonio, TX), Ozel; Huseyin Z. (Istanbul, TK)
Assignee:	Ozelle Pharmaceuticals, Inc. (San Antonio, TX)
Application Number:	09/401,494
Patent Claims:	1. A substantially sterile water-extract of Nerium species having an endotoxin concentration of less than about 150 units/mL. 2. The extract defined in claim 1, wherein the Nerium species comprises Nerium oleander. 3. The extract defined in claim 1, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 150 units/mL. 4. The extract defined in claim 1, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 120 units/mL. 5. The extract defined in claim 1, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 100 units/mL. 6. The extract defined in claim 1, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 80 units/mL. 7. The extract defined in claim 1, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 50 units/mL. 8. The extract defined in claim 1, wherein the extract is in liquid form. 9. The extract defined in claim 1, wherein the extract is in aqueous form. 10. The extract defined in claim 1, wherein the extract is in solid form. 11. The extract defined in claim 1, wherein the extract is in powdered form. 12. The extract defined in claim 11, wherein the powdered form of the extract is prepared by drying a liquid comprising the extract. 13. The extract defined in claim 12, wherein said drying comprises freeze-drying. 14. The extract defined in claim 12, wherein said drying comprises spray-drying. 15. The extract defined in claim 12, wherein said drying comprises at least one of heating and evaporating. 16. A pharmaceutical composition comprising a substantially sterile water-extract of Nerium species having an endotoxin concentration of less than about 150 units/mL, together with at least one pharmaceutically acceptable excipient therefor. 17. The pharmaceutical composition defined in claim 16, wherein the Nerium species comprises Nerium oleander. 18. The pharmaceutical composition defined in claim 16, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 150 units/mL. 19. The pharmaceutical composition defined in claim 16, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 120 units/mL. 20. The pharmaceutical composition defined in claim 16, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 100 units/mL. 21. The pharmaceutical composition defined in claim 16, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 80 units/mL. 22. The pharmaceutical composition defined in claim 16, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 50 units/mL. 23. The pharmaceutical composition defined in claim 16, wherein the pharmaceutical composition is in the form of an injectable liquid. 24. The pharmaceutical composition defined in claim 16, wherein the pharmaceutical composition is in the form of a topical formulation. 25. The pharmaceutical composition defined in claim 24, wherein the topical formulation comprises a cream. 26. The pharmaceutical composition defined in claim 16, wherein the pharmaceutical formulation is in the form of an oral formulation. 27. The pharmaceutical composition defined in claim 26, wherein the oral formulation is selected from the group comprising tablets, caplets and capsules. 28. A process for producing a pharmaceutical composition comprising the steps of: (i) mixing a substantially sterile water-extract of Nerium species with at least one pharmaceutically acceptable excipient and water, the extract having an endotoxin concentration of less than about 150 units/mL; and (ii) drying the mixture produced in Step (i). 29. The process defined in claim 28, wherein the Nerium species comprises Nerium oleander. 30. The process defined in claim 28, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 150 units/mL. 31. The process defined in claim 28, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 120 units/mL. 32. The process defined in claim 28, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 100 units/mL. 33. The process defined in claim 28, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 80 units/mL. 34. The process defined in claim 28, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 50 units/mL. 35. The process defined in claim 28, comprising the further step of reconstituting the dried pharmaceutical composition with a liquid carrier to produce an injectable liquid. 36. The process defined in claim 28, wherein the pH of the mixture during Step (i) is maintained in the range of from about 5 to about 8. 37. The process defined in claim 28, wherein the pH of the mixture during Step (i) is maintained in the range of from about 5 to about 7. 38. The process defined in claim 28, wherein Step (ii) comprises freeze-drying the mixture. 39. The process defined in claim 28, wherein Step (ii) comprises spray-drying the mixture. 40. The process defined in claim 28, wherein Step (ii) comprises at least one of heating and evaporating the mixture.

Details for Patent 6,565,897

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		2018-09-24