Claims
- 1. A substantially sterile extract of Nerium species.
- 2. The extract defined in claim 1, wherein the Nerium species comprises Nerium oleander.
- 3. The extract defined in claim 1, wherein the concentration of endotoxins in the extract is less than about 300 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 150 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 120 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 100 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 80 units/mL.
- 8. 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.
- 9. The extract defined in claim 1, wherein the extract is in liquid form.
- 10. The extract defined in claim 1, wherein the extract is in aqueous form.
- 11. The extract defined in claim 1, wherein the extract is in solid form.
- 12. The extract defined in claim 1, wherein the extract is in powdered form.
- 13. The extract defined in claim 12, wherein the powdered form of the extract is prepared by drying a liquid comprising the extract.
- 14. The extract defined in claim 13, wherein said drying comprises freeze-drying.
- 15. The extract defined in claim 13, wherein said drying comprises spray-drying.
- 16. The extract defined in claim 13, wherein said drying comprises at least one of heating and evaporating.
- 17. A method for producing a substantially sterile extract of Nerium species, the method comprising the steps of:
(i) dispersing plant matter of the Nerium species in water; (ii) heating the dispersed plant matter for at least about 1.0 hour; (iii) separating the heated water from the plant matter to produce a crude extract; and (iv) sterilizing the crude extract to produce the substantially sterile extract of Nerium species.
- 18. The method defined in claim 17, wherein the Nerium species is Nerium oleander.
- 19. The method defined in claim 17, wherein Step (ii) is conducted at a temperature of at least about 40° C.
- 20. The method defined in claim 17, wherein Step (ii) is conducted at a temperature in the range of from about 70° C. to about 120° C.
- 21. The method defined in claim 17, wherein Step (ii) is conducted at a temperature in the range of from about 80° C. to about 110° C.
- 22. The method defined in claim 17, wherein Step (ii) is conducted at a temperature in the range of from about 90° C. to about 100° C.
- 23. The method defined in claim 17, wherein Step (ii) is conducted for a period in the range of from about 1.0 to about 24.0 hours.
- 24. The method defined in claim 17, wherein Step (ii) is conducted for a period in the range of from about 1.0 to about 10.0 hours.
- 25. The method defined in claim 17, wherein Step (ii) is conducted for a period in the range of from about 1.0 to about 5.0 hours.
- 26. The method defined in claim 17, wherein Step (iv) comprises reducing the concentration of endotoxins in the extract to a value less than about 300 units/mL.
- 27. The method defined in claim 17, wherein Step (iv) comprises reducing the concentration of endotoxins in the extract to a value in the range of from about 20 units/mL to about 150 units/mL.
- 28. The method defined in claim 17, wherein Step (iv) comprises reducing the concentration of endotoxins in the extract to a value in the range of from about 20 units/mL to about 120 units/mL.
- 29. The method defined in claim 17, wherein Step (iv) comprises reducing the concentration of endotoxins in the extract to a value in the range of from about 20 units/mL to about 100 units/mL.
- 30. The method defined in claim 17, wherein Step (iv) comprises reducing the concentration of endotoxins in the extract to a value in the range of from about 20 units/mL to about 80 units/mL.
- 31. The method defined in claim 17, wherein Step (iv) comprises reducing the concentration of endotoxins in the extract to a value in the range of from about 20 units/mL to about 50 units/mL.
- 32. The method defined in claim 17, wherein Step (iv) comprises filter sterilizing the crude extract.
- 33. The method defined in claim 17, wherein Step (iv) comprises passing the crude extract through a filter having an average porosity of less than about 1 μm.
- 34. The method defined in claim 17, wherein Step (iv) comprises passing the crude extract through a filter having an average porosity of less than about 0.8 μm.
- 35. The method defined in claim 17, wherein Step (iv) comprises passing the crude extract through a filter having an average porosity of less than about 0.5 μm.
- 36. The method defined in claim 17, wherein Step (iv) comprises passing the crude extract through a filter having an average porosity of about 0.2 μm.
- 37. The method defined in claim 17, wherein, prior to Step (iv), the crude extract is subject to a further heating step.
- 38. The method defined in claim 37, wherein the further heating step is conducted for a period of at least about 1.5 hours at a temperature of at least about 100° C.
- 39. A pharmaceutical composition comprising a substantially sterile extract of Nerium species, together with at least one pharmaceutically acceptable excipient therefor.
- 40. The pharmaceutical composition defined in claim 39, wherein the Nerium species comprises Nerium oleander.
- 41. The pharmaceutical composition defined in claim 39, wherein the concentration of endotoxins in the extract is less than about 300 units/mL.
- 42. The pharmaceutical composition defined in claim 39, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 150 units/mL.
- 43. The pharmaceutical composition defined in claim 39, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 120 units/mL.
- 44. The pharmaceutical composition defined in claim 39, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 100 units/mL.
- 45. The pharmaceutical composition defined in claim 39, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 80 units/mL.
- 46. The pharmaceutical composition defined in claim 39, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 50 units/mL.
- 47. The pharmaceutical composition defined in claim 39, wherein the pharmaceutical composition is in the form of an injectable liquid.
- 48. The pharmaceutical composition defined in claim 39, wherein the pharmaceutical composition is in the form of a topical formulation.
- 49. The pharmaceutical composition defined in claim 48, wherein the topical formulation comprises a cream.
- 50. The pharmaceutical composition defined in claim 39, wherein the pharmaceutical formulation is in the form of an oral formulation.
- 51. The pharmaceutical composition defined in claim 50, wherein the oral formulation is selected from the group comprising tablets, caplets and capsules.
- 52. A process for producing a pharmaceutical composition comprising comprising the steps of:
(i) mixing a substantially sterile extract of Nerium species with at least one pharmaceutically acceptable excipient and water; (ii) drying the mixture produced in Step (i).
- 53. The process defined in claim 52, wherein the Nerium species comprises Nerium oleander.
- 54. The process defined in claim 52, wherein the concentration of endotoxins in the extract is less than about 300 units/mL.
- 55. The process defined in claim 52, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 150 units/mL.
- 56. The process defined in claim 52, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 120 units/mL.
- 57. The process defined in claim 52, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 100 units/mL.
- 58. The process defined in claim 52, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 80 units/mL.
- 59. The process defined in claim 52, wherein concentration of endotoxins in the extract is in the range of from about 20 units/mL to about 50 units/mL.
- 60. The process defined in claim 52, comprising the further step of reconstituting the dried pharmaceutical composition with a liquid carrier to produce an injectable liquid.
- 61. The process defined in claim 52, wherein the pH of the mixture during Step (i) is maintained in the range of from about 5 to about 8.
- 62. The process defined in claim 52, wherein the pH of the mixture during Step (i) is maintained in the range of from about 5 to about 7.
- 63. The process defined in claim 52, wherein Step (ii) comprises freeze-drying the mixture.
- 64. The process defined in claim 52, wherein Step (ii) comprises spray-drying the mixture.
- 65. The process defined in claim 52, wherein Step (ii) comprises at least one of heating and evaporating the mixture.
RELATED APPLICATION
[0001] This patent application claims the priority date of United States provisional patent application S.No. 60/101,622, filed Sep. 24, 1998, the contents of which are hereby incorporated by reference.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60101622 |
Sep 1998 |
US |