Claims
- 1. A pharmaceutical preparation comprising:
(a) botulinum neurotoxin; (b) lactose; and (c) phosphatidylcholine effectively made into a liposome which incorporates said botulinum neurotoxin.
- 2. The pharmaceutical preparation of claim 1 wherein said botulinum neurotoxin is 95-99% pure botulinum neurotoxin complex.
- 3. The pharmaceutical preparation of claim 1 wherein said botulinum neurotoxin is 95-99% pure purified botulinum neurotoxin.
- 4. The pharmaceutical preparation of claim 1 wherein said botulinum neurotoxin is 95-99% pure botulinum neurotoxin.
- 5. The pharmaceutical preparation of claim 2 wherein said botulinum neurotoxin complex is selected from the group consisting of botulinum neurotoxin complex types A, B, C1, C2, D, E, F and G.
- 6. The pharmaceutical preparation of claim 3 wherein said purified botulinum neurotoxin is selected from the group consisting of botulinum neurotoxin complex types A, B, C1, C2, D, E, F and G.
- 7. The pharmaceutical preparation of claim 4 wherein said botulinum neurotoxin is selected from the group consisting of botulinum neurotoxin types A, B, C1, C2, D, E, F and G.
- 8. The pharmaceutical preparation of claim 1 wherein said preparation is lyophilized.
- 9. The pharmaceutical preparation of claim 8 wherein said preparation is stable such that it has substantially no loss of neurotoxin potency for a period of one year when stored at −5 to 37 degrees C.
- 10. The pharmaceutical preparation of claim 8 wherein said preparation is stable such that it has substantially no loss of neurotoxin potency for a period of four years when stored at −5 to 37 degrees C.
- 11. The pharmaceutical preparation of claim 8 wherein upon reconstitution, said preparation retains at least 75% of its neurotoxin potency.
- 12. The pharmaceutical preparation of claim 8 wherein upon reconstitution, said preparation retains at least 75% of its neurotoxin potency.
- 13. The pharmaceutical preparation of claim 8 wherein upon reconstitution, said preparation retains at least 90% of its neurotoxin potency.
- 14. A method of making a pharmaceutical preparation, the method comprising:
(a) providing a solution of phosphatidylcholine in ethanol; (b) subjecting said solution of phosphatidylcholine in ethanol to evaporation until a lipid film is formed; (c) passing an inert gas through the lipid film; (d) re-suspending said lipid film in a sterile chloride solution with phosphate buffer contain botulinum neurotoxin creating an emulsion; (e) homogenizing said emulsion; and (f) sequentially filtering the homogenized emulsion.
- 15. The method of claim 14 further comprising the steps of:
(g) distributing the homogenized and filter emulsion into containers; (h) freezing said emulsion in said containers; and (i) lyophilizing said emulsion.
- 16. The method of claim 15 further comprising the step of hermetically sealing said containers having said lyophilized emulsion with an atmosphere of inert gas introduced over the lypophilized emulsion in the container.
- 17. A method of treating a mammal to achieve a therapeutic effect, the method comprising the step of administering the pharmaceutical preparation of claim 1 to said mammal.
- 18. A method of treating a mammal to achieve a therapeutic effect, the method comprising:
(a) reconstituting the pharmaceutical preparation of claim 8; and (b) administering said reconstituted pharmaceutical preparation to said mammal.
- 19. A pharmaceutical preparation consisting essentially of:
(a) botulinum neurotoxin; (b) lactose; and (c) phosphatidylcholine effectively made into a liposome which incorporates said botulinum neurotoxin.
- 20. The pharmaceutical preparation of claim 19 wherein said botulinum neurotoxin is 95-99% pure botulinum neurotoxin complex.
- 21. The pharmaceutical preparation of claim 19 wherein said botulinum neurotoxin is 95-99% pure purified botulinum neurotoxin.
- 22. The pharmaceutical preparation of claim 19 wherein said botulinum neurotoxin is 95-99% pure botulinum neurotoxin.
- 23. The pharmaceutical preparation of claim 20 wherein said botulinum neurotoxin complex is selected from the group consisting of botulinum neurotoxin complex types A, B, C1, C2, D, E, F and G.
- 24. The pharmaceutical preparation of claim 21 wherein said purified botulinum neurotoxin is selected from the group consisting of botulinum neurotoxin complex types A, B, C1, C2, D, E, F and G.
- 25. The pharmaceutical preparation of claim 22 wherein said botulinum neurotoxin is selected from the group consisting of botulinum neurotoxin types A, B, C1, C2, D, E, F and G
Parent Case Info
[0001] The benefit of U.S. Provisional Application No. 60/385,286, filed May 31, 2002, under 35 U.S.C. Section 119(e), and any other applicable laws, is hereby claimed.
Provisional Applications (1)
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Number |
Date |
Country |
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60385286 |
May 2002 |
US |