Claims
- 1. A method of producing a terminally sterilized topical patch preparation, said method comprising:
exposing a topical patch preparation to electron beam radiation for a period of time sufficient to terminally sterilize said topical patch preparation; whereby a terminally sterilized topical patch preparation is produced.
- 2. The method of claim 1, wherein said topical patch preparation is sealed in a packaging material containing an aluminum layer.
- 3. The method of claim 2, wherein said sealed topical patch preparation is produced by:
(a) providing a topical patch preparation; (b) packaging said topical patch preparation in packaging material comprising an aluminum layer; and (c) sealing said packaged topical patch preparation.
- 4. The method of claim 1, wherein said electron beam radiation is low level electron beam radiation.
- 5. The method of claim 4, wherein said low level electron beam radiation ranges from about 5 to 19 kGy.
- 6. The method of claim 4, wherein said low level electron beam radiation ranges from about 8 to 15 kGy.
- 7. The method of claim 1, wherein said preparation is exposed for a period of time ranging from about 40 to 80 sec.
- 8. A method of producing a sealed, terminally sterilized topical patch preparation, said method comprising:
(a) producing a sealed topical patch preparation by the method comprising:
(i) providing a topical patch preparation; (ii) packaging said topical patch preparation in packaging material comprising an aluminum layer; and (iii) sealing said packaged topical patch preparation; and (b) exposing said sealed topical patch preparation to low level electron beam radiation for a period of time sufficient to terminally sterilize said topical patch preparation; whereby a sealed, terminally sterilized topical patch preparation is produced.
- 9. The method of claim 8, wherein said low level electron beam radiation ranges from about 5 to 19 kGy.
- 10. The method of claim 8, wherein said low level electron beam radiation ranges from about 8 to 15 kGy.
- 11. The method of claim 8, wherein said preparation is exposed for a period of time ranging from about 40 to 80 sec.
- 12. A terminally sterilized topical patch preparation produced according to the method of claim 1.
- 13. A terminally sterilized topical patch preparation, said preparation comprising:
a fibrous material; and an adhesive gel composition; wherein said preparation contains nonviable microorganisms.
- 14. The preparation of claim 13, wherein said adhesive gel composition comprises:
an active agent; a water-soluble polymer gel; water; and a water holding agent.
- 15. The preparation of claim 14, wherein said active agent is a local anesthetic.
- 16. The preparation of claim 13, wherein said preparation is sealed in packaging material.
- 17. The preparation of claim 16, wherein said packaging material comprises an aluminum layer.
- 18. The preparation of claim 14, wherein said nonviable microorganisms are electron beam irradiated microorganisms.
- 19. A method of delivering an active agent to a subject, said method comprising:
applying a terminally sterilized topical patch preparation comprising an active agent to a skin surface of said subject; whereby said active ingredient is delivered to a subject.
- 20. The method of claim 19, wherein said preparation is the preparation of claim 14.
- 21. A kit for use in transdermal delivery of an active agent to a subject in need thereof, said kit comprising:
(a) a terminally sterilized topical patch preparation comprising an active agent; and (b) instructions for using said preparation to practice the method of claim 19.
- 22. A method of producing a terminally sterilized topical patch preparation, said method comprising:
exposing a water-containing topical patch preparation to electron beam radiation for a period of time sufficient to terminally sterilize said topical patch preparation, to produce a terminally sterilized topical patch preparation.
- 23. The method of claim 22, wherein said topical patch preparation is sealed in a packaging material containing an aluminum layer.
- 24 The method of claim 23, wherein said sealed topical patch preparation is produced by:
(a) providing a topical patch preparation; (b) packaging said topical patch preparation in packaging material comprising an aluminum layer; and (c) sealing said packaged topical patch preparation.
- 25. The method of claim 22, wherein said electron beam radiation is low level electron beam radiation.
- 26. The method of claim 22, wherein said preparation is exposed for a period of time ranging from about 40 to 80 sec.
- 27. The method according to claim 22, wherein said water-containing topical patch preparation comprises a water-soluble polymer, water and a water holding agent.
- 28. A terminally sterilized topical patch preparation produced according to the method of claim 22.
- 29. A method of producing a terminally heat sterilized adhesive gel composition, said method comprising:
exposing an adhesive gel composition to electron beam radiation for a period of time sufficient to terminally sterilize said topical patch preparation; whereby a terminally sterilized adhesive gel composition is produced.
- 30. The method of claim 29, wherein said adhesive gel composition comprises a pharmaceutically active agent.
- 31. The method of claim 30, wherein said pharmaceutically active agent is present in said adhesive gel composition in an amount ranging from about 0.2 to about 10.0%.
- 32. The method of claim 30, wherein said pharmaceutically active agent is a local anesthetic.
- 33. The method of claim 29, wherein said adhesive gel composition comprises:
(a) a water-soluble polymer gel; (b) water; and (c) a water retaining agent.
- 34. The method of claim 29, wherein said adhesive gel composition is sealed in a packaging material comprising an aluminum layer.
- 35. The method of claim 34, wherein said sealed adhesive gel composition is produced by:
(a) providing an adhesive gel composition; (b) packaging said adhesive gel composition in a packaging material comprising an aluminum layer; and (c) sealing said packaged adhesive gel composition in said packaging material.
- 36. The method of claim 29, wherein said electron beam radiation is low level electron beam radiation.
- 37. The method of claim 36, wherein said low level electron beam radiation ranges from about 5 to about 19 kGy.
- 38. The method of claim 29, wherein said preparation is exposed for a period of time ranging from about 40 to about 80 seconds.
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of application Ser. No. 09/813,652 now U.S. Pat. No. ______; which application, pursuant to 35 U.S.C. § 119 (e), claims priority to the filing date of the U.S. Provisional Patent Application Serial No. 60/191,608 filed Mar. 23, 2000 and Serial No. 60/218,220, filed on Jul. 14, 2000; the disclosures of which are herein incorporated by reference.
Provisional Applications (2)
|
Number |
Date |
Country |
|
60191608 |
Mar 2000 |
US |
|
60218220 |
Jul 2000 |
US |
Continuations (1)
|
Number |
Date |
Country |
Parent |
09813652 |
Mar 2001 |
US |
Child |
10733161 |
Dec 2003 |
US |