Claims
- 1. A method of producing a scaled, 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 comprising: (a) an active agent retaining layer comprising a pharmaceutically active agent; and (b) a support for said active agent retaining layer; (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; to produce a scaled, terminally sterilized topical patch preparation.
- 2. The method of claim 1, wherein said low level electron beam radiation ranges from about 5 to 19 kGy.
- 3. The method of claim 1, wherein said low level electron beam radiation ranges about 8 to 15 kGy.
- 4. The method of claim 1, wherein said preparation is exposed for a period of time ranging from about 40 to 80 sec.
- 5. A scaled, terminally sterilized topical patch preparation produced according to the method of claim 1.
CROSS REFERENCE TO RELATED APPLICATIONS
Pursuant to 35 U.S.C. §119 (e), this application claims priority to the filing date of the U.S. Provisional Patent Application Ser. No. 60/191,608 filed Mar. 23, 2000 and Ser. No. 60/218,220, filed on Jul. 14, 2000; the disclosures of which are herein incorporated by reference.
US Referenced Citations (19)
Provisional Applications (2)
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Number |
Date |
Country |
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60/191608 |
Mar 2000 |
US |
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60/218220 |
Jul 2000 |
US |