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Claims for Patent: 6,425,892

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Claims for Patent: 6,425,892

Title: Device for transdermal electrotransport delivery of fentanyl and sufentanil
Abstract:The invention provides an improved electrotransport drug delivery system for analgesic drugs, namely fentanyl and sufentanil. The fentanyl/sufentanil is provided as a water soluble salt (e.g., fentanyl hydrochloride), preferably in a hydrogel formulation, for use in an electrotransport device (10). In accordance with the present invention, a transdermal electrotransport delivered dose of fentanyl/sufentanil is provided which is sufficient to induce analgesia in (e.g., adult) human patients suffering from moderate-to-severe pain associated with major surgical procedures.
Inventor(s): Southam; Mary (Menlo Park, CA), Bernstein; Keith J. (Somerville, NJ), Noorduin; Henk (Bergen op Zoom, NL)
Assignee: ALZA Corporation (Mountain View, CA)
Application Number:09/781,041
Patent Claims: 1. A method of obtaining analgesia in a human patient who is suffering from pain, consisting of transdermally delivering solely by electrotransport a dose of about 20 .mu.g to about 60 .mu.g of fentanyl over a predetermined delivery period of up to about 20 minutes, terminating said delivery at the end of said delivery period and thereafter repeating such transdermal administering up to about 100 additional of said doses over a period of 24 hours.

2. The method of claim 1, wherein about 35 .mu.g to about 45 .mu.g of fentanyl is delivered over a delivery period of about 5 to 15 minutes.

3. The method of claim 1, wherein about 40 .mu.g of fentanyl is delivered over the delivery period.

4. The method of claim 1, wherein the delivery period is about 10 minutes.

5. The method of claim 1, wherein the additional doses are 35 .mu.g to 45 .mu.g doses of fentanyl.

6. The method of claim 1, wherein the fentanyl comprises a fentanyl salt.

7. The method of claim 6, wherein the fentanyl salt comprises fentanyl hydrochloride.

8. The method of claim 1, wherein the doses are self-administered by the patient suffering from pain.

9. The method of claim 8, wherein the patient is allowed to self-administer no more than six of said doses per hour.

10. A method of obtaining analgesia in a human patient who is suffering from pain, consisting of transdermally delivering solely by electrotransport a dose of about 2.3 .mu.g to about 7.0 .mu.g of sufentanil over a predetermined delivery period of up to about 20 minutes, terminating said delivery at the end of said delivery period and thereafter repeating such transdermal administering up to about 100 additional of said doses over a period of 24 hours.

11. The method of claim 10, wherein about 4 .mu.g to about 5.5 .mu.of sufentanil is delivered over a delivery period of about 5 to 15 minutes.

12. The method of claim 10, wherein about 4.7 .mu.g of sufentanil is delivered over the delivery period.

13. The method of claim 10, wherein the delivery period is about 10 minutes.

14. The method of claim 10, wherein the additional doses are 4 .mu.g to 5.5 .mu.g doses of sufentanil.

15. The method of claim 10, wherein the sufentanil comprises a sufentanil salt.

16. The method of claim 15, wherein the sufentanil salt comprises sufentanil hydrochloride.

17. The method of claim 10, wherein the doses are self-administered by the patient suffering pain.

18. The method of claim 17, wherein the patient is allowed to self-administer no more than six of said doses per hour.
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