Method and device for transdermal electrotransport delivery of fentanyl and sufentanil
First Claim
1. A method of obtaining self-administered analgesia in a human patient who is suffering from pain consisting of transdermally delivering solely by electrotransport a dose of about 20 μ
- g to about 60 μ
g of fentanyl over a predetermined delivery period of up to about 20 minutes from an electrotransport device which includes a donor reservoir hydrogel formulation comprised of fentanyl, terminating said delivery at the end of said delivery period and allowing the patient to self-administer from about 10 to about 100 additional of said doses over a period of 24 hours.
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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 (eg, fentanyl hydrochloride) dispersed in a hydrogel formulation for use in an electrotransport device (10). In accordance with one aspect of the invention, the concentration of fentanyl/sufentanil in the donor reservoir (26) solution is above a predetermined minimum concentration, whereby the transdermal electrotransport flux of fentanyl/sufentanil is maintained independent of the concentration of fentanyl/sufentanil in solution. In accordance with a second aspect of the present invention, the donor reservoir (26) of the electrotransport delivery device (10) is comprised of silver and the donor reservoir (26) contains a predetermined “excess” loading of fentanyl/sufentanil halide to prevent silver ion migration with attendant skin discoloration. In accordance with a third aspect of the present invention, a transdermal electrotransport delivered dose of fentanyl/sufentanil is provided which is sufficient to induce analgesia in (eg, adult) human patients suffering from moderate-to-severe pain associated with major surgical procedures.
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Citations
20 Claims
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1. A method of obtaining self-administered analgesia in a human patient who is suffering from pain consisting of transdermally delivering solely by electrotransport a dose of about 20 μ
- g to about 60 μ
g of fentanyl over a predetermined delivery period of up to about 20 minutes from an electrotransport device which includes a donor reservoir hydrogel formulation comprised of fentanyl, terminating said delivery at the end of said delivery period and allowing the patient to self-administer from about 10 to about 100 additional of said doses over a period of 24 hours. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 19)
- g to about 60 μ
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10. A method of obtaining self-administered analgesia in a human patient who is suffering from pain consisting of transdermally delivering solely by electrotransport a dose of about 2.3 μ
- g to about 7.0 μ
g of sufentanil over a predetermined delivery period of up to about 20 minutes from an electrotransport device which includes a donor reservoir hydrogel formulation comprised of sufentanil, terminating said delivery at the end of said delivery period and allowing the patient to self-administer from about 10 to about 100 additional of said doses over a period of 24 hours. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 20)
- g to about 7.0 μ
Specification