Apparatus and method for transdermal delivery of fentanyl-based agents
A fentanyl, drug technology, applied in the field of fentanyl drug-based transdermal release devices, can solve the problems of liquid drugs entering the skin, increasing complexity and cost, and reservoir pressurization, etc.
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Embodiment 1
[0234] An aqueous solution containing 2.5% by weight of fentanyl citrate and having a pH of about 3.8 was prepared. Sufficient fluorescein was added to this solution to yield a concentration of 0.001M. This reagent is used to evaluate the coating quality after drying.
[0235]Titanium foil strips are prepared by cleaning their surface with an alkaline detergent, and drying. 5 microliters of the coating solution (or formulation) was applied and dried at room temperature for 4 hours. When viewed under a fluorescence microscope, the coating was found to be of very poor quality, demonstrating the poor wetting properties of the fentanyl solution. When 0.1% by weight hydroxyethylcellulose (Dow Chemical, Midland MI) was added to the same coating solution, the coating was significantly improved.
Embodiment 2
[0237] A 2.5% by weight aqueous solution of fentanyl citrate was prepared having a pH of approximately 3.8. Add 0.1% by weight of hydroxyethyl cellulose (M n =1000KDa, Mw=1900KDa) and 0.2% by weight of surfactant Tween 20. The coating solution was then applied to the microprojections using the coating method described in US Publication No. 2002 / 0132054, which is incorporated herein by reference in its entirety. The coating was evaluated and found to be uniformly distributed over the entire jet body. found the 2cm 2 The coated and dried spray in the device contained 50 micrograms of fentanyl base. When the device was applied to a human by using the applicator described in US Publication 2002 / 0123675 for 1 hour, a release of greater than 70% of the fentanyl contained on the projectile was obtained.
Embodiment 3
[0239] A 1.5% by weight aqueous solution of fentanyl citrate was prepared having a pH of approximately 3.8. To this solution was added 2% by weight of hydroxyethylcellulose and 0.2% by weight of surfactant Tween 20. The resulting gel is then added to the microspray reservoir system. The device is administered to a human for 8 hours as described in US Application Nos. 60 / 514,433 and 60 / 514,387, which are hereby incorporated by reference in their entirety. After administration, blood samples were taken at various time points and evaluated for fentanyl levels. Pharmacokinetic evaluation of the results showed a rapid onset of action with prolonged release over the duration of administration.
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