IP Library Granted Patent US 8,449,907
Granted Patent B2
US 8,449,907 · App. 13/192,178 · Granted May 28, 2013

Fentanyl suspension-based silicone adhesive formulations and devices for transdermal delivery of fentanyl

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Quick Facts
Patent No.
US 8,449,907
App. No.
13/192,178
Granted
May 28, 2013
Kind
B2
Abstract

Silicone adhesive formulations are provided, in which fentanyl particles are suspended one or more a solvated silicone adhesives. The formulations can be used for manufacturing improved, matrix-type transdermal devices for administering fentanyl.

Claims (1)

1. A method for making a monolithic suspension-blend transdermal patch comprising: (a) contacting an inner layer of a backing layer having inner and outer surfaces and being substantially impervious to fentanyl with first surface of a first adhesive layer, the adhesive layer comprising a uniform suspension of a 72 to 168 hour period therapeutically-effective amount of fentanyl particles suspended in a silicone adhesive, the fentanyl particles consisting essentially of non-recrystallized fentanyl, the silicone adhesive comprising heptane solvent fully-solvated silicone adhesive from which the heptane solvent is substantially removed, the heptane solvated adhesive being incapable of dissolving greater than 1% w/w of said fentanyl particles; and (b) contacting a second surface of the adhesive layer with a removable release liner; wherein the fentanyl load of the suspension-based patch ranges from about 1 to about 15% w/w (dry weight) based upon the weight of the fentanyl silicone adhesive suspension; whereby when the suspension-blend patch is administered to a subject in need thereof, the adhesive layer delivers from about 5 μg/hr to about 250 μg/hr of the fentanyl to the subject for the period.

Assignments (4)
PATENT RELEASE Recorded Dec 10, 2012
From: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
To: DEY PHARMA L.P. (F/K/A DEY, L.P.); MYLAN PHARMACEUTICALS, INC.; MYLAN BERTEK PHARMACEUTICALS INC.; MYLAN TECHNOLOGIES, INC.; SOMERSET PHARMACEUTICALS, INC.; MYLAN INSTITUTIONAL INC. (F/K/A UDL LABORATORIES, INC.); MYLAN INC.
Reel/Frame 029440/0967 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2011
From: MILLER, KENNETH J., II; GOVIL, SHARAD K.; BHATIA, KULJIT SINGH
To: MYLAN PHARMACEUTICALS INC.
Reel/Frame 027368/0650 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2011
From: MILLER, KENNETH J., II; GOVIL, SHARAD K.; BHATIA, KULJIT SINGH
To: MYLAN PHARMACEUTICALS, INC.
Reel/Frame 027368/0754 →
SECURITY AGREEMENT Recorded Nov 21, 2011
From: MYLAN PHARMACEUTICALS, INC.; MYLAN BERTEK PHARMACEUTICALS INC.; MYLAN TECHNOLOGIES, INC.; MYLAN INSTITUTIONAL INC. (F/K/A UDL LABORATORIES, INC.); SOMERSET PHARMACEUTICALS, INC.; DEY PHARMA, L.P. (F/K/A DEY L.P.)
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 027270/0799 →