Fentanyl suspension-based silicone adhesive formulations and devices for transdermal delivery of fentanyl
AssigneeMylan Pharmaceuticals Inc.
InventorsKenneth Miller, Sharad Govil, Kuljit Bhatia
Life of this patent
Estimating the term…
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.
Claims55
A monolithic patch for administering fentanyl transdermally to an individual, comprising:
- (a) a backing layer substantially impervious to the fentanyl to be administered transdermally;
- (b) a fentanyl-containing adhesive layer in contact with at least a portion of the backing layer, the adhesive layer being cast from a formulation comprising a blend of fentanyl particles suspended in one or more solvated silicone adhesives;
- and
- (c) a removable release liner in contact with the adhesive layer.
A method for making a laminate, which is useful for making a monolithic patch for transdermal administration of fentanyl, comprising:
- a) selecting a solvent that can substantially or fully solvate a silicone adhesive while keeping fentanyl, when blended with the solvated adhesive, suspended in the solvated adhesive;
- b) blending fentanyl particles with one or more silicone adhesives which are solvated with the above solvent, to form a blend formulation in which fentanyl particles are suspended in the solvated adhesives;
- c) casting the blend formulation onto a support material;
- and
- d) removing the solvent, to produce a laminate containing the support material and a fentanyl suspension-containing adhesive layer.
A method for making a laminate, which is useful for making a monolithic patch for transdermal administration of fentanyl, comprising:
- a) selecting a solvent that can substantially or fully solvate a silicone adhesive while keeping fentanyl particles, when blended with the solvated adhesive, suspended in the solvated adhesive;
- b) solvating said silicone adhesive in said solvent;
- c) forming a slurry of fentanyl particles in a silicone fluid;
- d) blending the slurry from step c) with the solvated silicone adhesive of step b) so as to form a blend formulation in which fentanyl particles are suspended in the solvated adhesive;
- e) casting the blend formulation onto a support material;
- and
- f) removing the solvent to produce a laminate containing the support material and a fentanyl suspension-containing adhesive layer.
A method for administering fentanyl transdermally to an individual in need of such administration, comprising applying to the skin of the individual a monolithic patch comprising:
- (a) a backing layer substantially impervious to the fentanyl to be administered transdermally;
- and
- (b) a fentanyl-containing adhesive layer in contact with the backing layer, the adhesive layer being cast from a formulation comprising a blend of fentanyl suspended in one or more solvated silicone adhesives.
Dependencies are inferred from the claim text.