Solubility parameter based drug delivery system and method for altering drug saturation concentration
First Claim
1. An improved pressure-sensitive adhesive composition of the type suitable for controlled release of a bioactive agent from a pressure-sensitive adhesive matrix, the composition comprising:
- a blend of a first polymeric adhesive having a first solubility parameter and a second polymeric adhesive having a second solubility parameter, the first and second solubility parameters being different from one another by an increment of at least 2 (J/cm3)½
and resulting in a characteristic net solubility parameter of the blend which can selectably adjust the saturation concentration of a bioactive agent contained in the pressure-sensitive adhesive composition and thereby modulate the release of the bioactive agent.
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Abstract
The method of adjusting the saturation concentration of a drug in a transdermal composition for application to the dermis, which comprises mixing polymers having differing solubility parameters, so as to modulate the delivery of the drug. This results in the ability to achieve a predetermined permeation rate of the drug into and through the dermis. In one embodiment, a dermal composition of the present invention comprises a drug, an acrylate polymer, and a polysiloxane. The dermal compositions can be produced by a variety of methods known in the preparation of drug-containing adhesive preparations, including the mixing of the polymers, drug, and additional ingredients in solution, followed by removal of the processing solvents. The method and composition of this invention permit selectable loading of the drug into the dermal formulation and adjustment of the delivery rate of the drug from the composition through the dermis, while maintaining acceptable shear, tack, and peel adhesive properties.
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Citations
70 Claims
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1. An improved pressure-sensitive adhesive composition of the type suitable for controlled release of a bioactive agent from a pressure-sensitive adhesive matrix, the composition comprising:
a blend of a first polymeric adhesive having a first solubility parameter and a second polymeric adhesive having a second solubility parameter, the first and second solubility parameters being different from one another by an increment of at least 2 (J/cm3)½
and resulting in a characteristic net solubility parameter of the blend which can selectably adjust the saturation concentration of a bioactive agent contained in the pressure-sensitive adhesive composition and thereby modulate the release of the bioactive agent.- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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27. A dermal adhesive composition comprising:
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a) a multiple polymer adhesive system consisting essentially of a blend of 2-96% by weight of an acrylic-based polymer and 98-4% by weight of a silicone-based polymer, the multiple polymer adhesive system being in an amount of about 99-50% by weight of the dermal adhesive composition;
b) a bioactive agent in the amount of 0.3-50% by weight of the dermal adhesive composition;
c) a co-solvent for the bioactive agent in the amount of 0-30% by weight of the dermal adhesive composition; and
d) an enhancer in the amount of 0-20% by weight of the dermal adhesive composition. - View Dependent Claims (28)
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29. A transdermal drug delivery device comprising a blend of:
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(a) a first polymeric material having a first solubility parameter; and
(b) a second polymeric material having a second solubility parameter, said first and second solubility parameters being different from one another and resulting in a characteristic net solubility parameter of the blend; and
a drug intimately mixed with said polymeric material blend, the saturation concentration of the drug in the blend being responsive to the characteristic net solubility parameter. - View Dependent Claims (30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44)
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45. A method of making a transdermal drug delivery system of the type having a drug-containing pressure-sensitive adhesive, the method comprising the step of:
forming a pressure-sensitive adhesive diffusion matrix by blending at least two polymers having differing solubility parameters so that the net solubility parameter of the composition selectably adjusts the saturation concentration of a drug in the pressure-sensitive diffusion matrix and thereby modifies the delivery rate of the drug from the pressure-sensitive diffusion matrix and through the dermis. - View Dependent Claims (46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66)
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67. A method of adjusting the saturation concentration of a drug in a transdermal drug delivery composition, for application to the dermis, which comprises blending a plurality of polymers having differing solubility parameters, so as to modulate the delivery of the drug from the composition and through the dermis.
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68. A method of modulating the delivery rate of a drug from a transdermal drug delivery system of the type having a drug-containing pressure-sensitive adhesive diffusion matrix, which method comprises the steps of:
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a) selecting at least two immiscible polymeric materials as components of a multiple polymer adhesive system such that the system has a net solubility parameter which results in a modified saturation concentration of a drug in the system while keeping the diffusion coefficient of the drug in the system the same or greater; and
b) blending the at least two polymers to form a pressure-sensitive adhesive diffusion matrix. - View Dependent Claims (69, 70)
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Specification