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US5173302A Expired / Lapsed US ⏱️ 0.0 years remaining

Hydrophilic pressure sensitive adhesive for topical administration of hydrophobic drugs

Assignee: Ludlow Corp
•
Filing: 1990-09-28
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Granted: 1992-12-22
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Expires: 2010-09-28
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Abstract

Abstract Novel hydrogel formulations useful as adhesive reservoirs for topical or transdermal drugs employ as the polymer base a crosslinked polymer or copolymer of 2-acrylamido-2-methylpropanesulfonic acid or a salt thereof. The gels are prepared from polymerizable compositions comprising: 20%-50% of a monofunctional monomer component, at least 75% of said component comprising 2-acrylamido-2-methylpropane sulfonic acid or a salt thereof, the balance being selected from the group consisting of acrylic acid, water soluble acrylic functional monomers and vinyl pyrrolidone; 30%-50% of a glycol component selected from the group consisting of compounds of the formula HO-(C2H4O)n-H, HO-(C3H6O)m-H and mixtures thereof, where n is in the range of about 4 to about 16 and m is 1-4; between about 0.02% and about 0.20% of a crosslinking monomer; an amount of a free radical polymerization initiator effective for initiating polymerization of said monofunctional monomer and crosslinking monomer components; and a therapeutically effective amount of a topically or transdermally deliverable drug, at least about 60% of said drug being dissolved in the formulation.

Inventors

  • 👤 Carolann M. Holmblad
  • 👤 Joan M. Bergstrom
  • 👤 Terese A. Bartlett

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-09 05:33
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/70; A61K9/7023; A61K9/703; A61K9/7038; A61K9/7046; A61K9/7053; A61K9/7061; A61L; A61L15/00; A61L15/16; A61L15/42; A61L15/58

Claims Analysis

Total Claims: 25
Claim 1
Independent Claim 138 words
A polymerizable composition comprising: 20%-50% of a monofunctional monomer component, at least 75% of said component comprising 2-acrylamido-2-methylpropane sulfonic acid or a salt thereof, the balance being selected from the group consisting of acrylic acid, water soluble acrylic functional monomers and vinyl pyrrollidone; 30%-50% of a hymectant selected from the group consisting of compounds of the formula HO--(C.sub.2 H.sub.4 O).sub.n --H, HO--(C.sub.3 H.sub.6 O).sub.m --H and mixtures thereof, where n is in the range of about 4 to about 16 and m is 1-4; between about 0.02% and about 0.20% of a crosslinking monomer; an amount of a free radical polymerization initiator effective for initiating polymerization of said monofunctional monomer and crosslinking monomer components; and a therapeutically effective amount of a topically or transdermally deliverable drug, at least about 60% of said drug being dissolved in the formulation.
Claim 2
Dependent Claim 138 words
A polymerizable composition comprising: 20%-50% of a monofunctional monomer component, at least 75% of said component comprising 2-acrylamido-2-methylpropane sulfonic acid or a salt thereof, the balance being selected from the group consisting of acrylic acid, water soluble acrylic functional monomers and vinyl pyrrollidone; 30%-50% of a hymectant selected from the group consisting of compounds of the formula HO--(C.sub.2 H.sub.4 O).sub.n --H, HO--(C.sub.3 H.sub.6 O).sub.m --H and mixtures thereof, where n is in the range of about 4 to about 16 and m is 1-4; between about 0.02% and about 0.20% of a crosslinking monomer; an amount of a free radical polymerization initiator effective for initiating polymerization of said monofunctional monomer and crosslinking monomer components; and a therapeutically effective amount of a topically or transdermally deliverable drug, at least about 60% of said drug being dissolved in the formulation.
Claim 3
Dependent Claim 13 words
A composition as in claim 1 wherein said drug is a hydrophobic drug.
Claim 4
Dependent Claim 13 words
A composition as in claim 2 wherein the hydrophobic drug is a corticosteroid.
Claim 5
Dependent Claim 33 words
A composition as in claim 3 wherein the hydrophobic drug is selected from the group consisting of hydrocortisone and its pharmaceutically acceptable esters, betamethasone and its pharmaceutically acceptable esters, fluocinoide and trimcinolone acetonide.
Claim 6
Dependent Claim 12 words
A composition as in claim 4 wherein the hydrophobic drug is hydrocortisone.
Claim 7
Dependent Claim 19 words
A composition as in claim 5 wherein the hydrocortisone is present at a level of about 0.5-1% by weight.
Claim 8
Dependent Claim 13 words
A composition as in claim 3 wherein the hydrophobic drug is hydrocortisone hemisuccinate.
Claim 9
Dependent Claim 20 words
A composition as in claim 7 wherein the hydrocortisone hemisuccinate is present at a level of about 0.5-3.0% by weight.
Claim 10
Dependent Claim 10 words
A composition as in claim 7 having a neutral pH.
Claim 11
Dependent Claim 15 words
A composition as in claim 1 wherein the drug is an analgesic, antiinfective or anesthetic.
Claim 12
Dependent Claim 23 words
A composition as in claim 1 wherein the monofunctional monomer component is present at a level of between about 25% and about 50%.
Claim 13
Dependent Claim 24 words
A composition as in claim 11 wherein the monofunctional monomer component includes acrylic acid in addition to said 2-acrylamido-2-methylpropane sulfonic acid or salt thereof.
Claim 14
Dependent Claim 22 words
A composition as in claim 12 wherein the acrylic acid comprises between about 6% and about 18% of said monofunctional monomer component.
Claim 15
Dependent Claim 13 words
A composition as in claim 1 wherein the humectant is polyethylene glycol 300.
Claim 16
Dependent Claim 23 words
A tacky, drug containing adhesive leaving substantially no residue when pulled from skin comprising a cured product of the formulation of claim 1.
Claim 17
Dependent Claim 16 words
An adhesive as in claim 15 wherein the drug is substantially dissolved in said cured formulation.
Claim 18
Dependent Claim 16 words
An adhesive as in claim 15 wherein the drug is a corticosteroid, antiinfective, analgesic or anesthetic.
Claim 19
Dependent Claim 28 words
An adhesive as in claim 17 wherein the drug is selected from hydrocortisone and its pharmaceutically acceptable esters, betamethasone and its pharmaceutically acceptable esters, fluocinoide and triaminicinolone acetonide.
Claim 20
Dependent Claim 15 words
An adhesive as in claim 18 wherein the drug is hydrocortisone or an ester thereof.
Claim 21
Dependent Claim 13 words
An adhesive as in claim 15 wherein the drug is a hydrophobic drug.
Claim 22
Dependent Claim 36 words
A therapeutic patch for topical or transdermal application of a drug having a laminate structure comprising a flexible top liner, a reinforced layer of an adhesive as in claim 15 and a peelable bottom release liner.
Claim 23
Dependent Claim 36 words
A patch as in claim 21 wherein the flexible top liner is a flexible polyether polyurethane sheet material, the adhesive is reinforced with a fabric material and the bottom release liner is a polyester sheet material.
Claim 24
Dependent Claim 16 words
A patch as in claim 22 wherein the reinforcing fabric is a spun bonded polyester fabric.
Claim 25
Dependent Claim 37 words
A patch as in claim 21 prepared by applying a polymerizable composition as in claim 1 to said bottom liner through said reinforcing fabric, photocuring the polymerizable composition and then covering the composition with the bottom liner.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1995-12-22 1996-06-22 1996-12-22 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1999-12-22 2000-06-22 2000-12-22 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2003-12-22 2004-06-22 2004-12-22 $7700.00 Window Closed / Lapsed

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