US4764382A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Device for controlled release drug delivery
Assignee: Hercon Laboratories Corp
•
Filing: 1986-04-09
•
Granted: 1988-08-16
•
Expires: 2006-04-09
Abstract
Abstract A device for the controlled release and delivery of a pharmacologically active agent, comprising a vinyl gel layer and a pharmacologically active agent uniformly dispersed in the layer in a pharmacologically effective amount, the vinyl layer comprising an emulsion polymerized polyvinyl chloride resin, a primary plasticizer for the polyvinyl chloride resin, and an organic, nonvolatile gel forming additive in an amount sufficient to form a gel.
Inventors
- 👤 Agis F. Kydonieus
- 👤 Bret Berner
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-08 12:15
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/70; A61K9/7023; A61K9/703; A61K9/7084; A61K47/00; A61K47/30; A61K47/32
Claims Analysis
Total Claims: 30
Claim 1
Independent Claim
67 words
A device for the controlled release and delivery of a pharmacologically active agent, comprising a gelled vinyl plastisol layer and a pharmacologically active agent uniformly dispersed in the layer in a pharmacologically effective amount, said vinyl layer comprising an emulsion polymerized polyvinyl chloride resin, a primary plasticizer for the polyvinyl chloride resin, and an organic, nonvolatile gel forming additive in an amount sufficient to form a gel.
Claim 2
Independent Claim
67 words
A device for the controlled release and delivery of a pharmacologically active agent, comprising a gelled vinyl plastisol layer and a pharmacologically active agent uniformly dispersed in the layer in a pharmacologically effective amount, said vinyl layer comprising an emulsion polymerized polyvinyl chloride resin, a primary plasticizer for the polyvinyl chloride resin, and an organic, nonvolatile gel forming additive in an amount sufficient to form a gel.
Claim 3
Dependent Claim
45 words
The device according to claim 1, wherein the resin is present in an amount of 10 to 75 weight percent and the primary plasticizer is present in an amount of 20 to 85 weight percent, based on the total weight of the vinyl gel layer.
Claim 4
Dependent Claim
33 words
A device as in claim 2, wherein the gel forming additive is present in an amount of from 5 to 30% by weight, based on the total weight of the vinyl gel layer.
Claim 5
Dependent Claim
33 words
A device as claimed in claim 3, wherein the pharmacologically active agent is present in an amount of 0.1% to 50% by weight, based on the total weight of the vinyl gel layer.
Claim 6
Dependent Claim
78 words
A device as in claim 1, wherein the polyvinyl chloride resin is present in an amount of from 20 to 65%, the primary plasticizer is present in an amount of from 20 to 60% by weight, the gel forming additive is present in an amount of from about 8 to 25%, and the pharmacologically active agent is present in an amount of from 0.1% to 50% by weight, based on the total weight of the vinyl gel layer.
Claim 7
Dependent Claim
37 words
A device as claimed in claim 1, wherein the gel forming additive is at least one ingredient selected from isopropylpalmitate, isopropyl myristate, mineral oil, silicone oil, unepoxidized soybean oil, castor oil, linseed oil, olive oil, or petrolatum.
Claim 8
Dependent Claim
19 words
A device as claimed in claim 1, wherein the gel forming additive is a non-ionic surfactant kor a triglyceride.
Claim 9
Dependent Claim
23 words
A device as in claim 1, wherein said primary plasticizer is dioctyl phthalate, a polymeric adipate plasticizer, epoxidized soybean oil or dioctyl adipate.
Claim 10
Dependent Claim
22 words
A device as in claim 1, wherein the pharmacologically active agent is nitroglycerin, timolol, albuterol, isosorbide dinitrate, clonidine, guanfacine, nadolol or prostaglandin.
Claim 11
Dependent Claim
14 words
A device as claimed in claim 1, wherein the pharmacologically active agent is nitroglycerin.
Claim 12
Dependent Claim
15 words
A device as claimed in claim 10, wherein the gel forming additive is isopropyl palmitate.
Claim 13
Dependent Claim
14 words
A device as claimed in claim 11, wherein the primary plasticizer is dioctyl phthalate.
Claim 14
Dependent Claim
31 words
The device according to claim 1, wherein the gel layer is opaque, has a tensile strength below 50 psi, a break elongation below 10% and a tear strength below 20 lbs/inch.
Claim 15
Dependent Claim
17 words
The device according to claim 1, including a backing layer on one side of the gel layer.
Claim 16
Dependent Claim
44 words
A device as claimed in claim 1, wherein the drug is in solid form and the gel forming additive is isopropyl palmitate or isopropyl myristate present in an amount of 15 to 25 weight percent based on the weight of the vinyl gel layer.
Claim 17
Dependent Claim
44 words
A device as claimed in claim 1, wherein the drug is in liquid form and the gel forming additive is isopropyl palmitate or isopropyl myristate present in an amount of 5 to 15 weight percent based on the weight of the vinyl gel layer.
Claim 18
Dependent Claim
34 words
A device as claimed in claim 1, wherein the gel forming additive is mineral oil present in an amount of 15 to 25 weight percent, based on the weight of the vinyl gel layer.
Claim 19
Dependent Claim
34 words
A device as claimed in claim 1, wherein the gel forming additive is silicone oil present in an amount of 10 to 25 weight percent, based on the weight of the vinyl gel layer.
Claim 20
Dependent Claim
18 words
The device according to claim 1, wherein the gel has a tensile strength of 500 psi or below.
Claim 21
Dependent Claim
16 words
The device according to claim 19, wherein the gel has a tensile strength below 350 psi.
Claim 22
Dependent Claim
16 words
The device according to claim 19, wherein the gel has a tensile strength below 150 psi.
Claim 23
Dependent Claim
16 words
The device according to claim 19, wherein the gel has a tensile strength below 75 psi.
Claim 24
Dependent Claim
39 words
The device according to claim 1, comprising about 5 to 25 weight percent nitroglycerin, about 30 to 50 weight percent PVC, about 25 to 50 weight percent of primary plasticizer, and about 5 to 20% of gel forming additive.
Claim 25
Dependent Claim
21 words
The device according to claim 23, wherein the primary plasticizer is dioctyl adipate and the gel forming additive is isopropyl palmitate.
Claim 26
Dependent Claim
21 words
A device according to claim 23, wherein the gel is opaque and has a tensile strength of 500 psi or below.
Claim 27
Dependent Claim
50 words
A device as claimed in claim 23, wherein the polyvinyl chloride is present in an amount of 43%, the primary plasticizer is present in an amount of 29%, the nitroglycerin is present in an amount of 8% and the gel forming additive is present in an amount of about 20%.
Claim 28
Dependent Claim
31 words
The device according to claim 1, wherein the gel has a tensile strength below 75 psi, an elongation at break below 25% and a tear strength of less than 30 lbs/inch.
Claim 29
Independent Claim
84 words
A method for the transdermal delivery of nitroglycerin to a patient to provide said patient with nitroglycerin, comprising applying to said patient a device for the controlled release and delivery of nitroglycerin, the device comprising a vinyl gel layer and nitroglycerin uniformly dispersed in the layer in a pharmacologically effective amount, the vinyl layer comprising an emulsion polymerized polyvinyl chloride resin, a primary plasticizer for the polyvinyl chloride resin, and an organic, nonvolatile gel forming additive in an amount sufficient to form a gel.
Claim 30
Independent Claim
84 words
A method for the transdermal delivery of nitroglycerin to a patient to provide said patient with nitroglycerin, comprising applying to said patient a device for the controlled release and delivery of nitroglycerin, the device comprising a vinyl gel layer and nitroglycerin uniformly dispersed in the layer in a pharmacologically effective amount, the vinyl layer comprising an emulsion polymerized polyvinyl chloride resin, a primary plasticizer for the polyvinyl chloride resin, and an organic, nonvolatile gel forming additive in an amount sufficient to form a gel.
References Cited (Backward Citations)
US1624089A
Cited
US2286636A
Cited
US2500891A
Cited
US2635085A
Cited
CH288880A
Cited
GB842492A
Cited
US3212495A
Cited
CA930668A
Cited
US3833520A
Cited
US4150109A
Cited
US3946106A
Cited
US3992518A
Cited
US4053580A
Cited
US4073291A
Cited
US4289749A
Cited
US4291015A
Cited
US4292303A
Cited
US4292302A
Cited
US4292301A
Cited
US4294820A
Cited
US4421737A
Cited
US4336243A
Cited
US4631301A
Cited
US4636543A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1991-08-16 | 1992-02-15 | 1992-08-16 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1995-08-16 | 1996-02-15 | 1996-08-16 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1999-08-16 | 2000-02-15 | 2000-08-16 | $7700.00 | Window Closed / Lapsed |