US5405366A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Adhesive hydrogels having extended use lives and process for the preparation of same
Assignee: Ludlow Corp
•
Filing: 1992-11-12
•
Granted: 1995-04-11
•
Expires: 2012-11-12
Abstract
Abstract This invention relates to a non-stringy adhesive hydrophilic gel comprising an aqueous mixture of a radiation crosslinkable water-soluble polymer, at least one humectant effective to extend the moisture retaining characteristics of the gel and which inhibits the ability of radiant energy to crosslink the water-soluble polymer, a pharmacologically active agent, and a crosslinking promoter effective to counteract the crosslinking inhibitory effect of humectant. The aqueous mixture is exposed to radiant energy effective to provide a non-stringy adhesive cohesive homogeneous hydrophilic gel that has an extended in-use lifetime. The gels can be formed into PATCHES for long term application of the pharmacologically active agent to a patient.
Inventors
- 👤 Adrian S. Fox
- 👤 Christine A. Czap
- 👤 Robin R. Wiser
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 19:45
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0014; A61K47/00; A61K47/06; A61K47/08; A61K47/10; A61K47/30; A61K47/32; A61K9/70; A61K9/7023; A61L; A61L15/00; A61L15/16; A61L15/42; A61L15/44; A61L15/58; A61L15/60; A61L24/00; A61L24/001; A61L24/0031; A61L26/00; A61L26/0009; A61L26/0014; A61L26/0019; A61L2300/00; A61L2300/40; A61L2300/41
Claims Analysis
Total Claims: 71
Claim 1
Independent Claim
123 words
A non-stringy adhesive hydrophilic gel comprising an aqueous mixture of at least one crosslinkable water-soluble polymer, at least one humectant in an amount of from 1 to 40 weight percent, said amount being effective to extend the moisture retaining characteristics of said gel and to inhibit the ability of radiant energy to crosslink said polymer, and a crosslinking promoter in an amount effective to counteract said crosslink-inhibiting effect of said humectant, said aqueous mixture exposed to a dose of radiant energy effective to provide a non-stringy adhesive cohesive homogeneous hydrophilic gel that (i) retains moisture for longer periods than a hydrophilic gel prepared without said humectant; and (ii) remains flexible after being stored at about 0° F. for at least about 16 hours.
Claim 2
Dependent Claim
123 words
A non-stringy adhesive hydrophilic gel comprising an aqueous mixture of at least one crosslinkable water-soluble polymer, at least one humectant in an amount of from 1 to 40 weight percent, said amount being effective to extend the moisture retaining characteristics of said gel and to inhibit the ability of radiant energy to crosslink said polymer, and a crosslinking promoter in an amount effective to counteract said crosslink-inhibiting effect of said humectant, said aqueous mixture exposed to a dose of radiant energy effective to provide a non-stringy adhesive cohesive homogeneous hydrophilic gel that (i) retains moisture for longer periods than a hydrophilic gel prepared without said humectant; and (ii) remains flexible after being stored at about 0° F. for at least about 16 hours.
Claim 3
Dependent Claim
33 words
The gel of claim 1 which provides a rolling ball distance of at least about 10 mm using a 16.5 mm, 21.7 g stainless steel ball in a tack rolling ball method test.
Claim 4
Dependent Claim
38 words
The gel of claims 1 or 2 which further comprises a water-soluble electrolyte in an amount effective to reduce the transverse electrical resistance of the gel to an impedance at 60 Hz of less than about 1000 ohms.
Claim 5
Dependent Claim
28 words
The gel of claim 3 wherein the water-soluble electrolyte is present in an amount effective to reduce the impedance of the gel to less than about 100 ohms.
Claim 6
Dependent Claim
20 words
The gel of claims 1 or 2 in which said water-soluble polymer is poly(ethylene oxide), poly(vinyl pyrrolidone or mixtures thereof.
Claim 7
Dependent Claim
29 words
The gel of claim 1 wherein said water-soluble polymer is poly(vinyl pyrrolidone) and which further comprises poly(ethylene oxide) in an amount sufficient to increase the viscosity of the gel.
Claim 8
Dependent Claim
39 words
The gel of claims 1 or 2 which further comprises one or more additional uniformly dispersed additives selected from the group consisting of preservatives, stabilizers, fire retardants, pigments, refractive particles, bactericides, antibiotics, cosmetics, moisturizers, pharmacologic agents and mixtures thereof.
Claim 9
Dependent Claim
25 words
The gel of claim 7 in which each additive which is included is present at a concentration of about 0,001 to about 3 weight percent.
Claim 10
Dependent Claim
16 words
The gel of claims 1 or 2 which further comprises a scrim in intimate contact therewith.
Claim 11
Dependent Claim
15 words
The gel of claim 9 wherein the scrim comprises a low area-weight synthetic water-insoluble polymer.
Claim 12
Dependent Claim
37 words
The gel of claims 1 or 2 in which the humectant is castor oil, ethoxylated castor oil, saccharide isomerates, glycerol, propylene glycol, poly(ethylene glycol), N-methyl pyrrolidone, N-ethyl pyrrolidone, diacetone alcohol, γ-butyryl lactone, ethyl lactate and combinations thereof.
Claim 13
Dependent Claim
24 words
The gel of claims 1 or 2 in which the humectant is present at a concentration of about 1 to about 40 weight percent.
Claim 14
Dependent Claim
16 words
The gel of claim 3 in which the water-soluble electrolyte is an inorganic or organic salt.
Claim 15
Dependent Claim
28 words
The gel of claim 3 in which the water-soluble electrolyte is selected from the group consisting of potassium salts, sodium salts, magnesium salts, calcium salts and mixtures thereof.
Claim 16
Dependent Claim
32 words
The gel of claims 1 or 2 in which the aqueous mixture is exposed to a dose of radiant energy of at least about 0.5 Mrad to less than about 4 Mrad.
Claim 17
Dependent Claim
18 words
The gel of claim 15 in which the dose of radiant energy is less than about 2 Mrad.
Claim 18
Dependent Claim
27 words
The gel of claim 5 in which the water-soluble polymer is poly(vinyl pyrrolidone) and is present at a concentration of about 10 to about 30 weight percent.
Claim 19
Dependent Claim
27 words
The gel of claim 5 in which the water-soluble polymer is poly(ethylene oxide) and is present at a concentration of about 0.1 to about 20 weight percent.
Claim 20
Dependent Claim
26 words
The gel of claim 3 in which the amount of water-soluble electrolyte ranges from about 5 to about 8 percent by weight of said aqueous mixture.
Claim 21
Dependent Claim
29 words
The gel of claims 1 or 2 in which the crosslinking promoter is selected from the group consisting of N,N'-methylene-bis-acrylamide, ethylene glycol dimethacrylate, triethylene glycol dimethacrylate or mixtures thereof.
Claim 22
Dependent Claim
23 words
The gel of claim 20 in which said crosslinking promoter is present at a concentration of about 0.5 to about 3 weight percent.
Claim 23
Dependent Claim
23 words
The gel of claim 3 in which the water-soluble electrolyte is present at a concentration of about 0.1 to about 10 weight percent.
Claim 24
Independent Claim
145 words
A method of forming a non-stringy adhesive hydrophilic gel which comprises: preparing an aqueous mixture by adding at least one crosslinkable water-soluble polymer to water in an amount effective to provide a crosslinkable hydrophilic gel; adding at least one humectant in an amount of from 1 to 40 weight percent, said amount being effective to extend the moisture retaining characteristics of the gel and to inhibit the ability of radiant energy to crosslink said polymer; and adding a crosslinking promoter in an amount effective to counteract the crosslink inhibiting effect of the humectant; and exposing said aqueous mixture to a dose of radiant energy effective to provide a non-stringy adhesive cohesive homogeneous hydrophilic gel that (i) retains moisture for longer periods than a hydrogel prepared without said humectant and (ii) remains flexible after being stored at about 0° F. for at least about 16 hours.
Claim 25
Independent Claim
145 words
A method of forming a non-stringy adhesive hydrophilic gel which comprises: preparing an aqueous mixture by adding at least one crosslinkable water-soluble polymer to water in an amount effective to provide a crosslinkable hydrophilic gel; adding at least one humectant in an amount of from 1 to 40 weight percent, said amount being effective to extend the moisture retaining characteristics of the gel and to inhibit the ability of radiant energy to crosslink said polymer; and adding a crosslinking promoter in an amount effective to counteract the crosslink inhibiting effect of the humectant; and exposing said aqueous mixture to a dose of radiant energy effective to provide a non-stringy adhesive cohesive homogeneous hydrophilic gel that (i) retains moisture for longer periods than a hydrogel prepared without said humectant and (ii) remains flexible after being stored at about 0° F. for at least about 16 hours.
Claim 26
Dependent Claim
37 words
The method of claim 23 in which the resulting gel provides a rolling ball distance of at least about 10 mm using a 16.5 mm, 21.7 g stainless steel ball in a tack rolling ball method test.
Claim 27
Independent Claim
31 words
The method of claims 23 or 24 which further comprises casting the aqueous mixture onto a substrate in a desired shape and configuration before exposing the cast mixture to radiant energy.
Claim 28
Dependent Claim
20 words
The method of claim 25 wherein the substrate remains in contact with the gel to form an article of manufacture.
Claim 29
Dependent Claim
11 words
A gel produced by the method of claims 23 or 24.
Claim 30
Dependent Claim
11 words
An article of manufacture produced by the method of claim 26.
Claim 31
Dependent Claim
24 words
An article of manufacture for therapeutic treatment of a wound comprising the gel of claims 1 or 2 in combination with a gel-supporting substrate.
Claim 32
Dependent Claim
36 words
The article of claim 29 wherein said gel has first and second sides, said substrate being in contact with said first side and further comprising a backing member that is in contact with said second side.
Claim 33
Dependent Claim
19 words
The article of claim 30 which further comprises score lines for defining a plurality of subunits of said article.
Claim 34
Dependent Claim
14 words
The article of claim 29 which is suitable for use as a wound dressing.
Claim 35
Dependent Claim
21 words
An article for therapeutic treatment of a wound comprising the gel of claim 3 in combination with a conductive gel-supporting substrate.
Claim 36
Dependent Claim
13 words
The article of claim 33 which is suitable for use as an electrode.
Claim 37
Dependent Claim
46 words
A method of electrical wound healing which comprises (i) contacting an area of the body affected by a wound with the electrode of claim 34 and (ii) applying an electrical impulse to said area through said electrode for a period of time effective to promote healing.
Claim 38
Dependent Claim
26 words
The method of claim 35 in which said electrode has an impedance of a sufficiently low value to minimize the occurrence of burns on the skin.
Claim 39
Dependent Claim
112 words
A hydrogel composition having adhesive and cohesive properties which is capable of transferring active agents contained in said hydrogel to a patient when said hydrogel composition is affixed to said patient, comprising: an aqueous mixture in at least one crosslinkable water soluble polymer in an amount effective to provide a crosslinkable hydrophilic gel; at least one humectant in an amount of from about 1 to 40 weight percent, said amount being effective to extend moisture retaining characteristics of the gel and to inhibit radiant energy from crosslinking said water soluble polymer; a crosslinking promoter in an amount effective to counteract crosslinking inhibitory effects of said humectant; and at least one active agent.
Claim 40
Dependent Claim
112 words
A hydrogel composition having adhesive and cohesive properties which is capable of transferring active agents contained in said hydrogel to a patient when said hydrogel composition is affixed to said patient, comprising: an aqueous mixture in at least one crosslinkable water soluble polymer in an amount effective to provide a crosslinkable hydrophilic gel; at least one humectant in an amount of from about 1 to 40 weight percent, said amount being effective to extend moisture retaining characteristics of the gel and to inhibit radiant energy from crosslinking said water soluble polymer; a crosslinking promoter in an amount effective to counteract crosslinking inhibitory effects of said humectant; and at least one active agent.
Claim 41
Dependent Claim
40 words
The hydrogel composition of claim 37 wherein said gel (i) retains moisture for longer periods than a hydrophilic gel prepared without said humectant; and (ii) remains flexible after being stored at about 0° F. for at least about 16 hours.
Claim 42
Dependent Claim
11 words
The hydrogel composition of claim 38 wherein said gel is non-stringy.
Claim 43
Dependent Claim
44 words
The hydrogel composition of claim 37 wherein said agent is selected from the group of topical analgesics, topical-counter irritants, antiseptics, appetite suppressants, asthma release preparations, decongestants, corn, wart and callous removers, non-steroidal anti-inflammatory drugs, wound healing enhancers, antihistamines, anxiety controllers, nicotine, and headache preparations.
Claim 44
Dependent Claim
37 words
The composition of claim 37 wherein said humectant is selected from the group of castor oil, ethoxylated castor oil, saccharide isomerates, glycerol, propylene glycol, poly(ethylene glycol), N-methylpyrrolidone, N-ethylpyrrolidone, diacetone alcohol, gamma-butyryl lactone, ethyl lactate and combinations thereof.
Claim 45
Dependent Claim
23 words
The composition of claim 37 wherein said crosslinkable water-soluble polymer is selected from the group of poly(ethylene oxide), poly(vinyl pyrrolidone) or mixtures thereof.
Claim 46
Dependent Claim
26 words
The composition of claim 37 wherein said crosslinking promoter is selected from the group consisting of N,N'-methylene-bis-acrylamide, ethylene glycol dimethacrylate, triethylene glycol dimethacrylate or mixtures thereof.
Claim 47
Dependent Claim
11 words
The composition of claim 37 wherein said agent is pharmacologically active.
Claim 48
Dependent Claim
13 words
The composition of claim 44 wherein said agent is a non-steroidal anti-inflammatory drug.
Claim 49
Dependent Claim
14 words
The composition of claim 45 wherein said agent is 5-50% of said gel composition.
Claim 50
Independent Claim
105 words
A method of providing a hydrogel composition containing at least one active agent comprising: providing an aqueous mixture of at least one crosslinkable water-soluble polymer in an amount effective to provide a crosslinkable hydrophilic gel; adding at least one humectant in an amount of from 1 to 40 weight percent, said amount being sufficient to extend moisture retaining characteristics of said gel and to inhibit radiant energy from crosslinking said polymer; adding a crosslinking promoter in an amount effective to counteract crosslinking inhibiting effects of said humectant; and exposing said mixture to radiant energy effective to provide a homogenous hydrophilic gel containing said active agent.
Claim 51
Independent Claim
105 words
A method of providing a hydrogel composition containing at least one active agent comprising: providing an aqueous mixture of at least one crosslinkable water-soluble polymer in an amount effective to provide a crosslinkable hydrophilic gel; adding at least one humectant in an amount of from 1 to 40 weight percent, said amount being sufficient to extend moisture retaining characteristics of said gel and to inhibit radiant energy from crosslinking said polymer; adding a crosslinking promoter in an amount effective to counteract crosslinking inhibiting effects of said humectant; and exposing said mixture to radiant energy effective to provide a homogenous hydrophilic gel containing said active agent.
Claim 52
Dependent Claim
39 words
The method of claim 47 wherein said gel (i) retains moisture for longer periods than a hydrophilic gel prepared without said humectant; and (ii) remains flexible after being stored at about 0° F. for at least about 16 hours.
Claim 53
Dependent Claim
10 words
The method of claim 48 wherein said gel is non-stringy.
Claim 54
Dependent Claim
22 words
The method of claim 47 wherein said active agent is incorporated into said mixture prior to exposing said mixture to radiant energy.
Claim 55
Dependent Claim
22 words
The method of claim 47 wherein said active agent is incorporated into said gel after exposing of said mixture to radiant energy.
Claim 56
Dependent Claim
43 words
The method of claim 47 wherein said agent is selected from the group of topical analgesics, topical-counter irritants, antiseptics, appetite suppressants, asthma release preparations, nicotine, decongestants, corn, wart and callous removers, non-steroidal anti-inflammatory drugs, wound healing enhancers, antihistamines, anxiety controllers, and headache preparations.
Claim 57
Dependent Claim
37 words
The method of claim 51 wherein said humectant is selected from the group of castor oil, ethoxylated castor oil, saccharide isomerates, glycerol, propylene glycol, poly(ethylene glycol), N-methylpyrrolidone, N-ethylpyrrolidone, diacetone alcohol, gamma-butyryl lactone, ethyl lactate and combinations thereof.
Claim 58
Dependent Claim
22 words
The method of claim 52 wherein said crosslinkable water-soluble polymer is selected from the group poly(ethylene oxide), poly(vinyl pyrrolidone) or mixtures thereof.
Claim 59
Dependent Claim
25 words
The method of claim 53 wherein said crosslinking promoter is selected from the group of N,N'-methylene-bis-acrylamide, ethylene glycol dimethacrylate, triethylene glycol dimethacrylate or mixtures thereof.
Claim 60
Dependent Claim
14 words
The method of claim 53 wherein said crosslinking promoter is 0.5-3% of said mixture.
Claim 61
Dependent Claim
12 words
The method of claim 47 wherein said agent is pharmacologically active agent.
Claim 62
Dependent Claim
15 words
The method of claim 57 wherein said pharmacologically active agent is a non-steroidal anti-inflammatory drug.
Claim 63
Dependent Claim
17 words
The method of claim 47 wherein said radiant energy is provided in the form an electron beam.
Claim 64
Dependent Claim
23 words
The method of claim 58 wherein said mixture is exposed to an electron beam to a dose of up to about 4 Mrad.
Claim 65
Dependent Claim
18 words
The method of claim 47 further comprising adhering a plastic liner to at least one side said gel.
Claim 66
Dependent Claim
35 words
The method of claim 23 in which the humectant is castor oil, ethoxylated castor oil, saccharide isomerates, glycerol, propylene glycol, poly(ethylene glycol), N-methyl pyrrolidone, N-ethyl pyrrolidone, diacetone alcohol, γ-butyryl lactone, ethyl lactate and combinations thereof.
Claim 67
Independent Claim
205 words
A method of electrical wound healing which comprises (i) contacting an area of the body affected by a wound with an electrode comprising a non-stringy adhesive hydrophilic gel and a water-soluble electrolyte in an amount effective to reduce the transverse electrical resistance of the gel to an impedance at 60 Hz of less than about 1000 ohms, in combination with a conductive gel-supporting substrate, said gel comprising an aqueous mixture of at least one crosslinkable water-soluble polymer, at least one humectant in an amount of from 1 to 40 weight percent, said amount being effective to extend the moisture retaining characteristics of said gel and to inhibit the ability of radiant energy to crosslink said polymer, and a crosslinking promoter in an amount effective to counteract said crosslink-inhibiting effect of said humectant, said aqueous mixture exposed to a dose of radiant energy effective to promote a non-stringy adhesive cohesive homogeneous hydrophilic gel that (a) retains moisture for longer periods than a hydrophilic gel prepared without said humectant; and (b) remains flexible after being stored at about 0° F. for at least about 16 hours; and (ii) applying an electrical impulse to said area through said electrode for a period of time effective to promote healing.
Claim 68
Independent Claim
205 words
A method of electrical wound healing which comprises (i) contacting an area of the body affected by a wound with an electrode comprising a non-stringy adhesive hydrophilic gel and a water-soluble electrolyte in an amount effective to reduce the transverse electrical resistance of the gel to an impedance at 60 Hz of less than about 1000 ohms, in combination with a conductive gel-supporting substrate, said gel comprising an aqueous mixture of at least one crosslinkable water-soluble polymer, at least one humectant in an amount of from 1 to 40 weight percent, said amount being effective to extend the moisture retaining characteristics of said gel and to inhibit the ability of radiant energy to crosslink said polymer, and a crosslinking promoter in an amount effective to counteract said crosslink-inhibiting effect of said humectant, said aqueous mixture exposed to a dose of radiant energy effective to promote a non-stringy adhesive cohesive homogeneous hydrophilic gel that (a) retains moisture for longer periods than a hydrophilic gel prepared without said humectant; and (b) remains flexible after being stored at about 0° F. for at least about 16 hours; and (ii) applying an electrical impulse to said area through said electrode for a period of time effective to promote healing.
Claim 69
Dependent Claim
26 words
The method of claim 63 in which said electrode has an impedance of a sufficiently low value to minimize the occurrence of burns on the skin.
Claim 70
Dependent Claim
39 words
The method of claim 63 in which the gel is formulated to provide a rolling ball distance of at least about 10 mm using a 16.5 mm, 21.7 g stainless steel ball in a tack rolling ball method test.
Claim 71
Independent Claim
31 words
The method of claims 35 or 63 in which the water-soluble electrolyte is present in an amount effective to reduce the impedance of the gel to less than about 100 ohms.
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