US5113860A
Expired / Lapsed
US
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Non-invasive transmucosal drug level monitoring method
Assignee: ENTREGA LABS LLC
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Filing: 1991-03-15
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Granted: 1992-05-19
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Expires: 2011-03-15
Abstract
Abstract Non-invasive transmucosal drug monitoring methods involving devices comprising an acid-functional polymeric resin dispersed substantially throughout a hydrophobic support matrix. The device when adhered to a mucosal surface can absorb some chemicals in amounts proportional to the actual blood levels of the chemicals.
Inventors
- 👤 Roy L. McQuinn
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-08 18:16
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/94
Claims Analysis
Total Claims: 32
Claim 1
Independent Claim
189 words
A method of measuring the blood level of a drug in a mammal, comprising the steps of: a) adhering a device to a mucosal surface of a mammal, which device comprises: (i) a particulate polymeric resin comprising at least about 55% by weight of carboxylic acid moieties based on the total weight of the polymeric resin, and (ii) about 10 to about 200 parts by weight of a hydrophobic support matrix, based on 100 parts by weight of the resin, wherein the resin is dispersed substantially throughout the support matrix, and which is substantially free of drug, contains less than about 9% water by weight based on the weight of the polymeric resin, exhibits substantially no instantaneous adhesion to dry skin, and adheres to a mucosal surface; b) allowing the device to remain adhered for a time sufficient to allow the device to absorb the drug in an amount proportional to the blood level of the drug; c) removing the device; d) measuring the amount of the drug in the device; and e) correlating the amount of the drug in the device to the blood level of the drug.
Claim 2
Independent Claim
189 words
A method of measuring the blood level of a drug in a mammal, comprising the steps of: a) adhering a device to a mucosal surface of a mammal, which device comprises: (i) a particulate polymeric resin comprising at least about 55% by weight of carboxylic acid moieties based on the total weight of the polymeric resin, and (ii) about 10 to about 200 parts by weight of a hydrophobic support matrix, based on 100 parts by weight of the resin, wherein the resin is dispersed substantially throughout the support matrix, and which is substantially free of drug, contains less than about 9% water by weight based on the weight of the polymeric resin, exhibits substantially no instantaneous adhesion to dry skin, and adheres to a mucosal surface; b) allowing the device to remain adhered for a time sufficient to allow the device to absorb the drug in an amount proportional to the blood level of the drug; c) removing the device; d) measuring the amount of the drug in the device; and e) correlating the amount of the drug in the device to the blood level of the drug.
Claim 3
Independent Claim
172 words
A method of measuring the relative blood level of a drug in a mammal, comprising the steps of: a) adhering a device to a mucosal surface of a mammal which device comprises: (i) a particulate polymeric resin comprising at least about 55% by weight of carboxylic acid moieties based on the total weight of the polymeric resin, and (ii) about 10 to about 200 parts by weight of a hydrophobic support matrix, based on 100 parts by weight of the resin, wherein the resin is dispersed substantially throughout the support matrix, and which is substantially free of drug, contains less than about 9% water by weight based on the weight of the polymeric resin, exhibits substantially no instantaneous adhesion to dry skin, and adheres to a mucosal surface; b) allowing the device to remain adhered for a predetermined period of time; c) removing the device; d) measuring the amount of the drug in the device; and e) comparing the result from step d) to a previous result obtained in the same manner.
Claim 4
Independent Claim
172 words
A method of measuring the relative blood level of a drug in a mammal, comprising the steps of: a) adhering a device to a mucosal surface of a mammal which device comprises: (i) a particulate polymeric resin comprising at least about 55% by weight of carboxylic acid moieties based on the total weight of the polymeric resin, and (ii) about 10 to about 200 parts by weight of a hydrophobic support matrix, based on 100 parts by weight of the resin, wherein the resin is dispersed substantially throughout the support matrix, and which is substantially free of drug, contains less than about 9% water by weight based on the weight of the polymeric resin, exhibits substantially no instantaneous adhesion to dry skin, and adheres to a mucosal surface; b) allowing the device to remain adhered for a predetermined period of time; c) removing the device; d) measuring the amount of the drug in the device; and e) comparing the result from step d) to a previous result obtained in the same manner.
Claim 5
Dependent Claim
19 words
A method according to claim 1, wherein the device when placed on the mucosal surface is free of drug.
Claim 6
Dependent Claim
18 words
A method according to claim 1, wherein the support matrix component of the device is a polytetrafluoroethylene web.
Claim 7
Dependent Claim
21 words
A method according to claim 1, wherein the polymeric resin component of the device consists essentially of acrylic acid monomer units.
Claim 8
Dependent Claim
36 words
A method according to claim 5, wherein the resin component of the device is covalently crosslinked with about 0.75% to about 2% by weight based on the total weight of the resin of a polyalkenyl polyether.
Claim 9
Dependent Claim
27 words
A method according to claim 1, wherein the resin component of the device has an average particle size of between about 1 μm and about 100 μm.
Claim 10
Dependent Claim
27 words
A method according to claim 1, wherein the resin component of the device has an average particle size of between about 2 μm and about 10 μm.
Claim 11
Dependent Claim
31 words
A method according to claim 1, wherein the device comprises about 50 to about 100 parts by weight of the support matrix based on 100 parts by weight of the resin.
Claim 12
Dependent Claim
28 words
A method according to claim 1, wherein up to about 30% of the carboxylic acid moieties of the resin component of the device are neutralized by a base.
Claim 13
Dependent Claim
22 words
A method according to claim 10, wherein the base is selected from the group consisting of Al(OH) 3 and Ca(OH) 2 .
Claim 14
Dependent Claim
12 words
A method according to claim 10, wherein the base is a polyamine.
Claim 15
Dependent Claim
31 words
A method according to claim 1, wherein the device comprises about 15 to about 50 parts by weight of the support matrix based on 100 parts by weight of the resin.
Claim 16
Dependent Claim
25 words
A method according to claim 1, wherein the device contains less than about 4% water by weight based on the total weight of the resin.
Claim 17
Dependent Claim
25 words
A method according to claim 1, wherein the device contains less than about 2% water by weight based on the total weight of the resin.
Claim 18
Dependent Claim
18 words
A method according to claim 1, wherein the support matrix component of the device is an elastomeric component.
Claim 19
Dependent Claim
17 words
A method according to claim 1, wherein the support matrix component of the device is a hydrocarbon.
Claim 20
Dependent Claim
48 words
A method according to claim 1, wherein the support matrix component of the device comprises a block styrene-butadiene-styrene copolymer, a block styrene-isoprene-styrene isoprene-styrene copolymer, a polyisobutylene, an isoprene rubber, a carboxy-functional polyisoprene, a hydroxy-functional polyisoprene, an acrylate elastomer, or a mixture of two or more of the foregoing.
Claim 21
Dependent Claim
18 words
A method according to claim 18, wherein the support matrix component of the device further comprises a plasticizer.
Claim 22
Dependent Claim
64 words
A method according to claim 16, wherein the support matrix component of the device is a mixture comprising about 5% to about 50% by weight of a polyisobutylene with a viscosity average molecular weight between about 500,000 and about 2.5 million, and about 50% to about 95% by weight of a polyisobutylene with a viscosity average molecular weight between about 40,000 and about 100,000.
Claim 23
Dependent Claim
64 words
A method according to claim 16, wherein the support matrix component of the device is a mixture comprising about 15% to about 25% by weight of a polyisobutylene with a viscosity average molecular weight between about 500,000 and about 2.5 million, and about 75% to about 85% by weight of a polyisobutylene with a viscosity average molecular weight between about 40,000 and about 100,000.
Claim 24
Dependent Claim
58 words
A method according to claim 16, wherein the support matrix component of the device is a mixture comprising about 20% by weight of a polyisobutylene with a viscosity average molecular weight between about 500,000 and about 2.5 million, and about 80% by weight of a polyisobutylene with a viscosity average molecular weight between about 40,000 and about 100,000.
Claim 25
Dependent Claim
50 words
A method according to claim 16, wherein the support matrix component of the device is a mixture comprising about 20% by weight of a polyisobutylene with a viscosity average molecular weight about 1.25 million and about 80% by weight of a polyisobutylene with a viscosity average molecular weight about 53,000.
Claim 26
Dependent Claim
64 words
A method according to claim 16, wherein the device is made by a process comprising the steps of: (1) adding the constituent or constituents of the elastomeric component to a mill; (2) milling the constituent or constituents to form a substantially homogeneous elastomeric component; (3) milling the particulate polymeric resin and the homogeneous elastomeric component from step (2) to form a substantially homogeneous composition.
Claim 27
Dependent Claim
63 words
A method according to claim 24, wherein the constituents of the elastomeric component of the device are: about 5% to about 50% by weight of a polyisobutylene with a viscosity average molecular weight between about 500,000 and about 2.5 million; and about 50% to about 95% by weight of a polyisobutylene with a viscosity average molecular weight between about 40,000 and about 100,000.
Claim 28
Dependent Claim
63 words
A method according to claim 24, wherein the constituents of the elastomeric component of the device are: about 15% to about 25% by weight of a polyisobutylene with a viscosity average molecular weight between about 500,000 and about 2.5 million, and about 75% to about 85% by weight of a polyisobutylene with a viscosity average molecular weight between about 40,000 and about 100,000.
Claim 29
Dependent Claim
57 words
A method according to claim 24, wherein the constituents of the elastomeric component of the device are: about 20% by weight of a polyisobutylene with a viscosity average molecular weight between about 500,000 and about 2.5 million, and about 80% by weight of a polyisobutylene with a viscosity average molecular weight between about 40,000 and about 100,000.
Claim 30
Dependent Claim
49 words
A method according to claim 24, wherein the constituents of the elastomeric component of the device are: about 20% by weight of a polyisobutylene with a viscosity average molecular weight about 1.25 million and about 80% by weight of a polyisobutylene with a viscosity average molecular weight about 53,000.
Claim 31
Dependent Claim
56 words
A method according to claim 24, wherein the constituents of the elastomeric component of the device are: about 60% to 100% of a polyisobutylene with a viscosity average molecular weight of about 750,000 to about 1,100,000 and 0% to about 40% of a polyisobutylene with a viscosity average molecular weight of about 40,000 to about 100,000.
Claim 32
Dependent Claim
16 words
A method according to claim 1 wherein the device has a flexible film backing applied thereto.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1995-05-19 | 1995-11-18 | 1996-05-19 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1999-05-19 | 1999-11-18 | 2000-05-19 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2003-05-19 | 2003-11-18 | 2004-05-19 | $7700.00 | Window Closed / Lapsed |