US4938759A
Expired / Lapsed
US
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Transdermal delivery device having a rate controlling adhesive
Assignee: Alza Corp
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Filing: 1986-09-02
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Granted: 1990-07-03
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Expires: 2006-09-02
Abstract
Abstract A transdermal delivery device having a release-rate controlling-adhesive is disclosed having improved delivery characteristics. The device employs a polyisobutylene/mineral oil adhesive formulation and an ethylene/viny acetate (EVA) drug reservoir formulation. The device is useful in delivering a wide variety of transdermally administrable drugs, particularly those which are moderately soluble in mineral oil. Preferred embodiments deliver timolol base and atropine base from an EVA (40% VA) reservoir formulation.
Inventors
- 👤 David J. Enscore
- 👤 Eun S. Lee
- 👤 Su I. Yum
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-27 19:11
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/70; A61K9/7023; A61K9/703; A61K9/7038; A61K9/7046; A61K9/7053; A61K9/7084; A61K9/7092
Claims Analysis
Total Claims: 38
Claim 1
Independent Claim
106 words
A medical device for the transdermal administration of a drug said device conforming to the Rate Controlling Adhesive Relationship and comprising: (a) a drug reservoir comprising a drug dispersed with an ethylene/vinyl acetate copolymer having a vinyl acetate content in the range of about 15-60% by weight; and (b) a PIB/MO adhesive for maintaining said reservoir in drug transferring relationship to the skin, said adhesive being bonded to said drug reservoir and being disposed in the path of diffusional flow of drug from said reservoir to the skin such that substantially all drug must pass through the adhesive by diffusion from the reservoir to the skin.
Claim 2
Dependent Claim
106 words
A medical device for the transdermal administration of a drug said device conforming to the Rate Controlling Adhesive Relationship and comprising: (a) a drug reservoir comprising a drug dispersed with an ethylene/vinyl acetate copolymer having a vinyl acetate content in the range of about 15-60% by weight; and (b) a PIB/MO adhesive for maintaining said reservoir in drug transferring relationship to the skin, said adhesive being bonded to said drug reservoir and being disposed in the path of diffusional flow of drug from said reservoir to the skin such that substantially all drug must pass through the adhesive by diffusion from the reservoir to the skin.
Claim 3
Dependent Claim
19 words
The device of claim 1 wherein said vinyl acetate content is in the range of about 28-40% by weight.
Claim 4
Dependent Claim
19 words
The device of claim 1 wherein said drug is initially present in said reservoir at a concentration above saturation.
Claim 5
Dependent Claim
23 words
The device of claim 1 wherein said drug is moderately soluble in mineral oil and has a melting point above about 50° C.
Claim 6
Dependent Claim
35 words
The device of claim 4 wherein said drug is selected from the group consisting of timolol, fentanyl, atropine, clonidine, propranolol, isosorbide dinitrate, scopolamine, estradiol, phenylpropanolamine, ouabain, salbutamol, quanabenz, labetolol, haloperidol, bromocryptine, ephedrine, chlorpheniramine and metrifonate.
Claim 7
Dependent Claim
43 words
The device of claim 1 wherein the concentration of said drug in the reservoir is sufficient to maintain the activity of the drug in said carrier at unit activity for a time period in the range of from 24 hours to 7 days.
Claim 8
Dependent Claim
14 words
The device of claim 1 wherein said drug is the base form of timolol.
Claim 9
Dependent Claim
22 words
The device of claim 7 wherein said ethylene vinyl acetate copolymer has a viny acetate content in the range of about 28-40%.
Claim 10
Dependent Claim
13 words
The device of claim 8 wherein said vinyl acetate content is about 40%.
Claim 11
Dependent Claim
14 words
The device of claim 1 wherein said drug is the base form of atropine.
Claim 12
Dependent Claim
21 words
The device of claim 10 wherein said ethylene/vinyl acetate copolymer has a vinyl acetate content in the range of about 28-40%.
Claim 13
Dependent Claim
13 words
The device of claim 11 wherein said vinyl acetate content is about 40%.
Claim 14
Dependent Claim
21 words
The device of claim 4 wherein said ethylene/vinyl acetate copolymer has a vinyl acetate content in the range of about 28-40%.
Claim 15
Dependent Claim
13 words
The device of claim 13 wherein said vinyl acetate content is about 40%.
Claim 16
Dependent Claim
18 words
The device of claim 5 wherein said ethylene/vinyl acetate copolymer has a vinyl acetate content of about 28-40%.
Claim 17
Dependent Claim
13 words
The device of claim 15 wherein said vinyl acetate content is about 40%.
Claim 18
Dependent Claim
83 words
A medical device for the transdermal delivery of a drug moderately soluble in mineral oil and having a melting point above about 50° C. comprising a laminate of: (a) an impermeable backing; (b) a drug reservoir lamina comprising said drug dispersed within an ethylene/vinyl acetate polymer at a concentration above the saturation concentration of said drug in said polymer, said polymer having a vinyl acetate content in the range of about 15-60%; and (c) a release-rate controlling adhesive lamina comprising a MO/PIB adhesive.
Claim 19
Dependent Claim
83 words
A medical device for the transdermal delivery of a drug moderately soluble in mineral oil and having a melting point above about 50° C. comprising a laminate of: (a) an impermeable backing; (b) a drug reservoir lamina comprising said drug dispersed within an ethylene/vinyl acetate polymer at a concentration above the saturation concentration of said drug in said polymer, said polymer having a vinyl acetate content in the range of about 15-60%; and (c) a release-rate controlling adhesive lamina comprising a MO/PIB adhesive.
Claim 20
Dependent Claim
46 words
The device of claim 17 wherein said drug is contained in said reservoir at a concentration sufficient to maintain the activity of said drug in said polymer at an activity of one for a period of time in the range of 24 hours to 7 days.
Claim 21
Dependent Claim
18 words
The device of claim 17 wherein said vinyl acetate content is in the range of from about 28-40%.
Claim 22
Dependent Claim
13 words
The device of claim 17 wherein said vinyl acetate content is about 40%.
Claim 23
Dependent Claim
46 words
The device of claim 20 wherein said drug is contained in said reservoir at a concentration sufficient to maintain the activity of said drug in said polymer at an activity of one for a period of time in the range of 24 hours to 7 days.
Claim 24
Dependent Claim
20 words
The device of claim 17 further comprising a release-liner lamina forming the surface of the device opposite said impermeable backing.
Claim 25
Dependent Claim
69 words
A medical device for the transdermal delivery of timolol comprising a laminate of: (a) an impermeable backing; (b) a timolol reservoir lamina comprising timolol base dispersed within an ethylene/vinyl acetate polymer at a concentration above the saturation concentration of said timolol base in said polymer, said polymer having a vinyl acetate content in the range of about 15-60%; and (c) a release-rate controlling adhesive lamina comprising a MO/PIB adhesive.
Claim 26
Dependent Claim
69 words
A medical device for the transdermal delivery of timolol comprising a laminate of: (a) an impermeable backing; (b) a timolol reservoir lamina comprising timolol base dispersed within an ethylene/vinyl acetate polymer at a concentration above the saturation concentration of said timolol base in said polymer, said polymer having a vinyl acetate content in the range of about 15-60%; and (c) a release-rate controlling adhesive lamina comprising a MO/PIB adhesive.
Claim 27
Dependent Claim
46 words
The device of claim 23 wherein said drug is contained in said reservoir at a concentration sufficient to maintain the activity of said drug in said polymer at an activity of one for a period of time in the range of 24 hours to 7 days.
Claim 28
Dependent Claim
18 words
The device of claim 23 wherein said vinyl acetate content is in the range of from about 28-40%.
Claim 29
Dependent Claim
13 words
The device of claim 23 wherein said vinyl acetate content is about 40%.
Claim 30
Dependent Claim
46 words
The device of claim 26 wherein said drug is contained in said reservoir at a concentration sufficient to maintain the activity of said drug in said polymer at an activity of one for a period of time in the range of 24 hours to 7 days.
Claim 31
Dependent Claim
20 words
The device of claim 23 further comprising a release-liner lamina forming the surface of the device opposite said impermeable backing.
Claim 32
Dependent Claim
69 words
A medical device for the transdermal delivery of atropine comprising a laminate of: (a) an impermeable backing; (b) a atropine reservoir lamina comprising atropine base dispersed within an ethylene/vinyl acetate polymer at a concentration above the saturation concentration of said atropine base in said polymer, said polymer having a vinyl acetate content in the range of about 15-60%; and (c) a release-rate controlling adhesive lamina comprising a MO/PIB adhesive.
Claim 33
Dependent Claim
69 words
A medical device for the transdermal delivery of atropine comprising a laminate of: (a) an impermeable backing; (b) a atropine reservoir lamina comprising atropine base dispersed within an ethylene/vinyl acetate polymer at a concentration above the saturation concentration of said atropine base in said polymer, said polymer having a vinyl acetate content in the range of about 15-60%; and (c) a release-rate controlling adhesive lamina comprising a MO/PIB adhesive.
Claim 34
Dependent Claim
46 words
The device of claim 29 wherein said drug is contained in said reservoir at a concentration sufficient to maintain the activity of said drug in said polymer at an activity of one for a period of time in the range of 24 hours to 7 days.
Claim 35
Dependent Claim
18 words
The device of claim 29 wherein said vinyl acetate content is in the range of from about 28-40%.
Claim 36
Dependent Claim
13 words
The device of claim 29 wherein said vinyl acetate content is about 40%.
Claim 37
Dependent Claim
46 words
The device of claim 32 wherein said drug is contained in said reservoir at a concentration sufficient to maintain the activity of said drug in said polymer at an activity of one for a period of time in the range of 24 hours to 7 days.
Claim 38
Dependent Claim
20 words
The device of claim 29 further comprising a release-liner lamina forming the surface of the device opposite said impermeable backing.
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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) | 1993-07-02 | 1994-01-01 | 1994-07-03 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1997-07-02 | 1998-01-01 | 1998-07-03 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2001-07-02 | 2002-01-01 | 2002-07-03 | $7700.00 | Window Closed / Lapsed |