US4645502A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Transdermal delivery of highly ionized fat insoluble drugs
Assignee: Alza Corp
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Filing: 1985-05-03
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Granted: 1987-02-24
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Expires: 2005-05-03
Abstract
Abstract A medical device for the transdermal delivery of highly ionized, fat insoluble drugs comprises an aqueous drug reservoir having a physiological pH, said reservoir preferably being a gel maintained in an impermeable receptacle by a highly permeable support member disposed between the gel and a permeable contact adhesive. A permeation enhancer reservoir delivers a permeation enhancer to the skin through the aqueous reservoir and through a permeation enhancer release rate controlling membrane which is permeable to the permeation enhancer and impermeable to the drug and water. In a preferred embodiment the permeation enhancer release rate controlling membrane forms at least a portion of said receptacle.
Inventors
- 👤 Robert M. Gale
- 👤 David J. Enscore
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 18:03
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/70; A61K9/7023; A61K9/703; A61K9/7084
Claims Analysis
Total Claims: 14
Claim 1
Independent Claim
175 words
A medical device for the transdermal delivery of a highly ionized, fat insoluble drug comprising, in combination: a. aqueous drug reservoir means comprising at at least 50% water having said drug dissolved therein; b. receptacle means containing said reservoir means, said receptacle means being substantially impermeable to the contents of said reservoir means; c. highly permeable reservoir retaining means disposed over the the skin proximal surface of said aqueous reservoir means; d. permeation enhancer delivery means for delivering a permeation enhancer to the skin through said aqueous reservoir means, said permeation enhancer delivery means being disposed in permeation enhancer transferring relationship to said aqueous reservoir means and comprising: (i) a source of permeation enhancer, and (ii) permeation enhancer release rate controlling means disposed between said source of permeation enhancer and said aqueous reservoir means, said permeation enhancer release rate controlling means comprising a material permeable to said permeation enhancer and substantially impermeable to water and said drug; and e. means for maintaining said medical device in permeation enhancer and drug transmitting relationship to the skin.
Claim 2
Dependent Claim
175 words
A medical device for the transdermal delivery of a highly ionized, fat insoluble drug comprising, in combination: a. aqueous drug reservoir means comprising at at least 50% water having said drug dissolved therein; b. receptacle means containing said reservoir means, said receptacle means being substantially impermeable to the contents of said reservoir means; c. highly permeable reservoir retaining means disposed over the the skin proximal surface of said aqueous reservoir means; d. permeation enhancer delivery means for delivering a permeation enhancer to the skin through said aqueous reservoir means, said permeation enhancer delivery means being disposed in permeation enhancer transferring relationship to said aqueous reservoir means and comprising: (i) a source of permeation enhancer, and (ii) permeation enhancer release rate controlling means disposed between said source of permeation enhancer and said aqueous reservoir means, said permeation enhancer release rate controlling means comprising a material permeable to said permeation enhancer and substantially impermeable to water and said drug; and e. means for maintaining said medical device in permeation enhancer and drug transmitting relationship to the skin.
Claim 3
Dependent Claim
19 words
The medical device of claim 1 wherein the pH of said aqueous reservoir is in the range of 4.5-8.5.
Claim 4
Dependent Claim
35 words
The medical device of claim 1 wherein said means for maintaining said medical device on the skin comprises a layer of a permeable adhesive disposed on the skin proximal surface of said reservoir retaining means.
Claim 5
Dependent Claim
47 words
The medical device of claim 1 wherein said permeation enhancer release rate controlling means comprises at least a portion of said receptacle means and said permeation enhancer is confined behind the skin distal surface of said receptacle means by an impermeable backing sealed to said receptacle means.
Claim 6
Dependent Claim
37 words
The medical device of claim 1 wherein said source of permeation enhancer comprises a multiplicity of microcapsules of permeation enhancer within said permeation enhancer release rate controlling means; said microcapsules being dispersed through said aqueous reservoir means.
Claim 7
Dependent Claim
16 words
The medical device of claim 1 wherein said aqueous reservoir means contains undissolved drug dispersed therethrough.
Claim 8
Dependent Claim
21 words
The medical device of claim 1 wherein said drug is dissolved within said aqueous reservoir means at a level below saturation.
Claim 9
Dependent Claim
36 words
The medical device of claim 1 wherein said means for maintaining said medical device on the skin comprises a peripherally disposed layer of adhesive outside the path of drug and permeation enhancer flow to the skin.
Claim 10
Dependent Claim
18 words
The medical device of claim 2 wherein said aqueous reservoir comprises a gel containing at least 50% water.
Claim 11
Dependent Claim
45 words
The medical device of claim 2 wherein said drug is selected from the group consisting of the ionized form of indomethacin, acetazolamide, methazolamide, acetylsalisylic acid, naltrexone, naloxone, nalbuphine, phenylephrine, chlorpheniramine, phenylpropanolamine, clonidine, dextromethorphan, atropine, fentanyl, apomorphine, propranolol, lidocaine, tetracycline, oxytetracycline, tetracaine, dibucaine, terbutaline, and brompheniramine.
Claim 12
Dependent Claim
18 words
The medical device of claim 10 wherein said aqueous reservoir comprises a gel containing at least 50% water.
Claim 13
Dependent Claim
38 words
The medical device of claim 2 wherein said permeation enhancer is selected from the group consisting of the alkyl substituted sulfoxides, mono and di-substituted alkyl polyethylene glycols, lower alkyl alcohols; n-methyl pyrrolidone, dimethyl lauramine, diethyltoleamide and 1-substituted azacycloalkan-2-ones.
Claim 14
Dependent Claim
49 words
The medical device of claim 2 wherein said drug is selected from the group consisting of ionized naloxone, nalbuphine, phenylpropanolamine, chlorphenaramine, and phenylepherine; said permeation enhancer is n-decylmethylsulfoxide and said permeation enhancer release rate controlling material is selected from the group consisting of ethylene vinyl acetate copolymers and polyethylene.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1990-02-23 | 1990-08-25 | 1991-02-24 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1994-02-23 | 1994-08-25 | 1995-02-24 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1998-02-23 | 1998-08-25 | 1999-02-24 | $7700.00 | Window Closed / Lapsed |