US4814183A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Device for the controlled release of drugs with Donnan-like modulation by charged insoluble resins
Assignee: Merck and Co Inc
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Filing: 1987-08-31
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Granted: 1989-03-21
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Expires: 2007-08-31
Abstract
Abstract The instant invention is directed to a drug delivery device for the controlled release of beneficial agents and drugs into an environment of use comprising: (A) a core composition comprising (a) a water insoluble, non-diffusible charged resin entity, and (b) a diffusible, water soluble ionizable therapeutically active ingredient carrying the same charge as said resin entity; and (B) a substantially imperforate water-insoluble wall surrounding said core composition, prepared from a semipermeable material substantially impermeable to the core composition and permeable to the passage of an external fluid in the environment of use, with said wall having a hole(s) for release of the therapeutic agent through the water insoluble wall.
Inventors
- 👤 Gaylen M. Zentner
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-03 20:22
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0002; A61K9/0004
Claims Analysis
Total Claims: 21
Claim 1
Independent Claim
103 words
A drug-delivery device for the controlled release of therapeutically active ingredient into an environment of use which comprises: (A) a core composition comprising (a) a water insoluble, non-diffusible charged resin entity, and (b) a diffusible water soluble ionizable therapeutically active ingredient carrying the same charge as said resin entity; and (B) a substantially imperforate water insoluble wall surrounding said core composition and prepared from a semipermeable material substantially impermeable to core composition and permeable to the passage of an external fluid in the environment of use, with said wall having a means for release of the therapeutic agent through the water insoluble wall.
Claim 2
Dependent Claim
103 words
A drug-delivery device for the controlled release of therapeutically active ingredient into an environment of use which comprises: (A) a core composition comprising (a) a water insoluble, non-diffusible charged resin entity, and (b) a diffusible water soluble ionizable therapeutically active ingredient carrying the same charge as said resin entity; and (B) a substantially imperforate water insoluble wall surrounding said core composition and prepared from a semipermeable material substantially impermeable to core composition and permeable to the passage of an external fluid in the environment of use, with said wall having a means for release of the therapeutic agent through the water insoluble wall.
Claim 3
Dependent Claim
50 words
A drug-delivery device according to claim 1, wherein the resin entity is a cationic resin selected from the group consisting of polystyrene, epoxy-amine, phenolic or condensate polymeric backbones containing an active group of quaternary ammonium, secondary amine, tertiary amine in an aromatic matrix or tertiary amine in an aliphatic matrix.
Claim 4
Dependent Claim
30 words
A drug-delivery device according to claim 1, wherein the resin entity is an anionic resin with acrylic, methacrylic or phenolic polymeric backbones with phosphonic acid or carboxylic acid active groups.
Claim 5
Dependent Claim
28 words
A drug-delivery device according to claim 1, wherein the resin entity is an anionic resin with polystyrene or phenolic polymeric backbones containing an active group of sulfonic acid.
Claim 6
Dependent Claim
32 words
A drug-delivery device according to claim 1, wherein the resin entity is a cellulose polymer selected from the group consisting of diethylamino-ethyl cellulose, carboxymethyl cellulose, guanidoethyl cellulose, sulfoethyl cellulose, and sulfopropyl cellulose.
Claim 7
Dependent Claim
17 words
A drug-delivery device according to claim 1, wherein the resin entity is a cross-linked vinyl pyridine polymer.
Claim 8
Dependent Claim
31 words
A drug-delivery device according to claim 1, wherein the therapeutically active ingredient is soluble in an external fluid and exhibits an osmotic pressure gradient across the wall against the external fluid.
Claim 9
Dependent Claim
46 words
A drug-delivery device according to claim 1, wherein the therapeutically active ingredient has limited solubility in the external fluid and is mixed with an osmotically effective solute that is soluble in the fluid, which exhibit an osmotic pressure gradient across the wall against the external fluid.
Claim 10
Dependent Claim
41 words
A drug-delivery device according to claim 1, further comprising: (C) 0 to 50 parts per 100 parts of wall material, of plasticizer and flux regulating additives and (D) 0 to 40 parts per 100 parts of wall material, of surfactant additive.
Claim 11
Dependent Claim
18 words
A drug-delivery device according to claim 1, wherein said water insoluble wall is 1 to 1,000 microns thick.
Claim 12
Dependent Claim
16 words
A drug-delivery device according to claim 10 wherein said wall is 20 to 500 microns thick.
Claim 13
Dependent Claim
17 words
A drug-delivery device according to claim 1, wherein at least 0.05 ng of active agent are used.
Claim 14
Dependent Claim
17 words
A drug-delivery device according to claim 12, wherein at least 1 microgram of active agent is used.
Claim 15
Dependent Claim
39 words
A drug-delivery device according to claim 1, wherein said semipermeable material is selected from the group consisting of cellulose esters, acylated polysaccharides, polyurethane, polymers of acrylic and methacrylic acid and esters thereof, poly (ortho ester)s, polyacetals and mixtures thereof.
Claim 16
Dependent Claim
23 words
A drug-delivery device according to claim 14, wherein said semipermeable material is selected from the group consisting of cellulose esters and acylated polysaccharides.
Claim 17
Dependent Claim
29 words
A drug-delivery device according to claim 15, wherein said semipermeable material is selected from the group consisting of polyurethanes and polymers of acrylic and methacrylic acid and esters thereof.
Claim 18
Dependent Claim
22 words
A drug-delivery device according to claim 15, wherein said semipermeable material is selected from the group consisting of poly(ortho esters)s and polyacetals.
Claim 19
Dependent Claim
17 words
A drug-delivery device according to claim 1, further comprising a water insoluble, permeable, non-rate controlling microporous wall.
Claim 20
Dependent Claim
24 words
A drug-delivery device according to claim 18, wherein the microporous wall is separated from the semipermeable wall by a layer of fluid soluble material.
Claim 21
Dependent Claim
19 words
A drug-delivery device according to claim 18, wherein the microporous wall is in direct contact with the semipermeable wall.
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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) | 1992-03-20 | 1992-09-19 | 1993-03-21 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-03-20 | 1996-09-19 | 1997-03-21 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-03-20 | 2000-09-19 | 2001-03-21 | $7700.00 | Window Closed / Lapsed |