US5068110A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Stabilization of enteric coated dosage form
Assignee: Warner Lambert Co LLC
•
Filing: 1989-07-14
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Granted: 1991-11-26
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Expires: 2009-07-14
Abstract
Abstract The present invention is a stabilized enteric-coated pharmaceutical dosage form and processes for the preparation thereof. Dissolution stability after storage of the dosage form under high stress conditions is improved by an enteric-coated dosage form having an enteric coating wherein the coating is of the acrylic resin kind of from 14 mg/cm2 to 24 mg/cm2 or an enteric coating wherein the coating is of the acetate kind of from 14 mg/cm2 to 24 mg/cm2 and having a second coating of hydrophilic coating for example, hydroxypropyl cellulose, hydroxymethyl cellulose or hydroxypropylmethyl cellulose.
Inventors
- 👤 Mahdi B. Fawzi
- 👤 Daniel A. Kubert
- 👤 Kuchi S. Murthy
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-02 09:34
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/48; A61K9/4891
Claims Analysis
Total Claims: 11
Claim 1
Independent Claim
57 words
An enteric coated pharmaceutical capsule having acetates or derivatives thereof comprising cellulose acetate phthalate or polyvinyl acetate phthalate as the enteric coatign where in the improvement is an enteric coating level consisting of from 14 mg/cm 2 to 24.0 mg/cm 2 and a protective coating comprising a hydrophilic coating comprising hydroxypropyl cellulose, hydroxymethyl cellulose or hydroxypropylmethyl cellulose.
Claim 2
Dependent Claim
57 words
An enteric coated pharmaceutical capsule having acetates or derivatives thereof comprising cellulose acetate phthalate or polyvinyl acetate phthalate as the enteric coatign where in the improvement is an enteric coating level consisting of from 14 mg/cm 2 to 24.0 mg/cm 2 and a protective coating comprising a hydrophilic coating comprising hydroxypropyl cellulose, hydroxymethyl cellulose or hydroxypropylmethyl cellulose.
Claim 3
Dependent Claim
20 words
A dosage form of claim 1 wherein the high enteric coating level comprises enteric coating of 15 mg/cm 2 .
Claim 4
Dependent Claim
13 words
A dosage form of claim 1 wherein the second coating comprises hydroxypropyl cellulose.
Claim 5
Dependent Claim
49 words
An enteric coated pharmaceutical capsule having dissolution stability wherein the stability is provided by coating levels consisting of from 14 mg/cm 2 to 24.0 mg/cm 2 comprising enteric coating wherein the coating is acetates or derivativfes thereof and a second coating comprising hydroxypropyl cellulose, hydroxymethyl celluose or hydroxypropylmethyl cellulose.
Claim 6
Dependent Claim
49 words
An enteric coated pharmaceutical capsule having dissolution stability wherein the stability is provided by coating levels consisting of from 14 mg/cm 2 to 24.0 mg/cm 2 comprising enteric coating wherein the coating is acetates or derivativfes thereof and a second coating comprising hydroxypropyl cellulose, hydroxymethyl celluose or hydroxypropylmethyl cellulose.
Claim 7
Dependent Claim
20 words
A dosage form of claim 4 wherein the high enteric coating level comprises enteric coatign of 15 mg/cm 2 .
Claim 8
Dependent Claim
13 words
A dosage form of claim 4 wherein the second coating comprises hydroxypropyl cellulose.
Claim 9
Dependent Claim
34 words
An enteric coated pharmaceutical capsule having acrylic resins and derivatives thereof as the enteric coating wherein the improvement is a enteric coating level consisting of from 14 mg/cm 2 to 24.0 mg/cm 2 .
Claim 10
Dependent Claim
34 words
An enteric coated pharmaceutical capsule having acrylic resins and derivatives thereof as the enteric coating wherein the improvement is a enteric coating level consisting of from 14 mg/cm 2 to 24.0 mg/cm 2 .
Claim 11
Dependent Claim
20 words
A dosage form of claim 4 wherein the high enteric coating level comprises enteric coating of 15 mg/cm 2 .
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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) | 1994-11-25 | 1995-05-27 | 1995-11-26 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1998-11-25 | 1999-05-27 | 1999-11-26 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2002-11-25 | 2003-05-27 | 2003-11-26 | $7700.00 | Window Closed / Lapsed |