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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
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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 17:15
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 .

References Cited (Backward Citations)

US4001390A Cited
US4176175A Cited
US4287221A Cited
BE881462A Cited
GB2043442A Cited
WO1983000284A1 Cited
US4457907A Cited
US4716041A Cited
US4600645A Cited

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

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