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US4644031A Expired / Lapsed US ⏱️ 0.0 years remaining

Coating for pharmaceutical dosage forms

Assignee: Roehm GmbH Darmstadt
•
Filing: 1985-02-01
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Granted: 1987-02-17
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Expires: 2005-02-01
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Abstract

Abstract Coated pharmaceutical dosage forms which are resistant to gastric juice and release their active ingredient rapidly at a predetermined pH value in the range from pH 5 to pH 8 are obtained in accordance with the invention by coating pharmaceutical dosage forms with an aqueous dispersion containing dispersed latex particles of a first polymer which contains carboxyl groups and is water soluble between pH 5 and pH 8 and of a second water insoluble film forming polymer, in a weight ratio between 60:40 and 5:95.

Inventors

  • 👤 Klaus Lehmann
  • 👤 Dieter Dreher
  • 👤 Harry Goetz

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-30 22:47
CPC Classifications
C; C09; C09D; C09D133/00; C09D133/04; C09D133/06; C09D133/062; C09D133/064; A; A61; A61K; A61K9/00; A61K9/20; A61K9/28; A61K9/2806; A61K9/2833; A61K9/284; A61K9/2846; A61K9/48; A61K9/50; A61K9/5005; A61K9/5021; A61K9/5026; C09D133/08; C08; C08L; C08L33/00; C08L33/04; C08L33/06; C08L33/062; C08L33/064; C08L33/08

Claims Analysis

Total Claims: 14
Claim 1
Independent Claim 70 words
An aqueous dispersion adaptable to use for coating pharmaceutical dosage forms, said dispersion having a pH below 6 and comprising (A) dispersed latex particles of a polymer containing carboxyl groups which is water insoluble at a pH below 5 but becomes water soluble at least in a portion of the pH range between pH 5 and pH 8, and (B) dispersed latex particles of a water insoluble film forming polymer.
Claim 2
Dependent Claim 70 words
An aqueous dispersion adaptable to use for coating pharmaceutical dosage forms, said dispersion having a pH below 6 and comprising (A) dispersed latex particles of a polymer containing carboxyl groups which is water insoluble at a pH below 5 but becomes water soluble at least in a portion of the pH range between pH 5 and pH 8, and (B) dispersed latex particles of a water insoluble film forming polymer.
Claim 3
Dependent Claim 21 words
An aqueous dispersion as in claim 1 wherein said polymers (A) and (B) are emulsion polymers of vinyl and/or vinylidene monomers.
Claim 4
Dependent Claim 30 words
An aqueous dispersion as in claim 2 wherein said polymer containing carboxyl groups contains from 10 to 70 weight percent of at least one of acrylic acid and methacrylic acid.
Claim 5
Dependent Claim 22 words
An aqueous dispersion as in claim 2 wherein said polymers (A) and (B) comprise alkyl esters of acrylic acid and/or methacrylic acid.
Claim 6
Dependent Claim 24 words
An aqueous dispersion as in claim 2 having a combined content of said polymers (A) and (B) from 10 to 40 percent by weight.
Claim 7
Dependent Claim 24 words
An aqueous dispersion as in claim 1 wherein said film forming polymer has a dynamic glass transition temperature between 10° C. and 60° C.
Claim 8
Dependent Claim 36 words
A method for making a coated pharmaceutical dosage form resistant to gastric juice which comprises coating a medicament core with an aqueous dispersion of a coating composition as in claim 1 and drying said coated core.
Claim 9
Dependent Claim 22 words
A method as in claim 7 wherein the coated pharmaceutical dosage form is dried with air at a temperature below 60° C.
Claim 10
Dependent Claim 67 words
A pharmaceutical dosage form resistant to gastric juice comprising a medicament core having thereover a coating comprising (A) a polymer containing carboxyl groups which is water insoluble at a pH below 5 but becomes water soluble at least in a portion of the pH range between pH 5 and pH 8, and (B) a water insoluble film forming polymer, in a weight ratio between 60:40 and 5:95.
Claim 11
Dependent Claim 67 words
A pharmaceutical dosage form resistant to gastric juice comprising a medicament core having thereover a coating comprising (A) a polymer containing carboxyl groups which is water insoluble at a pH below 5 but becomes water soluble at least in a portion of the pH range between pH 5 and pH 8, and (B) a water insoluble film forming polymer, in a weight ratio between 60:40 and 5:95.
Claim 12
Dependent Claim 19 words
A pharmaceutical dosage form as in claim 9 wherein said coating has a thickness between 10 and 50 microns.
Claim 13
Dependent Claim 32 words
A pharmaceutical dosage form as in claim 9 in the form of small particles wherein the weight of said coating is between 10 and 20 percent by weight of the coated core.
Claim 14
Dependent Claim 34 words
A pharmaceutical dosage form as in claim 9 in the form of tablets, dragees, or capsules wherein the weight of said coating is between 3 and 5 percent by weight of the coated core.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1990-02-16 1990-08-18 1991-02-17 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1994-02-16 1994-08-18 1995-02-17 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1998-02-16 1998-08-18 1999-02-17 $7700.00 Window Closed / Lapsed

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