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US5165937A Expired / Lapsed US ⏱️ 0.0 years remaining

Controlled release tablets containing flavoxate

Assignee: Recordati SA
•
Filing: 1991-12-26
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Granted: 1992-11-24
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Expires: 2011-12-26
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Abstract

Abstract Solid dosage form for the controlled release of flavoxate hydrochloride is described. The dosage form includes a matrix allowing gradual release of the flavoxate hydrochloride contained within it, a suitable binder which limits the dimensions of the finished solid dosage form, and an acidifying agent which ensures stability of the flavoxate hydrochloride with time and improves its release profile by making it independent of pH.

Inventors

  • 👤 Giancarlo Santus
  • 👤 Alberto Tajana

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-05 20:52
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2004; A61K9/2022; A61K9/205; A61K9/2054; A61K31/00; A61K31/33; A61K31/395; A61K31/435; A61K31/44; A61K31/445; A61K9/2013; A61K9/2027; A61P; A61P13/00; A61P13/02; A61P15/00

Claims Analysis

Total Claims: 11
Claim 1
Independent Claim 150 words
A solid dosage form for the controlled release of a therapeutically effective amount of a flavoxate salt, said solid dosage form comprising: a) a flavoxate salt; b) a polymer mixed with said flavoxate to form a controlled release matrix, said polymer selected from the group consisting of methylcellulose, acrylic copolymers and hydroxypropylmethyl-cellulose; c) a binding agent mixed with said matrix, said binding agent present in a ratio of about 1:20 by weight to said flavoxate salt, and said binding agent selected from the group consisting of polyvinylpyrrolidone, cellulose and polyvinyl alcohol; and d) an acidifying agent mixed with said matrix, said acidifying agent selected from the group consisting of citric acid and tartaric acid, said acidifying agent rendering the dissolution of the dosage independent of the pH of the dissolving medium said matrix divided into individual dosage forms, such that each dosage contains a therapeutically effective amount of flavoxate salt.
Claim 2
Dependent Claim 150 words
A solid dosage form for the controlled release of a therapeutically effective amount of a flavoxate salt, said solid dosage form comprising: a) a flavoxate salt; b) a polymer mixed with said flavoxate to form a controlled release matrix, said polymer selected from the group consisting of methylcellulose, acrylic copolymers and hydroxypropylmethyl-cellulose; c) a binding agent mixed with said matrix, said binding agent present in a ratio of about 1:20 by weight to said flavoxate salt, and said binding agent selected from the group consisting of polyvinylpyrrolidone, cellulose and polyvinyl alcohol; and d) an acidifying agent mixed with said matrix, said acidifying agent selected from the group consisting of citric acid and tartaric acid, said acidifying agent rendering the dissolution of the dosage independent of the pH of the dissolving medium said matrix divided into individual dosage forms, such that each dosage contains a therapeutically effective amount of flavoxate salt.
Claim 3
Dependent Claim 24 words
The solid dosage form of claim 1, wherein said hydroxypropylmethylcellulose polymer is present at a ratio of 1:10 by weight to the flavoxate salt.
Claim 4
Dependent Claim 25 words
The solid dosage form of claim 1, wherein said acidifying agent is present at a ratio of about 1:8 by weight to the flavoxate salt.
Claim 5
Dependent Claim 31 words
The solid dosage form of claim 1, wherein each individual dosage form is coated with a water-soluble film and wherein the dissolution of the dosage is not affected by said film.
Claim 6
Dependent Claim 26 words
The solid dosage form of claim 4, wherein said water-soluble film and wherein the dissolution of the dosage is not affected by said film comprises hydroxypropylmethylcellulose.
Claim 7
Dependent Claim 14 words
The solid dosage form of claim 1, wherein said flavoxate salt is flavoxate hydrochloride.
Claim 8
Dependent Claim 22 words
The solid dosage form of claim 6, wherein each individual dosage form contains from about 400 to 1200 mg of flavoxate hydrochloride.
Claim 9
Dependent Claim 15 words
The solid dosage form of claim 1, wherein said solid dosage form is a tablet.
Claim 10
Dependent Claim 100 words
A controlled release tablet of a therapeutically effective amount of flavoxate hydrochloride, said tablet comprising: a) flavoxate hydrochloride; b) hydroxypropylmethylcellulose mixed with said flavoxate to form a controlled release matrix; c) polyvinyl alcohol mixed with said matrix; and c) an acidifying agent selected from the group consisting of citric acid and tartaric acid, said agent mixed with said matrix and said acidifying agent rendering the dissolution of the dosage independent of the pH of the dissolving medium, said matrix divided into individual dosage forms and compressed into tablets, such that each tablet contains a therapeutically effective amount of flavoxate hydrochloride.
Claim 11
Dependent Claim 100 words
A controlled release tablet of a therapeutically effective amount of flavoxate hydrochloride, said tablet comprising: a) flavoxate hydrochloride; b) hydroxypropylmethylcellulose mixed with said flavoxate to form a controlled release matrix; c) polyvinyl alcohol mixed with said matrix; and c) an acidifying agent selected from the group consisting of citric acid and tartaric acid, said agent mixed with said matrix and said acidifying agent rendering the dissolution of the dosage independent of the pH of the dissolving medium, said matrix divided into individual dosage forms and compressed into tablets, such that each tablet contains a therapeutically effective amount of flavoxate hydrochloride.

References Cited (Backward Citations)

US4428955A Cited
US4550115A Cited
US4702918A Cited
US4814176A Cited
EP0250374A1 Cited
EP0266707A2 Cited
JPS63154619A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1995-11-24 1996-05-25 1996-11-24 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1999-11-24 2000-05-25 2000-11-24 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2003-11-24 2004-05-25 2004-11-24 $7700.00 Window Closed / Lapsed

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