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US4834965A
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Controlled release pharmaceutical composition
Assignee: Euro Celtique SA
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Filing: 1987-11-12
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Granted: 1989-05-30
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Expires: 2007-11-12
Abstract
Abstract A solid, controlled release pharmaceutical composition is provided with enhanced levels of control over drug release. The composition comprises an acid addition salt or a quarternary ammonium salt of an organic base drug complexed with an anionic surfactant and distributed in a matrix of a hydrophilic polymer. The complex formation between the drug which is preferably an acid addition salt of an organic an organic amine, and the surfactant, which is preferably a sulphosuccinate, distributed in the hydrophilic polymer matrix, which is preferably a water soluble hydroxyalkylcelulose ether results in a composition with excellent controlled released characteristics.
Inventors
- 👤 Rosa Martani
- 👤 Elisabeth Le Huede
- 👤 Jeanne Dumas
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-05 08:48
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2004; A61K9/2022; A61K9/205; A61K9/2054; A61K9/2013
Claims Analysis
Total Claims: 12
Claim 1
Independent Claim
116 words
A solid, oral, controlled release pharmaceutical dosage form pharmaceutical composition comprising a matrix, formed of a pharmaceutically acceptable, water soluble, non-ionic, hydrophilic cellulose ether having a molecular weight of at least 50,000 having distributed therethorugh the complex drug of an acid addition salt of quaternary ammonium salt of an organic base drug and an anionic surfactant, the combined weight of said cellulose ether and anionic surfactant being between 10% and 60%, and said dosage form containing between 1 mg and 30 mg of said anionic surfactant, said complex being water soluble between pH 1.5 and 7.0, whereby the rate of drug release from said dosage form is independent of pH between said pH 1.5 and 7.0
Claim 2
Dependent Claim
116 words
A solid, oral, controlled release pharmaceutical dosage form pharmaceutical composition comprising a matrix, formed of a pharmaceutically acceptable, water soluble, non-ionic, hydrophilic cellulose ether having a molecular weight of at least 50,000 having distributed therethorugh the complex drug of an acid addition salt of quaternary ammonium salt of an organic base drug and an anionic surfactant, the combined weight of said cellulose ether and anionic surfactant being between 10% and 60%, and said dosage form containing between 1 mg and 30 mg of said anionic surfactant, said complex being water soluble between pH 1.5 and 7.0, whereby the rate of drug release from said dosage form is independent of pH between said pH 1.5 and 7.0
Claim 3
Dependent Claim
18 words
A composition according to claim 1 wherein the drug is an acid addition salt of an organic base.
Claim 4
Dependent Claim
18 words
A composition according to claim 2 wherein the drug is an acid addition salt of an organic amine.
Claim 5
Dependent Claim
29 words
A composition according to claim 1 wherein the drug is an acid addition salt of metoclopramide, codeine, ethylmorphine, morphine, dextromethorphan, quinidine, quinine, dihydrocodeine, hydromorphone, perphenazine, diltiazem, meptazinol or flupirtine.
Claim 6
Dependent Claim
37 words
A composition according to claim 1 wherein the drug is metoclopramide hydrochloride, codeine phosphate, ethylmorphine hydrochloride, morphine sulphate, dextromethorphan hydrobromide, quinidine polygalacturonate, quinine sulphate, dihydrocodeine tartrate, hydromorphone hydrochloride, perphenazine hydrochloride, dilitiazem hydrochloride, meptazinol hydrochloride or flupirtine maleate.
Claim 7
Dependent Claim
14 words
A composition according to claim 1 wherein the anionic surfactant is a sulphonate surfactant.
Claim 8
Dependent Claim
13 words
A composition according to claim 6 wherein the anionic surfactant is sulphosuccinate surfactant.
Claim 9
Dependent Claim
15 words
A composition according to claim 7 wherein the anionic surfactant is a dialkyl sulphosuccinate surfactant.
Claim 10
Dependent Claim
18 words
A composition according to claim 8 wherein the anionic surfactant is an alkali metal salt of dioctyl sulphosuccinate.
Claim 11
Dependent Claim
144 words
Method for the preparation of the solid, oral, controlled release pharmaceutical composition of claim 1, which comprises dissolving said anionic surfactant in a C 1 -C 6 alkyl alcohol or an aqueous alcoholic solvent to form a solution thereof, mixing said water soluble, non-ionic cellulose ether having the molecular weight of at least 50,000 with the thus formed solution to form a homogeneous mixture thereof, granulating the thus formed homogenous mixture to form granules, drying the thus-formed granules, mixing said complex drug with said granules and compressing and shaping the thus formed mixture, whereby the drug complexes with the anionic surfactant to form a complex that is water soluble at pH between 1.5 and 7.0 and the cellulose ether forms a matrix through which the complex is distributed, whereby the rate of release of the drug from the composition is independent of the pH.
Claim 12
Dependent Claim
23 words
The solid, oral, controlled release pharmaceutical composition of claim 1 wherein said hydrophilic cellulose ether has a molecular weight of at least 75,000.
References Cited (Backward Citations)
US4540566A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1992-05-29 | 1992-11-28 | 1993-05-30 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-05-29 | 1996-11-28 | 1997-05-30 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-05-29 | 2000-11-28 | 2001-05-30 | $7700.00 | Window Closed / Lapsed |