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US4137300A Expired / Lapsed US ⏱️ 0.0 years remaining

Sustained action dosage forms

Assignee: Novartis Corp
•
Filing: 1977-06-14
•
Granted: 1979-01-30
•
Expires: 1997-06-14
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Abstract

Abstract By incorporating solid drug substances into mixtures of higher alkanols and/or alkanoic acids melting above 25° C, forming granules thereof and covering them with a prolamine, a pharmaceutical dosage form is obtained, which slowly and evenly releases the drug within the gastrointestinal tract of a mammal.

Inventors

  • 👤 Pravin Sheth
  • 👤 Lewis J. Leeson

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-26 23:34
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/48; A61K9/50; A61K9/5005; A61K9/5021; A61K9/5052; A61K9/20; A61K9/2004; A61K9/2013; A61K9/2022; A61K9/2063; A61K9/4841; A61K9/4866; A61K9/14; A61K9/16; A61K9/1605; A61K9/1617

Claims Analysis

Total Claims: 16
Claim 1
Independent Claim 62 words
A sustained action dosage form of the type comprising at least (a) a core-mixture of a pharmacologically effective substance and at least two members selected from a higher alkanol and alkanoic acid melting above 25° C. and (b) an outer layer of a prolamine, wherein the proportions of said effective substance: said alkanol/acid: said prolamine vary from about 100:5:3 to about 100:200:80.
Claim 2
Dependent Claim 62 words
A sustained action dosage form of the type comprising at least (a) a core-mixture of a pharmacologically effective substance and at least two members selected from a higher alkanol and alkanoic acid melting above 25° C. and (b) an outer layer of a prolamine, wherein the proportions of said effective substance: said alkanol/acid: said prolamine vary from about 100:5:3 to about 100:200:80.
Claim 3
Dependent Claim 16 words
A dosage form as claimed in claim 1, wherein the pharmacologically effective substance is a solid.
Claim 4
Dependent Claim 24 words
A dosage form as claimed in claim 1, wherein the higher alkanol is a straight chain primary alkanol with 14 to 24 carbon atoms.
Claim 5
Dependent Claim 21 words
A dosage form as claimed in claim 3, wherein the higher alkanol is cetyl or stearyl alcohol, or various mixtures thereof.
Claim 6
Dependent Claim 25 words
A dosage form as claimed in claim 1, wherein the higher alkanoic acid is a straight chain fatty acid with 14 to 24 carbon atoms.
Claim 7
Dependent Claim 23 words
A dosage form as claimed in claim 5, wherein the higher alkanoic acid is myristic, palmitic or stearic acid, or various mixtures thereof.
Claim 8
Dependent Claim 32 words
A dosage form as claimed in claim 4, wherein cetostearyl alcohol is used as alkanol mixture, containing about 24 to 50% of cetyl alcohol and about 76 to 50% of stearyl alcohol.
Claim 9
Dependent Claim 18 words
A dosage form as claimed in claim 1, wherein the prolamine is a globular protein obtained from grains.
Claim 10
Dependent Claim 20 words
A dosage form as claimed in claim 8, wherein the prolamine is zein, gliadin or hordenin, or various mixtures thereof.
Claim 11
Dependent Claim 20 words
A dosage form as claimed in claim 1, wherein said proportions for tablets vary from about 100:17:4 to about 100:25:8.
Claim 12
Dependent Claim 20 words
A dosage form as claimed in claim 1, wherein said proportions for capsules vary from about 100:25:5 to about 100:35:7.
Claim 13
Dependent Claim 82 words
A process for the preparation of sustained release dosage forms, which consists in (a) mixing a pharmacologically effective substance with at least two members selected from a higher alkanol and alkanoic acid melting above 25° C, (b) heating the mixture to about 55°-65° C., c) granulating the resulting solid mixture with a solution of a prolamine, (d) evaporating the solvent of said solution and (e) compressing the resulting granules into tablets, or breaking said tablets and filling the resulting granules into capsules.
Claim 14
Dependent Claim 82 words
A process for the preparation of sustained release dosage forms, which consists in (a) mixing a pharmacologically effective substance with at least two members selected from a higher alkanol and alkanoic acid melting above 25° C, (b) heating the mixture to about 55°-65° C., c) granulating the resulting solid mixture with a solution of a prolamine, (d) evaporating the solvent of said solution and (e) compressing the resulting granules into tablets, or breaking said tablets and filling the resulting granules into capsules.
Claim 15
Dependent Claim 74 words
A process for the preparation of sustained release dosage forms, which consists in (a) mixing a pharmacologically effective substance with at least two members selected from a higher alkanol and alkanoic acid melting above 25° C., (b) granulating the resulting solid mixture with a solution of a prolamine, (c) evaporating the solvent of said solution and (d) compressing the resulting granules into tablets, or breaking said tablets and filling the resulting granules into capsules.
Claim 16
Dependent Claim 74 words
A process for the preparation of sustained release dosage forms, which consists in (a) mixing a pharmacologically effective substance with at least two members selected from a higher alkanol and alkanoic acid melting above 25° C., (b) granulating the resulting solid mixture with a solution of a prolamine, (c) evaporating the solvent of said solution and (d) compressing the resulting granules into tablets, or breaking said tablets and filling the resulting granules into capsules.

References Cited (Backward Citations)

US874310A Cited
US2895880A Cited
US3184386A Cited
US3079303A Cited
US3062720A Cited
US3108046A Cited
US3147187A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1982-01-29 1982-07-31 1983-01-30 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1986-01-29 1986-07-31 1987-01-30 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1990-01-29 1990-07-31 1991-01-30 $7700.00 Window Closed / Lapsed

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