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Claims for Patent: 4,137,300

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Claims for Patent: 4,137,300

Title: Sustained action dosage forms
Abstract:By incorporating solid drug substances into mixtures of higher alkanols and/or alkanoic acids melting above 25.degree. 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.
Inventor(s): Sheth; Pravin (Springfield, NJ), Leeson; Lewis J. (Roseland, NJ)
Assignee: Ciba-Geigy Corporation (Ardsley, NY)
Application Number:05/806,424
Patent Claims: 1. 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.degree. 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.

2. A dosage form as claimed in claim 1, wherein the pharmacologically effective substance is a solid.

3. A dosage form as claimed in claim 1, wherein the higher alkanol is a straight chain primary alkanol with 14 to 24 carbon atoms.

4. A dosage form as claimed in claim 3, wherein the higher alkanol is cetyl or stearyl alcohol, or various mixtures thereof.

5. 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.

6. A dosage form as claimed in claim 5, wherein the higher alkanoic acid is myristic, palmitic or stearic acid, or various mixtures thereof.

7. 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.

8. A dosage form as claimed in claim 1, wherein the prolamine is a globular protein obtained from grains.

9. A dosage form as claimed in claim 8, wherein the prolamine is zein, gliadin or hordenin, or various mixtures thereof.

10. A dosage form as claimed in claim 1, wherein said proportions for tablets vary from about 100:17:4 to about 100:25:8.

11. A dosage form as claimed in claim 1, wherein said proportions for capsules vary from about 100:25:5 to about 100:35:7.

12. 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.degree. C, (b) heating the mixture to about 55.degree.-65.degree. 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.

13. 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.degree. 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.
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