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Claims for Patent: 4,803,081

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Claims for Patent: 4,803,081

Title: New pharmaceutical preparations with extended release
Abstract:An extended release perparation of an active compound with very low solubility containing the active compound dissolved or dispersed in a semi-solid or liquid non-ionic solubilizer and whereby the amount by weight of the solubilizer is at least equal to the amount by weight of the active compound as well as a process for the preparation thereof.
Inventor(s): Falk; Karl-Erik L. (Lindome, SE), Hugosson; Sven M. (Kungsbacka, SE), Rosinski; Adam (Molndal, SE), Sjogren; John A. (Molnlycke, SE)
Assignee: Aktiebolaget Hassle (Molndal, SE)
Application Number:07/034,500
Patent Claims: 1. A solid preparation providing extended release of an active compound with very low solubility in water copmrising a solution or dispersion of an effective amount of the active compound in a semi-solid or liquid nonionic solubilizer, wherein the amount by weight of the solubilizer is at least equal to the amount by weight of the active compound, and a release controlling system to provide extended release.

2. A preparation according to claim 1 wherein the non-ionic solubilizer is selected from esters and/or ethers of polyethyleneglycols.

3. A preparation according to claim 1 wherein the non-ionic solubilizer is selected from polyethoxylated fatty acids, hydroxylated fatty acids or fatty alcohols.

4. A preparation according to claim 1 wherein the non-ionic solubilizer is selected from polyethoxylated castor oil, polyethoxylated hydrogenated castor oil, a polyethoxylated fatty acid from castor oil or a polyethoxylated fatty acid from hydrogenated castor oil.

5. A preparation according to claim 4 wherein the non-ionic solubilizer is esters of hydrogenated castor oil fatty acids wit oxyethylated glycerine, especially Cremophor.RTM. 40 (BASF).

6. A preparation according to claim 1 wherein the proportions between the active compound and the solubilizer varies in the range from 1:1 to 1:10, preferably in the range from 1:2 to 1:6.

7. A preparation according to claim 1 wherein the active compound has a solubility in water of 1:1000 or less by weight and is solubilizable in the non-ionic solubilizer or in a combination of water and the non-ionic solubilizer.

8. A preparation according to claim 1 wherein the active compound comprises one or more substituted dihydropyridines.

9. A preparation according to claim 8 wherein the substituted dihydropyridine is nifedipine.

10. A preparation according to claim 8 wherein the substituted dihydropyridine is felodipine.

11. A preparation according to claim 1 wherein the release is controlled by an inert porous matrix, a diffusion retarding coating or a disintegrating coating.

12. A preparation according to claim 1 wherein the release is controlled by a hydrophilic gel system.

13. A preparation according to claim 12 wherein the hydrophilic gelforming component constitutes between 20-80% by weight of the preparation.

14. A preparation according to claim 12 wherein the hydrophilic gel system comprises hydroxypropyl methylcellulose.

15. A preparation according to claim 14 wherein the hydroxypropyl methylcellulose has a hydroxypropyl content of 4-12% by weight.

16. A preparation according to claim 12 wherein the hydrophilic gel system contains carboxypolymethylene.

17. A process for making a solid preparation that provides extended release of an active compound with very low solubility in water comprising

dissolving or dispersing an effective amount of the active compound in a semi-solid or liquid nonionic solubilizer, the amount by weight of said solubilizer being at least equal to the amount by wight of the active compound, and

incorporating the resulting solution or dispersion into a suitable release controlling system to form a pharmaceutical dosage unit.
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