Drug delivery system
First Claim
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1. A unit dosage drug delivery system which comprises:
- a) a multiple layer capsule housing, comprising at least two coupled layers, sheaths or films from different materials, the first outer layer or sheath with hydrophilic character and the inner sheaths or films with hydrophobic character; and
b) a capsule filling, embodying one or more active drug substances, with conventional or extended drug release properties, with a remarkable hydrophobic character.
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Abstract
The present invention deals with a pharmaceutical product in unit dosage form and a unit dosage drug delivery system which comprises a multiple layer capsule or housing having two or more layers, the layers being of materials, wherein the outer layer possesses a hydrophilic character and the inner layer possesses a hydrophobic character, and a capsule filling wherein one or more drug substances are admixed, dissolved, suspended or agglomerated in a hydrophobic support.
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Citations
48 Claims
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1. A unit dosage drug delivery system which comprises:
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a) a multiple layer capsule housing, comprising at least two coupled layers, sheaths or films from different materials, the first outer layer or sheath with hydrophilic character and the inner sheaths or films with hydrophobic character; and b) a capsule filling, embodying one or more active drug substances, with conventional or extended drug release properties, with a remarkable hydrophobic character. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. A method of preparing a unit dosage drug delivery system, which comprises the steps of:
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a) providing a capsule housing comprising the following ingredients; i) a first outer hydrophilic layer, consisting either of a mixture or gelatin, glycerin and/or modified sorbitol solution, water or alternatively of other suitable compounds, alike polyphenyl compounds; ii) a second inner hydrophobic film or sheath from silicone, silicone mixture or other pharmaceutically acceptable silicone polymers; and iii) an optional inner third or additional films or sheaths, made from silicone polymers or waxes or alternatively from jaluronic acid polymers; and b) providing a capsule filling comprising the following ingredients; i) one or more active drug substances which are admixed, dissolved, suspended or agglomerated in an hydrophobic support; ii) silicone resin having a viscosity in the range of from 100 to 1,100 cSt and specific gravity in the range of from 0.96 to 1.02; iii) optional components particularly sodium lauryl-sarcosinate in the range from 0.1% to 2.0% and absolute ethanol in the range from 1.0% to 30.0% of the capsule filling; and iv) optional release modifying substances providing an extended release of the active medicinal drug, said modifying substances selected from the group consisting of;
beeswax, silicone waxes and natural or modified stearic acid, palmitic acid, myristic acid, lauric acid, stearyl alcohol, cetyl alcohol, glyceryl stearate, ethyl oleate, arachids oil, cotton seed oil, rape seed oil, liquid paraffin and polyethylene glycol from 400 to 20,000. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38)
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39. A medicated composition which comprises a pharmaceutically acceptable carrier and a therapeutically effective amount of a unit dosage drug delivery system comprising:
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a) a first outer hydrophilic layer, consisting either of a mixture or gelatin, glycerin and/or modified sorbitol solution, water or alternatively or other suitable compounds, alike polyphenyl compounds; b) a second inner hydrophobic film or sheath from silicone, silicone mixture or other pharmaceutically acceptable silicone polymers; c) an optional inner third or additional films or sheaths, made from silicone polymers or waxes or alternatively from jaluronic acid polymers; and d) a capsule filling comprising; i) one or more active drug substances which are admixed, dissolved, suspended or agglomerated in an hydrophobic support; ii) silicone resin having a viscosity in the range of from 100 to 1,100 cSt and specific gravity in the range of from 0.96 to 1.02; iii) optional components particularly sodium lauryl-sarcosinate in the range from 0.1% to 2.0% and absolute ethanol in the range from 1.0% to 30.0% of the capsule filling; and iv) optional release modifying substances, providing an extended release of the active medicinal drug, said modifying substances selected from the group consisting of;
beeswax, silicone waxes and natural or modified stearic acid, palmitic acid, myristic acid, lauric acid, stearyl alcohol, cetyl alcohol, glyceryl stearate, ethyl oleate, arachids oil, cotton seed oil, rape seed oil, liquid paraffin and polyethylene glycol from 400 to 20,000. - View Dependent Claims (40, 41, 42, 43, 44, 45, 46, 47)
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48. A pharmaceutical product in unit dosage form which comprises:
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a) a multiple layer capsule housing having two or more layers, said layers being of different materials, wherein the outer layer possesses a hydrophilic character and the inner layer possesses a hydrophobic character; and b) a filling comprising one or more drug substances which are admixed, dissolved, suspended or agglomerated in an hydrophobic support.
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Specification