Free-flowing solid formulations with improved bio-availability of poorly water soluble drugs and process for making the same
First Claim
1. A composition comprising:
- 1 to 30 percent by weight of a pharmaceutical agent or drug that has poor solubility in water;
5 to 60 percent by weight of a pharmaceutically acceptable surfactant;
10 to 40 percent by weight of water;
1 to 20 percent by weight of a pharmaceutically acceptable unsaturated fatty acid ester;
0 to 50 percent by weight of a pharmaceutically acceptable water miscible polyol, and 1 to 10 percent by weight of a pharmaceutically acceptable phospholipid.
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Abstract
A free-flowing solid formulations of drugs or pharmaceutical agents which have poor aqueous solubility are obtained by admixing a liquid or gel composition that includes 1 to 30 percent by weight of the drug, 5 to 60 percent by weight of a surfactant, 10 to 40 percent by weight of water; 1 to 20 percent by weight of unsaturated fatty acid ester, 0 to 50 percent by weight water miscible pharmaceutically acceptable polyol and 1 to 10 percent by weight of phospholipid with a pharmaceutically acceptable suitable solid carrier and thereafter drying the admixture. The free-flowing powder is suitable for being formed into tablets or capsules. The drug or pharmaceutical agent is solubilized in the formulation and has significantly improved bio-availability when compared to the drug tested in its pure form.
74 Citations
18 Claims
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1. A composition comprising:
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1 to 30 percent by weight of a pharmaceutical agent or drug that has poor solubility in water;
5 to 60 percent by weight of a pharmaceutically acceptable surfactant;
10 to 40 percent by weight of water;
1 to 20 percent by weight of a pharmaceutically acceptable unsaturated fatty acid ester;
0 to 50 percent by weight of a pharmaceutically acceptable water miscible polyol, and 1 to 10 percent by weight of a pharmaceutically acceptable phospholipid. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A composition comprising:
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1 to 30 percent by weight of a pharmaceutical agent or drug that has poor solubility in water;
5 to 60 percent by weight of a pharmaceutically acceptable surfactant selected from the groups consisting of polyoxyethylene sorbitan fatty acid esters, polyoxyethylene alkyl ethers, polyoxyethylene castor oil derivatives, polyoxyethylene stearates, and saturated polyglycolized glycerides;
10 to 40 percent by weight of water;
1 to 20 percent by weight of a pharmaceutically acceptable unsaturated fatty acid ester selected from the groups consisting of ethyl linoleate, palmitoleic acid, oleic acid and linoleic acid;
0 to 50 percent by weight of a pharmaceutically acceptable water miscible polyol selected from the group consisting of propylene glycol, glycerol, diethylene glycol, diethylene glycol monoethyl ether and polyethylene glycol, and 1 to 10 percent by weight of a pharmaceutically acceptable phospholipid selected from the group consisting of lecithin, phosphatidylethanolamine, phosphatidylserine and phosphatidylinositol. - View Dependent Claims (14, 15, 16, 17)
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18-41. -41. (canceled)
Specification