Process for preparing a finely self-emulsifiable pharmaceutical composition
First Claim
1. A process for preparing a finely self-emulsifiable pharmaceutical composition comprising a drug of low water solubility, the process comprising the steps of:
- (a) providing at least one pharmaceutically acceptable fatty acid and at least one pharmaceutically acceptable organic amine;
(b) providing a pharmaceutically acceptable solvent for the at least one fatty acid and a pharmaceutically acceptable solvent for the at least one organic amine;
(c) admixing together with the at least one fatty acid the solvent for the at least one fatty acid and the solvent for the at least one organic amine to form a pre-nix in which the fatty acid is substantially completely dissolved;
(d) admixing together with the pre-mix the at least one organic amine to form a mixture in which the organic amine is substantially completely dissolved; and
(e) admixing together with the mixture the drug of low water solubility in dissolved and/or solubilized form to form a pharmaceutical composition.
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Abstract
An orally deliverable pharmaceutical composition is provided comprising a drug of low water solubility and a solvent liquid that comprises at least one pharmaceutically acceptable solvent, at least one pharmaceutically acceptable fatty acid and at least one pharmaceutically acceptable organic amine, wherein (a) a substantial portion, for example at least about 15% by weight, of the drug is in dissolved or solubilized form in the solvent liquid, and (b) the fatty acid and the organic amine are present in total and relative amounts such that the composition is finely self-emulsifiable in simulated gastric fluid. A process for preparing such a composition is also provided.
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24 Claims
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1. A process for preparing a finely self-emulsifiable pharmaceutical composition comprising a drug of low water solubility, the process comprising the steps of:
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(a) providing at least one pharmaceutically acceptable fatty acid and at least one pharmaceutically acceptable organic amine;
(b) providing a pharmaceutically acceptable solvent for the at least one fatty acid and a pharmaceutically acceptable solvent for the at least one organic amine;
(c) admixing together with the at least one fatty acid the solvent for the at least one fatty acid and the solvent for the at least one organic amine to form a pre-nix in which the fatty acid is substantially completely dissolved;
(d) admixing together with the pre-mix the at least one organic amine to form a mixture in which the organic amine is substantially completely dissolved; and
(e) admixing together with the mixture the drug of low water solubility in dissolved and/or solubilized form to form a pharmaceutical composition. - 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, 24)
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Specification