SELF-EMULSIFYING PHARMACEUTICAL COMPOSITIONS OF HYDROPHILIC DRUGS AND PREPARATION THEREOF
First Claim
1. An oral self micro-emulsifying pharmaceutical composition, which comprises:
- (a) a therapeutically effective amount of a hydrophilic drug or its pharmaceutically acceptable salt;
(b) one or more solvents capable of dissolving the hydrophilic drug or its pharmaceutically acceptable salt to form a drug-solvent solution;
(c) a surfactant system comprising one or more surfactants, said surfactant system exhibiting a hydrophilic-lipophilic balance (HLB) value ranging from about 8 to about 17; and
(d) one or more hydrophilic carriers which are compatible with said drug-solvent solution and said surfactant system;
wherein the pharmaceutical composition is in a form of a self-emulsifying formulation for oral administration.
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Abstract
The present invention provides an oral self micro-emulsifying pharmaceutical composition of a hydrophilic drug or a pharmaceutically acceptable salt thereof which, in addition to the hydrophilic drug, one or more solvents for solving the hydrophilic drug to form a drug-solvent solution and a surfactant system, further comprises one or more hydrophilic carrier which are compatible with said drug-solvent solution and the surfactant system. The oral self micro-emulsifying pharmaceutical composition of the invention exhibits comparative bioavailability to that of the hydrophilic drug through injection and is stable during storage. A method for preparing the oral self micro-emulsifying pharmaceutical composition is also provided.
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18 Claims
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1. An oral self micro-emulsifying pharmaceutical composition, which comprises:
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(a) a therapeutically effective amount of a hydrophilic drug or its pharmaceutically acceptable salt; (b) one or more solvents capable of dissolving the hydrophilic drug or its pharmaceutically acceptable salt to form a drug-solvent solution; (c) a surfactant system comprising one or more surfactants, said surfactant system exhibiting a hydrophilic-lipophilic balance (HLB) value ranging from about 8 to about 17; and (d) one or more hydrophilic carriers which are compatible with said drug-solvent solution and said surfactant system; wherein the pharmaceutical composition is in a form of a self-emulsifying formulation for oral administration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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Specification