STABLE SOLUTIONS OF SPARINGLY SOLUBLE ACTIVES
First Claim
1. A stable pharmaceutical composition comprising a soft gelatin capsule that comprises at least one sparingly soluble active drug and a solvent system, wherein the solvent system comprises a solvent, a co-solvent, a solubilizer, a surfactant, an aqueous solution of alkali and a crystal growth inhibitor.
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Abstract
The present invention relates to a stable pharmaceutical composition comprising soft gelatin capsules containing at least one sparingly soluble active drug (singly or in combination with sparingly soluble and/or soluble drugs) and a solvent system, wherein the solvent system comprises of solvent, co-solvent, solubilizer(s), surfactant, aqueous solution of alkali and crystal growth inhibitor. The present invention further relates to process for preparing a stable pharmaceutical composition of sparingly soluble active drug(s) in soft gelatin capsules.
26 Citations
28 Claims
- 1. A stable pharmaceutical composition comprising a soft gelatin capsule that comprises at least one sparingly soluble active drug and a solvent system, wherein the solvent system comprises a solvent, a co-solvent, a solubilizer, a surfactant, an aqueous solution of alkali and a crystal growth inhibitor.
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5-10. -10. (canceled)
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18. A process for preparing a stable gelatin capsule dosage form of at least one sparingly soluble active drug comprising the steps of:
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a. solubilizing the at least one sparingly soluble active drug in a solvent system, wherein the solvent system comprises a solvent, a co-solvent, a solubilizer, a surfactant, an aqueous solution of alkali and a crystal growth inhibitor; and b. encapsulating the solution of the at least one sparingly soluble active drug in the solvent system in soft gelatin shell dosage form. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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Specification