Pharmaceutical compositions providing enhanced drug concentrations
First Claim
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1. A composition comprising:
- (a) a drug in a pharmaceutically acceptable solubility-improved form that is an amorphous form of the drug; and
(b) a concentration-enhancing polymer selected from the group consisting of cellulose acetate phthalate, cellulose acetate trimellitate, hydroxypropyl methyl cellulose phthalate, hydroxypropyl methyl cellulose acetate succinate, hydroxypropyl methyl cellulose acetate, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, methyl cellulose, hydroxyethyl methyl cellulose, hydroxyethyl cellulose acetate, hydroxyethyl ethyl cellulose, carboxymethyl ethyl cellulose, acrylate and methacrylate copolymers, vinyl polymers and copolymers having substituents of hydroxyl, alkylacyloxy, and cyclicamido, and mixtures thereof,wherein said drug alone has an aqueous solubility of up to 2 mg/mL at pH 1 to 8, and said composition is not a molecular dispersion.
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Abstract
A drug in a solubility-improved form is combined with a concentration-enhancing polymer in a sufficient amount so that the combination provides substantially enhanced drug concentration in a use environment relative to a control comprising the same amount of the same solubility-improved form of drug without the concentration-enhancing polymer.
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Citations
10 Claims
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1. A composition comprising:
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(a) a drug in a pharmaceutically acceptable solubility-improved form that is an amorphous form of the drug; and (b) a concentration-enhancing polymer selected from the group consisting of cellulose acetate phthalate, cellulose acetate trimellitate, hydroxypropyl methyl cellulose phthalate, hydroxypropyl methyl cellulose acetate succinate, hydroxypropyl methyl cellulose acetate, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, methyl cellulose, hydroxyethyl methyl cellulose, hydroxyethyl cellulose acetate, hydroxyethyl ethyl cellulose, carboxymethyl ethyl cellulose, acrylate and methacrylate copolymers, vinyl polymers and copolymers having substituents of hydroxyl, alkylacyloxy, and cyclicamido, and mixtures thereof, wherein said drug alone has an aqueous solubility of up to 2 mg/mL at pH 1 to 8, and said composition is not a molecular dispersion. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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Specification