Compressed solid dosage form manufacturing process well-suited for use with drugs of low aqueous solubility and compressed solid dosage forms made thereby
First Claim
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1. A compressed pharmaceutical dosage form comprising:
- a) a pharmacologically active compound having low aqueous solubility, and b) starch in an amount of greater than about 25 weight percent.
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Abstract
A pharmaceutical formulation of compounds with low aqueous solubility and method of manufacture thereof. The formulation may include a pharmacologically active compound having low aqueous solubility and starch in the amount of greater than about 25 weight percent. A manufacturing method may include blending the active compound and starch, compressing the blend into a solid, comminuting the solid into granules, wetting the granules, drying the granules, and tabletting the dried granules to make a solid pharmaceutical formulation.
40 Citations
52 Claims
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1. A compressed pharmaceutical dosage form comprising:
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a) a pharmacologically active compound having low aqueous solubility, and b) starch in an amount of greater than about 25 weight percent. - View Dependent Claims (3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 19, 26, 28, 29, 30)
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2. A compressed pharmaceutical dosage form comprising:
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a) a pharmacologically active compound having low aqueous solubility, and b) starch in an amount of from about 35 to about 80 weight percent.
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14. A compressed pharmaceutical dosage form comprising raloxifene hydrochloride wherein the raloxifene hydrochloride has a particle size distribution such that d(50) is greater than or equal to about 35 μ
- m measured by laser light scattering.
- View Dependent Claims (15, 16, 17, 18, 20, 21, 22, 23, 24, 25, 27)
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31. A process for preparing a compressed pharmaceutical dosage form for a drug with low aqueous solubility comprising:
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a) blending a particulate pharmacologically active compound and starch, b) compressing the blend into a coherent solid, c) comminuting the coherent solid into granules, d) wetting the granules with a liquid, e) drying the wetted granules to form dried granules, and f) tabletting the dried granules. - View Dependent Claims (32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49)
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50. A compressed pharmaceutical dosage form comprising:
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a) raloxifene hydrochloride in an amount of about 25 weight percent, and b) starch in an amount of from about 25 to about 90 weight percent. - View Dependent Claims (51, 52)
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Specification