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Claims for Patent: 5,932,247

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Claims for Patent: 5,932,247

Title: Pharmaceutical composition for piperidinoalkanol compounds
Abstract:The invention provides a pharmaceutical composition in solid unit dosage form, comprising, a) a therapeutically effective amount of a piperidinoalkanol compound or a pharmaceutically acceptable salt thereof; and, b) at least one inert ingredient.
Inventor(s): Ortyl; Thomas T. (Overland Park, KS), Skultety; Paul F. (Leawood, KS), Mitchell; Kristen C. (Lee's Summit, MO), Phadke; Deepak S. (Olathe, KS), Attarchi; Faraneh (Kansas City, MO), Pierce; Marguerite L. (Fairway, KS), Schoeneman; Aaron W. (Lee's Summit, MO), Schnitz; Joseph M. (Kansas City, MO)
Assignee: Hoechst Marion Roussel, Inc. (Cincinnati, OH)
Application Number:08/948,005
Patent Claims: 1. A pharmaceutical composition in solid unit dosage form prepared by a process comprising blending together a compound of the formula: ##STR10## wherein X is a number ranging from about zero to 5, and the individual optical isomers thereof, with microcrystalline cellulose, lactose and pregelatinized starch; adding a solution of gelatin in water mixing; drying and milling the mixture; and adding croscarmellose sodium with mixing, wherein the resulting mixture is filled into capsules.

2. A pharmaceutical composition in solid form wherein croscarmellose sodium, microcrystalline cellulose, lactose, pregelatinized starch, gelatin and magnesium stearate are present in amounts of about 4.8%, 33.7%, 33.7%, 9.6%, 3.5% and 0.5%, respectively, by weight of the composition, wherein the final mixture is pressed into a tablet from which the quantity of compound of the formula: ##STR11## wherein X is a number ranging from about zero to 5, and the individual optical isomers thereof, dissolved in 45 minutes, is not less than 75% of label in water at about 37.degree. C. and about 50 rpm when measured using USP Apparatus 2.

3. A pharmaceutical composition in solid form wherein croscarmellose sodium, microcrystalline cellulose, lactose, pregelatinized starach, gelatin and magnesium stearate are present in amounts of about 4.8%, 25.7%, 25.7%, 9.6%, 3.5% and 0.75% respectively, by weight of the composition wherein the final mixture is pressed into a tablet from which the quantity of compound of the formula: ##STR12## wherein X is a number ranging from about zero to 5, and the individual optical isomers thereof, dissolved in 45 minutes, is not less than 75% of label in 0.001 N aqueous hydrochloric acid at abaout 37.degree. C. and about 50 rpm when measured using USP Apparatus 2.

4. A pharmaceutical composition in solid form wherein croscarmellose sodium, microcrystalline cellulose, pregelatinized starch, and magnesium stearate are present in amounts of about 6%, 33.3%, 30% and 0.75% respectively, by weight of the composition wherein the final mixture is pressed into a tabalet from which the quantity of compound of the formula: ##STR13## wherein X is a number ranging from about zero to 5, and the individual optical isomers thereof, dissolved in 45 minutes, is not less than 75% of label in 0.001 N aqueous hydrochloric acid at about 37.degree. C. and about 50 rpm when measured using USP Apparatus 2.
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