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Claims for Patent: 5,612,367

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Claims for Patent: 5,612,367

Title: Method of enhancing bioavailability of pharmaceutical agents
Abstract:The invention provides a pharmaceutical composition comprising a particular physical form of N-[4-[5-(cyclopentyloxycarbonyl)amino-1-methylindol-3-yl-methyl]-3-methoxy benzoyl]-2-methylbenzenesulphonamide and polyvinylpyrrolidone. It also provides methods for preparing this physical form, and another physical form of N-[4-[5-(cyclopentyloxycarbonyl)amino-1-methylindol-3-yl-methyl]-3-methoxy benzoyl]-2-methylbenzenesulphonamide useful in the preparation of the first mentioned physical form. The compositions are useful in the treatment of diseases in which leukotrienes are implicated, for example asthma.
Inventor(s): Timko; Robert J. (West Chester, PA), Bradway; Randy J. (Downingtown, PA), Clements; Arlene (Turnersville, NJ)
Assignee: Zeneca Limited (London, GB2)
Application Number:08/474,191
Patent Claims: 1. A method of enhancing the bioavailability of N-[4-[5-(cyclopentyloxycarbonyl)amino-1-methylindol-3-yl-methyl]-3-methoxy benzoyl]-2-methylbenzenesulphonamide upon oral administration to living mammals, said method comprising formulating a pharmaceutical composition comprising, as active ingredient, an amorphous physical form of N-[4-[5-(cyclopentyloxycarbonyl)amino-1-methylindol-3-yl-methyl]-3-methoxy benzoyl]-2-methylbenzenesulphonamide, which is substantially free of other physical forms, and has an infra-red spectrum (0.5% in KBr) having sharp peaks at 1690, 1530, 1490, 1420, 1155, 1060, 862 and 550 cm.sup.-1, in combination with polyvinylpyrrolidone.

2. A method of stabilizing an amorphous physical form of N-[4-[5-(cyclopentyloxycarbonyl)amino-1-methylindol-3-yl-methyl]-3-methoxy benzoyl]-2-methylbenzenesulphonamide, having an infra-red spectrum (0.5% in KBr) having sharp peaks at 1690, 1530, 1490, 1420, 1155, 1060, 862 and 550 cm.sup.-1, in a pharmaceutical composition for administration to living mammals, said method comprising formulating a pharmaceutical composition comprising said amorphous physical form, substantially free of other physical forms, in combination with polyvinylpyrrolidone.

3. The method of claim 1 or 2 wherein said pharmaceutical composition further comprises a pharmaceutically acceptable carrier.

4. The method of claim 1 or 2 wherein said amorphous physical form is present in an amount of from 1 to 90% by weight, based upon the total weight of the composition.

5. The method of claim 4 wherein the polyvinylpyrrolidone is present in an amount of from 1 to 20% by weight, based upon the total weight of the composition.

6. The method of claim 3 wherein the pharmaceutically acceptable carrier is selected from mannitol, lactose, sorbitol, glucose, sucrose, dextrose, fructose, xylitol, microcrystalline cellulose, powdered cellulose and hydroxypropylmethylcellulose.

7. The method of claim 1 or 2 wherein the composition further comprises a processing adjuvant selected from croscarmellose sodium, sodium starch glycolate, starch, magnesium stearate, stearic acid, talc and powdered vegetable stearine.

8. The method of claim 1 or 2 wherein the composition is in the form of a tablet.
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