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Claims for Patent: 5,482,963

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Claims for Patent: 5,482,963

Title: Pharmaceutical agents useful as leukotriene antagonists
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): Holohan; James J. (Macclesfield, GB2), Edwards; Ieuan J. (Congleton, GB2), Timko; Robert J. (West Chester, PA), Bradway; Randy J. (Downingtown, PA), Clements; Arlene (Turnersville, NJ)
Assignee: Zeneca Limited (London, GB2)
Application Number:08/116,781
Patent Claims: 1. A pharmaceutical composition, which comprises, as active ingredient, an amorphous physical form of N-[4-[5-(cyclopentyloxycarbonyl)amino-1-methylindol-3-yl-methyl]-3methoxyb enzoyl]-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, and polyvinylpyrrolidone.

2. A composition as claimed in claim 1, which further comprises a pharmaceutically acceptable carrier.

3. A composition as claimed in claim 1, in which the active ingredient is present in an amount of from 1 to 90% by weight, based upon the total weight of the composition.

4. A composition as claimed in claim 1 or claim 3, in which the polyvinylpyrrolidone is present in an amount of from 1 to 20% by weight, based upon the total weight of the composition.

5. A composition as claimed in claim 1 or claim 2, in which the pharmaceutically acceptable carrier is selected from mannitol, lactose, sorbitol, glucose, sucrose, dextrose, fructose, xylitol, microcrystalline cellulose, powdered cellulose and hydroxypropylmethylcellulose.

6. A composition as claimed in claim 1 or claim 2, which further comprises a processing adjuvant selected from croscarmellose sodium, sodium starch glycolate, starch, magnesium stearate, stearic acid, talc and powdered vegetable stearine.

7. A composition as claimed in claim 1 or claim 2, which is in the form of a tablet.

8. A method of antagonising one or more of the actions of leukotrienes in a living mammal, which comprises administering to said mammal an effective amount of a pharmaceutical composition as claimed in claim 1.
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