Generated: May 28, 2017
|Title:||Process for preparing pharmaceutical composition containing a heterocyclic amide|
|Abstract:||The invention provides a pharmaceutical composition comprising a particular physical form of N-[4-[5-(cyclopentyloxy-carbonyl)amino-1-methylindol-3-yl-methyl]-3-methox ybenzoyl]-2-methyl-benzenesulphonamide 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 Joseph (Macclesfield, GB), Edwards; Ieuan John (Congleton, GB)|
|Assignee:||Zeneca Limited (London, GB)|
1. A physical form of N-[4-[5-(cyclopentyloxycarbonyl)-amino-1-methylindol-3-yl-methyl]-3-methox ybenzoyl]-2-methylbenzenesulphonamide substantially free of other physical
forms, which physical form 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, prepared by a process which comprises spray drying a solution of
2. The physical form of claim 1 wherein the process by which said physical form is prepared comprises spray drying an aqueous acetone solution of N-[4-[5-(cyclopentyloxycarbonyl)amino-1-methylindol-3-yl-methyl]-3-methoxy benzoyl]-2-methylbenzenesulphonamide.
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