Crystalline material
AssigneePfizer Inc.
InventorsAlan Craig Bentham, Alan John Pettman, Keith Stephen Ruddock
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Abstract
The present invention relates to amlodipine free base in a crystalline form, to pharmaceutical formulations comprising such material, processes of manufacture and its use in therapy.
Claims9
A crystalline form of the free base of 2-[(2-aminoethoxy)]-methyl-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine (amlodipine).
Crystalline amlodipine free base for use in therapy.
Use of crystalline amlodipine free base in the manufacture of a medicament for the treatment of ischaemic heart disease or hypertension.
A method of treating ischaemic heart disease or hypertension in a human patient comprising administration of an effective amount of crystalline amlodipine free base.
Use of crystalline amlodipine free base in the manufacture of a pharmaceutically acceptable salt or solvate of amlodipine.
A pharmaceutical composition comprising crystalline amlodipine free base
- and one or more pharmaceutically acceptable diluents or carriers and, optionally, one or more other physiologically active agents.
A process for the preparation of crystalline amlodipine free base comprising the steps of:
- (i) isolating amlodipine free base;
- and
- (ii) crystallising the material obtained in (i) using a suitable solvent or mixture of solvents.
Dependencies are inferred from the claim text.