Process for the Preparation of Crystalline Perindopril
AssigneeLek Pharmaceuticals D.D.
InventorsBranko Jenko, Anton Copar
Life of this patent
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Abstract
The present invention relates to a new process for the preparation of crystalline perindopril. The present invention also relates to new alkyl ammonium salts of perindopril and the processes for the preparation thereof.
Claims31
A process for the preparation of crystalline perindopril comprising the steps of:
- (a) transforming crude perindopril to a perindopril alkyl ammonium salt selected from the group consisting of tert-octylammonium salt of perindopril and neopentylammonium salt of perindopril, and (b) regenerating perindopril from said alkyl ammonium salts and isolating crystalline perindopril.
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tert-Octylammonium salt of perindopril.
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Crystalline tert-octylammonium salt of perindopril characterized by powder x-ray diffraction pattern as depicted in FIG. 3.
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Neopentylammonium salt of perindopril.
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A pharmaceutical composition comprising a therapeutically effective amount of neopentylammonium salt of perindopril, tert-octylammonium salt of perindopril or high pure crystalline perindopril having at least 99% of chromatographic purity, together with one or more pharmaceutically acceptable carriers or other excipients.
A pharmaceutical composition comprising inclusion complexes of neopentylammonium salt of perindopril, tert-octylammonium salt of perindopril or high pure crystalline perindopril having at least 99% of chromatographic purity, with cyclodextrins or their alkylated and hydroxyalkylated derivatives together with one or more pharmaceutically acceptable carriers or other excipients.
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Dependencies are inferred from the claim text.