CRYSTALLINE FORMS OF [R-(R,R)]-2-(4-FLUOROPHENYL)-BETA, DELTA-DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1H-PYRROLE-1-HEPTANOIC ACID HEMI CALCIUM SALT (ATORVASTATIN)

• Main Authors: BRIGGS CHRISTOPHER A, HARASAWA KIKUKO, ICHIKAWA SHIGERU, NAKAGAWA SHINSUKE, MINOHARA KAZUO, WADE ROBERT A, JENNINGS REX ALLEN
• Format: Patent
• Language: English; Romanian
• Published: 30.08.2005
• Edition: 7
• Subjects: CHEMISTRY; HETEROCYCLIC COMPOUNDS; HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; METALLURGY; ORGANIC CHEMISTRY; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

The invention relates to crystalline forms of [R-R*,R*)]-2-(4-fluorophenyl)-beta-delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin) employed as pharmaceuticals, named Form I, Form II and Form IV, defined by their X-ray powder diffraction pattern and/or NMR tests, as well as to processes for preparing the same, to pharmaceutical compositions containing them and to their use as hypolipidemic and hypocholesterolemic agents. Invenţia se referă la forme cristaline ale sării semicalcice a acidului [(R-(R*, R*)]-2-(4-fluorofenil)-beta-delta-dihidroxi-5-(1-metiletil)-3-fenil-4-[(fenilamino)carbonil]-1H-pirol-1-heptanoic (atorvastatin), utilizate ca produse farmaceutice, denumite Forma I, Forma II şi Forma IV, care sunt definite prin modelul de difracţie cu raze X a pulberii şi/sau prin determinări de Rezonanţă Magnetică Nucleară, precum şi la procedee de preparare a acestora, la compoziţii farmaceutice, care le conţin, şi la utilizarea lor, ca agenţi hipolipidemici şi hipocolesterolemici. ŕ