Zentiva, A.s.

Zentiva K.s.

Jan Stach

Ludek Ridvan

Ondrej Dammer

Kamal Jarrah

Monika Zatopkova

Josef Cinibulk

Stanislav Radl

Lukas Krejcik

Petr Hruby

Hana Brusova

Michal Voslar

Ales Halama

Petr Lehnert

Ondrej Klecan

Jan Rymes

Pavel Zvatora

Ondrej Pisa

Kristyna Benediktova

Michal Zapadlo

Lucie Krumbholcova

Josef Cerny

Ivo Strelec

A method of manufacturing an amorphous form of the hemi-calcium salt of (3R, 5R) 7-[3-phenyl-4-phenylcarbamoyl-2-(4-fluorophenyl)-5-isopropyl-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid of formula (I), in which (3R, 5R) 7-[3-phenyl-4-phenylcarbamoyl-2-(4-fluorophenyl)-5-isopropyl-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid or its salt with a cation Mwherein Mis either a cation of an alkali metal or an ammonium cation of formula RNHwherein R is lower C&#x2013;Calkyl, n may reach values ranging between 0 and 3, is, without isolating the intermediate in the form of the hemi-calcium salt or of another salt, acid or lactone, converted, in a solution, by the treatment with the calcium salt or calcium hydroxide, or a calcium C&#x2013;Calcoholate, to the hemi-calcium salt, and the latter is precipitated with a C&#x2013;Chydrocarbon or dialkylether of formula ROR, wherein each of Rand Ris a C&#x2013;Calkyl group. The starting acid or its salt is prepared starting from (3R, 5R) tert-butyl (6-{2-[3-phenyl-4-phenylcarbamoyl-2-(4-fluorophenyl)-5-isopropyl-pyrrol-1-yl]-ethyl}-2,2-dimethyl-[1,3]dioxane-4-yl) acetate of formula II.

Method of manufacturing an amorphous form of the hemi-calcium salt of (3R,5R) 7-3-phenyl-4-phenylcarbamoyl-2-(4-fluorophenyl)-5-isopropyl-pyrrol-1-yll-3, 5-dihydroxyheptanoic acid (actorvastatin)

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Prague, Czechia

Jan Stach