Pliva, Farmaceutska Industrija, Dionicko Drustvo

Pliva Pharmaceutical Industry, Incorporated

Miljenko Dumić

Aleksandar Danilovski

Gorjana Lazarevski

Darko Filic

Marijan Tudja

Knezevic Zdravka

Dominik Cincic

Katica Lazaric

Marina Oresic

Bozena Klepić

Ernest Mestrovic

Alojz Dumbovic

Darko Filić

Mladen Vinković

Dejan-Kresimir Bucar

The invention relates to a novel polymorph V of torasemide, to a process for its preparation, to its use as a raw material for the preparation of crystalline modifications I and III of torasemide, to amorphous torasemide modifications and to pharmaceutically acceptable salts of torasemide, to pharmaceutical forms containing the said novel polymorph V of torasemide as the active ingredient as well as to its use.

Polymorph V of torasemide

Substantially pure amorphous 9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin A. In addition, this disclosure is directed to a process for the preparation thereof from crude 9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin A via orthorhombic isostructural pseudopolymorphs of 9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin A, of the general formula I:wherein S represents a water-miscible or water-immiscible organic solvent, characterized by the orthorhombic space group P222, with average unit cell parameters a=8.2 to 9.7 &#x212b;, b=11.5 to 13.5 &#x212b;, c=44.5 to 47.0 &#x212b;, &#x3b1;=&#x3b2;=&#x3b3;=90&#xb0;, wherein a, b and c represent the crystal axes lengths and &#x3b1;, &#x3b2; and &#x3b3; represent the angles between the crystal axes. In addition, pharmaceutical compositions containing the substantially pure amorphous 9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin A are disclosed, as well as a method for the treatment of bacterial and protozoal infections, and inflammation related diseases in humans and animals by administration of a pharmaceutical composition containing same.

Amorphous 9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin A, process for preparing the same, and uses thereof

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Zagreb, Croatia

Miljenko Dumić