Pliva Hrvatska D.o.o.

Pliva Pharmaceutical Industry, Incorporated

Knezevic Zdravka

Aleksandar Danilovski

Gorjana Lazarevski

Darko Filic

Miljenko Dumić

Ernest Mestrovic

Katica Lazaric

Marina Oresic

Alojz Dumbovic

Dominik Cincic

Mladen Vinković

Dejan-Kresimir Bucar

The present disclosure related to a method of treating an infection by oral administration of a single dose of a fast dissolving form of azithromycin. The disclosure also relates to a method of reducing the adverse effects arising from treatment of a subject having an infection by administering a single dose of a fast dissolving form of azithromycin.

Single dose fast dissolving azithromycin

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

Knezevic Zdravka