Medac Gesellschaft Fur Klinische Spezialpraparate Mbh

Heraeus Precious Metals Gmbh & Co. Kg

Sloan-kettering Institute for Cancer Research

Tero Kunnari

Holger Rauter

Holger Bindernagel

Andrew Lupton

Stefan Wallert

Sascha Weiser

Steffen Jost

Jenin Grein

The present invention provides a crystalline Form A of Compound 1, also referred to as Granaticin B, and pharmaceutically compositions thereof. The present invention also provides methods of treating a microbial infection, or a disease, disorder, or condition associated with abnormal cellular proliferation, using crystalline Form A of Compound 1 or pharmaceutical compositions thereof. 

Polymorph of granaticin B

A method for purifying epidaunorubicin is provided. The purification method involves the removal of the impurity epi-feudomycin, which is formed as a by-product in the biotechnological production of epidaunorubicin.

Purification of epidaunorubicin

A crystalline epirubicin hydrochloride and a method for its production are provided. The method for producing the crystalline epirubicin hydrochloride includes the steps: (a) providing epirubicin hydrochloride, (b) producing a mixture containing the provided epirubicin hydrochloride and at least one alcohol selected from the group 1-butanol, 2-butanol, and 1-pentanol, and (c) crystallizing epirubicin hydrochloride from this mixture.

Crystallization of epirubicin hydrochloride

4'-epidaunorubicin hydrochloride is provided in a crystalline form which is stable and readily soluble. A process of producing the crystalline form includes crystallizing 4&#x2032;-epidaunorubicin hydrochloride in a solvent system including (a) solvent A selected from Cand Chalogenated solvents and mixtures thereof, (b) solvent B selected from C-Cstraight and branched alcohols and mixtures thereof, and (c) solvent C selected from C-Cstraight and branched alcohols and mixtures thereof, wherein solvent C is selected to provide lower solubility to 4&#x2032;-epidaunorubicin hydrochloride than solvent B. A method of producing an anthracycline using crystalline 4&#x2032;-epidaunorubicin hydrochloride is also provided.

Crystalline 4'-epidaunorubicin hydrochloride and use thereof

4'-epidaunorubicin hydrochloride is provided in a crystalline form which is stable and readily soluble. A process of producing the crystalline form includes crystallizing 4&#x2032;-epidaunorubicin hydrochloride in a solvent system including (a) solvent A selected from Cand Chalogenated solvents and mixtures thereof, (b) solvent B selected from C-Cstraight and branched alcohols and mixtures thereof, and (c) solvent C selected from C-Cstraight and branched alcohols and mixtures thereof, wherein solvent C is selected to provide lower solubility to 4&#x2032;-epidaunorubicin hydrochloride than solvent B.

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Aschaffenburg, Germany

Tero Kunnari