Fresenius Kabi Oncology Limited

Minakshi Garg

Dhiraj Khattar

Rajesh Khanna

Sanjay Motwani

Mukti Yadav

Vikas Chandel

Vijay Kumar Kyama

Vikas Bhandari

Sunny Chopra

The present invention relates to a process of preparing a stable pharmaceutical composition of compounds which are susceptible to hydrolysis comprising a. Addition of required quantity of pharmaceutically acceptable lyophilization excipients optionally in Water for Injection in a formulation vessel; b. Addition of organic solvent to form a appropriate proportion of aqueous and organic solvent; c. Maintaining the temperature of the formulation vessel from the range &#x2212;5&#xb1;1&#xb0; C. to &#x2212;5&#xb1;3&#xb0; C.; d. Addition of required quantity of compound susceptible to hydrolysis to form a solution and lyophilizing the solution.

Process for preparing stable pharmaceutical compositions of compounds susceptible to hydrolysis

Described herein are ready to use, non-aqueous pharmaceutical compositions comprising 5-aza-2'-deoxycitidine and at least one aprotic solvent. The pharmaceutical compositions may further comprise at least one protic solvent. Also described are processes for preparing the pharmaceutical compositions and their use for the treatment of patients suffering from myelodysplastic syndromes.

Stable pharmaceutical composition of 5-aza-2'-deoxycitidine

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Gurgaon, India

Minakshi Garg