Stable formulation of azacitidine or salts thereof and their process for preparation
OwnerManish Chawla, Narendra Soni +2inventors
InventorsManish Chawla, Narendra Soni, Kashyap Nagariya, Sanjay Ghanshyambhai Patel
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Abstract
The present invention relates to a stable pharmaceutical composition comprising azacitidine or its pharmaceutically acceptable salts, one or more sugar alcohols and one or more pharmaceutically acceptable excipients, wherein said composition is suitable for parenteral administration. The invention also relates to processes for preparing the preparation of such reconstitutable formulations. The invention also relates to therapeutic methods of use of such formulations and to use of such formulations in the manufacture of medicaments.
Claims12
A stable pharmaceutical composition comprising azacitidine or its pharmaceutically acceptable salts, one or more sugar alcohols and one or more pharmaceutically acceptable excipients, wherein said composition is suitable for parenteral administration.
A kit comprising a stable reconstitutable pharmaceutical composition suitable for parenteral administration comprising azacitidine or its pharmaceutically acceptable salts, one or more sugar alcohols and one or more pharmaceutically acceptable excipients, and a reconstitution vehicle.
A process for preparing a sable pharmaceutical composition comprising the following steps:
- a) sifting azacitidine or its pharmaceutically acceptable salts and sugar alcohols in suitable containers;
- b) sifting both the powders of step a) together with geometric mixing through a #100 ASTM SS sieve;
- c) sterilizing the powder blend of step b) by gamma radiation;
- and
- d) filling the sterilized powder of step c) in glass vials and sealing.
Dependencies are inferred from the claim text.