Composition comprising bortezomib
AssigneeFtf Pharma Private Limited
InventorsJayanta Kumar Mandal, Sandip P. Mehta
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Abstract
The present invention provides a pharmaceutical composition of bortezomib. In particular, present invention provides ready-to-dilute injectable formulations comprising bortezomib, a non-aqueous solvent and a pH modifying or pH adjusting agent. Further, the present invention also relates to the process of manufacturing ready-to-dilute injectable formulations comprising bortezomib. The product prepared by following the process disclosed in the present application is stable at room temperature and possesses adequate shelf life (for example for 18-24 months).
Claims20
A composition for a ready-to-dilute injectable pharmaceutical formulation of bortezomib comprising:
- about 7.0 mg/mL to about 17.5 mg/mL bortezomib;
- a non-aqueous solvent;
- a non-buffer pH modifying or pH adjusting agent;
- and
- optionally an anti-oxidant,
- wherein the amount of dissolved oxygen in said composition is 10 parts per million (ppm) or less.
A non-aqueous solution composition of bortezomib produced by the following process:
- removing dissolved oxygen from a non-aqueous solvent to produce a substantially oxygen free non-aqueous solvent;
- adding a pH modifying or pH adjusting agent to adjust the pH of said substantially oxygen free non-aqueous solvent to from about pH 1.0 to about pH 7.0;
- adding bortezomib to said pH adjusted substantially oxygen free non-aqueous solvent to produce said non-aqueous solution composition, wherein said non-aqueous solution composition comprises from about 7.0 mg/mL to about 17.5 mg/mL of bortezomib;
- and
- optionally adding an anti-oxidant to said non-aqueous solution composition.
Dependencies are inferred from the claim text.