PHARMACEUTICAL DEVELOPMENT AND CHARACTERIZATION OF NOVEL STERILE INJECTABLE FORMULATIONS FOR ANTINEOPLASTIC AGENT
Raghuveera Hathibelagal Goruva*, Anjaneyulu Vinukonda, Neelesh Chaubey and Harish Pandey
ABSTRACT
Trilaciclib dihydrochloride, is a kinase inhibitor, chemically; he chemical name for trilaciclib is 2'-{[5-(4-methylpiperazin-1-yl)pyridin-2-yl]amino}-7',8'dihydro-6'H-spiro[cyclohexane-1,9'-pyrazino[1',2':1,5]pyrrolo[2,3-d]pyrimidin]-6'-one. Trilaciclib dihydrochloride is commercially available COSELA (trilaciclib) for injection, which is a lyophilized formulation available as 300 mg / vial and (trilaciclib) for injection is a yellow lyophilized cake supplied in a single-dose vial. Each vial contains one 300 mg strength single-dose vial. The current investigation was designed to alternative stable liquid composition of Trilaciclib using minimum solvent(s) or low or no use of excipients. The present invention provides a stable, non-aqueous, ready-to-use parenteral composition comprising: Trilaciclib or pharmaceutically acceptable salt thereof, acidifying agent, optionally a surfactant, one or more solvents or co-solvents.
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