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AssigneeRichter Gedeon Vegyeszeti Gyar Rt.
InventorsMaria Gazdag, Gabor Szepesi, Takacsi Nagy, Szikla Z. Papp, Laszlo Nagy, Eva E. Kiss, Bobjak M. Zsoldos
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The invention relates to novel, parenterally useful, stable aqueous pharmaceutical compositions, mainly injectable solutions containing a bis-indole alkaloid. The compositions contain the zinc complex of a bis-indole alkaloid, preferably vincristine, vinblastine or 5'-nor-dihydrovinblastine together with a bivalent metal gluconate and a preserving agent dissolved in a mono- or polyhydric alcohol. The invention further relates to a process for the preparation of the above compositions. The composition according to the invention can be utilized for the parenteral administration of bis-indole alkaloids in the cancer chemotherapy.
A parenteral composition consisting essentially of a zinc complex of a vincristine or vinblastine, water as a carrier, a stabilizing amount of a bivalent metal gluconate and a preserving amount of a preserving agent dissolved in a mono- or polyhydric alcohol.
A process for the stabilization of a parenterally useful composition consisting essentially of a zinc complex of a bis-indole alkaloid complex, water, a bivalent metal gluconate stabilizing agent, and a preserving agent dissolved in a mono- or polyhdric alcohol, said process consisting essentially of dissolving a bis-indole alkaloid salt in water to form a first solution, mixing the first solution with an aqueous solution of zinc sulfate to form a second solution, which consists essentially of the alkaloid-zinc complex, mixing the second solution with an aqueous solution with a preserving agent dissolved in a mono- or polyhydric alcohol to form the stabilized aqueous parenteral complex solution of vincristine or vinblastine.
A process as claimed in claim5, which comprises using ethanol, n-propanol, isopropanol or ethylene glycol as mono- or polyhydric alcohol.
Dependencies are inferred from the claim text.