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AssigneeZentiva k.s.
InventorsJaroslav RIHA, Ludek RIDVAN, Michal DOUSA, Tomas KUBELKA, Petr GIBALA, Frantisek BARTACEK, Pawel STASIAK, Stanislav KALASEK, Anna Kluk, Vít Zvonícek
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The present invention relates to pharmaceutical compositions comprising metformin with low amounts of nitrosamine impurities and methods for producing the same. More specifically, the present invention relates to methods and compositions that reduce the amount of nitrosable compounds in the active pharmaceutical ingredient and/or reduce the conversion of nitrosable compounds into nitrosamines in the finished dosage form.
A pharmaceutical composition comprising metformin or a salt thereof and an antioxidant, free radical scavenger or reducing agent, wherein the composition comprises less than 100 ppm of peroxide impurities and more than 50 ppm of dimethylamine.
A combined pharmaceutical preparation comprising metformin or a salt thereof, an antioxidant, free radical scavenger or reducing agent and a sodium-glucose co-transporter-2 (SGLT2) inhibitor and/or a dipeptidyl peptidase-4 (DPP-4) inhibitor, wherein the composition comprises less than 100 ppm of peroxide impurities and more than 50 ppm of dimethylamine.
Dependencies are inferred from the claim text.