PHARMACEUTICAL COMPOSITIONS WITH LOW AMOUNTS OF NITROSAMINE IMPURITIES AND METHODS FOR PRODUCING THE SAME

• Main Authors: RIHA, Jaroslav, DOUSA, Michal, STASIAK, Pawel, RIDVAN, Ludek, BARTACEK, Frantisek, KALASEK, Stanislav, GIBALA, Petr, KUBELKA, Tomas
• Format: Patent
• Language: English; French
• Published: 21.04.2022
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

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. La présente invention concerne des compositions pharmaceutiques comprenant de la metformine avec de faibles quantités d'impuretés nitrosamine et leurs procédés de production. Plus précisément, la présente invention concerne des procédés et des compositions qui réduisent la quantité de composés nitrosables dans le principe pharmaceutique actif et/ou réduisent la conversion de composés nitrosables en nitrosamines dans la forme pharmaceutique finie.