WO2024127365 - STABLE PHARMACEUTICAL COMPOSITION OF AN AMINE DRUG

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Publication Number WO/2024/127365
Publication Date 20.06.2024
International Application No. PCT/IB2023/062817
International Filing Date 15.12.2023
Title [English] STABLE PHARMACEUTICAL COMPOSITION OF AN AMINE DRUG [French] COMPOSITION PHARMACEUTIQUE STABLE D'UN MEDICAMENT AMINE
Applicants ** SUN PHARMACEUTICAL INDUSTRIES LIMITED Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E) Mumbai, Maharashtra 400 063, IN
Inventors ** AGNIHOTRI, Kapil Sun Pharmaceutical Industries Limited Research and Development Centre-II Village Sarhaul, Sector - 18, Udyog Vihar Industrial Area Gurugram, Haryana 122015, IN SINGH, Pawan Kumar Sun Pharmaceutical Industries Limited Research and Development Centre-II Village Sarhaul, Sector - 18, Udyog Vihar Industrial Area Gurugram, Haryana 122015, IN FANDA, Anuj Kumar Sun Pharmaceutical Industries Limited Research and Development Centre-II Village Sarhaul, Sector - 18, Udyog Vihar Industrial Area Gurugram, Haryana 122015, IN MADAN, Sumit Sun Pharmaceutical Industries Limited Research and Development Centre-II Village Sarhaul, Sector - 18, Udyog Vihar Industrial Area Gurugram, Haryana 122015, IN SINGH, Romi Sun Pharmaceutical Industries Limited Research and Development Centre-II Village Sarhaul, Sector - 18, Udyog Vihar Industrial Area Gurugram, Haryana 122015, IN WAGH, Avinash Sun Pharmaceutical Industries Limited Survey No. 127/1, Tandalja Road Vadodara, Gujarat 390012, IN PATEL, Daxesh Sun Pharmaceutical Industries Limited Survey No. 127/1, Tandalja Road Vadodara, Gujarat 390012, IN KURIL, Virendra Ramkrupal Sun Pharmaceutical Industries Limited Survey No. 127/1, Tandalja Road Vadodara, Gujarat 390012, IN
Priority Data 202221073257  17.12.2022  IN
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Abstract [English] The present disclosure relates to a stable multiparticulate composition comprising coated discrete units of an amine drug or a pharmaceutically acceptable salt thereof, with stabilizing amount of one or more nitrite quencher. The composition provides effective control of the level of nitrosamine drug substance-related impurities (NDSRIs) in the drug product during shelf life of the product. [French] La présente invention concerne une composition multiparticulaire stable comprenant des unités discrètes enrobées d'un médicament amine ou d'un sel pharmaceutiquement acceptable de celui-ci, avec une quantité stabilisante d'un ou plusieurs extincteurs nitrités. La composition permet une régulation efficace du niveau d'impuretés nitroamines liées aux substances médicamenteuses (nDSRI) dans le produit médicamenteux pendant la durée de conservation du produit.