HUMAN EFFICACIOUS DOSE AND DOSAGE SCHEDULE OF SPR720

    公开(公告)号:US20240366599A1

    公开(公告)日:2024-11-07

    申请号:US18646893

    申请日:2024-04-26

    Abstract: The present disclose provides methods of treating NTM-PD and other bacterial infections, including pulmonary tuberculous and nontuberculous mycobacteria infections. Clinical studies have established the safety of SPR720 up to daily oral dosages of 2000 mg and shown that once daily oral dosing is sufficient to provide efficacious plasma levels of the active agent, SPR719. Clinical studies have also shown that there is no significant food effect for SPR720 and that the drug may be given in to a patient in the fed or fasted state. Clinical studies have also established that SPR720 can be administered safely to elderly patients. The present disclosure provides a method of treating a bacterial infection in a patient comprising administering a daily oral dose of SPR720, or a pharmaceutically acceptable salt thereof, the oral dose comprising 100 mg SPR720 to 1500 mg SPR720.

    HIGH DOSAGE TEBIPENEM PIVOXIL TABLET FORMULATION

    公开(公告)号:US20220142986A1

    公开(公告)日:2022-05-12

    申请号:US17525619

    申请日:2021-11-12

    Abstract: The disclosure provides a tebipenem pivoxil HBr formulation in the form of a tablet core comprising at least 70% (w/w) tebipenem pivoxil HBr, and in certain embodiment more than 80% (w/w) tebipenem pivoxil HBr. The disclosure provides a tebipenem pivoxil HBr tablet core comprising at least 70% w/w tebipenem pivoxil HBr, 5-25% w/w of a diluent, 0.5 to 5% w/w of a glidant, 0.5 to 5% w/w of a lubricant, and optionally 0.5 to 5% w/w of disintegrant. The disclosure provides methods of treating a patient who has a bacterial infection such as complicated urinary tract infection (cUTI), acute and chronic pyelonephritis, an upper or lower respiratory infection, or bacteremia by administering a formulation of the disclosure to the patient.

    TEBIPENEM PIVOXIL CRYSTALLINE FORMS, COMPOSITIONS INCLUDING THE SAME, METHODS OF MANUFACTURE, AND METHODS OF USE

    公开(公告)号:US20210122753A1

    公开(公告)日:2021-04-29

    申请号:US17136759

    申请日:2020-12-29

    Abstract: The disclosure is directed to new crystalline tebipenem pivoxil salt forms, including a crystalline tebipenem pivoxil ethane sulfonate salt form (Form A), a crystalline tebipenem pivoxil ketoglutarate salt form (Form A), tebipenem pivoxil maleate salt forms (Form A and Form B), a tebipenem pivoxil malate salt form (Form A), a tebipenem pivoxil methane sulfonate salt form (Form B), a tebipenem pivoxil hydrobromide salt form (Form B), and a tebipenem pivoxil edisylate salt form (Form A). The disclosure also includes a composition, comprising a crystalline tebipenem pivoxil salt and a pharmaceutically acceptable carrier and further includes a method for treating an antibiotic resistant bacterial infection, comprising administering to a patient in need of such treatment a therapeutically effective amount of a crystalline tebipenem pivoxil salt.

    TEBIPENEM PIVOXIL CRYSTALLINE FORMS, COMPOSITIONS INCLUDING THE SAME, METHODS OF MANUFACTURE, AND METHODS OF USE

    公开(公告)号:US20250051334A1

    公开(公告)日:2025-02-13

    申请号:US18823147

    申请日:2024-09-03

    Abstract: The disclosure is directed to new crystalline tebipenem pivoxil salt forms, including a crystalline tebipenem pivoxil ethane sulfonate salt form (Form A), a crystalline tebipenem pivoxil ketoglutarate salt form (Form A), tebipenem pivoxil maleate salt forms (Form A and Form B), a tebipenem pivoxil malate salt form (Form A), a tebipenem pivoxil methane sulfonate salt form (Form B), a tebipenem pivoxil hydrobromide salt form (Form B), and a tebipenem pivoxil edisylate salt form (Form A). The disclosure also includes a composition, comprising a crystalline tebipenem pivoxil salt and a pharmaceutically acceptable carrier and further includes a method for treating an antibiotic resistant bacterial infection, comprising administering to a patient in need of such treatment a therapeutically effective amount of a crystalline tebipenem pivoxil salt.

    HIGH DOSAGE TEBIPENEM PIVOXIL TABLET FORMULATION

    公开(公告)号:US20250049766A1

    公开(公告)日:2025-02-13

    申请号:US18665330

    申请日:2024-05-15

    Abstract: The disclosure provides a tebipenem pivoxil HBr formulation in the form of a tablet core comprising at least 70% (w/w) tebipenem pivoxil HBr, and in certain embodiment more than 80% (w/w) tebipenem pivoxil HBr. The disclosure provides a tebipenem pivoxil HBr tablet core comprising at least 70% w/w tebipenem pivoxil HBr, 5-25% w/w of a diluent, 0.5 to 5% w/w of a glidant, 0.5 to 5% w/w of a lubricant, and optionally 0.5 to 5% w/w of disintegrant. The disclosure provides methods of treating a patient who has a bacterial infection such as complicated urinary tract infection (cUTI), acute and chronic pyelonephritis, an upper or lower respiratory infection, or bacteremia by administering a formulation of the disclosure to the patient.

    TEBIPENEM PIVOXIL CRYSTALLINE FORMS, COMPOSITIONS INCLUDING THE SAME, METHODS OF MANUFACTURE, AND METHODS OF USE

    公开(公告)号:US20230331728A1

    公开(公告)日:2023-10-19

    申请号:US18332566

    申请日:2023-06-09

    CPC classification number: C07D477/20 A61K45/06

    Abstract: The disclosure is directed to new crystalline tebipenem pivoxil salt forms, including a crystalline tebipenem pivoxil ethane sulfonate salt form (Form A), a crystalline tebipenem pivoxil ketoglutarate salt form (Form A), tebipenem pivoxil maleate salt forms (Form A and Form B), a tebipenem pivoxil malate salt form (Form A), a tebipenem pivoxil methane sulfonate salt form (Form B), a tebipenem pivoxil hydrobromide salt form (Form B), and a tebipenem pivoxil edisylate salt form (Form A). The disclosure also includes a composition, comprising a crystalline tebipenem pivoxil salt and a pharmaceutically acceptable carrier and further includes a method for treating an antibiotic resistant bacterial infection, comprising administering to a patient in need of such treatment a therapeutically effective amount of a crystalline tebipenem pivoxil salt.

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