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11 条记录 (耗时 0.013 秒)

    Pharmaceutical compositions of testosterone
    1.
    发明授权
    Pharmaceutical compositions of testosterone 有权

    公开(公告)号：US11311554B2

    公开(公告)日：2022-04-26

    申请号：US16363376

    申请日：2019-03-25

    申请人： SLAYBACK PHARMA LLC

    发明人： Umangi K. Soni ,  Prem Prakash Singh ,  Hanimi Reddy Bapatu ,  Praveen Kumar Subbappa ,  Ajay Kumar Singh

    IPC分类号： A61K31/568 ,  A61K9/00 ,  A61P5/26 ,  A61K47/06

    摘要： The present invention provides stable pharmaceutical compositions, comprising a pharmaceutically effective amount of testosterone or a pharmaceutically acceptable ester thereof, a pharmaceutically acceptable oil vehicle, and a stabilizing amount of benzyl alcohol, for example, about 1% to 3% weight/volume of benzyl alcohol. The present invention also provides a process for stabilizing testosterone-containing pharmaceutical compositions by ageing them at a temperature of about 20° C. to about 60° C. for at least 48 hours, e.g., prior to secondary packing and labeling. These compositions were stable over the shelf life of the product, without exhibiting crystal formation, even upon storing at temperatures of about 2° C. to about 8° C. Other aspects of the invention relate to methods for making such pharmaceutical compositions, and methods of using such pharmaceutical compositions for hormone replacement therapy, e.g., in a male patient having a condition associated with symptoms of deficiency or absence of endogenous testosterone.

    Pharmaceutical compositions of testosterone
    2.
    发明授权
    Pharmaceutical compositions of testosterone 有权

    公开(公告)号：US11642355B2

    公开(公告)日：2023-05-09

    申请号：US17696319

    申请日：2022-03-16

    申请人： SLAYBACK PHARMA LLC

    发明人： Umangi K. Soni ,  Prem Prakash Singh ,  Hanimi Reddy Bapatu ,  Praveen Kumar Subbappa ,  Ajay Kumar Singh

    IPC分类号： A61K31/568 ,  A61K9/00 ,  A61P5/26 ,  A61K47/06

    CPC分类号： A61K31/568 ,  A61K9/0019 ,  A61K47/06 ,  A61P5/26

    摘要： The present invention provides stable pharmaceutical compositions, comprising a pharmaceutically effective amount of testosterone or a pharmaceutically acceptable ester thereof, a pharmaceutically acceptable oil vehicle, and a stabilizing amount of benzyl alcohol, for example, about 1% to 3% weight/volume of benzyl alcohol. The present invention also provides a process for stabilizing testosterone-containing pharmaceutical compositions by ageing them at a temperature of about 20° C. to about 60° C. for at least 48 hours, e.g., prior to secondary packing and labeling. These compositions were stable over the shelf life of the product, without exhibiting crystal formation, even upon storing at temperatures of about 2° C. to about 8° C. Other aspects of the invention relate to methods for making such pharmaceutical compositions, as well as methods of using such pharmaceutical compositions for hormone replacement therapy, e.g., in a male patient having a condition associated with symptoms of deficiency or absence of endogenous testosterone.

    PHARMACEUTICAL COMPOSITIONS OF NILOTINIB
    3.
    发明申请
    PHARMACEUTICAL COMPOSITIONS OF NILOTINIB 有权

    公开(公告)号：US20210077485A1

    公开(公告)日：2021-03-18

    申请号：US16953728

    申请日：2020-11-20

    申请人： SLAYBACK PHARMA LLC

    发明人： Paras P. Jain ,  Ajay Kumar Singh ,  Keerthi Priya ,  Girish Kumar Jain ,  Girish G. Kore ,  Sandeep Jain ,  Hanimi Reddy Bapatu

    IPC分类号： A61K31/4985 ,  A61K9/20 ,  A61K9/10

    摘要： Amorphous solid dispersions of nilotinib fumarate or nilotinib tartrate are provided, as well as pharmaceutical compositions thereof, wherein the compositions exhibit enhanced bioavailability in the fasted state. Preferably, the compositions may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Cmax, AUC0-t and/or AUC0-infinity) of nilotinib, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.

    PHARMACEUTICAL COMPOSITIONS OF LURASIDONE
    4.
    发明申请
    PHARMACEUTICAL COMPOSITIONS OF LURASIDONE 审中-公开

    公开(公告)号：US20200222394A1

    公开(公告)日：2020-07-16

    申请号：US16697415

    申请日：2019-11-27

    申请人： SLAYBACK PHARMA LLC

    发明人： Paras P. Jain ,  Ajay Kumar Singh ,  Praveen Kumar Subbappa ,  Keerthi Priya ,  Girish Kumar Jain ,  Girish G. Kore ,  Hanimi Reddy Bapatu ,  Sandeep Jain

    IPC分类号： A61K31/496 ,  A61K47/38 ,  A61K47/32 ,  A61K9/20

    摘要： Solid dispersions of lurasidone or a pharmaceutically acceptable salt thereof are described, as well as pharmaceutical formulations thereof, and methods for making such formulations. Preferably, the solid dispersions are prepared by hot-melt extrusion or spray-drying, and comprise lurasidone with a pharmaceutically acceptable carrier (e.g., hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), polyvinyl pyrrolidine vinyl acetate (PVP/VA) copolymer, hydroxypropyl methylcellulose phthalate (HPMCP), or mixtures thereof). The pharmaceutical composition may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Tmax, Cmax, AUC0-t and/or AUC0-infinity) of lurasidone, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.

    Pharmaceutical compositions of Lurasidone
    7.
    发明授权
    Pharmaceutical compositions of Lurasidone 有权

    公开(公告)号：US11103503B2

    公开(公告)日：2021-08-31

    申请号：US16774457

    申请日：2020-01-28

    申请人： SLAYBACK PHARMA LLC

    发明人： Paras P. Jain ,  Ajay Kumar Singh ,  Praveen Kumar Subbappa ,  Keerthi Priya ,  Girish Kumar Jain ,  Girish G. Kore ,  Hanimi Reddy Bapatu ,  Sandeep Jain

    IPC分类号： A61K31/496 ,  A61K9/20 ,  A61K47/38 ,  A61K47/32

    摘要： Solid dispersions of lurasidone or a pharmaceutically acceptable salt thereof are described, as well as pharmaceutical formulations thereof, and methods for making such formulations. Preferably, the solid dispersions are prepared by hot-melt extrusion or spray-drying, and comprise lurasidone with a pharmaceutically acceptable carrier (e.g., hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), polyvinyl pyrrolidine vinyl acetate (PVP/VA) copolymer, hydroxypropyl methylcellulose phthalate (HPMCP), or mixtures thereof). The pharmaceutical composition may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Tmax, Cmax, AUC0-t and/or AUC0-infinity) of lurasidone, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.

    Pharmaceutical compositions of lurasidone
    9.
    发明授权
    Pharmaceutical compositions of lurasidone 有权

    公开(公告)号：US11103502B2

    公开(公告)日：2021-08-31

    申请号：US16697415

    申请日：2019-11-27

    申请人： SLAYBACK PHARMA LLC

    发明人： Paras P. Jain ,  Ajay Kumar Singh ,  Praveen Kumar Subbappa ,  Keerthi Priya ,  Girish Kumar Jain ,  Girish G. Kore ,  Hanimi Reddy Bapatu ,  Sandeep Jain

    IPC分类号： A61K31/496 ,  A61K9/20 ,  A61K47/38 ,  A61K47/32

    摘要： Solid dispersions of lurasidone or a pharmaceutically acceptable salt thereof are described, as well as pharmaceutical formulations thereof, and methods for making such formulations. Preferably, the solid dispersions are prepared by hot-melt extrusion or spray-drying, and comprise lurasidone with a pharmaceutically acceptable carrier (e.g., hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), polyvinyl pyrrolidine vinyl acetate (PVP/VA) copolymer, hydroxypropyl methylcellulose phthalate (HPMCP), or mixtures thereof). The pharmaceutical composition may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Tmax, Cmax, AUC0-t and/or AUC0-infinity) of lurasidone, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.