公开(公告)号：US20240050416A1

公开(公告)日：2024-02-15

申请号：US18357295

申请日：2023-07-24

申请人： Slayback Pharma LLC

发明人： Shailendra Mandge ,  Venkateshwar Reddy Keesara ,  Harish Gunda ,  Naga Venkata Durga Prasad Ketha ,  Satheesh Balasubramanian ,  Sumitra Ashokkumar Pillai ,  Sushant Omprakash Dube ,  Praveen Kumar Subbappa

IPC分类号： A61K31/437 ,  A61K9/48

CPC分类号： A61K31/437 ,  A61K9/4825 ,  A61K9/4866 ,  A61K9/4858

摘要： The present invention relates to stable pharmaceutical compositions comprising apixaban or its pharmaceutically acceptable salts thereof. The present invention further relates to a capsule composition comprising a therapeutically effective amount of apixaban solubilized or dispersed in a pharmaceutically acceptable carrier, wherein the therapeutically effective amount of apixaban ranges from about 0.5 mg/unit dosage form to about 50 mg/unit dosage form. The present invention also provides manufacturing processes thereof and use of the said compositions for prevention, treatment or prophylaxis of disorders in human patients in need thereof.

公开(公告)号：US20230301945A1

公开(公告)日：2023-09-28

申请号：US18163811

申请日：2023-02-02

申请人： Slayback Pharma LLC

发明人： Shailendra Mandge ,  Venkateshwar Reddy Keesara ,  Harish Gunda ,  Naga Venkata Durga Prasad Ketha ,  Satheesh Balasubramanian . ,  Sumitra Ashokkumar Pillai ,  Praveen Kumar Subbappa

IPC分类号： A61K31/17 ,  A61K47/18 ,  A61K9/08 ,  A61K47/14 ,  A61K47/26 ,  A61K47/36 ,  A61K47/38

CPC分类号： A61K31/17 ,  A61K9/08 ,  A61K47/14 ,  A61K47/183 ,  A61K47/26 ,  A61K47/36 ,  A61K47/38

摘要： The present invention relates to stable oral pharmaceutical compositions in the form of a solution comprising:

hydroxyurea at a concentration of about 10 mg/mL to about 500 mg/mL;
at least one pharmaceutically acceptable liquid vehicle; and

one or more amino acids selected from the group consisting of glycine, alanine, glutamic acid, L-arginine, lysine, L-cysteine, methionine and mixtures thereof, wherein the level of carbamoyloxyurea in the solution is less than 0.5 % w/w as measured by HPLC when the solution is stored at 25° C./60% RH for at least 3 months. The invention further relates to processes for the production of the compositions, methods for their administration, and their use for treatment of diseases treatable by hydroxyurea.

公开(公告)号：US20240180934A1

公开(公告)日：2024-06-06

申请号：US18441397

申请日：2024-02-14

申请人： SLAYBACK PHARMA LLC

发明人： Shailendra MANDGE ,  Harish Gunda ,  Naga Venkata Durga Prasad Ketha ,  Venkateshwar Reddy Keesara ,  Satheesh Balasubramanian ,  Sumitra Ashokkumar Pillai

IPC分类号： A61K31/675 ,  A61K9/00 ,  A61K9/08 ,  A61K47/10 ,  A61K47/14

CPC分类号： A61K31/675 ,  A61K9/0053 ,  A61K9/08 ,  A61K47/10 ,  A61K47/14

摘要： The present invention relates to stable liquid oral compositions of cyclophosphamide having extended stability, methods for their administration, processes for their production, and use of these compositions for treatment of diseases treatable by cyclophosphamide. The invention also relates to a kit comprising stable liquid oral compositions of cyclophosphamide.

公开(公告)号：US20210121480A1

公开(公告)日：2021-04-29

申请号：US17078702

申请日：2020-10-23

申请人： SLAYBACK PHARMA LLC

发明人： Vijayabhanu Prattipati ,  Venkateshwar Reddy Keesara ,  Naga Venkata Durga Prasad Ketha ,  Hanimi Reddy Bapatu

IPC分类号： A61K31/57 ,  A61K31/565 ,  A61K9/48

摘要： The present application relates to stable pharmaceutical compositions for oral administration comprising a progesterone alone, or optionally in combination with an estradiol. The pharmaceutical compositions may further include a solubilizing agent, a surfactant and optionally other pharmaceutical acceptable excipients. Preferably, the estradiol does not precipitate for at least 12 months, and the pharmaceutical compositions are stable for at least 12 months under normal storage conditions at room temperature. Also, when the pharmaceutical compositions are stored for 6 months at 40° C./75% relative humidity (RH), the level of Impurity-M in the composition is less than about 0.2% (w/w) as measured by HPLC. The pharmaceutical compositions may be used for the treatment of moderate to severe vasomotor symptoms due to menopause in post-menopausal women.

公开(公告)号：US20240197705A1

公开(公告)日：2024-06-20

申请号：US18420099

申请日：2024-01-23

申请人： Slayback Pharma LLC

发明人： Shailendra Mandge ,  Venkateshwar Reddy Keesara ,  Harish Gunda ,  Naga Venkata Durga Prasad Ketha ,  Satheesh Balasubramanian ,  Sumitra Ashokkumar Pillai ,  Sushant Omprakash Dube ,  Praveen Kumar Subbappa

IPC分类号： A61K31/444 ,  A61K9/48

CPC分类号： A61K31/444 ,  A61K9/4825 ,  A61K9/4858 ,  A61K9/4866 ,  A61K9/4891

摘要： The present invention relates to stable pharmaceutical compositions comprising apixaban or its pharmaceutically acceptable salts thereof. The present invention further relates to a capsule composition comprising a therapeutically effective amount of apixaban solubilized or dispersed in a pharmaceutically acceptable carrier, wherein the therapeutically effective amount of apixaban ranges from about 0.5 mg/unit dosage form to about 50 mg/unit dosage form. The present invention also provides manufacturing processes thereof and use of the said compositions for prevention, treatment or prophylaxis of disorders in human patients in need thereof.

公开(公告)号：US11931370B2

公开(公告)日：2024-03-19

申请号：US17961943

申请日：2022-10-07

申请人： Slayback Pharma LLC

发明人： Shailendra Mandge ,  Harish Gunda ,  Naga Venkata Durga Prasad Ketha ,  Venkateshwar Reddy Keesara ,  Satheesh Balasubramanian ,  Sumitra Ashokkumar Pillai

IPC分类号： A01N43/00 ,  A01N43/46 ,  A61K9/00 ,  A61K9/08 ,  A61K31/55 ,  A61K31/675 ,  A61K47/10 ,  A61K47/14

CPC分类号： A61K31/675 ,  A61K9/0053 ,  A61K9/08 ,  A61K47/10 ,  A61K47/14

摘要： The present invention relates to stable liquid oral compositions of cyclophosphamide having extended stability, methods for their administration, processes for their production, and use of these compositions for treatment of diseases treatable by cyclophosphamide. The invention also relates to a kit comprising stable liquid oral compositions of cyclophosphamide.

公开(公告)号：US20230285368A1

公开(公告)日：2023-09-14

申请号：US18117808

申请日：2023-03-06

申请人： Slayback Pharma LLC

发明人： Sushant Omprakash Dube ,  Girish G. Kore ,  Naga Venkata Durga Prasad Ketha ,  Sumitra Ashokkumar Pillai ,  Praveen Kumar Subbappa

IPC分类号： A61K31/437 ,  A61K47/26 ,  A61K47/10 ,  A61K47/20 ,  A61K47/32

CPC分类号： A61K31/437 ,  A61K47/26 ,  A61K47/10 ,  A61K47/20 ,  A61K47/32

摘要： Liquid pharmaceutical compositions of apixaban or pharmaceutically acceptable salts thereof are described. More specifically, stable oral liquid pharmaceutical compositions of apixaban for oral administration are provided, wherein the composition is stable for extended periods of time. More specifically, stable liquid pharmaceutical compositions of apixaban at concentrations of 0.4 mg/mL or more are provided. Stable oral liquid compositions of apixaban, methods for their administration, processes for their production, and use of these compositions for treatment of diseases treatable by apixaban are disclosed.