Abstract: 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.

Abstract: 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.

Abstract: Stable pharmaceutical compositions are provided, 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.

Abstract: Stable injectable compositions comprising glucagon or a pharmaceutically acceptable salt, solvate, or hydrate thereof are disclosed, which comprise (a) a therapeutically effective amount of glucagon; (b) at least one pharmaceutically acceptable solvent; (c) at least one stabilizing agent; (d) at least one sugar; and (e) optionally, at least one pharmaceutically acceptable excipient; wherein said injectable solution is stable and ready-to-use, and wherein pH of the said solution ranges from 3.8 to 4.2. Preferably, the composition is provided in a sealed container, e.g., an ampoule, a vial, a pre-filled syringe or an auto-injector. Further, stable injectable solutions are disclosed, which comprise glucagon or a pharmaceutically acceptable salt, solvate, or hydrate thereof, and which are suitable for subcutaneous, intravenous or intramuscular administration. Methods for manufacturing stable injectable solutions of glucagon are also disclosed.

Abstract: 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.

Abstract: The present invention relates to stable liquid composition suitable for parenteral administration in the form of a solution comprising: (a) netupitant at a concentration of about 0.5 mg/mL to about 20 mg/ml; (b) at least one pharmaceutically acceptable stabilizer at a concentration of 1 mg/mL to 22 mg/mL selected from the group consisting of tromethamine, phosphoric acid, aspartic acid, tartaric acid, citric acid, maleic acid, ascorbic acid and mixtures thereof; and (c) at least one pharmaceutically acceptable vehicle, wherein the composition is in the form of a solution and has a pH of 2 to 6. The compositions are suitable for subcutaneous, intravenous, or intramuscular administration. The invention further relates to methods for manufacturing the compositions and methods of using such compositions for prevention, treatment or management of nausea and vomiting.

Abstract: Stable pharmaceutical compositions are provided, 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.

Abstract: Stable injectable compositions comprising glucagon or a pharmaceutically acceptable salt, solvate, or hydrate thereof are disclosed, which comprise (a) a therapeutically effective amount of glucagon; (b) at least one pharmaceutically acceptable solvent; (c) at least one stabilizing agent; (d) at least one sugar; and (e) optionally, at least one pharmaceutically acceptable excipient; wherein said injectable solution is stable and ready-to-use, and wherein pH of the said solution ranges from 3.8 to 4.2. Preferably, the composition is provided in a sealed container, e.g., an ampoule, a vial, a pre-filled syringe or an auto-injector. Further, stable injectable solutions are disclosed, which comprise glucagon or a pharmaceutically acceptable salt, solvate, or hydrate thereof, and which are suitable for subcutaneous, intravenous or intramuscular administration. Methods for manufacturing stable injectable solutions of glucagon are also disclosed.

Abstract: The present invention relates to stable liquid compositions suitable for parenteral administration in the form of a solution comprising: (a) netupitant and optionally palonosetron; (b) at least one pharmaceutically acceptable stabilizer; (c) at least one pharmaceutically acceptable solubilizer; and (d) at least one pharmaceutically acceptable vehicle, wherein netupitant is present at a concentration of about 0.5 mg/mL to about 20 mg/mL and the solution has a pH of about 2 to about 6. The compositions are suitable for subcutaneous, intravenous, or intramuscular administration. The invention further relates to methods for manufacturing the compositions and methods of using such compositions for prevention, treatment or management of nausea and vomiting.

Abstract: The present invention relates to liquid pharmaceutical compositions of edaravone. More specifically, stable solutions of edaravone for enteral administration are provided, wherein the composition is stable for extended period of time. The present invention further relates to stable solutions of edaravone, methods for their administration, processes for their production, and use of these compositions for treatment of diseases treatable by edaravone.

Abstract: 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.

Abstract: Liquid pharmaceutical compositions of baclofen or a pharmaceutically acceptable salt thereof are described. More specifically, stable liquid pharmaceutical compositions of baclofen at concentrations of 2 mg/mL or more are provided. Preferably, the liquid pharmaceutical compositions are suitable for oral administration, and stable at pH ranges of 3-8 over a variety of storage conditions, including long-term storage for extended periods of time. Various methods for preparing stable liquid pharmaceutical compositions of baclofen are described. Methods of treating spasticity using the inventive pharmaceutical compositions are also provided.

Abstract: The present invention relates to stable pharmaceutical compositions for parenteral administration comprising aprepitant. The present invention further relates to a method for manufacturing the composition as well as to the use of these compositions. Also included are stable pharmaceutical compositions for parenteral administration comprising aprepitant and palonosetron. The pharmaceutical compositions are stable oil-in-water emulsions for parenteral administration and are particularly useful for the prevention and control of acute and delayed chemotherapy-induced nausea and vomiting (CINV), for the prevention of postoperative nausea and vomiting (PONV), and/or for the prevention of radiation induced nausea and vomiting (RINV).

Abstract: Modified-release pharmaceutical compositions of ruxolitinib or a pharmaceutically acceptable salt thereof are disclosed. Preferably, the invention relates to oral modified-release pharmaceutical compositions of ruxolitinib, which enable once-daily administration. Oral modified-release compositions of ruxolitinib, methods for their administration, processes for their preparation, and use of these compositions for treatment of diseases treatable by ruxolitinib are also described.

Abstract: 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.

Abstract: Stable injectable compositions comprising glucagon or a pharmaceutically acceptable salt, solvate, or hydrate thereof are disclosed. Preferably, the composition is provided in a sealed container, e.g., an ampoule, a vial, a pre-filled syringe or an auto-injector. Further, stable injectable solutions are disclosed, which comprise glucagon or a pharmaceutically acceptable salt, solvate, or hydrate thereof, and which are suitable for subcutaneous, intravenous or intramuscular administration. Methods for manufacturing stable injectable solutions of glucagon are also disclosed.

Abstract: 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.

Abstract: 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.

Abstract: Stable pharmaceutical compositions are provided, 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.

Abstract: The present invention relates to stable liquid compositions suitable for parenteral administration in the form of a solution comprising: (a) netupitant and optionally palonosetron; (b) at least one pharmaceutically acceptable stabilizer; (c) at least one pharmaceutically acceptable solubilizer; and (d) at least one pharmaceutically acceptable vehicle, wherein netupitant is present at a concentration of about 0.5 mg/mL to about 20 mg/mL and the solution has a pH of about 2 to about 6. The compositions are suitable for subcutaneous, intravenous, or intramuscular administration. The invention further relates to methods for manufacturing the compositions and methods of using such compositions for prevention, treatment or management of nausea and vomiting.