Abstract: A concentrate esmolol formulation is provided that is safer than current concentrate (e.g., 250 mg/ml) esmolol compositions. The concentrate esmolol formulation can include from about 40-60 mg/ml of esmolol hydrochloride. The concentrate esmolol composition allows a practitioner the flexibility of choosing a bolus volume for direct injection to a patient or, optionally, to use the composition to make a customized, diluted composition of esmolol. Methods of the present invention provide for the reduction of potential adverse health consequences resulting in the improper dosing of prior art concentrate compositions of esmolol. Also, a medical product is provided that includes a concentrate esmolol housed in a container, and a package housing the container and instructions.

Abstract: A ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition for the treatment of cardiac conditions and diagnosis applications, comprising methyl-3-[4-(2-hydroxy-3-isopropylamino)propoxy]phenylpropionate hydrochloride (Esmolol hydrochloride), a buffering agent, ethanol and propylene glycol which capable of been stored in modified flexible plastic container, heat-sterilized without deformation and/or integrity of the closure system been compromised, as well as method for its manufacture, is disclosed.

Abstract: A ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition for the treatment of cardiac conditions and diagnosis applications, comprising methyl-3-[4-(2-hydroxy-3-isopropylamino)propoxy]phenylpropionate hydrochloride (Esmolol hydrochloride), a buffering agent, ethanol and propylene glycol. The ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition is capable of being stored in a modified flexible plastic container that may be heat-sterilized without deformation and/or without having the integrity of the closure system being compromised. A method for the manufacture of the ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition is also disclosed.

Abstract: A ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition for the treatment of cardiac conditions and diagnosis applications, comprising methyl-3-[4-(2-hydroxy-3-isopropylamino) propoxy]phenylpropionate hydrochloride (Esmolol hydrochloride), a buffering agent, ethanol and propylene glycol which capable of been stored in modified flexible plastic container, heat-sterilized without deformation and/or integrity of the closure system been compromised, as well as method for its manufacture, is disclosed.

Abstract: A ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition for the treatment of cardiac conditions and diagnosis applications, comprising methyl-3-[4-(2-hydroxy-3-isopropylamino)propoxy]phenylpropionate hydrochloride (Esmolol hydrochloride), a buffering agent, ethanol and propylene glycol. The ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition is capable of being stored in a modified flexible plastic container that may be heat-sterilized without deformation and/or without having the integrity of the closure system being compromised. A method for the manufacture of the ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition is also disclosed.

Abstract: A ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition for the treatment of cardiac conditions and diagnosis applications, comprising methyl-3-[4-(2-hydroxy-3-isopropylamino)propoxy]phenylpropionate hydrochloride (Esmolol hydrochloride), a buffering agent, ethanol and propylene glycol. The ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition is capable of being stored in a modified flexible plastic container that may be heat-sterilized without deformation and/or without having the integrity of the closure system being compromised. A method for the manufacture of the ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition is also disclosed.

Abstract: Disclosed are concentrate esmolol injection essentially free from other related esters of esmolol and diluted esmolol compositions. The concentrate esmolol formulation includes from about 25-1000 mg/ml of esmolol and about 1-25% w/v of benzyl alcohol and the combination thereof. The compositions can also be used as multi-dose compositions. The present invention also discloses diluted, ready-to-use compositions of esmolol prepared by dilution of the present invention concentrates. Also disclosed are methods of making and using the ready-to-use compositions of the present invention.

Abstract: A concentrated esmolol formulation is provided that is distinguishable from a diluted form of the concentrated esmolol formulation.

Abstract: An aqueous, stable, sterile pharmaceutical composition of the thrombin inhibitor argatroban in a solution containing an acid to solubilize the argatroban, substantially free from dehydrated alcohol is described, as well as a method for its preparation.

Abstract: An aqueous, stable, sterile pharmaceutical composition of the thrombin inhibitor argatroban in a solution containing an acid to solubilize the argatroban, substantially free from dehydrated alcohol is described, as well as a method for its preparation.

Abstract: Formulations comprising argatroban and methods of making and using the formulations are provided. In an embodiment, the formulation comprises a solution having an argatroban concentration ranging from greater than about 10 to about 500 mg/mL. The solution can comprise an aqueous solution. The solution can be packaged in a sealed container that may either be aseptically-filled or subjected to sterilization to reduce the microbiological burden of the formulation. The solution can further be diluted and administered to persons needing same.

Abstract: An aqueous, stable, sterile pharmaceutical composition of the thrombin inhibitor argatroban in a solution containing an acid to solubilize the argatroban, substantially free from dehydrated alcohol is described, as well as a method for its preparation.

Abstract: An aqueous, stable, sterile pharmaceutical composition of the thrombin inhibitor argatroban in a solution containing an acid to solubilize the argatroban, substantially free from dehydrated alcohol is described, as well as a method for its preparation.

Abstract: An aqueous, stable, sterile pharmaceutical composition of the thrombin inhibitor argatroban in a solution containing an acid to solubilize the argatroban, substantially free from dehydrated alcohol is described, as well as a method for its preparation.

Abstract: Formulations comprising argatroban and methods of making and using the formulations are provided. In an embodiment, the formulation comprises a solution having an argatroban concentration ranging from greater than about 10 to about 500 mg/mL. The solution can comprise an aqueous solution. The solution can be packaged in a sealed container that may either be aseptically-filled or subjected to sterilization to reduce the microbiological burden of the formulation. The solution can further be diluted and administered to persons needing same.

Abstract: Argatroban formulations and methods of making and using the formulations are provided. In an embodiment, the present disclosure provides a solid-state salt formulation of argatroban. Upon reconstitution, the solid-state argatroban forms a solution that can be essentially free of particles and suitable for administration. The solid-state argatroban can be in a crystalline and/or amorphous form. The solid-state argatroban can be packaged in a sealed container that may be aseptically-filled to reduce the microbiological burden of the formulation. The solid-state argatroban can be reconstituted with a solution and administered to persons needing same.

Abstract: Disclosed are concentrate esmolol injection essentially free from other related esters of esmolol and diluted esmolol compositions. The concentrate esmolol formulation includes from about 25-1000 mg/ml of esmolol and about 1-25% w/v of benzyl alcohol and the combination thereof. The compositions can also be used as multi-dose compositions. The present invention also discloses diluted, ready-to-use compositions of esmolol prepared by dilution of the present invention concentrates. Also disclosed are methods of making and using the ready-to-use compositions of the present invention.

Abstract: A concentrate esmolol formulation is provided that is safer than current concentrate (e.g., 250 mg/ml) esmolol compositions. The concentrate esmolol formulation can include from about 40-60 mg/ml of esmolol hydrochloride. The concentrate esmolol composition allows a practitioner the flexibility of choosing a bolus volume for direct injection to a patient or, optionally, to use the composition to make a customized, diluted composition of esmolol. Methods of the present invention provide for the reduction of potential adverse health consequences resulting in the improper dosing of prior art concentrate compositions of esmolol. Also, a medical product is provided that includes a concentrate esmolol housed in a container, and a package housing the container and instructions.

Abstract: A concentrated esmolol formulation is provided that is distinguishable from a diluted form of the concentrated esmolol formulation. In one embodiment, the concentrated esmolol formulation allows identification of the concentrate even after transfer of the concentrate out of a labeled primary container. The concentrated esmolol formulation can include from about 25 to about 1000 mg/ml of esmolol hydrochloride, a buffering agent and a color additive. Any number of color additives may be included such as indocyanine green, phenopheylene, hemoglobin, cyanocobalamine, patent blue, and indigo carmine vitamin B2 and naturally occurring vitamins and minerals. The amount included in the formulation is highly dependent on the color additive selected. The color additive should be included in an amount sufficient to easily distinguish the concentrated esmolol formulation from at least about a 1:4 dilution of the concentrate.

Abstract: An aqueous, stable, sterile pharmaceutical composition of the thrombin inhibitor argatroban in a solution containing an acid to solubilize the argatroban, substantially free from dehydrated alcohol is described, as well as a method for its preparation.