Vasopressin premix systems and uses thereof
Inventors
Garber, II, Robert W. • Cope, Sydney • Mantei, Jason • Doty, Mark
Assignees
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Publication Number
US-12447190-B1
Publication Date
2025-10-21
Expiration Date
Abstract
Provided is a system comprising a flexible container for intravenous administration which comprises a premix vasopressin pharmaceutical formulation, and uses thereof.
Core Innovation
The invention provides a sealed container system for stable storage of a pharmaceutical premix vasopressin formulation. The premix vasopressin formulation is an aqueous formulation having a pH of about 3.1 to 4.5 and comprising about 0.1 unit/mL to about 1.0 unit/mL vasopressin, sodium chloride, and sodium lactate. The primary container is a multi-layer plastic container comprising a layer of polyethylene, and the primary container is an intravenous bag having a volume of 50 mL to 500 mL.
The premix vasopressin formulation is stabilized for at least 5 months of storage at 25 degrees Celsius in the sealed container system. In refined embodiments, the formulation includes sodium chloride at about 8.5 mg/mL to about 9.5 mg/mL and sodium lactate at about 2.5 mM to about 3.5 mM or about 280 μg/mL to about 400 μg/mL, and optionally includes pH adjustors that are sodium hydroxide and/or hydrochloric acid.
Further embodiments specify the premix vasopressin formulation as consisting essentially of about 0.1 unit/mL to about 0.5 unit/mL vasopressin, about 9 mg/mL sodium chloride, and about 3 mM sodium lactate, with a pH of about 3.5 to about 4.1 when optionally adjusted using sodium hydroxide and/or hydrochloric acid. The sealed container system is directed to stable storage of the premix vasopressin formulation in the multi-layer polyethylene intravenous bag, with stability for at least 5 months at 25 degrees Celsius.
Claims Coverage
The patent provides three independent claims. Each claim defines a sealed container system for stable storage of an aqueous premix vasopressin formulation in a multi-layer polyethylene intravenous bag, with explicit ranges for pH, vasopressin concentration, and ionic components, and a requirement for stability of at least 5 months at 25 degrees Celsius.
Sealed container system with pH 3.1 to 4.5 aqueous premix vasopressin and polyethylene IV bag stability at 25°C
A sealed container system having a primary multi-layer plastic intravenous bag comprising a layer of polyethylene containing an aqueous premix vasopressin formulation at pH about 3.1 to 4.5 with about 0.1 unit/mL to about 1.0 unit/mL vasopressin, sodium chloride, and sodium lactate, wherein the premix vasopressin formulation is stable for at least 5 months of storage at 25 degrees Celsius.
Sealed container system with specified ranges of vasopressin, sodium chloride, sodium lactate, optional pH adjustors, and 25°C stability
A sealed container system where the primary container comprises a premix vasopressin formulation having about 0.1 unit/mL to about 0.5 unit/mL vasopressin, about 8.5 mg/mL to about 9.5 mg/mL sodium chloride, about 2.5 mM to about 3.5 mM or about 280 μg/mL to about 400 μg/mL sodium lactate, optionally pH adjustors which is sodium hydroxide and/or hydrochloric acid, and the premix vasopressin formulation has a pH of about 3.1 to about 4.5, in a multi-layer polyethylene intravenous bag, with stability for at least 5 months of storage at 25 degrees Celsius.
Sealed container system consisting essentially of vasopressin, sodium chloride, sodium lactate, defined pH 3.5 to 4.1, and 25°C stability
A sealed container system where the premix vasopressin formulation consists essentially of about 0.1 unit/mL to about 0.5 unit/mL vasopressin, about 9 mg/mL sodium chloride, about 3 mM sodium lactate, and optionally pH adjustor(s) which is sodium hydroxide and/or hydrochloric acid, with an aqueous formulation pH of about 3.5 to about 4.1, in a multi-layer polyethylene intravenous bag, wherein the premix vasopressin formulation is stable for at least 5 months of storage at 25 degrees Celsius.
Across the independent claims, the inventive subject matter is the combination of a sealed multi-layer polyethylene intravenous bag with an aqueous premix vasopressin formulation defined by explicit pH and component concentration ranges together with a stability requirement of at least 5 months at 25 degrees Celsius.
Stated Advantages
Documented Applications
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