Stable ready-to-use carmustine pharmaceutical composition
Inventors
Pramanick, Sougata • Burhan, Aasiya Aslam • Gurjar, Mukund Keshav • PATEL, Hiren Pravinbhai • GONDALIYA, Deepak Pragjibhai
Assignees
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Publication Number
US-11865206-B2
Publication Date
2024-01-09
Expiration Date
Abstract
The present invention relates to a ready-to-use solution of carmustine that does not require dissolution or dilution of the carmustine prior to addition to saline and dextrose parenteral solutions. In particular, the invention relates to a stable liquid pharmaceutical composition containing carmustine in the form of ready-to-use solution and method for preparing the same.
Core Innovation
The invention relates to a method of administering carmustine to a patient using a carmustine solution that is not reconstituted from a lyophilizate. The carmustine solution includes carmustine at about 100 mg/mL to about 500 mg/mL together with a super refined polysorbate having a peroxide value below 10 meq O2/kg, and the carmustine solution is provided in a sealed container that is free of polyvinyl chloride and free of di-2-ethylhexylphthalate.
The method further provides for forming an administrable solution by adding the carmustine solution directly to 500 ml of a 0.9% sodium chloride injection solution or 500 ml of a 5% dextrose injection solution. The administrable solution is formed without any prior dissolution or prior dilution of the carmustine solution, and is then parenterally administered to the patient.
The document additionally describes stability and quality characteristics for the prepared carmustine solution. In particular, the solution is stored in a sealed container with a limited oxygen headspace and maintains carmustine content of at least 90% by weight after storage at 2–8°C for up to 3 months, with example data indicating retention of carmustine assay over that period.
Claims Coverage
One independent claim is identified. It covers a complete administration method in which an un-reconstituted carmustine solution formulated with a super refined polysorbate and provided in a PVC-free and DEHP-free sealed container is combined directly with either 0.9% sodium chloride or 5% dextrose to form an administrable solution, followed by parenteral administration.
Un-reconstituted carmustine solution with super refined polysorbate in PVC- and DEHP-free sealed container
A carmustine solution comprising about 100 mg/mL to about 500 mg/mL carmustine and a super refined polysorbate with a peroxide value below 10 meq O2/kg, where the carmustine solution has not been reconstituted from a lyophilizate and is provided in a sealed container that is free of polyvinyl chloride and free of di-2-ethylhexylphthalate.
Direct formation of administrable solution by adding carmustine solution to 0.9% sodium chloride or 5% dextrose without prior dissolution or dilution
Adding the carmustine solution directly to 500 ml of a 0.9% sodium chloride injection solution or 500 ml of a 5% dextrose injection solution to form an administrable solution without any prior dissolution or prior dilution of the carmustine solution.
Parenteral administration of the administrable solution
Parenterally administering the administrable solution to the patient.
The independent claim centers on a specific ready-to-use carmustine solution in a sealed container, direct combination with either 0.9% sodium chloride or 5% dextrose without prior dissolution or dilution, and subsequent parenteral administration.
Stated Advantages
Maintains carmustine content of at least 90% by weight after storage at 2–8°C for up to 3 months.
The solution is described as having a clear pale yellow appearance with low or controlled impurities.
Documented Applications
Administration of carmustine to a patient.
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