Emcure Pharmaceuticals has filed a patent for a stable liquid pharmaceutical composition of carmustine that is ready-to-use and does not require prior dissolution or dilution. The invention aims to provide a convenient solution for healthcare professionals by eliminating the need for additional steps before adding carmustine to saline and dextrose parenteral solutions. GlobalData’s report on Emcure Pharmaceuticals gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on Emcure Pharmaceuticals, cancer treatment biomarkers was a key innovation area identified from patents. Emcure Pharmaceuticals's grant share as of June 2023 was 1%. Grant share is based on the ratio of number of grants to total number of patents.
A recently filed patent (Publication Number: US20230135144A1) describes a method for administering carmustine, a chemotherapy drug, to patients. The method involves adding a carmustine solution directly to either a 0.9% sodium chloride injection solution or a 5% dextrose injection solution, without the need for prior dissolution or dilution of the carmustine solution. The resulting solution is then administered to the patient through a parenteral route.
The carmustine solution used in this method contains a concentration of about 100 mg/mL to about 500 mg/mL of carmustine. It also includes a super refined polysorbate with a peroxide value below 10 meq O2/kg and optionally an antioxidant. The carmustine solution is stored in a sealed container that is free of polyvinyl chloride and di-2-ethylhexylphthalate before being added to the injection solution.
The patent claims specify that the polysorbate used can be selected from polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, or mixtures thereof. However, the preferred polysorbate is super refined polysorbate 80. The administrable solution, after the addition of the carmustine solution to the injection solution, has a concentration of about 0.2 mg/mL of carmustine.
To ensure the stability and quality of the carmustine solution, the patent claims state that the polysorbate used should have a peroxide value between about 0.2 meq O2/kg and about 0.5 meq O2/kg. Additionally, the head space within the container holding the carmustine solution should contain not more than 6% oxygen. After being stored at 2°C to 8°C for 3 months in the sealed container, the carmustine solution should retain at least 90% by weight of the initial amount of carmustine and be free of visible particles.
In summary, this patent describes a method for administering carmustine to patients by directly adding a carmustine solution to an injection solution without prior dissolution or dilution. The method ensures the stability and quality of the carmustine solution by using specific concentrations of carmustine, a super refined polysorbate, and an appropriate container. The method aims to provide an effective and safe way of administering carmustine to patients undergoing chemotherapy.
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