The report provides a detailed analysis essential for establishing a Tipiracil production plant. It encompasses all critical aspects necessary for Tipiracil production, including the cost of Tipiracil production, Tipiracil plant cost, Tipiracil production costs, and the overall Tipiracil production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a Tipiracil production plant. These encompass production processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.
Tipiracil is a medicine that is used to treat certain types of advanced cancer, like colon and stomach cancers. It is used together with another drug called trifluridine (that breaks down easily), and it works by stopping that breakdown. It helps trifluridine stay in the body longer and work better at fighting the cancer. It works by getting into the cancer cells and stopping them from copying their DNA, which stops the cancer cells from growing and multiplying. It also helps block the growth of new blood vessels that cancer needs to get nutrients. This combination is given as a pill in cycles to patients who have already tried other treatments that did not work. It helps improve the chances of controlling the cancer and extending life in these cases.
The market for Tipiracil is influenced by increasing cases of metastatic colorectal cancer (mCRC) and refractory gastric cancers. It works as an important third-line oral therapy after failures of standard regimens like fluoropyrimidines, oxaliplatin, and irinotecan.
Its demand because of rise in ageing populations and the expanding colorectal cancer therapeutics market boosts its market growth. The industrial Tipiracil procurement is influenced by the high costs of its complex synthesis. Also, its market dynamics are further affected by patent protections limiting generic competition and pharmaceutical policies like reference pricing and government negotiations.
Raw Material for Tipiracil Production
According to the Tipiracil production plant project report, the key raw materials used in the production of Tipiracil include 5-Chloro-6-Chloromethyluracil-(2-Iminopyrrolidine)-Sodium Ethoxide-(N, N-Dimethylformamide).
Production Process of Tipiracil
The extensive Tipiracil production cost report consists of the following major industrial production process:
- From 5-Chloro-6-Chloromethyluracil : The production process of Tipiracil involves a reaction of a dichloro-substituted uracil derivative with 2-iminopyrrolidine and sodium ethoxide. The reaction takes place in N, N-dimethylformamide at room temperature. The crystallised product is collected by filtration, suspended in water, neutralised with acetic acid, and washed. The insoluble material is filtered, dissolved in dilute hydrochloric acid, treated with activated carbon, and filtered again. The filtrate is concentrated under reduced pressure, and the residue is washed with ethanol and collected by filtration to get pure Tipiracil as the final product.
Tipiracil has the molecular formula of C9H11ClN4O2 with a molecular weight of 242.66 g/mol. It appears as a white crystalline powder that is mostly in hydrochloride form. It has a melting point of 245 degree Celsius (with decomposition). It shows solubility of 5 mg/mL in water, good solubility in dilute acids and bases, slight solubility in methanol, and very low solubility in ethanol, acetone, and ethers. It has low lipophilicity with 3 hydrogen bond donors, 4 acceptors, 2 rotatable bonds, and a topological polar surface area of 92.81 Ų. It belongs to halopyrimidines with a chloro-substituted pyrimidine-2,4-dione structure linked to a 2-iminopyrrolidin-1-yl methyl group.