The report provides a detailed analysis essential for establishing a pacritinib production plant. It encompasses all critical aspects necessary for pacritinib production, including the cost of pacritinib production, pacritinib plant cost, pacritinib production costs, and the overall pacritinib production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a pacritinib 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.
Pacritinib is an oral kinase inhibitor that is used to treat myelofibrosis, which is a rare and serious type of bone marrow cancer that affects how the body makes blood cells. It is prescribed for adults who have medium or high-risk myelofibrosis. It is used in cases where patients have very low platelet counts, where other similar medicines like ruxolitinib are harmful. This drug works by blocking specific proteins in the body, which are overactive in this cancer and cause problems like an enlarged spleen, tiredness, night sweats, itching, and anaemia. It targets these proteins and helps shrink the spleen, easing those uncomfortable symptoms. Its common side effects include mild stomach issues like diarrhoea or nausea that most people can handle.
The market for pacritinib is driven by the increasing cases of myelofibrosis and other myeloproliferative neoplasms. Its preference over ruxolitinib and efficiency for targeted therapies that offer spleen volume reduction, symptom relief, contributes to its demand. The rising R&D investments by pharma companies, growing physician and patient awareness, personalised medicine trends, and expansion in high-purity formulations fuel its market. The industrial pacritinib procurement is influenced by high drug costs and price pressures in emerging markets. The need for strict regulatory approvals and reimbursement policies, along with dependence on speciality distributors, competition from other JAK inhibitors, , impacts its sourcing strategies.
Raw Material for Pacritinib Production
According to the pacritinib production plant project report, the key raw materials used in the production of pacritinib include 2,4-dichloropyrimidine, 3-formylphenylboronic acid, 2-halo-5-aminophenylmethanol, and cyanamide.
Production Process of Pacritinib
The extensive pacritinib production cost report consists of the following major industrial production process:
- From 2,4-dichloropyrimidine: The production process of pacritinib involves a convergent synthesis. In this process, the pyrimidine fragment goes through Grubbs-catalysed olefin metathesis with an aniline fragment bearing a protected hydroxyethoxy-pyrrolidine side chain. This is followed by deprotection and etherification with 2-(1-pyrrolidinyl)ethanol under acidic conditions using intermediates like 1-[3-(4-bromo-2-buten-1-yl)phenyl]-3-(dimethylamino)-2-propen-1-one and 2-halo-5-guanidinophenylmethanol. This is derived from guanidination of 2-halo-5-aminobenzyl alcohol, culminating in Suzuki coupling or final condensation, purification by recrystallisation from isopropanol to get pacritinib as the final product.
Pacritinib is a small-molecule kinase inhibitor that has a molecular formula of C28H32N4O3 and a molecular weight of around 472.6 g/mol. It appears as a light yellow to yellow crystalline solid, which is soluble in DMSO (up to 5 mg/mL). It has a pKa value of around 8.86-9.56 that indicates its basic properties. It has a low hydrogen donor count (1) and a moderate polar surface area of about 68.74 Ų, which contributes to its oral bioavailability. It has a low rotatable bond count (4), high refractivity (139.43), and high plasma protein binding (98.8%). It has a steady-state volume of distribution of 229 L, with the parent drug remaining the primary active circulating form.