The report provides a detailed analysis essential for establishing a Tofacitinib production plant. It encompasses all critical aspects necessary for Tofacitinib production, including the cost of Tofacitinib production, Tofacitinib plant cost, Tofacitinib production costs, and the overall Tofacitinib production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a Tofacitinib 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.
Tofacitinib is an FDA-approved drug that finds major applications in the pharmaceutical industry. It is widely utilized as an oral drug for the treatment of moderate to severely active rheumatoid arthritis (RA) in adults. Moreover, it is often indicated for the treatment of joint pain, psoriatic arthritis, ulcerative colitis, and swelling. Additionally, the compound also finds its application in the treatment of polyarticular course juvenile idiopathic arthritis in patients ≥2 years of age.
The market for Tofacitinib is largely driven by its application in the medical industry for the treatment of moderate-to-severe rheumatoid arthritis, which significantly fuels its market expansion. Its usage in the form of a medication for reducing pain, inflammation, and joint damage in patients with rheumatoid arthritis, and active ankylosing spondylitis further enhances its demand in the pharmaceutical industry.
Moreover, its employment in the form of an oral solution for the treatment of inflammatory diseases in patients ≥2 years of age effectively promotes its market growth. Additionally, several factors, such as the cost and the availability of raw materials (dimethyl decarbonate, etc.), compliance with healthcare regulations, and maintaining quality standards, significantly influence industrial Tofacitinib procurement globally. Furthermore, optimized distribution and logistics and novel discoveries in science lead to variations in the requirements for procurement.
Raw Material for Tofacitinib Production
According to the Tofacitinib production plant project report, the major raw materials for Tofacitinib production include Aminopyridine-Dimethyl Dicarbonate.
Production Process of Tofacitinib
The extensive Tofacitinib production cost report consists of the following industrial production process:
- Production from Aminopyridine: This method of production involves the use of aminopyridine as the starting material for the synthesis of tofacitinib. The process is initiated by the reaction of aminopyridine with dimethyl dicarbonate in the presence of potassium t-butoxide to form methyl carbamate, followed by the hydrogenation of this compound in the presence of Rh/C in n acetic acid and reductive amination with benzaldehyde and sodium triacetoxy borohydride to give cis-benzyl protected piperidine. Further, the reduction of the obtained compound is with lithium aluminum hydride (LiAlH4) in THF to form methyl amino piperidine (isolated as the dihydrochloride salt). Further, freebasing the di-hydrochloride salt with sodium hydroxide and converting it to the di-toluol-L-tartaric acid salt followed by crystallization to give enantioenriched tartrate salt. Further, the obtained compound undergoes a direct reaction with dichloride to form an intermediate coupled product. As the last step, the obtained intermediate undergoes hydrogenation in the presence of Degussa catalyst, concomitant debenzylation, and chloride removal, followed by the addition of cyanoacetate group to obtain tofacitinib as the final product.
Tofacitinib belongs to the class of medications called Janus kinase (JAK) inhibitors. It is majorly marketed under the trade name XELJANZ. Moreover, the molecular formula of the compound is C16H20N6O, and its molecular weight is 312.37 g/mol. The compound appears as a white crystalline solid that is stored at -20°C. Additionally, the density of the compound is 1.3g/cm3, and the value of its dissociation constant is pka= 6.04. It is generally administered in the form of its salt named Tofacitinib Citrate. It is slightly soluble in water but soluble in DMSO and ethanol with a solubility of up to 100 mg/ml. The boiling point of the compound is 585.8 °C., and its melting point is 198-202°C.
