Dofetilide Production Cost Reports

The report provides a detailed analysis essential for establishing a Dofetilide manufacturing plant. It encompasses all critical aspects necessary for Dofetilide production, including the cost of Dofetilide production, Dofetilide plant cost, Dofetilide production costs, and the overall Dofetilide manufacturing plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a Dofetilide production plant. These encompass manufacturing processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.

Dofetilide is an FDA-approved class III antiarrhythmic agent that finds its major applications in the medical and pharmaceutical sectors. It is widely used as an anti-arrhythmia drug in the treatment and prevention of atrial fibrillation and atrial flutter. It is also utilized as an oral drug in the maintenance of sinus rhythm in individuals at risk of forming atrial fibrillation and flutter. It also finds its application as a subject for ongoing research in the pharmaceutical field in studies related to cardiac disorders and new applications for treating other types of arrhythmias.

The demand for Dofetilide is primarily driven by its application as an FDA-approved antiarrhythmic agent in the production of antiarrhythmic medications, which largely promotes its market. Its utilization as an oral drug for the prevention and treatment of atrial fibrillation and atrial flutter also fuels its demand in the pharmaceutical and healthcare industries. Its involvement as a subject in the medical research and development industry for studies related to the treatment of life-threatening cardiac conditions and several types of arrhythmias further boosts its market growth.

The synthesis of Dofetilide requires specialized knowledge and facilities that adhere to Good Manufacturing Practices (GMP). Thus, any disruptions in manufacturing, such as equipment failures or supply shortages of raw materials, greatly affect the production and overall procurement process of Dofetilide. Additionally, fluctuations in the demand for Dofetilide from downstream industries, such as pharmaceutical, healthcare, and medical, further impact the pricing and industrial Dofetilide procurement.

Raw Material for Dofetilide Production

According to the Dofetilide manufacturing plant project report, the major raw materials for Dofetilide production include 4-(2-bromoethoxy)methanesulfonanilide and N-methyl-p-nitrophenethylamine and Dimethyl Sulfate.

Manufacturing Process of Dofetilide

The extensive Dofetilide production cost report consists of the following industrial manufacturing process:

• Production via Chemical Synthesis: This method of production involves the synthesis of Dofetilide by using 4-(2-bromoethoxy)methanesulfonanilide, N-methyl-p-nitrophenethylamine, and potassium carbonate as the raw materials. The process starts with the reaction of 4-(2-bromoethoxy)methanesulfonanilide is reacted with N-methyl-p-nitrophenethylamine in the presence of potassium carbonate in a solvent called acetonitrile. Further, the nitro group (a part of the molecule containing nitrogen and oxygen) in the newly formed compound is converted into an amine group (which contains just nitrogen and hydrogen) through catalytic reduction. In the final step, the amine group formed is treated with dimethyl sulfate in methylene chloride to obtain Dofetilide as the final product.

Dofetilide is a tertiary amino compound that exits in the form of a white to off-white crystalline powder with the molecular formula C19H27N3O5S2. Its molecular weight is 441.6 g/mol. The compound has a melting point of 260-266°C, and it also gets decomposed at this temperature. The compound is very slightly soluble in water and propan-2-ol, but soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous hydrochloric acid. Dofetilide has a LogP value of 1.8, and its pKa value is 8.99. Its topological polar surface area is 122 Ų. It is highly bioavailable (>90%) when administered orally, with peak plasma concentrations occurring at about 2-3 hours in the fasted state. It is generally sold under the brand name Tikosyn.