The report provides a detailed analysis essential for establishing a Tocainide production plant. It encompasses all critical aspects necessary for Tocainide production, including the cost of Tocainide production, Tocainide plant cost, Tocainide production costs, and the overall Tocainide production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a Tocainide 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.
Tocainide is an oral antiarrhythmic drug which is used to treat dangerous irregular heart rhythms by blocking sodium channels in heart muscle cells. This slows down faulty electrical signals, reduces the heart's overexcitability, especially in damaged or oxygen-starved areas and helps restore a steady heartbeat.
It is prescribed for life-threatening ventricular arrhythmias and targets conditions like sustained ventricular tachycardia, frequent premature ventricular contractions, and non-sustained ventricular tachycardia. It is useful in patients recovering from heart attacks where other treatments fail, allowing for both emergency use via quick infusion followed by long-term pills to prevent recurrences. Its common side effects include dizziness, nausea, vomiting, tremors, numbness and tingling, sweating, headache, blurred vision, nervousness, and rash.
The market for Tocainide is driven by rising global cases of cardiac arrhythmias. Its utilisation in epilepsy and neuropathic pain management, along with an ageing population which is more prone to heart rhythm disorders, contributes to its market growth. The technological advancements in antiarrhythmic formulations and shifting consumer preferences toward oral alternatives to injectables further support its market.
The focus on sourcing API from GMP-certified manufacturers with USDMF, EDMF/CEP, JDMF, KDMF, or WC filings to ensure regulatory compliance affects industrial Tocainide procurement. The quality assurance through batch testing, stability data, impurity profiles, scalable quantities for R&D to commercialisation, and specialised handling affect its sourcing.
Raw Material for Tocainide Production
According to the Tocainide production plant project report, the key raw materials used in the production of Tocainide include N-Boc-L-alanine and 2,6-dimethylaniline.
Production Process of Tocainide
The extensive Tocainide production cost report consists of the following major industrial production process:
- From N-Boc-L-alanine: The production process of Tocainide starts with coupling N-Boc-L-alanine and HOBt dissolved in anhydrous DCM under an inert atmosphere. This is followed by adding 2,6-dimethylaniline and slowly introducing DCC in DCM. The mixture stirs to form the Boc-protected intermediate. The reaction mixture is filtered to remove DCU precipitate, with the filtrate washed with saturated NaHCO3 solution, water, and brine, dried over anhydrous Na2SO4. The deprotection is followed by dissolving the intermediate in DCM and TFA, evaporating solvents and dissolving the residue in ethyl acetate. This is followed by washing with NaHCO3 to neutralise, drying, and concentrating to get Tocainide free base.
Tocainide has the molecular formula of C11H16N2O, and molecular weight of 192.26 g/mol, while its hydrochloride salt (common form) is C11H17ClN2O with 228.72 g/mol. It appears as a white to off-white crystalline powder with a bitter taste. It has a melting point at 246-247 degree Celsius, is freely soluble in water, soluble in DMSO, and stored at 2-8 degree Celsius in solid form. It shows logP values of 0.35-1.4, pKa (acidic) 3.73 and (basic) 9.56. It has a polar surface area of 58.61 Ų with refractivity of 59.61 m³·mol-¹ and polarizability of 21.8 ų. It has one ring, two rotatable bonds, low protein binding (10-20%), and high oral bioavailability near 100% with a plasma half-life of 11.5-15.5 hours.