Ibutilide Fumarate Production Cost Reports

The report provides a detailed analysis essential for establishing an Ibutilide Fumarate production plant. It encompasses all critical aspects necessary for Ibutilide Fumarate production, including the cost of Ibutilide Fumarate production, Ibutilide Fumarate plant cost, Ibutilide Fumarate production costs, and the overall Ibutilide Fumarate production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating an Ibutilide Fumarate 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.

Ibutilide fumarate is a Class III antiarrhythmic medication. It functions as a pharmaceutical active ingredient in cardiology for the rapid conversion of recent-onset atrial fibrillation or atrial flutter to sinus rhythm through intravenous injection in hospital settings. It works by prolonging the action potential duration in cardiac myocytes, which increases atrial and ventricular refractoriness via activation of a slow inward sodium current. Additionally, it is available in formulations like Fibricor and Corvert under FDA-regulated standards.

Ibutilide fumarate market growth is driven by the global rise in the cases of atrial fibrillation and other supraventricular arrhythmias, fuelled by ageing populations, lifestyle factors, and increasing geriatric demographics susceptible to cardiac conditions. The sustained clinical reliance on the drug for acute hospital-based cardioversion and expanding healthcare infrastructure in emerging markets like the Asia-Pacific region propel its demand.

The penetration of cost-effective generic alternatives alongside government investments in cardiovascular care boosts the market demand. Industrial Ibutilide Fumarate procurement is heavily influenced by its hospital-only distribution channel due to FDA-mandated requirements for continuous ECG monitoring and cardiac resuscitation facilities to mitigate risks like Torsades de Pointes, limiting it to well-equipped facilities and elevating treatment costs.

Raw Material for Ibutilide Fumarate Production

According to the Ibutilide Fumarate production plant project report, the various raw materials for Ibutilide Fumarate production include aniline and methanesulfonyl chloride.

Production Process of Ibutilide Fumarate

The extensive Ibutilide Fumarate production cost report consists of the following major industrial production process:

1. Production via a multi-step synthesis: The production process of Ibutilide fumarate starts with the reaction of aniline and methanesulfonyl chloride in pyridine at 15-20 degree Celsius under N2 to form methanesulfonanilide after crystallisation from ethyl acetate with Darco treatment. This intermediate undergoes AlCl3-catalysed Friedel-Crafts acylation with succinic anhydride (0.175 mol) in CS2 at rt to 55 degree Celsius, yielding 4-[(methylsulfonyl)amino]-γ-oxobenzenebutanoic acid after acidification, NaHCO3 purification, and reprecipitation. The keto-acid (0.044 mol) then couples with ethylheptylamine via HOBt/DCC activation in DMF at 5 degree Celsius to rt, producing the amide post-chromatography. Additionally, subsequent LiAlH4 reduction in THF at reflux for 27 h affords the free base Ibutilide after workup and silica gel purification. Final fumarate salt formation occurs by refluxing the base with hemimolar fumaric acid in CH2Cl2, crystallising upon cooling.

Properties of Ibutilide Fumarate

Ibutilide fumarate is a white to off-white solid with the molecular formula C44H76N4O10S2, and a molecular weight of 885.23 g/mol. Its chemical name is (E)-but-2-enedioic acid; N-[4-[4-[ethyl(heptyl)amino]-1-hydroxybutyl]phenyl]methanesulfonamide. It consists of a racemic mixture where both enantiomers show equipotent activity as a Class III antiarrhythmic. Its solubility characteristics include ≥25.6 mg/mL in DMSO, ≥16.4 mg/mL in water (with ultrasonication), and ≥2.69 mg/mL in ethanol (with ultrasonication), with storage recommended at -20 degree Celsius to maintain stability. It has a pKa of 10.4, polar surface area of 69.64 Ų, 28 rotatable bonds, two rings, hydrogen acceptor count of 4, hydrogen donor count of 2, refractivity of 109.18 m³·mol?¹, and polarizability of 46.39 ų.