Sotalol Production Cost Reports

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

Sotalol is the first of the class III antiarrhythmic drugs that find huge applications in the medical industry. It is widely used as an oral tablet for the treatment of life-threatening ventricular arrhythmias and supraventricular arrhythmias. Moreover, it also finds its application as an antiarrhythmic agent for treating and maintaining normal sinus rhythm in atrial fibrillation or flutter. Additionally, it is also employed as off-label medicine for the treatment of pharmacological cardioversion of atrial fibrillation, supraventricular tachycardia (SVT), postoperative atrial fibrillation after cardiac surgery, and premature ventricular contractions.

The market for Sotalol is primarily driven due to its key role as an anti-arrhythmia drug used largely in the therapy of cardiac arrhythmias and cardiac rhythm alteration, which remarkably boosts its demand in the pharmaceutical industry. Moreover, its application as a beta-adrenergic antagonist for the treatment of hemodynamically stable ventricular tachycardia further enhances its market expansion. Additionally, its employment as a medication for managing cases of paroxysmal atrial fibrillation effectively fuels its market growth. Furthermore, several factors, such as the availability of raw materials (aniline, etc.), pricing, compliance with medical regulations, scientific innovations, and quality standards, significantly influence industrial Sotalol procurement globally.

Raw Material for Sotalol Production

According to the Sotalol manufacturing plant project report, the major raw materials for Sotalol production include Methansulfonylchloride-Aniline.

Manufacturing Process of Sotalol

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

1. Production from Methansulfonylchloride: This method of production is initiated by the reaction of methansulfonylchloride with aniline to form methansulfonanilide. Further, the obtained methansulfonanilide is reacted with bromacetylbromide in the presence of aluminum chloride (AlCl3) and carbon disulfide (CS2) to produce 4-(bromacetyl)- methansulfonanilide. Then, the obtained compound is further reacted with isopropylamine to give 4-(1-oxo-2-isopropylaminoethyl)methansulfonanilide, followed by its reduction through hydrogenation in the presence of  Pd-C catalyst and sodium borohydride, which results in the formation of  4-(1-hydroxy-2-isopropylaminoethyl)methansulfonanilide or Sotalol as the final product.

Sotalol belongs to the class of ethanolamines. The compound is a sulfonamide that serves as a drug with antiarrhythmic properties. The molecular formula of the compound is C12H20N2O3S, and its molar mass is 272.37 g/mol. Moreover, the compound is available in the form of an oral tablet, oral solution, and intravenous injection. The scientific name of the compound is 4'-(1-hydroxy-2-(isopropylamino)ethyl)methane sulfonanilide. The drug is widely marketed under the brand name Betapace and Sorine. Additionally, the melting point of the compound is between 206.5-207 °C and its boiling point is 443.3°C. The compound exists in the form of a pale yellow to light yellow solid with a density of 1.298 g/cm3. It is hygroscopic and stored in a freezer at 20°C under an inert atmosphere.