Varenicline Production Cost Reports

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

Varenicline is a partial agonist of nicotinic acetylcholine receptors used as an aid to stop smoking addiction in individuals. It has shown a strong effect in avoiding both short-term and long-term relapses, making it the first medication of choice for quitting smoking. It is also recommended to be used as a nasal spray to treat the symptoms of dry eye condition. Thus, it finds its application in the pharmaceutical and medical industries.

The procurement of Varenicline is influenced by its application in the pharmaceutical and medical industries to stop smoking addiction in individuals. There are constant initiatives to discourage smoking, but a large segment of the population still smokes. Because of its rising rate, there is a constant need for smoking cessation medications, such as Varenicline. It has shown a strong effect in avoiding both short-term and long-term relapses, making it the first medication of choice for quitting smoking.

It has been demonstrated that Varenicline is just as effective as nicotine replacement treatment and is preferable over other drugs such as bupropion. It has also been demonstrated that Varenicline has a lesser incidence of withdrawal symptoms than other medications because of its partial agonist qualities. Overall, the industrial Varenicline procurement is influenced by its application in the pharmaceutical and medical industries to stop smoking addiction in individuals, the rising rate of smoking, its preference over drugs, lesser incidence of withdrawal symptoms, along with rising healthcare awareness among people, research and development, and regulatory approvals.

Raw Material for Varenicline Production

According to the Varenicline manufacturing plant project report, the key raw material used in the production of Varenicline include 2-bromo fluorobenzene.

Manufacturing Process of Varenicline

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

• Production from 2-bromo fluorobenzene: The manufacturing process of Varenicline involves several key steps. It starts with a Grignard reaction between magnesium and 2-bromo fluorobenzene. This mixture then undergoes a Diels-Alder reaction with cyclopentadiene to form an intermediate. In the next step, Osmium tetraoxide and N-methylmorpholine N-oxide (NMO) dihydroxylate this intermediate to create a diol intermediate. This diol is subsequently cleaved with sodium periodate to create a di-aldehyde. In the next step, the di-aldehyde is treated with benzyl amine and sodium acetoxyborohydride to form an intermediate, which is hydrogenated to remove the benzyl group, forming an amine hydrochloride intermediate.

The amine is reacted with trifluoroacetic anhydride and pyridine in dichloromethane to form trifluoroacetamide. Then, the dinitro compound is created by adding trifluoroacetamide to a premixed mixture of trifluoromethane sulfonic acid and nitric acid in dichloromethane. The dinitro compound is then reduced by hydrogenation in the presence of catalytic 5% Pd/C in isopropanol:water mixture, resulting in the diamine intermediate. This is quickly reacted with glyoxal in water at room temperature to form the final intermediate. In the final step, the trifluoroacetamide is then hydrolyzed with sodium hydroxide in toluene to form Varenicline.

Varenicline is commercially known as Chantix. Its molecular formula is C13H13N3, and it has a molecular weight of 211.26 g/mol. Its water solubility is 0.0877 mg/mL. It is stable when kept in the suggested storage conditions. Its log P value is 0.9. Varenicline is a member of the class of drugs which are partial agonists of the alpha4/beta2 subtype of the nicotinic acetylcholine receptor. It works as an aid to treat smoking addiction.