Sulfasalazine Production Cost Reports

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

Sulfasalazine is a disease-modifying antirheumatic drug that helps calm down inflammation in the body. It is used to treat ulcerative colitis by soothing the lining of the colon and preventing painful flare-ups that cause diarrhoea and bleeding. It is also utilised to control Crohn's disease to avoid long periods of sickness.

It is prescribed for joint problems, and doctors give it to adults and children with rheumatoid arthritis. It is preferred over regular painkillers that don't stop the damage to hands, knees, and other joints, easing swelling, stiffness, and morning aches over time. It also helps people with ankylosing spondylitis by loosening up the spine and hips to make bending and moving easier. It is also used to treat psoriatic arthritis to reduce both scaly skin patches and painful, swollen joints.

The market for Sulfasalazine is influenced by growing cases of ulcerative colitis, Crohn's disease, rheumatoid arthritis, and autoimmune disorders. The rise in the ageing population, enhanced diagnostics, greater healthcare access, and its usage as an affordable generic first-line option boost its market.

The industrial Sulfasalazine procurement is affected by GMP-compliant API sources providing USDMF, CEP, WC, and JDMF credentials. Also, better purity, detailed COA and DMF, and adherence to standards from established suppliers impact its sourcing strategies. North America and Europe leads its market because of elevated IBD cases and protocols, while the Asia-Pacific region is driven by regional advancements, with generics prevailing in retail and hospital.

Raw Material for Sulfasalazine Production

According to the Sulfasalazine production plant project report, the key raw materials used in the production of Sulfasalazine include phenol, heavy water, sulfuric acid, and diethyl ether.

Production Process of Sulfasalazine

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

1. From Phenol: The production process of Sulfasalazine starts with the preparation of salicylic acid. The phenol is heated in heavy water with H2SO4  and extracted with diethyl ether. This is dried over Na2SO4, and carboxylation with CO2 under pressure. Also, Sulfapyridine is obtained from the hydrolysis of N-acetyl-15N-sulfapyridine in 10% NaOH at reflux. Diazotisation of sulfapyridine generates the diazonium salt, which couples with salicylic acid to form crude Sulfasalazine.

Sulfasalazine appears as a bright yellow to orange crystalline powder with a faint odour. It has the molecular formula C18H14N4O5S and a molecular weight of 398.39 g/mol. It has a high melting point of around 255-259 degree Celsius with decomposition. It has low water solubility, as shown by slight solubility in acetone and DMSO. Its logP value is 2.3, making it lipophilic and suitable for enteric coatings. It has a topological polar surface area of 146 Ų and a density of 1.5 g/cm³. It goes through colonic bacterial azo reduction to sulfapyridine and 5-ASA, features three H-bond donors, nine acceptors, six rotatable bonds, and one defined stereocenter.