Tiopronin Production Cost Reports

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

Tiopronin is a special thiol medicine that helps to treat severe cystinuria (a rare genetic kidney disorder). In this condition body excretes too much cystine in the urine, causing it to form hard, painful kidney stones. It works by binding to the cystine through a chemical reaction called thiol-disulfide exchange. This turns it into a water-soluble form that stays dissolved in urine instead of crystallising into stones. It is prescribed for kids aged 9 and older, when basic treatments fail to control the problem.

It is available as easy-to-swallow 100 mg or 300 mg tablets in regular or delayed-release versions. It is also used in Wilson's disease (where it helps remove excess copper from the body), rheumatoid arthritis to ease joint pain and swelling, and in lab settings for stabilising nanoparticles.

The market for Tiopronin is driven by rising cases of cystinuria. The need for improved genetic diagnostics and awareness of rare diseases contributes to its market growth. The rise in ageing populations that are more prone to kidney issues and healthcare spending boosts its demand.

The industrial Tiopronin procurement is affected by the presence of GMP-certified API manufacturers and suppliers (e.g., lists by USDMF, CEP, JDMF) with scalable capacity. Also, strong supply chains are needed to manage raw material shortages or geopolitics and regulatory compliance. Other factors like R&D for advanced formulations (like injections, NO-releasing variants for dual cystinuria-infection management), and geographic focus on high-prevalence regions with strong infrastructure further affect its sourcing.

Raw Material for Tiopronin Production

According to the Tiopronin production plant project report, the key raw materials used in the production of Tiopronin include Glycine-(α-Chloropropionyl Chloride)-Sodium Carbonate-Sodium Hydroxide-Sodium Disulfide.

Production Process of Tiopronin

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

1. From Glycine and α-Chloropropionyl Chloride: The production process of Tiopronin starts with the preparation of α-chloropropionylglycine. First, glycine is dissolved in an aqueous sodium carbonate solution, and α-chloropropionyl chloride is slowly added. After stirring at room temperature for several hours, the mixture is acidified with hydrochloric acid to precipitate α-chloropropionylglycine. After that, α-chloropropionylglycine is dissolved with sodium hydroxide in water, and a sodium disulfide solution is added dropwise. The mixture is heated at and then cooled and poured into ice water, followed by acidification to pH 1 with hydrochloric acid. The product is extracted with ethyl acetate, washed, dried over sodium sulfate, filtered, and concentrated under reduced pressure to get crude Tiopronin, which is further purified by recrystallisation to get pure Tiopronin.

Tiopronin has a molecular formula of C5H9NO3S and a molecular weight of 163.19 g/mol. It appears as white to almost white opaque crystals or powder. It has a melting point of 93-98 degree Celsius and a predicted boiling point of 418.3 degree Celsius. It has a density of around 1.249 g/cm³ and a refractive index of about 1.522. It has low lipophilicity (XLogP3 -0.1), pKa of 3.36±0.10, three hydrogen bond donors, four acceptors, topological polar surface area of 66.4-67.4 Ų. It shows slight solubility in DMSO and methanol but limited water solubility. It is stable under an inert atmosphere at 2-8 degree Celsius and incompatible with strong oxidising agents.