The report provides a detailed analysis essential for establishing a tasimelteon production plant. It encompasses all critical aspects necessary for tasimelteon production, including the cost of tasimelteon production, tasimelteon plant cost, tasimelteon production costs, and the overall tasimelteon production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a tasimelteon 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.
Tasimelteon is a medication that provides similar effects to melatonin. It targets specific receptors in the brain to help regulate circadian rhythm and improve sleep patterns in people with certain rare disorders. It is approved for treating Non 24 Hour Sleep–Wake Disorder (Non 24) in totally blind adults. In this condition, the circadian rhythm does not sync with the 24-hour day, causing sleep times to drift later each day. This leads to nighttime insomnia, daytime sleepiness, and fatigue. It is used for nighttime sleep disturbances in patients with Smith-Magenis syndrome. It is available as capsules for adolescents and adults aged 16 and older, and as an oral suspension for children aged 3 to 15 years. It helps them fall asleep faster, stay asleep longer, and reduce disruptive nighttime behaviours.
The market for tasimelteon is influenced by its usage in Non-24-Hour Sleep-Wake Disorder in blind adults and sleep disturbances in Smith-Magenis syndrome patients. The expanded pediatric approvals, rising diagnosis of circadian disorders amid an ageing population, and improved awareness through screening tools boost its demand. The industrial tasimelteon procurement is influenced by step-therapy failures, specialist oversight, and limiting access in formularies and speciality pharmacies. Also, generic competition, distributor inventory issues, and dependence on contract manufacturers for API and product impact supply. The regulatory hurdles, like patent litigation, introduce uncertainty for buyers in government eProcurements, which affects their sourcing further.
Raw Material for Tasimelteon Production
According to the tasimelteon production plant project report, the key raw materials used in the production of tasimelteon include 2,3-bis(2-hydroxyethyl)phenol, p-toluenesulfonyl chloride, and triethylamine.
Production Process of Tasimelteon
The extensive tasimelteon production cost report consists of the following major industrial production process:
- From 2,3-bis(2-hydroxyethyl)phenol: The production process of tasimelteon starts with 2,3-bis(2-hydroxyethyl)phenol. This goes through selective tosylation with p-toluenesulfonyl chloride and triethylamine in dichloromethane to form the tris-tosylate intermediate. This intermediate goes through double elimination to get 4-vinyl-2,3-dihydrobenzofuran. This vinyl compound is epoxidised with 30% hydrogen peroxide and NaHCO3 in acetonitrile to give the epoxide. This epoxide goes through stereoselective cyclopropanation with diethyl cyanomethylphosphonate and sodium tert-amylate in refluxing toluene to get the trans-cyclopropane carbonitrile. The nitrile is reduced to the primary amine in ethanol, followed by resolution of the racemic amine with camphorsulfonic acid in ethanol to isolate the desired amine diastereomeric salt, which is then basified and extracted. Finally, the chiral amine is acylated with propionyl chloride and triethylamine in dichloromethane to get tasimelteon as the final product.
Tasimelteon, a melatonin receptor agonist for sleep-wake disorders, has a molecular formula of C15H19NO2 and a molecular weight of 245.3 g/mol. It features two chiral centres that appear as white to off-white, non-hygroscopic crystalline powder. It has a melting point of 78 degree Celsius. This shows high permeability and has an XLogP value of 2.2. It has one hydrogen bond donor and is soluble across the pH range in water. It is highly soluble in alcohols, acetonitrile, cyclohexane, ethyl acetate, and PEGs. It has a characteristic odour and is stable under normal conditions, but degrades in light.
