The report provides a detailed analysis essential for establishing a peramivir production plant. It encompasses all critical aspects necessary for peramivir production, including the cost of peramivir production, peramivir plant cost, peramivir production costs, and the overall peramivir production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a peramivir 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.
Peramivir is a neuraminidase inhibitor antiviral medication that is used for the treatment of acute, uncomplicated influenza A and B virus infections. It is utilised in adults and pediatric patients aged 6 months and older who have been symptomatic for no more than two days.
It is used in those hospitalised or unable to tolerate oral oseltamivir. It provides rapid viral load reduction and symptom relief against seasonal strains and avian subtypes, making it valuable during flu outbreaks or for high-risk patients. It is utilised in emergency stockpiling for severe cases, immunocompromised individuals, and scenarios involving oseltamivir resistance. Its common side effects include diarrhoea, nausea, vomiting, headache, insomnia, constipation, elevated liver enzymes, hyperglycemia, etc.
The market for peramivir is driven by recurrent seasonal and pandemic influenza outbreaks. The growing cases in hospitalised patients, the elderly, and immunocompromised groups, where it is preferred over oral oseltamivir contributes to its market demand. The rising drug-resistant strains like oseltamivir-resistant H1N1 or H3N2 that need alternative neuraminidase inhibitors boosts its demand. The government stockpiling for pandemic preparedness by agencies like the CDC, EMA, and Japan's health ministry, plus heightened awareness in high-burden regions, fuels its demand.
The combination therapies and improved formulations also support its growth in hospital settings. The industrial peramivir procurement is influenced by high treatment costs and limited regional availability due to specialised IV production.
Raw Material for Peramivir Production
According to the peramivir production plant project report, the key raw materials used in the production of peramivir include 2-azabicyclo[2.2.1]hept-5-en-3-one, 2-ethylbutyraldehyde, red aluminium, and acetyl chloride.
Production Process of Peramivir
The extensive peramivir production cost report consists of the following major industrial production process:
- From 2-azabicyclo[2.2.1]hept-5-en-3-one: The production of peramivir starts with a bicyclic cyclopentane precursor like 2-azabicyclo[2.2.1]hept-5-en-3-one. This involves chlorination, aldol condensation with 2-ethylbutyraldehyde derivatives, followed by hydrolysis, and cyclisation to form the core ring. The major steps include stereoselective reduction (with red aluminium), side chain installation via ethyl butyl addition, acetylation for the acetamido group, and hydroxy protection/deprotection. Finally, the guanidino group attachment through guanylation, followed by purification via recrystallisation, gives peramivir as the final product.
Peramivir free base has the molecular formula of C15H28N4O4 with a molecular weight of 328.41 g/mol. It appears as a white crystalline powder with 5 chiral centres on a cyclopentane ring core. It has a melting point of 170–172 degree Celsius (with decomposition). It has a density of 1.39 g/cm³ with a LogP value of -1.2, indicating a hydrophilic nature. It has aqueous solubility of around 20 mg/mL at 25 degree Celsius (sparingly soluble in deionised water). It has low plasma protein binding (<30%) and thermal stability suitable for intravenous formulations.