Opicapone Production Cost Reports

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

Opicapone is the newest type of medicine that blocks a body enzyme called catechol-O-methyltransferase (COMT). It is used as an adjunctive therapy in adults with Parkinson's disease who experience end-of-dose motor fluctuations. It works by reversibly inhibiting peripheral COMT enzyme activity, preventing the O-methylation of levodopa to 3-O-methyldopa. This prolongs levodopa's plasma levels and enhances its brain availability to sustain dopamine production and reduce "OFF" time by about 1 hour daily. It is taken 50 mg once daily at bedtime, at least 1 hour before or after levodopa and carbidopa regimens and preferably without food. Its side effects include dyskinesia (often managed by reducing levodopa dose), constipation, insomnia, and falls, with a favourable safety profile showing no excess discontinuations compared to placebo.

The market for opicapone is influenced by the rising global cases of Parkinson's disease. The ageing populations, greater awareness, improved diagnostics, and demand for convenient once-daily dosing that effectively reduces motor fluctuations, boost its demand. The sourcing of GMP-certified API from suppliers, where prices vary widely based on volume and origin, along with evaluations of quality certifications, affects industrial opicapone procurement.  The reliable supply chains through key partnerships, regulatory approvals, bioequivalence for generics, and favourable reimbursement policies further impact its sourcing strategies. Other factors like high costs, competition from cheaper generics and other COMT inhibitors like entacapone, and alternative therapies affect its market dynamics.

Raw Material for Opicapone Production

According to the opicapone production plant project report, the key raw materials used in the production of opicapone include 4,6-dimethyl-2-hydroxynicotinonitrile, sulfuryl chloride, and phosphoryl chloride.

Production Process of Opicapone

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

1. From 4,6-dimethyl-2-hydroxynicotinonitrile: The production process of opicapone involves several steps. First, 4,6-dimethyl-2-hydroxynicotinonitrile goes through chlorination to form 2,5-dichloro-4,6-dimethylnicotinonitrile. This is followed by DIBAL-H reduction, oximation to oxime, and NCS chlorination to imidoyl chloride. The condensation with 4-hydroxy-3-methoxy-5-nitrobenzonitrile forms the 1,2,4-oxadiazole ether, demethylation, and final N-oxidation to give opicapone.

Opicapone has the molecular formula of C₁₅H₁₀Cl₂N₄O₆ and a molecular weight of 413.17 g/mol. It is a solid with a density of 1.8 g/cm³ and boiling point around 701 degree Celsius at standard pressure. It has a 1,2,4-oxadiazole ring linking a dichloropyridine N-oxide to a resorcinol moiety with nitro and hydroxy groups. It shows high lipophilicity with a logP value of 4.6 with peripheral selectivity for COMT inhibition, and reversible binding without hepatic metabolism concerns of prior agents. It is sparingly soluble in water but compatible with pharmaceutical solvents. It is stable under GMP conditions for capsule formulation, with PSA 150.66 Ų contributing to its membrane permeability for sustained plasma effects despite rapid clearance.