Rotigotine Production Cost Reports

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

Rotigotine is a non-ergoline dopamine agonist that is delivered through a transdermal patch. It provides continuous 24-hour release to mimic natural dopamine levels for treating idiopathic Parkinson's disease and moderate-to-severe restless legs syndrome (RLS). It is utilised in early Parkinson's and serves as monotherapy to control motor symptoms like tremors, rigidity, and bradykinesia.

It is used in advanced stages as an adjunct to levodopa to reduce "off" time and improve morning motor function. It reduces uncomfortable sensations and urges to move limbs, offering steady symptom relief without daily oral dosing fluctuations. Its common side effects include nausea, vomiting, application site reactions (redness, itching, swelling at the patch), sleepiness or drowsiness, dizziness, insomnia, etc.

The market for rotigotine is influenced by rowing global burden of Parkinson's disease and restless legs syndrome. The rise in the ageing population and increased awareness contribute to its demand as a transdermal patch offering steady 24-hour dopamine delivery. It's better adherence compared to oral options, and expanding access in emerging markets like the Asia-Pacific, because of rising healthcare infrastructure, boosts its demand. The entry of generic and favourable reimbursement policies in North America and Europe influences industrial rotigotine procurement. The requirements for cold-chain handling to preserve patch efficacy, hospital formulary decisions favouring user-friendly formats, and R&D investments for new uses affect its sourcing further.

Raw Material for Rotigotine Production

According to the rotigotine production plant project report, the key raw materials used in the production of rotigotine include 2-Tetralone derivative, primary amine, and IRED enzyme (IR-36-M5).

Production Process of Rotigotine

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

1. By chemoenzymatic process: The production of rotigotine involves preparing a 2-tetralone derivative through conventional organic synthesis as the key ketone substrate. This ketone goes through stereoselective reductive amination catalysed by an engineered imine reductase (IRED) mutant, IR-36-M5. This takes place in the presence of the appropriate primary amine (N-propylamine component), cofactor regeneration system, and reducing equivalents in an aqueous buffer, which forms the chiral S-2-aminotetralin intermediate. The intermediate is then converted to rotigotine via a short sequence introducing the 2-thienylethyl ether side chain. This includes phenolic OH protection and activation, etherification, and deprotection, followed by standard work-up, extraction, and purification to give pure rotigotine.

Rotigotine has the molecular formula of C19H25NOS and a molecular weight of 315.48 g/mol. It appears as a white to pale beige crystalline powder with high lipophilicity (LogP around 4.2). It shows low water solubility, a melting point of 110-120 degree Celsius, and specific rotation indicating its (S)-enantiomer configuration. It has a tetrahydro-naphthalene core with a propyl[2-(thiophen-2-yl)ethyl]amino side chain, contributing to its D3 receptor selectivity. It has 1 hydrogen bond donor, 3 acceptors, and 6 rotatable bonds. It goes through oxidative metabolism primarily via CYP3A4 and shows strong plasma protein binding ( around 90%).