Pitolisant Production Cost Reports

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

Pitolisant is a medication that is used for people with a sleep disorder called narcolepsy that causes extreme daytime sleepiness and sometimes sudden muscle weakness called cataplexy. It works by targeting histamine H3 receptors in the brain, blocking them to increase natural wake-promoting chemicals. It helps patients feel more alert without the jittery effects of stronger stimulants like amphetamines. It is approved by the FDA for daytime sleepiness in narcolepsy and later for cataplexy. It is also used to improve alertness in adults with obstructive sleep apnea who still feel sleepy despite treatment and is approved for children as young as 6 years old. Its common side effects include trouble sleeping, headaches, nausea, and anxiety, but it's generally safe with low risk to the liver and no major abuse potential.

The market for pitolisant is influenced by increasing narcolepsy diagnoses and label expansions for cataplexy treatment, plus use in children. The strong demand for non-stimulant wake-promoting drugs with fewer side effects compared to options like modafinil contributes to their market demand.

The developments for new formulations addressing common patient issues like stomach problems and explorations into other disorders boost its demand. Its status as a premium-priced orphan drug, dependence on the main US license holder for supply, and lack of generic alternatives affect industrial pitolisant procurement. Other factors like insurance approvals, reliable supply chains from specialised makers, and import regulations, mainly for buyers seeking bulk API or hospital supplies impacts its sourcing.

Raw Material for Pitolisant Production

According to the pitolisant production plant project report, the key raw materials used in the production of pitolisant include piperidine, 3-chloropropan-1-ol, and 3-(4-chlorophenyl)propan-1-ol.

Production Process of Pitolisant

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

1. From piperidine: The production process of pitolisant involves several steps. First, piperidine reacts with 3-chloropropan-1-ol in a solvent like acetonitrile with base at reflux to form 3-(piperidin-1-yl)propan-1-ol intermediate. This alcohol is then converted to its mesylate using methanesulfonyl chloride and base. The mesylate or alkoxide goes through nucleophilic substitution with 3-(4-chlorophenyl)propan-1-ol, heated to get pitolisant as a free base. Finally, treatment with HCl gas or aq. HCl in solvent, followed by crystallisation, gives pure pitolisant hydrochloride.

Pitolisant hydrochloride appears as a white or almost white crystalline powder in solid form with a characteristic odour. It has the molecular formula of C17H26ClNO - HCl, with a molecular weight of 332.3 g/mol. It exhibits high water solubility (very soluble), along with solubility in ethanol, methylene chloride, DMF, DMSO, and PBS pH 7.2. It belongs to BCS class I due to high solubility and permeability, shows no explosion hazard, and is stable under normal conditions. All these physical and chemical properties make it useful to treat excessive daytime sleepiness and cataplexy in narcolepsy patients.