Phenelzine Production Cost Reports

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

Phenelzine is an irreversible, non-selective monoamine oxidase inhibitor (MAOI) antidepressant. It is used in treatment-resistant major depressive disorder, mainly atypical depression unresponsive to SSRIs or tricyclics. It is used in panic disorder and social anxiety disorder, where it eases monoamine neurotransmitters like serotonin, norepinephrine, and dopamine.

It shows efficacy in additional conditions like dysthymia, bipolar depression, post-traumatic stress disorder (PTSD), bulimia nervosa, and obsessive-compulsive disorder (OCD). It is employed in young women with comorbid mood and eating disorders. Its common side effects include dizziness, headache, drowsiness and insomnia, dry mouth, constipation, weight gain, low blood pressure, tremors, and sexual dysfunction.

The market for phenelzine is driven by its utilisation as a third-line antidepressant for treatment-resistant depression and atypical depression. The rising global mental health burdens and their demand for refractory cases where SSRIs and SNRIs fail contribute to the market growth. Its inclusion in guidelines for specific indications like bipolar depression or anxiety disorders boosts its market. The industrial phenelzine procurement is influenced by strict regulatory controls due to risks like hypertensive crises from tyramine interactions.

Also, limited generic competition from long-standing patents and niche status, keeping prices elevated, impacts its sourcing. Also, favour towards newer agents with better safety profiles, high production costs for quality-controlled APIs, and supply chain vulnerabilities for active ingredients affect its market dynamics.

Raw Material for Phenelzine Production

According to the phenelzine production plant project report, the key raw materials used in the production of phenelzine include phenethylamine, 3,3-pentamethylene oxaziridine, toluene, hydrochloric acid, and potassium carbonate.

Production Process of Phenelzine

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

1. From phenethylamine: The production of Phenelzine starts with the formation of a hydrazone intermediate. This takes place by adding 3,3-pentamethylene oxaziridine to a suspension of phenethylamine in toluene. The mixture goes through hydrolysis by adding hydrochloric acid, followed by separation of the aqueous layer containing the phenelzine salt. This is followed by neutralisation with potassium carbonate, which adjusts the pH to give phenelzine free base. This is extracted using isopropyl ether, and the solvent is distilled to isolate the oily residue. Finally, the crude phenelzine is dissolved in isopropyl alcohol, cooled, and treated dropwise with sulfuric acid in isopropyl alcohol to precipitate phenelzine sulfate.

Phenelzine free base has the molecular formula of C8H12N2 with a molecular weight of 136.19 g/mol. Its sulfate salt has the molecular formula of C8H14N2O4S and a molecular weight of 234.28 g/mol. It appears as a white to yellowish-white crystalline powder with a characteristic odour. The free base is a liquid at room temperature with a melting point <25 degree Celsius and a boiling point of around 74 degree Celsius.  Its sulfate salt is solid with a melting point between 157–161 degree Celsius and soluble in water (~29.1 g/L) but practically insoluble in most organic solvents. It features moderate lipophilicity with a LogP in the range 1.0–2.2. It has a polar surface area of 38–121 Ų with 2 hydrogen bond donors and acceptors, 3 rotatable bonds, and 1 ring. It has a density of 1.0 g/cm³ with collision cross-sections around 122–133 Ų in mass spectrometry.