Alfentanil Production Cost Reports

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

Alfentanil is a short-acting synthetic opioid analgesic from the fentanyl family. It is utilised as an intravenous adjunct during general anaesthesia maintenance. It is used with barbiturates, nitrous oxide, or oxygen, delivering potent analgesia, sedation, and hemodynamic stability. It is used in procedures like gynaecological surgeries, colonoscopies, tonsillectomies, appendectomies, and cholecystectomies.

It provides anaesthesia induction for short-duration operations because of its rapid onset (1.5 minutes) and brief half-life (5-10 minutes), enabling precise titration and quick recovery. It offers conscious sedation in monitored anaesthesia care (MAC) with minimal respiratory depression risk. It is also used in intensive care unit (ICU) infusions for pain and agitation management in ventilated patients, offering predictable pharmacokinetics to avoid accumulation.

The market for alfentanil is influenced by a rise in global surgical cases.  The growing ageing population, chronic ailments, and requirement for minimally invasive techniques contribute to its market growth. The need for short-acting opioids for perioperative analgesia, sedation, and induction, along with innovations in anaesthesia tech, boosts its market. Its increased clinician adoption for its rapid onset and recovery profile over fentanyl makes it a preferred option. The secure suppliers and GMP synthesis, because of single-source vulnerabilities, impact industrial alfentanil procurement. The precursor shortages, cost fluctuations, hospital formularies favouring economical options, regulatory FDA validations, and risks like diversion and counterfeits affect its market dynamics further.

Raw Material for Alfentanil Production

According to the alfentanil production plant project report, the key raw materials used in the production of alfentanil include 1-ethyl-1,2-dihydro-5H-tetrazol-5-one | 1,2-dibromoethane | triethylamine | acetonitrile | 4-(phenylamino)-4-(hydroxymethyl)piperidine.

Production Process of Alfentanil

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

1. From 1-ethyl-1,2-dihydro-5H-tetrazol-5-one: The production process of alfentanil involves a three-step process. First, the main alkylating agent 1-(2-bromoethyl)-4-ethyl-1,4-dihydro-5H-tetrazol-5-one is prepared by dissolving 1-ethyl-1,2-dihydro-5H-tetrazol-5-one in acetonitrile, adding excess 1,2-dibromoethane and triethylamine as base. After that, this bromoethyl compound couples with 4-(phenylamino)-4-(hydroxymethyl)piperidine using sodium hydride in THF. This is followed by treatment with methyl iodide and 15-crown-5 to form N-{1-{2-(4-ethyl-4,5-dihydro-5-oxo-1H-tetrazol-1-yl)ethyl}-4-(phenylamino)-4-(methoxymethyl)piperidine}. Finally, the piperidine intermediate is dissolved in chloroform and acylated with propionyl chloride to get alfentanil.

Alfentanil has the molecular formula of C21H32N6O3 and a molecular weight of 416.52 g/mol for the free base. It appears as a white to off-white crystalline solid with a melting point of around 140.8 degree Celsius. It has a pKa value of 6.5, enabling a rapid un-ionised fraction at physiological pH for quick onset. Its logP value is 2.16, making it moderately lipophilic. It shows water solubility around 34.6 mg/L (free base), higher for the hydrochloride salt. It has plasma protein binding of 92% with a polar surface area of 81.05 Ų and 6 H-bond acceptors, 9 rotatable bonds, 3 rings, and low ionisation.