The report provides a detailed analysis essential for establishing a Dolasetron production plant. It encompasses all critical aspects necessary for Dolasetron production, including the cost of Dolasetron production, Dolasetron plant cost, Dolasetron production costs, and the overall Dolasetron production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a Dolasetron 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.
Dolasetron (brand name Anzemet®) is a prescription antiemetic medication utilised as an active pharmaceutical ingredient (API) in the pharmaceutical industry. It is manufactured into antiemetic formulations such as oral tablets, injectables, fast-dissolving strips, and dispersible tablets to prevent nausea and vomiting associated with chemotherapy, postoperative recovery, and radiation therapy. Additionally, its limited veterinary applications include antiemetic treatments for dogs and cats to manage vomiting from various aetiologies. It also finds uses in R&D, where it undergoes preformulation studies, polymorphism optimisation, and bioavailability enhancements like hydrodolasetron derivatives for advanced delivery systems.
The market demand for Dolasetron is propelled by the expanding global antiemetics sector, where serotonin-receptor antagonists like dolasetron are utilised due to surging demand for chemotherapy-induced nausea and vomiting (CINV) prevention. The global rise in cancer cases, boost chemotherapy volumes and serotonin antagonist usage (e.g., alongside ondansetron and granisetron), along with postoperative and radiation therapy applications, boost the market growth for dolasetron.
The fluctuations in the costs and availability of the major raw materials utilised in the production process of dolasetron, such as a dialdehyde precursor, glycine ester, and acetonedicarboxylic acid, impact industrial dolasetron procurement. Furthermore, purity grades (USP/EP/JP), particle size, residual solvents, and heavy metal limits require verification for formulation compatibility, which also influences the overall procurement.
Raw Material for Dolasetron Production
According to the Dolasetron production plant project report, the various raw materials for Dolasetron production include a dialdehyde precursor, glycine ester, and acetonedicarboxylic acid.
Production Process of Dolasetron
The extensive Dolasetron production cost report consists of the following major industrial production process:
- Production via a multi-step chemical process: The production process of Dolasetron starts with Robinson-Schöpf cyclisation of a dialdehyde (from diol cleavage with sodium metaperiodate), glycine ester, and acetonedicarboxylic acid to form a ketone intermediate. In the next step, the resulting compound is reduced to an alcohol with sodium borohydride, protected with dihydropyran, and subjected to Dieckmann cyclisation and dealkoxycarbonylation for the quinolizidinone core. In the following step, alkylation with bromoacetaldehyde dimethyl acetal using bases like potassium methoxide in methanol at 70-120 degree Celsius introduces the tryptophol side chain. Finally, the reaction is followed by esterification with indole-3-carboxylic acid at the 8-position, deprotection, and acidification (pH 0.8-6.8) with toluene extraction to produce dolasetron.
Properties of Dolasetron
Dolasetron is a selective 5-HT3 receptor antagonist used as an antiemetic. It appears as a white to off-white, odourless crystalline powder in its base form with a molecular formula of C19H20N2O3, molecular weight of 324.38 g/mol (average), and monoisotopic mass of 324.147 g/mol. Its mesylate monohydrate salt, commonly formulated for clinical use, has a molecular weight of 438.50 g/mol and shows high solubility in water and methanol, slight solubility in chloroform, and insolubility in hexane. It has an estimated pKa of 5.68 (basic), polar surface area of 62.4 Ų, three hydrogen bond acceptors, one hydrogen donor, and three rotatable bonds, rapidly metabolising in vivo to its active metabolite hydrodolasetron.
