The report provides a detailed analysis essential for establishing an Apomorphine production plant. It encompasses all critical aspects necessary for Apomorphine production, including the cost of Apomorphine production, Apomorphine plant cost, Apomorphine production costs, and the overall Apomorphine production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating an Apomorphine 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.
Apomorphine is a dopamine agonist drug that is used to treat Parkinson's disease. It is used to manage "off" episodes where patients experience sudden difficulty in movement, walking, and speaking because of fluctuating response to standard therapies like levodopa. It works by mimicking dopamine in the brain, activating dopamine receptors to improve motor function and control muscle stiffness. It is administered subcutaneously or as a sublingual film for rapid absorption. It is used as an emetic and has been explored for treating conditions like erectile dysfunction and addiction cravings.
It mainly focuses on advanced Parkinson's disease management, helping reduce motor fluctuations and improving patient mobility and quality of life. It needs antiemetic co-administration to manage side effects like nausea and vomiting.
The Apomorphine market growth is fuelled by rising cases of Parkinson's disease globally. Its utilisation in managing advanced Parkinson's disease contributes to its market growth. The increased awareness, ageing populations, and improvements in drug delivery systems support its demand. Its market is also fuelled by innovation (subcutaneous apomorphine infusion device) and regulatory approvals of new formulations that expand its applications.
The industrial Apomorphine procurement is influenced by the complexity of production, strict regulatory controls for pharmaceuticals, reliance on specialised suppliers, and the need for cold chain logistics because of its sensitivity. Also, high development costs and competition from alternative therapies affect its accessibility and supply.
Raw Material for Apomorphine Production
According to the Apomorphine production plant project report, the key raw materials used in the production of Apomorphine include Morphine-Hydrochloric Acid.
Manufacturing Process of Apomorphine
The extensive Apomorphine production cost report consists of the following major industrial production process:
- From Morphine: The production process of Apomorphine involves a heating method. In this process, morphine is heated with an excess of concentrated hydrochloric acid at 140-150 degree Celsius for 2 to 3 hours. The morphine goes through an acid-catalysed dehydrative rearrangement that leads to a change in the molecular structure. After heating, the reaction mixture is cooled, allowing crude apomorphine hydrochloride to crystallise out due to its lower solubility in hydrochloric acid. The crude product is separated by filtration to get apomorphine hydrochloride as the final product.
Apomorphine is a chiral molecule with the molecular formula C17H17NO2 and a molecular weight of approximately 267.32 g/mol. It is a solid powder that is highly lipophilic, which makes it cross the blood-brain barrier efficiently. Its hydrochloride salt form has a molecular weight of about 312.79 g/mol, including associated water of hydration. It is stable under storage at room temperature and has a melting point around 147–149 degree Celsius.
It contains a catechol structure similar to dopamine, making it a potent dopamine receptor agonist. It has pKa values around 7.2 and 8.91, indicating its protonation states at physiological pH. It shows UV absorption maximum (λmax) around 274 nm. It is known to be easily auto-oxidised due to its catechol moiety. All these physical and chemical properties make it useful as a dopamine receptor agonist that acts on several dopamine receptor subtypes as well as some adrenergic and serotonergic receptors.