Risperidone (Risperdal) Manufacturing Plant Project Report 2024

About the Report

The Expert Market Research report, titled “Risperidone (Risperdal) Manufacturing Plant Project Report 2024 Edition: Industry Trends, Capital Investment, Price Trends, Manufacturing Process, Raw Materials Requirement, Plant Setup, Operating Cost, and Revenue Statistics,” provides an in-depth and comprehensive examination of the financial and operational aspects of establishing risperidone (Risperdal) plant.

The report is the result of extensive primary and secondary research, offering a detailed analysis of current market trends, including the effects of COVID-19 on both global and regional scales. It profiles key industry players, giving insights into their market strategies, production capacities, and financial performance, which are crucial for benchmarking and competitive analysis.

It delves into historical, current, and forecasted price trends, helping stakeholders understand market dynamics and price volatility. The report provides a thorough analysis of the mass balance and raw materials requirements, ensuring a clear understanding of the input-output ratios essential for efficient production. Detailed examinations of the various unit operations integral to the risperidone (Risperdal) manufacturing process are included, highlighting process optimisation techniques and technological advancements.

The report presents a comprehensive capital cost analysis, detailing the financial investment required for setting up a risperidone (Risperdal) plant. This includes an exhaustive breakdown of costs associated with raw materials, catchem, utilities, labour, packaging, transportation, land acquisition, construction, and machinery. Additionally, it offers an in-depth look at the operating costs, providing clarity on the recurring expenses involved in running the plant.

Projected profit margins and optimal product pricing strategies are outlined, offering guidance on maximising profitability. The report also addresses regulatory frameworks, environmental impacts, and sustainability measures pertinent to the risperidone (Risperdal) industry.

About Risperidone (Risperdal)

Risperidone (Risperdal) is an atypical antipsychotic medication used to treat schizophrenia, bipolar disorder, and irritability associated with autism in both adults and children. It works by balancing dopamine and serotonin levels in the brain. Common side effects include weight gain, drowsiness, and dizziness. However, usage of Risperdal is controversial due to its potential for serious side effects like metabolic changes and hormonal effects, especially in children.

Properties of Risperidone (Risperdal)

Risperidone is a second-generation antipsychotic medication with the chemical formula C23H27FN4O2 and a molar mass of 410.493 g/mol. The drug appears as a white to off-white powder with a melting point of 170°C (experimental) and a boiling point of 549.96°C (estimated). Risperidone is a lipophilic compound, which makes it practically insoluble in water. In fact, the estimated solubility of risperidone in water at 25°C is only 2.763 milligrams per liter (mg/L). Moreover, as a weak base, risperidone can accept protons in solution, and its pKa of 8.24 indicates the strength of this property. Risperidone can primarily break down in the liver by an enzyme called CYP2D6, which converts it into an active metabolite called 9-hydroxyrisperidone.

Manufacturing Process of Risperidone (Risperdal)

The synthesis of risperidone begins with the formation of the benzisothiazolone ring system through various chemical reactions, such as cyclization or condensation. Further chemical transformations are carried out to modify the functional groups on the benzisothiazolone ring, enhancing the drug's pharmacological properties. Side chains that contribute to risperidone's activity are then introduced through synthetic steps, including alkylation or acylation. Ensuring the correct stereochemistry is essential, as risperidone has specific chiral centres, and thus, stereo controlled reactions are employed. Risperidone is extensively metabolized in the liver, primarily via CYP2D6, with hydroxylation and N-dealkylation leading to the formation of 9-hydroxyrisperidone, which has similar pharmacological activity. Finally, after synthesis, the drug is formulated into various dosage forms, including oral tablets and extended-release injectable suspensions, such as Risperdal Consta and Perseris.

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Synthesis of Risperidone (Risperdal)

Risperidone, marketed under the brand name Risperdal, is a second-generation antipsychotic used primarily to treat schizophrenia and bipolar disorder. Here is a step-by-step description of its synthesis:

Step 1: Synthesis of 6-Fluoro-3-(4-piperidinyl)-1,2-benzisoxazole

The synthesis begins with the production of 6-fluoro-1,2-benzisoxazole, which is reacted with 4-piperidine in the presence of a base, typically potassium tert-butoxide,  and a solvent such as dimethylformamide (DMF).

Reaction: C7H4FNO + C5H11N → C12H14FN2O

Step 2: Synthesis of 1-(2-Ethoxyethyl)-4-(hydroxymethyl)piperidine

This involves the reaction of 4-piperidone with ethylene glycol and an alkyl halide (commonly ethyl bromide) to form 1-(2-ethoxyethyl) piperidine. The resulting compound is then reduced (e.g., using sodium borohydride) to introduce the hydroxymethyl group at the 4-position of the piperidine ring.

Reaction: C5H9NO + C2H6O2 + C2H5Br → C9H21NO2 → C9H21NO2(CH2OH)

Step 3: Coupling of the Two Key Intermediates

The final step involves coupling the 6-fluoro-3-(4-piperidinyl)-1,2-benzisoxazole with the 1-(2-ethoxyethyl)-4-(hydroxymethyl)piperidine. This is typically achieved using a dehydrating agent like dicyclohexylcarbodiimide (DCC) or a coupling agent such as EDC (1-Ethyl-3-(3-dimethylaminopropyl) carbodiimide).

Reaction: C12H14FN2O + C9H21NO2(CH2OH) → C23H27FN4O2 + H2O

The final product, C23H27FN4O2, is Risperidone.

This synthesis route highlights the typical processes involved in the production of Risperidone, involving organic synthesis techniques such as alkylation, reduction, and coupling reactions. The chemical structures and reaction conditions are adjusted according to industrial scale-up requirements, focusing on yield optimisation, safety, and cost-effectiveness.

Applications and Drivers of Risperidone (Risperdal)

Risperidone is primarily used to treat schizophrenia, bipolar disorder, and irritability associated with autism. It works by changing the effects of chemicals in the brain that regulate mood, behaviour, and thought processes. For schizophrenia, risperidone is effective in treating acute exacerbations and psychogenic polydipsia. In bipolar disorder, risperidone is effective in treating manic symptoms in acute manic episodes. In children and adolescents, it may be more effective than lithium or divalproex. It is also used to treat irritability in autistic children aged 5 to 16. It is available in various forms including tablets, orally disintegrating tablets, oral solution, and injection. Demand for Risperdal is growing due to the need for effective treatments of psychiatric disorders. The overall cases of psychiatric disorders has significantly increased due to modern lifestyles, high stress levels, and social pressures, which influencing market’s expansion.

Key Features of the Risperidone (Risperdal) Production Cost Report:

This production cost analysis report by Expert Market Research scrutinises the risperidone (Risperdal) manufacturing process, offering a comprehensive overview necessary for stakeholders considering venturing into this sector. Based on the latest economic data, the report encompasses detailed insights into the primary process flow, raw material requirements, reactions involved, utility costs, operating costs, capital investments, pricing strategies, and profit margins. This report is an indispensable resource for entrepreneurs, investors, researchers, consultants, business strategists, and all those who have any kind of stake in the risperidone (Risperdal) industry. It equips them with essential information and strategic insights to effectively navigate the complexities of the market.

The following sections detail the comprehensive scope of the prefeasibility report for a risperidone (Risperdal) production plant:

• Market Dynamics and Trends: This section analyses the prevailing market conditions, growth drivers, and trends impacting the risperidone (Risperdal) industry. It offers a thorough examination of demand fluctuations and projections.

• Impact of COVID-19: An assessment of how the pandemic has affected industry operations, supply chains, and overall market dynamics.

• Geographic Analysis: Detailed insights into the major regions active in risperidone (Risperdal) production and consumption, highlighting regional market specifics and growth potential.

• Key Industry Players: Profiles of leading manufacturers in the risperidone (Risperdal) sector, outlining their market share, strategic positions, and operational strengths.

• Price Fluctuations: Analysis of historical, current, and projected price trends, providing stakeholders with essential pricing intelligence.

• Technical Specifications and Process Description: A detailed overview of the risperidone (Risperdal) production process including the technology used and innovations within the industry.

• Raw Material Requirements and Sourcing: Evaluation of necessary raw materials, their sourcing strategies, and cost implications.

• Utility Requirements and Costs: Detailed analysis of utilities needed to produce risperidone (Risperdal), such as electricity, steam, and process water along with their cost assessments. 

• Labour Force Dynamics: Insights into manpower requirements, including skill specifications and labour cost projections.

• Packaging Needs: Overview of packaging requirements for risperidone (Risperdal) to ensure product integrity and cost efficiency.

• Logistics and Transportation: Examination of transportation needs and logistics planning for distribution and supply chain efficiency.

• Capital and Operating Costs: An in-depth look at investment requirements, including land acquisition and its development cost, civil work costs, construction, machinery procurement, and ongoing operational expenses, such as salaries and wages, plant overheads, tax and insurance as well as packaging, transportation, and administration costs.

• Financial Performance and Profitability Analysis: Projected profit margins and return on investment based on current market and operational parameters.

• Product Pricing Strategy: Recommendations on pricing mechanisms based on industry benchmarks and production costs.

• Environmental Impact and Regulatory Compliance: Analysis of environmental considerations and compliance with local and international regulations.

• Risk Assessment and Mitigation Strategies: Identification of potential risks associated with risperidone (Risperdal) production and strategies to mitigate them.

Key Questions Addressed:

• What are the detailed unit operations for risperidone (Risperdal) production?

• Who are major technology licensors with their process evaluation?

• How are raw materials or catchem procured and what are their cost implications?

• What utilities are essential for production and what will they cost?

• What are the labour requirements and how does this affect operational costs?

• What packaging solutions are optimal for cost and efficiency?

• What logistical arrangements are necessary for efficient product distribution?

• What are the estimated land and construction costs for a new risperidone (Risperdal) plant?

• How can profitability be maximised in the risperidone (Risperdal) market?

• What pricing strategy should be adopted for risperidone (Risperdal) to remain competitive?

This prefeasibility report aims to equip potential investors and existing manufacturers with crucial insights to make informed decisions in the risperidone (Risperdal) industry.