Methylergonovine Manufacturing Plant Project Report 2024

About the Report

The Expert Market Research report, titled “Methylergonovine 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 methylergonovine plant.

The report is the result of extensive primary and secondary research, offering a detailed analysis of current market trends. 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 methylergonovine 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 methylergonovine 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 methylergonovine industry.

About Methylergonovine

Methylergonovine, sold under the brand name Methergine, is a medication used to prevent and control postpartum haemorrhage. It acts directly on the smooth muscle of the uterus, increasing tone, rate, and amplitude of rhythmic contractions. Methylergonovine is a derivative of the ergoline and lysergamide classes, structurally related to ergometrine and lysergic acid diethylamide. Methylergonovine was first synthesised in 1935 and introduced for medical use in 1943. It is also on the World Health Organisation's List of Essential Medicines.

Properties of Methylergonovine

Methylergonovine, also known as methylergometrine, is a semisynthetic ergot alkaloid used as an oxytocic in obstetrics and migraine treatment. It is a solid with a melting point of 172°C and a molecular weight of 335.4 g/mol. Methylergonovine is sparingly soluble in water (0.1 g/L at 25°C) but freely soluble in alcohol and acetone. It is available as 0.2 mg tablets, 0.2 mg/mL injections, and in 0.2 mg/mL liquid form. Methylergonovine is contraindicated in patients with hypertension and pre-eclampsia and can cause side effects such as nausea, vomiting, and dizziness in up to 10% of patients.

Manufacturing Process of Methylergonovine

The process begins with obtaining the crude methylergonovine maleate product. This crude material is then melted and recrystallised, which offers advantages such as high stability, reproducibility, and ease of long-term storage. The next step is purification, where the crude product is dissolved in a mixture of methanol and ethanol, with activated charcoal added to remove impurities. The solution is then filtered while hot, and the filtrate is cooled to precipitate the purified methylergonovine maleate. Typical yields of this recrystallisation step range from 69-73%, with a purity of 99.87-99.88%.

The final step is formulation of the purified methylergonovine maleate into 0.2 mg tablets and a 0.2 mg/mL injectable solution. The tablets contain additional inactive ingredients such as acacia, lactose, and titanium dioxide, while the injectable solution includes maleic acid and sodium chloride. Through these careful manufacturing steps, a stable and high-quality methylergonovine maleate product is produced for use in obstetrics and migraine treatment.

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Synthesis of Methylergonovine

Methylergonovine is a derivative of ergometrine and can also be synthesised through a series of chemical reactions starting from lysergic acid. Below is a detailed description of the process:

1.    Raw Materials

The primary raw materials used in the production of methylergonovine include:

• Lysergic acid (C16H16N2O2)

• Dimethylamine (C2H7N)

• Formaldehyde (CH2O)

• Hydrogen (H2)

• Various solvents and reagents (e.g., ethanol, acetic acid, etc.)

2.    Synthesis of Ergometrine

The process begins with the reaction of lysergic acid with dimethylamine and formaldehyde to form ergometrine.

Reaction: C16H16N2O2 + C2H7N + CH2O → C19H23N3O2

This reaction is typically carried out in the presence of a solvent like ethanol and an acid catalyst.

3.    Methylation to Form Methylergonovine

Ergometrine is then subjected to methylation to form methylergonovine.

Reaction: C19H23N3O2 + CH3I → C20H25N3O2 + HI

This reaction involves the use of a methylating agent such as methyl iodide (CH3I).

4. Purification

The crude methylergonovine is purified through chromatography and is then dried and collected.

Applications and Drivers of Methylergonovine

Methylergonovine, a semi-synthetic ergot alkaloid, is primarily used for the prevention and control of postpartum haemorrhage. It acts directly on the smooth muscle of the uterus, increasing tone, rate, and amplitude of rhythmic contractions. This induces a rapid and sustained uterotonic effect which shortens the third stage of labour and reduces blood loss. Methylergonovine is available in both injectable and oral forms. The injectable form is administered intravenously or intramuscularly by a doctor in a hospital setting, while the oral tablets are taken 3-4 times daily for up to 1 week after delivery. By promoting strong, sustained uterine contractions, methylergonovine helps expel the placenta and control excessive bleeding after childbirth or abortion. Rising number of childbirths and associated complications is increasing the demand for this alkaloid.

Key Features of the Methylergonovine Production Cost Report:

This production cost analysis report by Expert Market Research scrutinises the methylergonovine 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 methylergonovine 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 methylergonovine production plant:

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

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

• Key Industry Players: Profiles of leading manufacturers in the methylergonovine 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 methylergonovine 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 methylergonovine, 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 methylergonovine 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 methylergonovine production and strategies to mitigate them.

Key Questions Addressed:

• What are the detailed unit operations for methylergonovine 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 methylergonovine plant?

• How can profitability be maximised in the methylergonovine market?

• What pricing strategy should be adopted for methylergonovine to remain competitive?

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