Metolazone Manufacturing Plant Project Report 2024

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 metolazone 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 metolazone 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 metolazone industry.

About Metolazone

Metolazone is a thiazide-like diuretic used primarily to treat congestive heart failure and high blood pressure. By inhibiting sodium reabsorption in the kidneys, it promotes increased urine output to reduce blood volume and pressure. Metolazone is often prescribed alongside loop diuretics for enhanced diuretic effect, although this combination can risk dehydration and electrolyte imbalances. Metolazone was patented in 1966 and approved for medical use in 1974. Developed by Dr. Bola Vithal Shetty, it gained popularity for its lower kidney toxicity compared to other diuretics. However, its unique mechanism makes it effective for patients with chronic kidney disease as well.

Properties of Metolazone

Metolazone is primarily used for managing hypertension and fluid retention associated with heart failure and kidney disease. Its chemical formula is C₁₆H₁₆ClN₃O₃S, with a molecular weight of 365.84 g/mol. The compound has a melting point of 260 °C and exhibits a pKa of approximately 7.9. Metolazone is sparingly soluble in water (0.1 mg/mL at 25 °C) but more soluble in organic solvents. It has a bioavailability of about 70% when taken orally and a half-life of approximately 14 hours, with up to 90% of the drug excreted unchanged in urine.

Manufacturing Process of Metolazone

The production process of metolazone begins with the procurement of raw materials, such as 2-methyl-3-o-tolyl-6-sulfamyl-7-chloro-1,2,3,4-tetrahydro-4-quinazolinone. The synthesis involves a series of chemical reactions, including sulfonation, chlorination, and cyclisation, to form the core structure of metolazone. Following synthesis, purification techniques such as crystallisation or chromatography are employed to isolate and purify the compound. Once purified, the active pharmaceutical ingredient (API) is mixed with excipients to create various tablet formulations, typically available in dosages of 2.5 mg, 5 mg, and 10 mg. Rigorous quality control testing is then conducted to assess potency, purity, and stability of the drug before it is packaged for distribution.

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Synthesis of Metolazone

The production of metolazone involves several key steps:

1. Synthesis of 2-Amino-4-chloro-5-sulfamoylbenzoic Acid

This intermediate is synthesized through the sulfonation of 2-amino-4-chlorobenzoic acid with chlorosulfonic acid.

Chemical Reaction:

C₇H₆ClNO₂ + ClSO₃H → C₇H₅ClN₂O₄S + HCl 

(2-Amino-4-chlorobenzoic Acid + Chlorosulfonic Acid → 2-Amino-4-chloro-5-sulfamoylbenzoic Acid + Hydrochloric Acid)

2. Synthesis of 2-Methyl-3-(4-sulfamoylphenyl)quinazolin-4(3H)-one

The intermediate is then reacted with 2-methylquinazolin-4(3H)-one to form the key intermediate.

Chemical Reaction:

C₇H₅ClN₂O₄S + C₉H₈N₂O → C₁₆H₁₂N₄O₃S + HCl 

(2-Amino-4-chloro-5-sulfamoylbenzoic Acid + 2-Methylquinazolin-4(3H)-one → 2-Methyl-3-(4-sulfamoylphenyl)quinazolin-4(3H)-one + Hydrochloric Acid)

3. Synthesis of Metolazone

The final step involves the methylation of the key intermediate to produce metolazone.

Chemical Reaction:

C₁₆H₁₂N₄O₃S + CH₃I → C₁₇H₁₄N₄O₃S + HI 

(2-Methyl-3-(4-sulfamoylphenyl)quinazolin-4(3H)-one + Methyl Iodide → Metolazone + Hydrogen Iodide)

4. Purification of Metolazone

The crude metolazone is dissolved in a suitable solvent and then cooled to precipitate pure metolazone crystals. The crystals are collected by filtration and dried.

Applications and Drivers of Metolazone

The metolazone market is primarily driven by its efficacy  in treating hypertension and edema associated with conditions like heart failure and renal disease. Hypertension remains the dominant application segment, with metolazone effectively lowering blood pressure and managing fluid retention. Additionally, the increasing prevalence of cardiovascular diseases and chronic kidney disorders is propelling market growth. For instance, metolazone is prescribed for patients experiencing edema due to congestive heart failure, renal disease, or hepatic cirrhosis. The drug's versatility in treating both mild and moderate hypertension further supports its market demand.

Key Features of the Metolazone Production Cost Report:

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

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

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

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

Key Questions Addressed:

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

• How can profitability be maximised in the metolazone market?

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

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