Tolbutamide (Orinase) Manufacturing Plant Project Report 2025

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 tolbutamide (Orinase) 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 tolbutamide (Orinase) 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 tolbutamide (Orinase) industry.

About Tolbutamide (Orinase)

Tolbutamide, marketed as Orinase, is a first-generation sulfonylurea used to manage type 2 diabetes by stimulating insulin secretion from the pancreas. It is typically prescribed alongside diet and exercise to improve blood sugar control in adults. Common side effects include nausea and heartburn, while serious risks involve hypoglycaemia and potential heart issues. Historically, tolbutamide was developed in the 1950s, becoming one of the first oral medications for diabetes. It was introduced in 1956 and represented a significant advancement in diabetes management at the time. Its use has declined with the advent of newer agents but remains a part of diabetes treatment protocols.

Properties of Tolbutamide (Orinase)

Tolbutamide has a molar mass of 270.35 g/mol and a melting point between 128.5-129.5°C. It is rapidly metabolized by the liver, has a short duration of action, and is generally safe for older patients. Tolbutamide is less commonly used today due to a higher incidence of adverse effects compared to newer sulfonylureas. It may interact with various medications, and patients should avoid prolonged sun exposure while taking it.

Manufacturing Process of Tolbutamide (Orinase)

The manufacturing process for tolbutamide (Orinase) begins with a reaction between 4-methylbenzenesulfonyl chloride and butylamine to form the intermediate N-(4-methylphenylsulfonyl)-N'-butylurea. This crude product is then purified and dried to remove any residual solvents. Next, it is micronised, a process that reduces the particle size of the drug substance. The micronized tolbutamide is then formulated into tablets, along with various excipients such as diluents, binders, disintegrants, and lubricants. Finally, the tolbutamide drug product is packaged for distribution and use.

Read more about this report - REQUEST FREE SAMPLE COPY IN PDF

Synthesis of Tolbutamide (Orinase)

The industrial production of tolbutamide involves the following steps:

Raw Materials

1.    p-Toluidine (C7H9N)

2.    Chlorosulfonic acid (HSO3Cl)

3.    Ammonia (NH3)

4.    Butylamine (C4H11N)

5.    Sodium hydroxide (NaOH)

6.    Water (H2O)

Process Steps:

Step 1: Sulfonation of p-Toluidine

p-Toluidine is reacted with chlorosulfonic acid to form p-toluidine-4-sulfonamide.

The chemical reaction is as follows: C7H9N + HSO3Cl → C7H8NHSO2Cl + HCl

Step 2: Amination with Ammonia

The intermediate p-toluidine-4-sulfonamide is then treated with ammonia to form p-toluidine-4-sulfonamide. 

The chemical reaction is as follows: C7H8NHSO2Cl + NH3 → C7H8NHSO2NH2 + HCl

Step 3: Alkylation with Butylamine

The p-toluidine-4-sulfonamide is then reacted with butylamine to form tolbutamide. 

The chemical reaction is as follows: C7H8NHSO2NH2 + C4H11N → C12H18N2O3S (Tolbutamide)

Applications and Drivers of Tolbutamide (Orinase)

As a member of the sulfonylurea class of medications, Tolbutamide is typically prescribed to enhance glycaemic control in patients whose diabetes is not adequately managed by lifestyle changes alone. Beyond its primary application, tolbutamide have also been used in conjunction with other antidiabetic agents, such as metformin or GLP-1 agonists, to improve blood sugar regulation, although now its use has declined with the advent of newer medications that offer better efficacy and safety profiles.

Key Features of the Tolbutamide (Orinase) Production Cost Report:

This production cost analysis report by Expert Market Research scrutinises the tolbutamide (Orinase) 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 tolbutamide (Orinase) 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 tolbutamide (Orinase) production plant:

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

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

• Key Industry Players: Profiles of leading manufacturers in the tolbutamide (Orinase) 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 tolbutamide (Orinase) 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 tolbutamide (Orinase), 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 tolbutamide (Orinase) 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 tolbutamide (Orinase) production and strategies to mitigate them.

Key Questions Addressed:

• What are the detailed unit operations for tolbutamide (Orinase) 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 tolbutamide (Orinase) plant?

• How can profitability be maximised in the tolbutamide (Orinase) market?

• What pricing strategy should be adopted for tolbutamide (Orinase) to remain competitive?

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