The report provides a detailed analysis essential for establishing an oxyphenbutazone production plant. It encompasses all critical aspects necessary for oxyphenbutazone production, including the cost of oxyphenbutazone production, oxyphenbutazone plant cost, oxyphenbutazone production costs, and the overall oxyphenbutazone production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating an oxyphenbutazone 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.
Oxyphenbutazone is a non-steroidal anti-inflammatory drug (NSAID) and active metabolite of phenylbutazone. It is applied in managing pain, inflammation, and swelling associated with various musculoskeletal and inflammatory conditions. It provides symptomatic relief in rheumatoid arthritis by reducing joint inflammation and stiffness.
It improves mobility in osteoarthritis through inhibition of prostaglandin synthesis that mediates pain and swelling, and eases symptoms in ankylosing spondylitis by targeting spinal and sacroiliac inflammation. It is used for the treatment of gouty arthritis to control acute flares. It is also utilized in post-operative pain management following orthopaedic or soft tissue procedures, muscle strains and sprains for faster recovery, and dental pain or temporomandibular joint disorders.
The market for oxyphenbutazone is driven by its use as a non-steroidal anti-inflammatory drug. Its utilisation in managing arthritis, gout, and post-operative pain, along with a stronger veterinary segment for animal pain relief in livestock and companion animals, contributes to its market growth. Its affordable pricing relative to newer NSAIDs and increasing cases of inflammatory conditions in ageing populations boost its demand. The strict regulations and restrictions, supply concentration from API producers in India and China, volatile raw material costs, and low-volume production challenges affect industrial oxyphenbutazone procurement. The competition from other alternatives like ibuprofen or celecoxib, quality control mandates, global tender preferences for low-cost generics in public health systems, etc., further impacts its sourcing.
Raw Material for Oxyphenbutazone Production
According to the oxyphenbutazone production plant project report, the key raw materials used in the production of oxyphenbutazone include protected aminophenol, nitrobenzene, and a reducing agent.
Production Process of Oxyphenbutazone
The extensive oxyphenbutazone production cost report consists of the following major industrial production process:
- From protected aminophenol and nitrobenzene: The production of oxyphenbutazone involves a condensation reaction. In this process, protected aminophenol reacts with nitrobenzene to form an azo-compound intermediate. This is followed by the selective reduction of the azo group to yield the corresponding hydrazobenzene derivative. This goes through cyclisation and deprotection steps under controlled acidic or basic conditions to get the pyrazolidinedione ring system. The final purification by recrystallisation gives pure oxyphenbutazone as the final product.
Oxyphenbutazone has the molecular formula of C19H20N2O3 (anhydrous base) with a molecular weight of 324.37 g/mol. It appears as a white to pale yellow crystalline powder. It has a melting point range of 96–125 °C with a boiling point of around 485.6 °C. Its flash point is around 247.5 °C and logP value of 3.56 making it lipophilic. It has a polar surface area of 70.08 Ų with a refractive index of around 1.60, density near 1.2 g/cm³, and pKa values reflecting weak acidity. It shows moderate solubility in organic solvents like ethanol and acetone, and limited water solubility, enhanced in salt forms. It has a vapour pressure below 0.01 mmHg, and stability under refrigerated storage (2-8 °C).