Budesonide Manufacturer

Manufacturing process of Budesonide

The manufacturing process of Budesonide API begins with a thorough inspection of equipment to ensure cleanliness, followed by verification of the availability of all utilities, raw materials, and packing materials required for the process. 

The preparation stage, a suitable solvent such as acetone or isopropanol is charged into a glass-lined reactor, and starting materials like 16α, 17α-acetal of prednisolone are added under continuous stirring while maintaining the temperature at 20–25°C.

During the reaction stage, a reaction agent (e.g., acid catalyst or oxidizing agent) is gradually added, and the temperature is increased to 50–55°C to initiate the reaction. The reaction is maintained for 360–420 minutes with continuous stirring, and progress is monitored using in-process tests such as HPLC.

Once the reaction is complete, the mixture is cooled to 20–25°C, and an aqueous solution (e.g., sodium chloride or water) is added to quench the reaction. The organic and aqueous layers are then separated using a separation funnel. The organic layer is concentrated under reduced pressure to obtain a crude product, which is further purified using recrystallization with solvents such as ethanol or methanol. The purified solution is heated to dissolve the product completely, then cooled gradually to 0–5°C to promote crystallization. The crystals are stirred for 120–240 minutes to enhance formation, filtered using a vacuum filter or centrifuge, and washed with a chilled solvent to remove impurities.

The wet product is transferred to a vacuum dryer and dried at 40–50°C under vacuum for 480–600 minutes to achieve the desired moisture content. The dried product is milled to achieve uniform particle size and sieved through a specified mesh for consistency.

Finally, Pack Budesonide in a clear poly bag and twist the mouth of the bag. Secure it with a PVC strip. Place this bag inside another poly bag, twist its mouth, and secure it with a PVC strip. Insert these bags into a triple-laminated aluminum bag and seal it properly. Finally, place the sealed aluminum bag in an HDPE container. Store Budesonide in a tightly closed, light-resistant container at a temperature below 30°C.