Transitioning Amiodarone Tablet Manufacturing: A Comparative Study of Batch and Continuous Wet Granulation

Area of Science:

• Pharmaceutical Technology
• Process Engineering
• Drug Manufacturing

Background:

• Traditional batch manufacturing processes can be time-consuming and less efficient.
• Optimizing granulation processes is key to improving drug product quality and manufacturing efficiency.

Purpose of the Study:

• To design and optimize a continuous wet granulation process for Amiodarone hydrochloride tablets.
• To compare the characteristics of granules and tablets produced via batch and continuous granulation methods.
• To validate the feasibility of continuous manufacturing for pharmaceutical production.

Main Methods:

• Utilized a Design of Experiments (DOE) approach with a central composite design for process optimization.
• Identified critical process parameters (screw speed, milling size) and dependent variables (dissolution, flowability, assay, disintegration, friability).
• Employed a twin-screw granulator for continuous processing and a high-shear mixer for batch processing.

Main Results:

• No significant differences were observed in in-process control parameters between batch and continuous processes.
• All formulations met target dissolution profiles, with dissolution equivalence demonstrated (similarity factor f2 > 50).
• Continuous granulation reduced manufacturing lead time by over 80% compared to the batch process.

Conclusions:

• Continuous wet granulation is a feasible and effective strategy for manufacturing Amiodarone hydrochloride tablets.
• Transitioning from batch to continuous manufacturing can significantly enhance productivity and operational efficiency without compromising product quality.
• This study supports the adoption of continuous manufacturing platforms in the pharmaceutical industry.