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Formulation Design of Amiodarone Hydrochloride Tablets Optimized for a Continuous Manufacturing Process
Ju-Hyun Yoon1, Chae-Won Jeon1, Young-Joon Park2
1Department of Biopharmaceutical Chemistry, Kookmin University, Seoul 02707, Republic of Korea.
Pharmaceutics
|July 28, 2026
Summary
This study developed an optimized amiodarone hydrochloride tablet formulation for continuous manufacturing. The new formulation enhances the initial dissolution rate, paving the way for efficient pharmaceutical production.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Continuous Manufacturing
Background:
- Amiodarone hydrochloride is a crucial Class III antiarrhythmic agent for treating and preventing arrhythmias.
- Essential national drug status highlights its clinical importance.
- The pharmaceutical industry is increasingly adopting continuous manufacturing processes.
Purpose of the Study:
- To assess the formulation of amiodarone hydrochloride into oral tablets.
- To enhance the initial dissolution rate of amiodarone hydrochloride tablets.
- To optimize the formulation for suitability in continuous manufacturing.
Main Methods:
- Physicochemical properties of amiodarone hydrochloride were predicted and experimentally validated.
- Binder and granulation liquid ratios were optimized for continuous wet granulation.
- Formulation development focused on improving dissolution characteristics.
Main Results:
- A novel amiodarone hydrochloride tablet formulation was successfully developed.
- The formulation is optimized for a continuous wet granulation process.
- Initial dissolution rate was significantly improved through formulation adjustments.
Conclusions:
- The developed formulation provides a foundation for continuous manufacturing of amiodarone hydrochloride tablets.
- Optimized formulation design enhances the applicability of continuous processes.
- This research supports efficient and modern pharmaceutical production methods.
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