Studies on preformulation and efficient manufacturing process for continuous production of amiodarone tablets through AI formulation software
The purpose of this study is to develop a dosage form for continuous processing of amiodarone tablets, an antiarrhythmic drug used to treat and prevent arrhythmias. We predicted and performed a comparative evaluation of the essential preformulation results of amiodarone tablets through our self-produced AI formulation design software. In this study, transparent and equilibrium solubility tests were conducted in various solvents, and degradation was checked to confirm the compatibility between amiodarone and excipients. Additionally, flowability study was performed to predict the physical properties of API. As solubility test results, it is ‘poorly soluble’ in most solvents, but ‘soluble’ in methanol. And as a compatibility study, the interaction between API and 22 Excipients was confirmed under long-term storage conditions (25℃/60%RH) and accelerated storage conditions (40℃/75%RH) for up to 4 weeks. As a result, Sodium Stearyl Fumarate, Magnesium Carbonate, and Calcium Hydroxide were found to be incompatible excipients. As a result of the flowability study of API, Carr’s index was confirmed to be 30. When the artificial intelligence results and actual measurement results were confirmed, solubility was compared in 72% and formulation in 81%. The results of this study can be used in the development of amiodarone generic drugs, especially in designing the optimal formulation for continuous process application. It is expected that it will become basic data
2024 Spring Convention