Solid-state preformulation studies of amiodarone hydrochloride

摘要

This paper deals with the application of fast screening tools such as FTIR, thermal analysis and DSC in the evaluation of compatibility between the active pharmaceutical ingredient amiodarone hydrochloride and different pharmaceutical excipients used in tablet formulations, such as polyvinylpyrrolidone, microcrystalline cellulose, starch, talc and anhydrous lactose. Samples were investigated initially immediately after preparation by FTIR analysis and later by TG/DTG/HF technique. It was found that under ambient condition, amiodarone hydrochloride was compatible with all selected excipients. During the non-isothermal thermal treatment in oxidative atmosphere, amiodarone showed incompatibility with lactose. The final investigations consisted of maintaining the samples under moderate thermal stress (48 h at 40 A degrees C), when DSC investigations revealed that thermal-induced interactions occurred with all selected excipients except talc.