Evaluation of pharmaceutical quality and bioequivalence for liposomal doxorubicin hydrochloride
발표자
이재성 (숭실대학교)
연구책임자
심가용 (숭실대학교 의생명시스템학부)
공동저자
이재성 (숭실대학교), 심가용 (숭실대학교 의생명시스템학부)
초록
내용
Liposomal doxorubicin, the first FDA-approved nanomedicine, significantly improved pharmacokinetics and reduced cardiotoxicity for anthracycline agents. However, its structural complexity makes bioequivalence (BE) and quality assessment for generics challenging. Following global regulatory guidance, this study identified key evaluation parameters for BE. We employed analytical techniques including particle size, zeta potential, Cryo-TEM, DSC, HPLC, pH, and osmolality across distinct batches. Establishing these criteria is crucial for approving safe, effective generic liposomal doxorubicin. Our findings provide essential methodologies and evaluation factors to facilitate the development of high-quality generic liposomal products.