Delving into the Latest Updates on Epirubicin Hydrochloride liposomes with Synapse

BACKGROUNDEpirubicin-HCl is highly efficient for breast cancer management at a concentration of 60-90 mg/m(2). However, its application is limited due to cumulative dose-dependent cardio-toxicity.PURPOSEThe main aim of this study was to formulate breast cancer-targeted liposomal carrier by surface conjugation of transferrin to minimize cardio-toxicity of drug along with improved pharmacokinetic profile.METHODLiposomes were formulated by ethanol injection method using HSPC, cholesterol and DSPG and later loaded with drug by the ammonium sulfate gradient method. The formulation was characterized for physicochemical properties like size, zeta potential, entrapment efficiency, TEM; in vitro tests like electro-flocculation, hemolysis and drug release; cell line study (MCF-7 cells); in vivo studies including LD50 determination, pharmacokinetic analysis, myocardial toxicity determination and stability.RESULTS AND DISCUSSIONOptimized formulation had molar ratio of 60:30:8:2 (HSPC:Chol:DSPG:mPEG-DSPE) with entrapment efficiency ∼83%, particle size below 200 nm and zeta potential about -20 mV. In vitro studies proved non-interfering property and drug release character of formulation while cell line studies demonstrated improvement in cell uptake and thereby increased cytotoxicity of targeted formulation. The IC50 value obtained for epirubicin solution, non-targeted and targeted liposomes was 0.675, 0.532 and 0.192 µg/ml, respectively. Furthermore, in vivo tests validated safety and distribution profile of prepared formulations.CONCLUSIONApt properties of prepared Epirubicin-HCl liposomal formulation warrant its clinical application in breast cancer treatment after further studies.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 1	CN	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	11 Oct 2019
Stomach Cancer	Phase 1	CN	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	11 Oct 2019
Neoplasms	IND Approval	CN	Shanghai Pharmaceutical Group (Benxi) North Pharmaceutical Co., Ltd.	18 Sep 2023
Neoplasms	IND Approval	CN	Shandong New Time Pharmaceutical Co. Ltd.	18 Sep 2023
Solid tumor	IND Application	CN	Shandong New Time Pharmaceutical Co. Ltd.	30 Jun 2023