OPTIMIZATION AND IN VITRO EVALUATION OF LAPATINIB-ENCAPSULATED LIPOMER SUSPENSION FOR EFFECTIVE CANCER THERAPY
DOI:
https://doi.org/10.22159/ijap.2026v18i2.57180Keywords:
Lapatinib, Lipomer, Drug delivery system, Quality by design, Central composite design, Stability studyAbstract
Objective: To establish and optimize a lipomer-based formulation of lapatinib (LAP) for addressing issues of poor solubility, bioavailability, drug release and stability.
Methods: Lipomer were synthesized using emulsification and solvent evaporation (ESE) methods. Optimization was performed for three critical formulation parameters: PLA, Soya lecithin, and DCM using a 33 central composite design (CCD) with a quality by design (QbD) approach. Characterization techniques included FTIR, DSC, FESEM, and TEM to evaluate structural integrity and drug entrapment. In vitro drug release studies and three-month stability studies at 4±2 °C and 40±2 °C, 75% relative humidity (RH) were conducted.
Results: Optimized formulation had the following physicochemical properties: particle size (PS): 88.5 nm, zeta potential (ZP): −22.2 mV, polydispersity index (PDI): 0.194, entrapment efficiency (%EE): 85.15%, cumulative drug release (%CDR): 88.85%, FTIR, DSC, FESEM, and TEM confirmed preserved structure and successful drug entrapment. In vitro release showed sustained, continuous drug release and stability studies indicated that the formulation remained stable under the tested conditions.
Conclusion: The lipomer-based delivery system enhances the solubility, bioavailability, and stability of LAP, offering a promising strategy for sustained drug delivery.
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