Identify critical quality attributes (CQAs) beyond the release testing specifications of the reference listed drug (RLD). Identify the critical quality attributes (CQAs) of key raw materials. Characterize the lipid composition, bilayer structural parameters, and drug encapsulation mechanisms of the RLD to support formulation screening and process optimization of in-house developed products, addressing challenges such as liposome instability, inconsistent pharmacological performance, batch-to-batch variability, and mismatched release profiles. Provide analytical data to support formulation and product sameness (Q1-Q2-Q3).
| HPLC for determination of drug content, encapsulation efficiency, and lipid composition. Laser diffraction particle size analyzer and dynamic light scattering for characterization of particle size distribution and zeta potential. Transmission electron microscopy (TEM) for visualization and characterization of liposome morphology and bilayer structure. Ion chromatography for determination of intra- and extraliposomal ionic concentration. Differential scanning calorimetry (DSC) for characterization of lipid phase transition temperature. Field-flow fractionation (FFF)-detectors for characterization of nanoparticle size distribution, vesicles, lipid fragments, and aggregates, as well as molecular weight distribution, molecular conformation, branching architecture, and swelling properties of sustained-release materials.
| Comprehensive liposome characterization (morphology, lamellarity, PEG-lipid layer thickness, phase transition temperature, particle size, zeta potential, etc.). Phospholipids and cholesterol. N-acetyl-L-tryptophan. Histidine. Determination of liposome drug content and encapsulation efficiency. In vitro release methods. Determination of sulfate ions, ammonium ions, and other ionic species. Lysophospholipids. Determination of leakage rate.
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