Analytical Development
Analytical Development
Foundation Science

Analytical Development Support

Lipoedge’s Analytical & Development Laboratory (ADL) conducts comprehensive physical and chemical characterisation for every liposomal product, confirming structural integrity, active potency, and formulation stability against validated pharmacopoeial standards before any batch is released. 

Physicochemical Characterisation

  • Particle Size, PDI & Zeta Potential Analysis: DLS-based nanoscale profiling (150–300 nm, PDI <0.5) ensures colloidal stability and predictable absorption.
  • Encapsulation Efficiency & Assay Validation: HPLC quantifies entrapped vs free actives, confirming >80% payload retention and batch consistency.
  • Structural & Morphological Confirmation: SEM, FTIR, and EDAX validate vesicle integrity, amorphous state conversion, and internal sequestration of actives.
  • Thermal & Stability Profiling: DSC, TGA, and ICH stability studies confirm formulation robustness, degradation resistance, and shelf-life reliability.
Physicochemical Characterization - Lipoedge

In Vitro (Chemical) Support

  • Simulated Digestion & Release Kinetics (INFOGEST): Evaluation across SSF, SGF, and SIF to assess liposomal stability and bioaccessible release behaviour.
  • Dialysis & Controlled Release Studies: Membrane diffusion models quantify sustained release vs free API under physiological conditions.
  • Antioxidant & Stability Assessment: DPPH, ABTS, and TBARS studies confirm enhanced oxidative stability of liposomal actives.
  • Transdermal Permeation (Franz Diffusion): Quantifies permeation, retention, and flux for liposomal cosmeceutical formulations.
In vitro Chemical Support - Lipoedge

In Vitro Biological Support

  • Cytotoxicity & Biocompatibility Testing (ISO 10993-5): MTT-based viability studies across L929, CHO, and HepG2 cell lines with LD₅₀ determination.
  • Hemocompatibility & RBC Safety: Hemolysis and osmotic fragility studies ensure erythrocyte compatibility at real-use concentrations.
  • Cellular Uptake & Intracellular Delivery: Caco-2 transport models and fluorescence tracking confirm absorption and intracellular release.
  • Mechanistic & Functional Cellular Studies: Cell-based disease models evaluate efficacy, signalling pathways, and comparative performance vs non-liposomal actives.
In Vitro Biological Support

In Vivo Support

  • OECD-Compliant Toxicity Studies: Acute, sub-acute, and sub-chronic evaluations with LD₅₀, NOAEL, and NOEL endpoints.
  • PK–PD & Bioavailability Assessment: ADME profiling confirms enhanced absorption and systemic availability of liposomal formulations.
  • Biodistribution & Targeting Studies: Organ-specific distribution and tissue penetration validated using labelled liposomes.
  • Efficacy & Mechanistic Validation: Disease model studies with biomarker analysis (ELISA, qRT-PCR, IHC) confirm therapeutic performance.
In Vivo Support - Lipoedge