Foundation Science

Analytical Method Development Support

At Lipoedge, Analytical Support and Method Development represent the definitive scientific bridge that validates your liposomal architecture from a raw physical mixture to a high-performance biological system. Utilising precision instrumentation like DLS, FTIR, EDAX, SEM/TEM microscopy, HPLC and DSC/TGA thermal analysers alongside advanced cell-culture models, we design customised testing protocols to map formulation’s encapsulation efficiency, assay percentage, structural integrity, digestive release kinetics, and cellular behaviour. This end-to-end validation suite delivers the rigorous data, troubleshooting blueprints, and regulatory-aligned documentation required to confidently scale products from lab to market.

Physicochemical Characterisation

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Assay & Encapsulation Efficiency  
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HPLC quantifies entrapped vs free actives, confirming >70% payload retention and batch consistency.

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Particle Size, PDI & Zeta Potential Analysis  
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DLS-based nanoscale profiling (200–300 nm, PDI <0.5) ensures colloidal stability and predictable absorption.
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Structural & Morphological Confirmation  
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SEM, FTIR, and EDAX validate vesicle integrity, amorphous state conversion, and internal sequestration of actives.
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Thermal & Stability Profiling  
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DSC, TGA, and ICH stability studies confirm formulation robustness, degradation resistance, and shelf-life reliability.

In Vitro Chemical Support

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

In Vitro Biological Support

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Cytotoxicity & Biocompatibility Testing (ISO 10993-5)  
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MTT-based viability studies across L929, CHO, and HepG2 cell lines with IC₅₀ determination.
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Hemocompatibility & RBC Safety  
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Hemolysis and osmotic fragility studies ensure erythrocyte compatibility at real-use concentrations.
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Cellular Uptake & Intracellular Delivery  
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Caco-2 transport models and fluorescence tracking confirm absorption and intracellular release.
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Mechanistic & Functional Efficacy Studies  
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Cell-based disease models evaluate efficacy, signalling pathways, and comparative performance vs non-liposomal actives.

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.