LipoEdge  ·  Support Team

Why In Vitro Biochemical Testing Matters

While physical characterisation confirms that a liposome has been correctly synthesised, in vitro biochemical testing demonstrates how it will behave in the human body. By mimicking real physiological environments, these tests evaluate the formulation’s true efficacy, protective strength, and digestive survival. This crucial layer of validation provides the exact guidelines needed to confirm if a product is optimised and ready for further cellular and in vivo studies.

Testing Capabilities
Testing
Stability Testing
Release Studies
In vitro release Study
Product Research
Product Specific Study
Testing

Stability Testing

  • Oxidative Stability
    

    Liposomal formulations, when exposed to oxidative stress, exhibit lower lipid peroxidation, indicating greater protection of the API against oxidative degradation.

  • Osmotic Stability
    

    Determines the stability of a liposomal system in solutions of different salt concentrations (hypotonic, isotonic and hypertonic). Consistent release patterns with slight deviation confirm superior liposomal integrity.

Stability Testing of Liposomal Formulations
Release Studies

In Vitro Release Study

  • In simulated Fluid
    

    Liposomal formulations are assessed using the INFOGEST protocol on in vitro digestion using simulated fluids

    • SSF (Simulated Salivary Fluid): To study the release pattern in the mouth phase. Important for understanding the release pattern of sublingual formulations.
    • SGF (Simulated Gastric Fluid): To study the release pattern in the gastric environment. A lower release indicates greater stability of the liposomal formulation.
    • SIF (simulated Intestinal Fluid): To study the release pattern in intestinal fluid. Higher and sustained release of API indicates greater bioavailability over a prolonged period
In vitro release Study
Product Research

Product Specific Study

  • Antioxidant Assay
    

    Liposomal APIs such as vitamin C & α-lipoic acid confirm free radical scavenging activity of liposome compared to non-liposomal APIs, indicating improved antioxidant capacity.

  • Melanogenesis Inhibition Assay
    

    In vitro enzymatic assay to determine the anti-tyrosinase activity of liposomal L-GSH.

  • GSH/GSSH determination
    

    In vitro enzymatic assay using DTNB to determine the stability of L-GSH when exposed to oxidative stress

  • Franz Diffusion Assay

    In vitro membrane permeation study to evaluate the transdermal or transmucosal penetration efficiency of liposomal APIs, compared to non-liposomal forms.

Product Specific Study
Services

Product-Specific Documentation We Provide

Physiological Stability Testing:

Evaluate stability under oxidative stress and measure structural integrity across diverse osmotic environments to guarantee robust API protection prior to biological entry.

Bio-Simulated Release Studies

Track precise API release kinetics across simulated fluids (salivary, gastric, and intestinal to validate digestive survival.

Product Specific Assays

Quantify formulation-specific therapeutic potency through targeted functional bioassays and Franz diffusion membrane permeation studies.

Problem Solving

Method Validation & Assay Precision Troubleshooting

Bioavailability & Release Optimization

Evaluation of ingredient release and absorption potential under simulated gastrointestinal conditions to predict in vivo performance.

Stability & Product Performance Assessment

Determine the stability and efficiency of liposomal and encapsulated actives under physiological and storage-relevant conditions.

Targeted Delivery Verification

Assessing and interpretation of site-specific release behavior and protection of active ingredients through gastric and intestinal environments.

Comparative Efficacy & Formulation Benchmarking

Generate scientific evidence to compare formulations, optimize compositions, and substantiate product claims.

Workflow

Product Testing & Validation Workflow

Step 01
Biochemical Stability Testing

Evaluate formulation structural integrity against oxidative degradation and osmotic stress variations to ensure baseline protection.

Step 02
Simulated Fluid Release Profiling

Map active ingredient release kinetics across simulated digestive stages (mouth, stomach, intestine)

Step 03
Customised Study Design

Designing customised experimental models and selecting specific assays tailored to the product’s delivery route, formulation characteristics, and target claims.

Step 04
Regulatory Dossier Compilation

Aggregate all physical, chemical, stability, and release data into a comprehensive technical file for regulatory submission and market approval.

Why LipoEdge

Why Collaborate with Lipoedge

End-to-End Analytical Support

Integrated in vitro evaluation from method design to data interpretation, ensuring seamless alignment between formulation, characterization, and performance testing.

Robust In-House Capabilities

Advanced testing including release kinetics, product-specific in vitro assays, and stability profiling- all conducted under one roof.

Regulatory Aligned Methodology

Studies designed using established models to support regulatory submissions and product claims.

Application-Specific Approach

Tailored experimental design, protocol modifications, and comparative studies based on product type and target market.

Expert Scientific Team

Driven by highly qualified and experienced scientists, forming the core strength of the department, ensuring accuracy, innovation, and reliable outcomes.

Partner with LipoEdge

How Can We Support
Your Goals?

Choose the path that fits your needs — from analytical testing to fully bespoke liposomal formulation design.

01
Standard Testing

Elevate Your Formulation Testing

Validate exactly how your liposomal products behave inside the human body using advanced, bio-simulated physiological modelling.

  • Verify Physiological Stability Profiles
  • Map Simulated Fluid Release Kinetics
  • Evaluate Product-Specific Bioassays
02
Custom Formulation

Resolve Complex Testing Challenges

Overcome complex biological delivery obstacles to guarantee your final consumer product achieves its targeted efficacy and performance claims.

  • Optimise Kinetic Release Profiles
  • Resolve Franz Diffusion Inconsistencies
  • Standardise Custom Bioassay Protocols
03
Capabilities Brochure

Download Our Capabilities Brochure

Equip your development team with our comprehensive analytical roadmap for premium, scientifically verified liposomal products.

  • Physiological Verification Blueprints
  • End-to-End Testing Framework
  • Our Specialised Assay Portfolio
Download Brochure
ISO-aligned protocols
Expert scientific team
Regulatory-ready data
End-to-end support
Lipoedge Knowledge Base

Frequently Asked Questions

01
Why is the INFOGEST protocol preferred for liposomal release studies?

The INFOGEST protocol provides a standardised, widely accepted framework that closely simulates gastrointestinal conditions. This ensures reproducible and comparable evaluation of liposomal release and bio-accessibility across formulations.

03
What role do bile salts and pancreatic enzymes play in liposomal release?

Bile salts and pancreatic enzymes disrupt phospholipid bilayers in the intestinal phase, enabling controlled release of encapsulated actives. This process allows precise quantification of the bioaccessible fraction.

05
Do we perform product-specific functional assays to validate formulation claims?

Yes. We offer a comprehensive suite of product-specific assays to validate the formulation’s nutraceutical and cosmeceutical performance. Our scientific team regularly designs, adapts, and validates testing protocols tailored entirely to your unique active ingredient and target market claims.

02
Why is minimal release expected in gastric conditions for liposomal systems?

Liposomal formulations are designed to remain stable in acidic gastric conditions, thereby protecting encapsulated actives. This stability supports targeted release in the intestinal phase, where absorption is highest.

04
Why is in vitro biochemical testing necessary if we have already completed physical characterization?

While physical characterisation confirms that your liposomes are structured correctly, in vitro biochemical testing demonstrates how well your liposomes will perform in the human body.