NABL Accredited · Topical Testing Laboratory

Franz Diffusion Cell Testing Laboratory India | In Vitro Permeation Studies | NABL

Franz diffusion cell testing for topical and transdermal formulations from an NABL-accredited pharmaceutical laboratory in India.

The Franz diffusion cell is the standard apparatus for measuring drug release and permeation from topical and transdermal pharmaceutical formulations. Auriga Research operates an NABL-accredited Franz diffusion cell testing laboratory with automated multi-cell systems that enable simultaneous testing across multiple replicates, providing statistically robust permeation data for formulation development, quality control, and regulatory submissions.

Our laboratory performs both IVRT (In Vitro Release Testing) using synthetic membranes for quality control purposes and IVPT (In Vitro Permeation Testing) using biological membranes for bioequivalence and formulation optimisation studies. Testing protocols follow FDA SUPAC-SS guidance, USP <1724>, and the FDA draft guidance for topical generic drug bioequivalence. Receptor samples are quantified using validated HPLC methods with complete permeation profiles, flux calculations, and statistical analysis.

Applications include formulation screening and optimisation for creams, ointments, gels, patches, and sprays; batch-to-batch consistency testing for commercial products; comparative permeation studies for generic topical submissions; and stability-linked permeation profiling to assess shelf-life impact on drug delivery performance.

Franz Diffusion Testing Capabilities

  • In vitro release testing (IVRT) with synthetic membranes per USP <1724>
  • In vitro permeation testing (IVPT) with biological membranes
  • Automated multi-cell Franz diffusion systems (6-12 cells per run)
  • Topical formulation screening — creams, ointments, gels, patches, sprays
  • Flux calculation, lag time determination, and permeation kinetics
  • Comparative permeation studies for topical generic bioequivalence
  • Temperature-controlled receptor compartments at 32 C (skin surface) or 37 C
  • HPLC-based quantification of receptor samples with validated methods

Turnaround Time

Standard IVRT/IVPT: 7-10 business days
Rush Testing: 5-7 business days
Comparative Permeation Study: 10-14 business days
Full Formulation Screening: 2-3 weeks

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Frequently Asked Questions — Franz Diffusion Cell Testing

What is a Franz diffusion cell and how does it work?
A Franz diffusion cell is a laboratory apparatus used to measure the rate and extent of drug permeation through a membrane — either synthetic or biological. It consists of a donor compartment (where the formulation is applied), a receptor compartment (filled with a suitable medium), and a membrane mounted between the two. The receptor medium is sampled at defined time intervals and analysed (typically by HPLC) to construct a permeation profile showing cumulative drug release over time.
What types of formulations can be tested using Franz diffusion cells?
Franz diffusion cell testing is applicable to topical and transdermal formulations including creams, ointments, gels, lotions, patches, sprays, foams, and emulsions. The technique is also used for ophthalmic preparations, nail lacquers, and mucosal delivery systems. Both in vitro release testing (IVRT) using synthetic membranes and in vitro permeation testing (IVPT) using biological membranes can be performed.
What is the difference between IVRT and IVPT?
IVRT (In Vitro Release Testing) uses synthetic membranes and measures the rate of drug release from the formulation into the receptor medium. It is used for quality control and batch-to-batch comparison. IVPT (In Vitro Permeation Testing) uses biological membranes such as excised human or animal skin and measures the rate and extent of drug permeation through the tissue barrier. IVPT is used for bioequivalence studies, formulation optimisation, and regulatory submissions for topical generics.
What is the turnaround time for Franz diffusion cell testing?
Standard Franz diffusion cell testing at Auriga Research is completed within 7-10 business days from sample receipt. This includes membrane preparation, multi-timepoint sampling over 6-24 hours, HPLC analysis of receptor samples, and data reporting. Rush services are available within 5-7 business days for urgent projects.
Does Auriga Research perform SUPAC-SS compliant diffusion testing?
Yes. Our Franz diffusion cell testing protocols comply with FDA SUPAC-SS guidance for semisolid dosage forms, USP <1724> for semisolid drug products, and the FDA draft guidance on IVRT and IVPT for topical bioequivalence. We use validated HPLC methods for receptor sample quantification and provide complete permeation profiles with statistical analysis.

Need Franz Diffusion Cell Testing for Your Topical Formulations?

NABL-accredited IVRT and IVPT testing with 7-10 day turnaround. Comprehensive permeation profiles for regulatory submissions.

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