Percutaneous Absorption

GLP and GMP-certified percutaneous absorption assays for topical products and extensive experience in IVRT & IVPT studies.

 

Kymos Group is one of the few CROs offering both GLP- and GMP-certified percutaneous absorption assays for topical products with the latest automated Hanson vertical diffusion Phoenix instruments (Franz cells testing).

These assays target developers and manufacturers of topical products and generics in need of dermal formulation characterizations, cosmetic safety, or biowaivers for topical generics through in vitro bioequivalence studies.

Our pioneering percutaneous absorption services, offered since 2017, were developed according to OECD, FDA, and EMA guidelines on the quality and equivalence of topical products.

Percutaneous Absorption

SERVICES

Our Percutaneous Absorption Services

Percutaneous Absorption

In Vitro Release Test (IVRT)

Drug released amounts and rates for transdermal semisolid topical products are measured by means of IVRT using artificial membranes in different topical applications:

  • Optimization and comparison of different formulations of topical products during the development phase.
  • Development and validation of methods to measure release and rates for different formulations of topical products.
  • Quality control for in vitro release of manufacturing batches of topical products.

In Vitro Permeation Test (IVPT)

Transdermal permeated amounts, flux rates, and layer distribution are measured by means of IVPT and skin samples and other tissues in different topical applications:

  • Bioequivalence of topical generics as an EMA/FDA-approved biowaiver alternative to costly clinical studies.
  • Optimization and comparison of formulations.
    Selection of suitable excipients.
  • Selection of lead candidate formulations for topical products.
  • Skin stripping and layering to measure skin penetration
    Safety assessments of cosmetic topical products.
  • Percutaneous absorption studies through skin or cornea.
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Team Discussion

Why Choose KYMOS?

  • Global Trust:

    • We are trusted by clients worldwide and support projects from formulation development to regulatory submission.

  • Regulatory Excellence:

    • In vitro method development in compliance with SUPAC-SS and FDA requirements. (Guidance for Industry: SUPAC_SS: Nonsterile Semisolid Dosage Forms. FDA, 1997); EMA Draft Guideline on Quality and Equivalence of Topical Products, 2018).
    • Permeation studies are carried out in accordance with OECD and EMA guidelines (Guideline for the testing of chemicals. Skin absorption: in vitro method. OECD 428, 2004; Guidance document for the conduct of skin absorption studies. OECD 28, 2004; EMA Draft Guideline on Quality and Equivalence of Topical Products, 2018)

  • Extensive Expertise:

    • Kymos Group has a specialized team working with IVRT & IVPT projects since 2017 in full compliance with relevant guidelines.
    • We are ready to support clients and partners at every step, streamlining the process of bringing new generics to market or developing innovative projects.

  • State-of-the-art equipment and techniques

    • Equipped with the latest automated Hanson vertical diffusion Phoenix instruments (Franz cells testing)

Services

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