In Vitro Release Testing (IVRT)

DiTEBA has superior scientific experience and expertise dedicated to method development and validation of release rate studies for topical formulations, including creams, lotions, ointments, gels, pastes, less viscous solutions and suspensions and transdermal patches for both product development and regulatory purposes.

IVRT cosmeceutical

In Vitro Release Testing (IVRT) services include:

  • In-process testing for formulation optimization
  • Quality control, lot to lot variability
  • IVRT as part of shelf life stability program for topical products
  • In Vitro and analytical method development and validation in full compliance with SUPAC-SS and FDA requirements
  • In Vitro release comparison testing for pre and post-changes formulations
  • In Vitro-In Vivo Correlation (IVIVC)
  • Data interpretation and FDA submission for approval of SUPAC-related changes

Our team possesses in-depth expertise in operating Franz Cell and Enhanced Cell systems for semisolid, pulmo­nary and rectal/vaginal formulations and routinely works with synthetic, biomimesis and tissue membranes, including human and animal skin.

As well, our expertise extends to paddle over disk apparatus for transdermal patches. As a result we can meet the challenges of the most complex in vitro release tasks while keeping to strict timelines in a cost-effective manner.

Download our free In Vitro Release Testing Best Practices e-Book

“We recently engaged DiTEBA to undertake an IVRT study for a topical spray formulation using the finite dose technique and static Franz Diffusion Cells. Not only did they resolve some very difficult technical obstacles, but they completed the project to our complete satisfaction. I am pleased we chose them to be our IVRT partner.”

- Dr. Chalil Abu-Gnim, Senior Director, Analytical R&D


In Vitro Permeation Testing (IVPT)

In Vitro Skin Percutaneous Absorption

DiTEBA offers quality IVPT method development, validation and testing services (according to OECD 428 testing guideline), for the determination of percutaneous absorption of active compounds and chemicals including, relative flux rates, transdermal permeability, and metabolic stability of the active compounds. Moreover, the impact of the formulation system on the active's percutaneous absorption can be highlighted.

  • Formulation Development
  • Preclinical phase
  • Phases I-III studies
  • Bioequivalence
  • Toxicology
  • Irritation assessment (Safety evaluation of pharmaceutical or cosmetic)

Skin (Membrane) Types

  • Full thickness human skin
  • Dermatomed skin and split skin
  • Epidermis
  • Stratum Corneum
  • Nasal, human origin
  • Vagina, human origin
  • Buccal human origin
  • Animal skin models

Cultured Normal Human 3D Tissue Models

  • Epidermis
  • Vaginal full thickness tissue
  • Gingival full thickness tissue
  • Gingival epithelial tissue
  • Oral Buccal full thickness tissue
  • Oral Buccal Epithelial mucosal tissue
  • Endocervical tissue
  • 3D human small intestinal tissue model

The in vitro Franz human skin finite dose model has proven to be a valuable tool for the study of percutaneous absorption and the determination of the pharmacokinetics of topically applied drugs. The method has historic precedent for accurately predicting in vivo percutaneous absorption kinetics.

a) Total Absorption (sum of all receptor solutions)
b) Rate and Extent of penetration across the study period(s)
c) Distribution of the applied dose in the skin and mass balance

  • Routes of administration:
    • Oral topical, sublingual
    • Topical, dermatological, rectal, external
    • Ophthalmic
    • Otic
    • Nasal topical
    • Lung administration, pulmonary delivery
    • Vaginal/inter-uterine
  • Topically applied dosage forms:
    • Creams
    • Ointments
    • Lotions
    • Liquids
    • Suspensions
    • Gels
    • Hydrogels
    • Pastes
    • Pump Sprays
    • Topical Aerosols
    • Foams
    • Microencapsulation/ Liposomes
    • Suppositories
    • Nail Lacquers