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In Vitro Release Testing (IVRT)

We have deep experience and expertise in method development and the validation of in vitro release rate studies for topical formulations, including creams, lotions, ointments, gels, pastes, less viscous solutions and suspensions and transdermal patches for both product development, BE biowaiver studies, and NDA new product submission.

In Vitro Release Testing (IVRT) services include:

  • Support formulation development and optimization
  • Quality control, product performance testing and shelf life stability programs
  • In Vitro release rate comparison testing for pre and post-changes formulations, confirm a product’s “sameness”
  • Bioequivalence (BE) as per FDA Project specific guidances (PSG)
  • Full compliance method development and validation with SUPAC-SS (as per FDA) and USP general chapter <1724> guidance

Our team is deeply experienced 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.

Our expertise also 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.