In-Vitro (IVRT/IVPT) Studies

  •  In vitro assessment of topical products is a critical aspect of the drug development process for semi-solid products (e.g., solutions, foams, sprays, creams, gels, lotions, ointments), allowing for informed selection of new chemical entities, optimization of prototype formulations during the nonclinical stage, and determination of bioequivalence of generics.
  • It can also serve as a tool to further understand the impact of different excipients on drug delivery, product quality, and formulation microstructure when used in parallel with other techniques, such as analyses of rheology, viscosity, microscopic characteristics, release rate, particle size, and oil droplet size distribution.
  • IVRT reflects various parameters and is an essential part of the stepwise approach to compare topical formulation and its ability to release active in similar quantity at similar rate.
  • The in vitro permeation test (IVPT), also known as in vitro skin penetration/permeation test, typically uses ex vivo human skin in conjunction with diffusion cells, such as Franz (or vertical) or Bronaugh (or
    flow-through) diffusion cells, and is the technique of choice for dermal pharmacokinetics assessment.


DALPL, having experienced team in In-Vitro Release Test (IVRT) and In-Vitro Permeation Test (IVPT) studies, analytical method validation and analytical method development, provides complete topical product development services utilizing in-vitro/in vivo penetration models and other scientific tools. We offer Method development, method validation and testing services that continue to
meet the fast-growing demand of regulatory requirements for these types of topical and transdermal drug analytical services.