Performance testing

- for topical products

R&D AND GMP SERVICE

There are many good reasons for including formulation performance testing in the formulation development program. The three key parameters to be studied are formulation stability, the release of the drug from the formulation and drug permeation characteristics. A formulation optimised for drug release and permeation is often more efficacious and may require a lower concentration of drug. This may reduce the cost of the final product as well as drug irritation, and also help justify clinical decision.

Zelmic uses in vitro performance testing to support:

  • In vitro release testing for post-approval QC and product changes/modifications according to GMP
  • In vitro release testing (IVRT) in Franz diffusion cells (PermeGear) or Bronuagh flow through cells
  • Typical membranes: Silicon sheets, Cellulose acetate, Molecular sieves, PTFE membranes, Strat M membranes
  • In vitro permeation testing (IVPT) in Franz diffusion cells (PermeGear) or Bronuagh flow through cells
  • Typical membranes: Excised animal or human skin, viable animal or human skin, cultured skin, bovine hoof membranes, human nails, synthetic membranes as human skin surrogates

The use of IVRT and IVPT for topical formulations at Zelmic:

In Vitro Release testing

  • Determining the release rate and diffusion of the drug in topical products
  • Scale-Up and Post-Approval Changes for semi-solids (SUPAC-SS)
  • Formulation development, optimisation and selection.
  • Product quality and performance

In Vitro Permeation testing

  • Selection of formulation composition and API
  • Understanding mechanism of cutaneous API transport
  • Prediction of skin concentrations
  • Prediction of in vivo bioavailability and bioequivalence
  • Metabolic activity
  • Safety argumentation
  • Efficacy argumentation
  • Biowaiver argumentation