In Vitro Drug Release Testing

MedPharm offers In Vitro Release Testing (IVRT) of formulations to better understand how the developed formulation will deliver an API to or across biological tissue. Absorption of APIs into or through a topical tissue depends upon a number of factors, primarily the APIs’ thermodynamic activity. IVRT can provide information on the mechanistic aspects of tissue permeability; the thermodynamic effects of drug solubility, partition coefficient, pH and drug-excipient interactions.  As such, IVRT is a very useful tool in demonstrating how a formulation will perform.

MedPharm uses IVRT as a readily available and easy-to-use tool to study the in vitro release profiles of APIs from topical and transdermal formulations in order to:

  • Ensure optimal thermodynamic activity
  • Optimise formulations and select lead formulations
  • Ensure that batch-to-batch performance and quality is uniform throughout the formulations’ shelf life
  • Demonstrate “sameness” for some scale-up and post-approval changes to semi-solid products (Note: IVRT is not a surrogate for bioequivalence)

IVRT studies are becoming increasingly popular with regulatory authorities. MedPharm IVRT studies are performed using validated methods based on the principles of the FDA, SUPAC-SS guidelines [FDA (CDER), 1997, Guidance for industry – SUPAC-SS Non-sterile Semisolid Dosage Form, Scale-up and post-approval changes: chemistry, manufacturing and controls; in vitro release testing and in vivo bioequivalence documentation.

Data produced by MedPharm have been accepted by regulatory authorities worldwide.