As dermaceutical formulations become more predominant, in vitro release testing (IVRT) is playing a progressively dynamic role in the determining the release performance and diffusion of these drug products — saving both time and cost compared with traditional bioequivalence studies.


IVRT Measures

  • The estimation of drug release from a given dosage form is important to drug product development. The precise technique employed is determined by the dosage form itself and the intended route of delivery from the given dosage form. For Oral solid dosage forms, dissolution testing has been used. Recently, for semisolid drug products, in vitro release testing (IVRT) has shown potential in evaluating drug release properties. An in vitro release rate can reflect the combined effect of several physical and chemical properties, including solubility and particle size of the active pharmaceutical ingredient (API) and rheological properties of the dosage form.
  • The common IVRT method employs an open chamber design like the Franz diffusion cell system and can be used with a synthetic membrane.
  • IVRT studies provides an effective method for the evaluation of drug release from semisolid drug products and with appropriately validated method, to measure manufacturing quality over time. Its use is increasing as both a development tool. The IVRT studies will soon become a required part of the regulatory package and, on a case-by-case basis.
  • The IVRT pivotal study comparing the [drug] release rates between the Test and RLD products should be performed in a same manner compatible with the general procedures and statistical analysis method specified in the United States Pharmacopeia (USP) General Chapter<1724> , Semisolid Drug Products – Performance Tests
What we offer to submit for filings to regulatory
  • IVRT Method Development Report
  • IVRT Method Validation Report
  • IVRT Pivotal Study Report

IVPT Measures

  • In Vitro permeation testing (IVPT) studies across biological membranes (skin tissues) for dermatological formulations that are applied to the skin are energetic to guide product development and establish product bioequivalence.
  • Therefore, an IVPT studies are recommended comparing the cutaneous pharmacokinetics of a drug permeations from the Test and Reference products using excised human skin with a competent skin barrier mounted on a qualified diffusion cell system.

IVPT Method development

Method Parameters:

  • Product dose amount
  • Sampling times
  • Stirring rate

IVPT Method Validation

Validation Components:

  • Membrane (skin) qualification
  • Receptor Solution Qualification
  • Receptor Solution Sampling Qualification
  • Receptor Solution Sample Analytical Method Validation
  • Environmental Control
  • Permeation Profile and Range
  • Precision and Reproducibility
  • Recovery, Mass Balance & Dose Depletion
  • Discrimination Sensitivity and Selectivity

IVPT Pilot Study

  • To evaluate number of donors required for the pivotal study.
  • Parallel assessment to be performed with a third product or formulation that is known or designed to be different from the RLD.

IVPT Pivotal study

  • The rate and extent of drug permeation through excised human skin from the test product and the RLD are comparable.