Special Studies
💉

IVRT & IVPT Studies

In-Vitro Release Testing and In-Vitro Permeation Testing for topical semi-solid products using Franz diffusion cells.

IVRTIVPTFranz CellTopical
Overview

About This Service

AnalytiLab specializes in In-Vitro Release Testing (IVRT) and In-Vitro Permeation Testing (IVPT) for topical semi-solid dosage forms including creams, gels, ointments, and transdermal patches. Using validated Franz diffusion cell methodology, we support bioequivalence studies, formulation development, and regulatory submissions for topical products.

FDA SUPAC-SSEMA Topicals GuidanceUSP <724>FDA BE Guidance for Topicals

Key Information

Cell Configuration6 and 12-cell Franz apparatus
Dosage FormsCreams, Gels, Ointments, Patches
Turnaround Time15–25 working days
Regulatory AcceptanceUSFDA, EMA

Accredited by

NABLISO 17025USFDA
Scope of Work

What's Included

IVRT for creams, gels, ointments, lotions
IVPT using human cadaver or animal skin
Synthetic membrane IVRT (cellulose acetate)
Flux calculation and permeation profiling
Comparative IVRT for bioequivalence
Formulation optimization support
Transdermal patch testing
Temperature-controlled Franz cell setup
Statistical analysis (f2 similarity factor)
FDA SUPAC-SS compliant protocols
Equipment

Instruments Used

Franz Diffusion Cells (6/12-cell)

IVRT and IVPT studies for topical products

HPLC (UV/PDA)

Drug quantification in receptor fluid

UV-Vis Spectrophotometer

Rapid screening and quantification

Synthetic Membranes

IVRT using cellulose acetate/polysulfone membranes

Compliance

Regulatory Standards

FDA SUPAC-SS
EMA Topicals Guidance
USP <724>
FDA BE Guidance for Topicals
Our Process

How We Work

01

Protocol Design

Study protocol designed per FDA/EMA guidance; membrane and receptor fluid selected.

02

Cell Setup & Equilibration

Franz cells assembled, membrane equilibrated, temperature controlled at 32°C.

03

Sample Application & Sampling

Formulation applied; receptor fluid sampled at defined time points.

04

Analysis & Report

HPLC quantification; flux, permeation profile, and f2 analysis; full study report.

Get Started

Ready to Start Your IVRT & IVPT Studies?

Our scientific team is ready to assist. Submit your sample or request a quote today.