In Vitro Permeation Testing (IVPT) Studies
In Vitro Permeation Testing (IVPT) Services in Navi Mumbai, India
In Vitro Permeation Testing (IVPT) is a powerful analytical technique used to measure drug permeation and absorption through the skin. It plays a critical role in the development and optimization of topical and transdermal formulations, helping to demonstrate bioequivalence, efficacy, and regulatory compliance.
At Topiox Research, located in Navi Mumbai, India, we specialize in performing IVPT studies following FDA, EMA, ICH, and OECD 428 guidelines. Our scientifically robust, audit-ready data supports pharmaceutical, cosmetic, and dermatological product development—from formulation optimization to bioequivalence (BE) submissions.
What Is In Vitro Permeation Testing (IVPT)?
IVPT measures the rate and extent of active pharmaceutical ingredient (API) permeation through human, animal, or synthetic membranes.
This testing simulates real-world conditions of topical drug application, providing valuable insight into:
Drug permeation rate and flux
across the skin.
API retention
in epidermis, dermis, and residual formulation.
Comparative bioavailability
between test and reference formulations.
Impact of formulation variables
such as viscosity, excipient ratios, and particle size.
Regulatory Framework for IVPT
Regulatory authorities globally recognize IVPT as a validated method for topical bioequivalence assessment:
- FDA Product-Specific Guidances (PSGs) recommend IVPT for non-systemic topical drug products.
- ICH M9 and EMA Reflection Papers support IVPT for comparative quality and bioequivalence assessments.
- OECD 428 outlines validated protocols for skin permeation studies under Good Laboratory Practice (GLP).
- Compliance with 21 CFR 320.24 ensures alignment with U.S. regulatory expectations for topical bioequivalence testing.
At Topiox Research, all IVPT studies are designed and executed to align with these global standards, ensuring regulatory acceptance and submission readiness. Additionally, our IVPT services align with Q3 and In-vitro Bioequivalence studies, ensuring complete compliance and scientific rigor.
Regulatory Framework for IVPT
Regulatory authorities globally recognize IVPT as a validated method for topical bioequivalence assessment:
recommend IVPT for non-systemic topical drug products.
support IVPT for comparative quality and bioequivalence assessments.
outlines validated protocols for skin permeation studies under Good Laboratory Practice (GLP).
ensures alignment with U.S. regulatory expectations for topical bioequivalence testing.
Our IVPT Services in Navi Mumbai
We provide comprehensive In Vitro Permeation Testing (IVPT) solutions combining analytical precision, scientific depth, and regulatory insight.
Study Design & Protocol Development
Customized IVPT protocols are designed in accordance with FDA, EMA, and OECD 428 guidelines. Parameters such as dose application, membrane type, temperature, and sampling intervals are optimized to generate meaningful permeation profiles.
In Vitro Permeation Studies (IVPS)
We perform studies using Franz diffusion cells or advanced flow-through systems, accurately quantifying drug flux, lag time, and cumulative permeation for test and reference formulations.
Data Analysis & Bioequivalence Assessment
Our analytical team calculates essential parameters, including:
Steady-state flux (Jss)
Lag time (Tlag)
Permeability coefficient (P)
Cumulative amount permeated (Q)
These data form the foundation of bioequivalence (IVBE) assessments and Q3 characterization.
Skin Retention & Distribution Profiling
We determine API deposition across different skin layers (epidermis, dermis, and receptor fluid), providing insights into drug localization and release dynamics.
Reporting & Regulatory Documentation
Comprehensive, audit-ready reports are prepared, including raw data, chromatograms, statistical analysis, and comparative summaries. Our documentation supports ANDA, NDA, and CTD submissions globally.
Applications of IVPT Testing
Our IVPT services support a wide range of products and research areas:
Topical Creams & Ointments
evaluation of drug permeation and retention.
Gels & Lotions
optimization of rheology, excipient selection, and drug delivery.
Transdermal Systems
quantification of systemic drug absorption through the skin.
Ophthalmic & Nasal Formulations
assessing local delivery and tissue penetration.
Cosmeceutical Products
testing actives in moisturizers, sunscreens, and anti-aging products.
The key difference between IVPT and IVRT
While IVPT (In Vitro Permeation Testing) focuses on drug penetration through the skin,
IVRT (In Vitro Release Testing) measures drug release from the formulation itself.
Together, these methods establish complete Q3 equivalence and In-vitro Bioequivalence (IVBE), forming the scientific backbone of topical product development.
Why Choose Topiox Research for IVPT Testing?
Regulatory Alignment
Our studies comply with FDA, EMA, ICH, and OECD 428 guidelines, ensuring global acceptance and seamless regulatory submissions.
Advanced Analytical Capabilities
We utilize Franz diffusion systems, HPLC, and LC-MS for precise quantification of permeated drug content, ensuring high accuracy and reproducibility.
Scientific Expertise
Our experienced scientists specialize in dermatological bioequivalence and formulation science, providing deep insights for formulation optimization.
Comprehensive Support
From protocol design to regulatory data submission, our end-to-end services ensure smooth execution and timely delivery.
Strategic Location
Based in Navi Mumbai, India, we cater to pharmaceutical and cosmetic companies across India and globally, ensuring accessibility and efficiency.
FAQs – In Vitro Permeation Testing (IVPT)
IVPT evaluates how efficiently an API permeates through skin or synthetic membranes, supporting bioequivalence and formulation optimization.
IVPT studies follow FDA PSGs, EMA Reflection Papers, ICH M9, and OECD 428, ensuring full regulatory compliance.
IVPT measures skin permeation, while IVRT measures drug release from the formulation. Both are essential for establishing Q3 equivalence.
We use dermatomed human skin, animal skin models, or synthetic membranes, depending on study requirements and regional regulations.
Typical IVPT studies are completed within 2–4 weeks, including method development, testing, and report generation.
Bridging Formulation and Regulatory Success Through IVPT
In Vitro Permeation Testing (IVPT) bridges the gap between formulation science and regulatory validation, ensuring your topical and transdermal products perform as intended.
At Topiox Research, our IVPT testing services in Navi Mumbai, India, combine scientific precision, advanced technology, and regulatory expertise to help you deliver bioequivalent, compliant, and market-ready products.
Contact us today to discuss your IVPT testing requirements and partner with a trusted leader in pharmaceutical and cosmetic permeation studies.