Accelerating the Path to Approval for Topical Generics: A Poster Case Study on Orthogonal Advanced In Vitro Characterisation

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Bringing A Topical Generic Drug Product to Market With Confidence

Bringing a topical generic drug product to market can be technically challenging, particularly where formulation microstructure, physicochemical properties and API solid-state form may influence product performance.

Presented at the 4th Annual Pharma Conference hosted by Malvern Panalytical, this downloadable poster case study explores how orthogonal advanced in vitro characterisation (AIVC) techniques can support topical generic development, helping teams build stronger evidence of product equivalence and make more informed development decisions.

Focused on a pour-on suspension product, the case study demonstrates how a comprehensive suite of physical characterisation techniques was applied in line with FDA guidance on Q3 characterisation of topical drug products submitted in ANDAs.

What The Poster Covers:

This case study poster explores the role of Q3 characterisation in topical generic drug development, including:

The difference between Q3 Basic Analysis and Q3 Comprehensive Analysis
Why study design is critical for complex topical formulations
How orthogonal techniques can support robust product equivalence assessment
The use of high-resolution imaging, particle size distribution and phase state assessment
How pH, viscosity, rheological behaviour and polymorphic form may influence topical product performance
The value of MDRS, Raman spectroscopy and X-ray diffraction (XRD) in API and formulation characterisation

Cormica’s Expertise in Topical Generic Characterisation

Cormica supports topical generic development through advanced analytical and physical characterisation, including MDRS, particle size analysis, Raman spectroscopy, XRD, rheology and physicochemical testing. Our decades of experience help generate reliable data for Q3 characterisation and regulatory submissions.

Speak to our experts to discuss how Cormica can support your topical generic development programme.

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Authors:

Daniel Gallagher

Daniel Gallagher has 10 years’ elemental analysis experience and has spent 4 years in Cormica Bradford’s Physical Characterisation team. His expertise spans complex samples and pharmaceutical development.

Ranjith Shapur

Team Leader with 13+ years’ experience in generic pharmaceuticals and CROs, specialising in solid-state characterisation, elemental impurities, analytical methods, advanced instrumentation and regulatory compliance.

Jismon Jose

Jismon is an analytical Scientist with 10+ years of experience in solid-state material characterisation, with expertise in method development, validation, polymorphic screening, and in vitro bioequivalence studies for OINDPs.

Caroline Aiken

Caroline Aiken is Technical Director at Cormica, with more than 15 years of experience supporting the pharmaceutical industry within a CRO environment. She has also led the Physical Characterisation team at the Bradford site for eight years.

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