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In Vitro Release Testing
Regulatory-Grade IVRT for Topical and Semisolid Drug Products
What Is In Vitro Release Testing (IVRT)?
In Vitro Release Tests (IVRT) are used to assess drug release from a formulation across a non-rate-limiting synthetic membrane. IVRT is a critical regulatory tool for demonstrating product equivalence and performance for topical, semisolid, and mucosal drug products.
IVRT studies support:
Optimization of thermodynamic activity
Manufacturing process changes
Generic bioequivalence (“sameness”)
25 Years of IVRT and IVPT Expertise
MedPharm has performed thousands of in vitro tests (IVRT and IVPT) over the last 25 years for companies worldwide. This data has supported more than 85 commercial products globally.
MedPharm is widely recognized by regulatory agencies in Europe, Japan, and the United States as subject matter experts in IVRT and IVPT.
Regulatory Applications for IVRT
United States:
IVRT supports regulatory filings and post-approval changes under:
Scale-Up and Post-Approval Changes for Semie Solids (SUPAC-SS)
Compositional changes ( excipient levels, grade, new supplier, etc.)
Manufacturing site changes
Process and equipment changes
Manufacturing and process modifications (e.g. mixing speed, equipment changes, etc.)
Abbreviated New Drug Applications (ANDA)
Liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes
Bioequivalence for generic (test) topical product to the reference listed drug (RLD)
New Drug Applications (NDA)
Fully validated IVRT as part of NDA submissions
Chinese:
IVRT supports compliance with:
Technical Guidelines for In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Studies of Locally Acting Chemical Generic Drugs
Scientific Staff
- The scientific staff undergoes a rigorous sampling qualification where each scientist must meet the acceptance criteria defined in the guidance. SMEs are available as Scientific Consultants for regulatory meetings, information requests (IR), deficiency letters (DL), and scientific justification.
Stages of IVRT Studies
- Method Development (IVRT and HPLC/UHPLC)
- HPLC/UHPLC Method Validation
- IVRT Method Validation
- IVPT Pivotal (Stage 1 and Stage 2 may apply)
Laboratories and Infrastructure
- 2,400 sq/ft of purpose-built labs
- Qualification, calibration on all instruments and equipment.
- SOPs clearly define the requirements for the use, maintenance, and calibration
- All vertical diffusion cells (VDC) qualified per USP/FDA/EMA guidance
- Proprietary heat blocks optimized to ensure consistent heat across study duration
- Fully automated vertical diffusion cell system (MedStat-HTTM) to cut IVRT timelines by 1/3
Quality, Data, and Reporting
MedPharm IVT laboratories have passed three FDA audits for in vitro testing with no 483s
MasterControl electronic Quality Management System (QMS)
Regulatory-friendly study plans, protocols, and reports
Standardized test conditions for faster, lower-risk throughput
Data stored in a qualified Electronic Content Management System (ECMS)
Key Examples of MedPharm’s Subject Matter Expertise:
