In Vitro Release Testing (IVRT) Studies
What is IVRT?
In Vitro Release Testing (IVRT) is a critical analytical technique used to evaluate the release rate of active pharmaceutical ingredients (APIs) from topical formulations. This method is essential for ensuring the consistency, quality, and performance of products such as creams, gels, and ointments. IVRT studies help in understanding how a drug is released from its formulation, which is crucial for both regulatory approval and market success.
IVRT Process
Preparation of the Test System
Sample Application
Diffusion Cell Setup
Incubation and Sampling
Analysis of Samples
Data Interpretation
Why IVRT Matters
IVRT studies are not just a regulatory requirement; they are a vital part of the product development process. By understanding the release characteristics of your formulations, you can ensure consistent performance, enhance product quality, and gain a competitive edge in the market.
In vitro release rate (IVRT) can reflect numerous and combined effects of several physical and chemical parameters, including solubility, particle size of the active pharmaceutical ingredient (API) and rheological properties of the dosage form. In vitro release testing (IVRT) is an FDA required test used to support pre- and post-approval manufacturing changes in compliance with SUPAC-SS requirements. IVRT allows for targeted and systematic drug development and guides the establishment of therapeutic equivalence. IVRT measures the release rate of a drug by using Franz diffusion cells and a non-interactive synthetic membrane or skin, and can be used to develop methods for analyzing a range of semi-solid dosage forms, including:
Topical Aerosols
Ointments
Liposomes/Ethosomes
Suspensions
Creams
Microencapsulation
Lotions
Why Choose VitelyBio for IVRT Studies?
At VitelyBio, our team is equipped with in-depth subject knowledge & technology to support your IVRT and Q1/Q2/Q3 requirements for accelerated development of generic drug products.
State-of-the-Art Facilities
VitelyBio boasts cutting-edge laboratories equipped with the latest technology to conduct precise and reliable IVRT studies. Our facilities are designed to meet the highest industry standards, ensuring accurate and reproducible results.
Regulatory Compliance
At VitelyBio, we understand the importance of regulatory compliance. Our IVRT studies are conducted in accordance with the guidelines set by regulatory authorities such as the FDA and EMA, ensuring that your products meet all necessary requirements.
Comprehensive Reporting
We provide detailed and comprehensive reports that include all necessary data and interpretations. Our reports are designed to be clear and concise, making it easy for you to understand the results and make informed decisions.
Expert Team
Our team of scientists and researchers are leaders in the field of pharmaceutical testing. With years of experience and specialized knowledge, they provide insightful analysis and innovative solutions tailored to your specific needs.
Customized Solutions
We recognize that each product is unique. VitelyBio offers customized IVRT study designs to address the specific characteristics and challenges of your formulations. Our personalized approach ensures that you receive the most relevant and actionable data.
Timely Delivery
We value your time and understand the importance of meeting deadlines. VitelyBio is committed to delivering high-quality results within the agreed timelines, helping you stay on track with your project milestones.