In Vitro Release Testing (IVRT)
Measuring Drug Release to Optimize Formulation Performance
At MedPharm, our in vitro release testing (IVRT) services provide critical insights into drug release rates, formulation performance, and batch-to-batch consistency for topical and transdermal drug products. IVRT plays a vital role in regulatory submissions, formulation development, and bioequivalence testing, helping pharmaceutical companies accurately assess and improve drug delivery profiles.
Utilizing GMP-compliant methods, regulatory-aligned protocols, and advanced instrumentation, MedPharm delivers precise, reproducible, and scientifically validated IVRT data to support IND, NDA, and ANDA submissions.
Key Components of In Vitro Release Testing (IVRT)
Regulatory-Compliant Drug Release Testing
- Measures drug release rates from creams, gels, ointments, lotions, foams, and transdermal patches
- Verifies batch-to-batch reproducibility and product quality control
- Supports bioequivalence assessments for NDA, ANDA, and 505(b)(2) applications
- Aligns with GMP and ICH-compliant testing methodologies for global submissions
IVRT Method Development & Validation
- Development of custom IVRT assays tailored to specific formulations
- Validation of methods for accuracy, precision, linearity, and reproducibility
- Generation of dissolution and diffusion profiles for topical and transdermal drugs
- Method validation aligned with IND, NDA, and ANDA requirements
Batch-to-Batch Consistency & Performance Analysis
- Comparison of drug release rates across batches to ensure consistency
- Evaluation of formulation changes and their impact during scale-up
- Studies on lot-to-lot variability to meet regulatory expectations
- Data-driven insights to support formulation stability and optimization
Bioequivalence & Generic Drug Development Support
- Use of IVRT as a surrogate for bioequivalence in ANDA filings
- Comparative studies of test formulations and reference listed drugs
- Analysis of dissolution and diffusion kinetics to support regulatory approval
- Support for product development under the 505(b)(2) regulatory pathway
Why MedPharm for IVRT?
- Decades of expertise in topical and transdermal drug product testing
- GMP-compliant IVRT assays designed for regulatory submissions
- Robust method development and validation strategies
- Seamless integration with formulation development and bioequivalence workflows
- Cutting-edge analytical instrumentation for accurate, reproducible results
Ensure Product Consistency and Regulatory Confidence with MedPharm
With proven IVRT methodologies, advanced laboratory capabilities, and a regulatory-first mindset, MedPharm helps ensure your topical and transdermal drug products deliver consistent performance, meet global regulatory expectations, and reach market success.
