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.

Using 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

• Adheres to industry standards 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

• Regulatory-focused IVRT assay design for submission support

• 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.