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Invitro studies (IVRT) – Invitro Release Testing for Topical Semi-Solid formulation (Cream, Gels, Ointments)

In Vitro Release Testing (IVRT)
Topical Semi-Solids – Creams, Gels, Ointments per FDA SUPAC-SS​

Overview Service

Capzer Pharmaceuticals provides cGMP In Vitro Release Testing (IVRT) for topical semi-solid formulations including creams, gels, and ointments across development, scale-up, and stability phases. Our FDA/DEA-registered laboratory employs vertical diffusion cell systems to measure drug release rates through synthetic membranes, supporting product performance characterization.​​

Our Approach

Utilizing USP apparatus with Franz/vertical diffusion cells, ~200 mg samples are applied to membranes over receptor media (e.g., surfactant solutions) at 32–35°C with continuous stirring. Samples are withdrawn at intervals (e.g., 1, 2, 4, 6 hours), analyzed by validated HPLC/UPLC, and release profiles compared via model-independent (f2) or model-dependent (zero-order) analysis per FDA topical guidance.

Key Capabilities

  • Method development/validation for Q1/Q2 sameness or bioequivalence demonstration.
  • Discriminatory testing detecting formulation/microstructure changes (viscosity, droplet size).
  • Automated/static systems supporting ANDA filings, post-approval changes (PACs).

Benefits for Partners

Partners gain IVRT data bridging Gabapentin topical variants or ophthalmic semi-solids to reference products from our ISO 17025-accredited facility, accelerating generic approvals while ensuring consistent drug release performance.

Other Service

Need for help?

Our expert team is here to support you with reliable pharmaceutical testing, analytical solutions, and regulatory guidance. Whether you have a query or need a customized service, we’re ready to assist you at every step.

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