22 August 2024

Customized In Vitro Elution Methods for Medical Devices

Combination products such as drug-eluting stents, drug-coated balloons, bioceramic materials, or vaginal rings need to be tested for their drug elution properties. For specific applications, customized solutions with scientific rationale can be used.

While traditional dissolution methods are not tailored to these non-conventional dosage forms, alternative techniques such as the flow-through cell (also known as USP 4) have been used for these applications.

As an example, a sensitive and robust method for determining the elution of two active drug substances from vaginal rings was developed using a USP Apparatus 4 system. The in vitro method was designed for both real-time testing (up to 21 days) and accelerated testing for QC purposes. It demonstrated the ability to discriminate between good and bad batches, has been fully validated (according to ICH guidelines), and approved by health authorities. That vaginal ring is now marketed, with the accelerated method used for commercial batches.

Read the full scientific publication entitled "A Novel Method for the Elution of Sirolimus (Rapamycin) in Drug-eluting Stents", published by Dissolution Technologies, Volume 18.

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