Dissolution testing of the lung dose
Dissolution testing
Emmace provides dissolution testing of the lung dose using a modified paddle over disc methodology. This analysis complements more standard tests such as impactor testing, and provides a deeper understanding. Dissolution tests help detect differences between batches and/or test and reference products.
Click here to view the direct in vessel dissolution poster presented at DDL 2023.
How to perform a dissolution test
When performing a dissolution test, the lung dose is captured uniformly on a suitable filter using a modified impactor set-up. The filter position in the impactor is adjusted depending on impactor air flow and which size fraction that is of interest for the investigation. Moreover, we can also provide dissolution testing of the dose that survives an anatomical throat.
The suitable number of doses withdrawn to the filter is determined so that the relative dissolution is independent of the number of doses and above LoQ (limit of quantification).
The filter is transferred to a paddle over disc arrangement and placed in a standard USP bath vessel.
Dependent on the compound to be studied, a suitable solvent and volume is selected.
Sample aliquots are removed at predetermined time intervals. The quantifications of the API(s) (Active Pharmaceutical Ingredients) in the samples are performed with HPLC (High-Performance Liquid Chromatography). The dissolution profiles are generated, and differences/similarities are identified.
We can analyze products and batches according to our standard test protocols. In addition we offer the opportunity to design the study in close collaboration with the client.
