Dissolution Testing of the Lung Dose/Fine Particle Dose

Emmace consulting provide dissolution testing of the lung dose using a modified paddle over disc methodology. This analysis provide additional understanding to more standard tests (e. g. Impactor testing) and may detect differences between batches and/or Test and Ref products.

Principles and work flow:

  • The lung dose is captured uniformly on a suitable filter using a standard impactor. The filter position in the Impactor is adjusted depending on impactor air flow and which size fraction that are of interest for the investigation. Moreover, we can also provide dissolution testing of the dose that survives an anatomical throat, such as the consortium throats.
  • The suitable no of doses withdrawn to the filter is determined so the relative dissolution is independent of no_of_doses and above LoQ.
  • The filter is transferred to a paddle over disc arrangement and placed in a standard USP bath vessel. Several filters can be analyzed in parallel
  • Dependent on the compound to be studied, a suitable solvent and volume is selected
  • Sample aliquots are removed at predetermined time intervals or continuously monitored using a fiber UV-Vis probe. The quantifications of the API(s) in the samples are performed with HPLC.
  • The dissolution profiles are generated, and differences/similarities are identified

We can analyze batches/products according to our standard test protocols but can also design the study closely together with Client.