Entry Port Selection for Detecting Particle Size Differences in Metered Dose Inhaler Formulations Using Cascade Impaction.

Autor: Naini, Venkatesh, Chaudhry, Saeed, Berry, Julianne, Sharpe, Stefan, Hart, John, Sequeira, Joel
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Zdroj: Drug Development & Industrial Pharmacy; Jan2004, Vol. 30 Issue 1, p75-82, 8p
Abstrakt: Different sized glass entry ports were evaluated for their drug collection efficiency during aerodynamic particle sizing of metered dose inhalers (MDIs) using cascade impaction. A comparison was made between collection efficiency in the entry port, impactor plates, and filter using the 1 L, 2 L, and 20 L glass entry ports and the USP and twin impinger entry ports. Entry port losses were dependent on the size of entry port selected, with 1–2 L ports showing optimal recovery on impactor plates, compared to the USP entry port. The 1 L entry port was further compared with the USP entry port in its ability to discriminate between subtle changes in particle size distribution (PSD) in an investigational hydrofluoroalkane (HFA)-based MDI formulation. Deliberately induced differences during product manufacture were easily detected using the 1 L entry port with the Andersen cascade impactor. The USP port was unable to distinguish among products with small particle size differences. An alternative entry port such as the 1 L glass entry port used in this study may provide better means of characterizing the PSD during formulation development and stability testing of MDIs. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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