gastroplustm simulations plus pulmonary module  (Simulations Plus Inc)

Journal: AAPS PharmSciTech

Article Title: Challenges with Developing In Vitro Dissolution Tests for Orally Inhaled Products (OIPs)

doi: 10.1208/s12249-012-9822-3

Figure Lengend Snippet: Table I

Article Snippet: To maximize the benefits of dissolution data for OIP development, however, much additional experimental, clinical, and statistical research is needed, especially in the following areas: Establishing quantitative in vitro–in vivo relationships between dissolution data and PK, PD or clinical data Establishing quantitative in vitro–in vivo relationships between dissolution data and PK, giving consideration to the appropriate dissolution timescale relative to mucocilary or macrophage particulate clearance mechanisms Improving the robustness and validation of the dissolution apparatus, particularly with regards to drug loading effects Using a truly predictive dissolution medium that correctly simulates dissolution in the lung The use of experimental dissolution data within predictive pharmacokinetic models [ e.g. , GastroPlusTM Simulations Plus Inc., Lancaster, CA pulmonary module data ( 45 ) or the published Hochhaus model data ( 46 )].

Techniques: Dissolution