Date of Award
M.S. in Pharmaceutical Science
Pharmaceutics and Drug Delivery
Michael A. Repka
The aim of the current investigation is to develop a sustained-release dry powder inhalation (DPI) formulation through continuous Hot Melt Extrusion (HME) process and see the impact of Sodium Bicarbonate (SB) and Mannitol (MAN) on the hydrophobic Eudragit RL PO (ERLPO) polymer. Ball milling and air-jet milling were utilized to have powder with a particle size range that is required for inhalation. Air-jet milled formulations shopromising particle size results compared to ball milled formulations. All solid-state characterization studies revealed no change on Theophylline (TH) crystallinity or occurrence of drug-excipient interactions in physical mixtures and formulations. X2 formulation released TH constantly over six hours and has an acceptable particle size range for a DPI, therefore, it was chosen as the best formulation. Due to the pores that created by SB during HME extrusion, X1 released about half of TH after 15 minutes and reached the maximum release on the eighth hour, nevertheless, its particles size was not appropriate for DPI. X3 had the most suitable particle size range for a DPI, however, it had no a sustained-release behavior and its release was the same as a pure TH. For future studies, X2 will be further investigated on Anderson Cascade impaction (ACI), a study that mimic the lung, and in-vivo study will be considered based on the ACI result.
Almotairy, Ahmed, "Characterization of Drug-Loaded Milled Extrudate Particles Produced by Hot Melt Extrusion Technology for Dry Powder Inhalers" (2019). Electronic Theses and Dissertations. 1538.