Evaluation of powder discharge-based KinetiSolTM (pKSD) as a fast and solvent-free particle engineering process for pulmonary drug delivery

Abstract

This research evaluated the viability of powder discharge-based KinetiSol (pKSD) as a rapid, solvent-free particle engineering technology for producing inhalable dry powders. This study focused on how the physicochemical characteristics of amorphous and crystalline excipients influence resulting powder morphology and aerosol performance.

Results from laser diffraction and SEM analysis confirmed that excipient properties, specifically morphology and solid-state, directly influence particle breakage during pKSD processing Hydroxypropyl β-cyclodextrin (HPBCD) and L-leucine blends exhibited a significant reduction in particle size (up to 3-fold), which enhanced aerosolization efficiency, yielding fine particle fractions (FPF) of 48 % and 51 %, respectively. Conversely, various grades of lactose and sulfobutylether β- cyclodextrin (SBECD) largely maintained their initial morphology and particle size, resulting in lower FPF values ranging from 21 % to 36 %.

Additionally, WAXS analysis confirmed that pKSD processing maintained the crystalline traces of the model drug, fenbendazole. These findings establish pKSD as a viable alternative for the engineering of inhalable particles.

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Materials

FBZ was purchased from Shenzhen Nexconn Pharmatechs LTD (Shenzhen, China). Inhalation grade lactose, LactoHale, and Respitose were supplied by DFE Pharma (Goch, Germany). L-Leucine was purchased from Alphaesar (Fisher Scientific, Pittsburgh, PA, USA). Captisol® (sulfobutylether-β-cyclodextrin, SBECD) was gifted by Ligand Pharmaceuticals (San Diego, CA, USA). Kleptose® HPB Parenteral grade (Hydroxypropyl β-cyclodextrin, HPBCD) was obtained from Roquette Pharma (Geneva, IL, USA).

Beatriz Behrend-Keim, Miguel O. Jara, Daniel A. Davis, Dave A. Miller, Robert O. Williams, Evaluation of powder discharge-based KinetiSolTM (pKSD) as a fast and solvent-free particle engineering process for pulmonary drug delivery, International Journal of Pharmaceutics, Volume 700, 2026, 127025, ISSN 0378-5173, https://doi.org/10.1016/j.ijpharm.2026.127025.