A Novel Technique to Assess Drug Substance Particle Size in a Complex Inhaled Formulation.
| Autor: | Dobson DP; Genentech, 1 DNA Way, South San Francisco, CA 94080, United States. Electronic address: dobsond1@gene.com., Saggu M; Genentech, 1 DNA Way, South San Francisco, CA 94080, United States., Pellett JD; Genentech, 1 DNA Way, South San Francisco, CA 94080, United States., Tso J; Genentech, 1 DNA Way, South San Francisco, CA 94080, United States; Ideaya Biosciences, 7000 Shoreline Ct #350, South San Francisco, CA 94080, United States. |
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| Jazyk: | angličtina |
| Zdroj: | Journal of pharmaceutical sciences [J Pharm Sci] 2023 Sep; Vol. 112 (9), pp. 2385-2388. Date of Electronic Publication: 2023 Jul 06. |
| DOI: | 10.1016/j.xphs.2023.06.020 |
| Abstrakt: | Dry powder inhalers, comprising an active pharmaceutical ingredient (API) and carrier excipients, are often used in the delivery of pulmonary drugs. The stability of the API particle size within a formulation blend is a critical attribute for aerodynamic performance but can be challenging to measure. The presence of excipients, typically at concentrations much higher than API, makes measurement by laser diffraction very difficult. This work introduces a novel laser diffraction approach that takes advantage of solubility differences between the API and excipients. The method allows insight into the understanding of drug loading effects on API particle stability of the drug product. Lower drug load formulations show better particle size stability compared with high drug load formulations, likely due to reduced cohesive interactions. Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.) |
| Databáze: | MEDLINE |
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