ArticlePharmaceutics2023
On the Physical Stability of Leucine-Containing Spray-Dried Powders for Respiratory Drug Delivery.
Article in Pharmaceutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed.
- Design and Development of Dry Powder Cyclodextrin Complexes of Zinc Diethyldithiocarbamate for Pulmonary Drug Delivery.Pharmaceutics · 2026Article
- Co-Spray-Dried Macitentan-Tadalafil with Leucine Microparticles for Inhalable Delivery in Pulmonary Arterial Hypertension.Pharmaceutics · 2026Article
- Engineering Inhalable Carboxymethyl Chitosan-Swellable Microgels for Pulmonary Delivery of Charged Hydrophilic Molecules.Gels (Basel, Switzerland) · 2025Article
- Spray-Drying Process Optimization and Modeling for an Inhaled Dry Powder of 5-Azacytidine for Treating Local and Metastatic Lung Cancer.Molecular pharmaceutics · 2025Article
- Development, Characterization, and in vitro Efficacy Evaluation of an Inhalable H1B Antimicrobial Peptide Formulation for Treating Non-Small Cell Lung Cancer.AAPS PharmSciTech · 2025Article
- Lung Delivery of Lactose-Free Microparticles Loaded with Azithromycin for the Treatment of Bacterial Infections.Pharmaceutics · 2025Article
- Nanoparticle-Based Dry Powder Inhaler Containing Ciprofloxacin for Enhanced Targeted Antibacterial Therapy.Pharmaceutics · 2025Article
- Comprehensive Aerodynamic and Physicochemical Stability Evaluations of Nanocrystal-Based Dry Powder Inhalers: The Role of Mannitol and Leucine in Enhancing Performance.Pharmaceutics · 2025Article
- Different Carriers for Use in Dry Powder Inhalers: Characteristics of Their Particles.Journal of aerosol medicine and pulmonary drug delivery · 2024Review
- On the Feasibility of Rugose Lipid Microparticles in Pressurized Metered Dose Inhalers with Established and New Propellants.AAPS PharmSciTech · 2024Article
- The Processing Space of the Spray-Dried Mannitol-Leucine System for Pulmonary Drug Delivery.Pharmaceutics · 2024Article
- Amorphization of Low Soluble Drug with Amino Acids to Improve Its Therapeutic Efficacy: a State-of-Art-Review.AAPS PharmSciTech · 2023Review
- Co-Delivery of a High Dose of Amphotericin B and Itraconazole by Means of a Dry Powder Inhaler Formulation for the Treatment of Severe Fungal Pulmonary Infections.Pharmaceutics · 2023Article
- Investigation of Physico-Chemical Stability and Aerodynamic Properties of Novel "Nano-in-Micro" Structured Dry Powder Inhaler System.Micromachines · 2023Article
- Bulk Flow Optimisation of Amorphous Solid Dispersion Excipient Powders through Surface Modification.Pharmaceutics · 2023Article
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Carrier-free spray-dried dispersions for pulmonary delivery, for which the demand is growing, frequently require the incorporation of dispersibility-enhancing excipients into the formulations to improve the efficacy of the dosage form. One of the most promising of such excipients, L-leucine, is expected to be approved for inhalation soon and has been studied exhaustively. However, during stability, small fibers protruding from the particles of leucine-containing powders have occasionally been observed. To clarify the origin of these fibers and assess their potential influence on the performance of the powders, three different classes of spray-dried leucine-containing formulation systems were studied over an 8-month accelerated stability program. These systems consisted of a large molecule biologic (bevacizumab) in conjunction with a glass former (trehalose), an amorphous small-molecular mass active (moxidectin), and a crystallizing active (mannitol). It was determined that the appearance of the fibers was due to the presence of small quantities of leucine in higher energy states, either because these were amorphous or present as a less stable crystalline polymorph. It was further shown that the growth of these leucine fibers caused no significant physicochemical instability in the powders. Nor, more importantly, did it decrease their aerosol performance in a dry powder inhaler or reduce the concentration of their active pharmaceutical ingredients.
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