ArticleInternational journal of pharmaceutics: X2021
Predicting process design spaces for spray drying amorphous solid dispersions.
Article in International journal of pharmaceutics: X, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- The expanding role of formulations to enable oral delivery of poorly water-soluble drugs.Nature reviews. Drug discovery · 2026Review
- Combining of Spray Drying and Dry Granulation to Prepare Orodispersible Tablets: Influence of Spray-Dried Particle Size on Tablet Properties.AAPS PharmSciTech · 2026Article
- Spray-Drying Process Optimization and Modeling for an Inhaled Dry Powder of 5-Azacytidine for Treating Local and Metastatic Lung Cancer.Molecular pharmaceutics · 2025Article
- Trends in amorphous solid dispersion drug products approved by the U.S. Food and Drug Administration between 2012 and 2023.International journal of pharmaceutics: X · 2024Article
- Thermodynamic Modeling of the Amorphous Solid Dispersion-Water Interfacial Layer and Its Impact on the Release Mechanism.Pharmaceutics · 2023Article
- Controlling the crystal structure of succinic acidRSC advances · 2023Article
- Stability-Enhanced Ternary Solid Dispersions of Glyburide: Effect of Preparation Method on Physicochemical Properties.Advances in pharmacological and pharmaceutical sciences · 2023Article
- Progress on COVID-19 Chemotherapeutics Discovery and Novel Technology.Molecules (Basel, Switzerland) · 2022Review
- Thermodynamic Balance vs. Computational Fluid Dynamics Approach for the Outlet Temperature Estimation of a Benchtop Spray Dryer.Pharmaceutics · 2022Article
- Article
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Amorphous solid dispersions (ASDs) are commonly manufactured using spray-drying processes. The product quality can be decisively influenced by the choice of process parameters. Following the quality-by-design approach, the identification of the spray-drying process design space is thus an integral task in drug product development. Aiming a solvent-free and homogeneous ASD, API crystallization and amorphous phase separation needs to be avoided during drying. This publication provides a predictive approach for determining spray-drying process conditions via considering thermodynamic driving forces for solvent drying as well as ASD-specific API/polymer/solvent interactions and glass transitions. The ternary API/polymer/solvent phase behavior was calculated using the Perturbed-Chain Statistical Associating Theory (PC-SAFT) and combined with mass and energy balances to find appropriate spray-drying conditions. A process design space was identified for the ASDs of ritonavir and naproxen with either poly(vinylpyrrolidone) or poly(vinylpyrrolidone-co-vinylacetate) spray dried from the solvents acetone, dichloromethane, or ethanol.
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