ArticlePharmaceutics2023
Continuous Manufacturing of Solvent-Free Cyclodextrin Inclusion Complexes for Enhanced Drug Solubility via Hot-Melt Extrusion: A Quality by Design Approach.
Article in Pharmaceutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed.
- Chitosan-Fucoidan Gel Formation for Food Packaging Film Development Incorporating Blackcurrant Anthocyanins for Monitoring Tuna Freshness.Gels (Basel, Switzerland) · 2026Article
- Theoretical View: Thermodynamics of the Saturation Dissolution of a Molecular (Solid) Dispersion of a Hydrophobic Molecule and Polymeric Surfactant in an Aqueous Solution.International journal of molecular sciences · 2025Article
- Comparative evaluation of ternary amorphous solid dispersions: Identifying optimal excipient systems for enhancing drug solubility.International journal of pharmaceutics: X · 2025Review
- Enhancing the solubility of celecoxib via lyophilized solid dispersions using computational and experimental approaches.Scientific reports · 2025Article
- Article
- Approaches for Inclusion Complexes of Ezetimibe with Cyclodextrins: Strategies for Solubility Enhancement and Interaction Analysis via Molecular Docking.International journal of molecular sciences · 2025Article
- Innovative Strategies and Advances in Drug Delivery Systems to Address Poor Solubility: A Comprehensive Review.Current drug targets · 2025Review
- Twin Screw Melt Granulation of Simvastatin: Drug Solubility and Dissolution Rate Enhancement Using Polymer Blends.Pharmaceutics · 2024Article
- Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation-Where Are We Now?AAPS PharmSciTech · 2024Review
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Authors and funding
8 authors.
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Abstract
Conventional cyclodextrin complexation enhances the solubility of poorly soluble drugs but is solvent-intensive and environmentally unfavorable. This study evaluated solvent-free hot-melt extrusion (HME) for forming cyclodextrin inclusion complexes to improve the solubility and dissolution of ibuprofen (IBU). Molecular docking confirmed IBU's hosting in Hydroxypropyl-β-cyclodextrin (HPβ-CD), while phase solubility revealed its complex stoichiometry and stability. In addition, an 11 mm twin-screw co-rotating extruder with PVP VA-64 as an auxiliary substance aided the complex formation and extrusion. Using QbD and the Box-Behnken design, we studied variables (barrel temperature, screw speed, and polymer concentration) and their impact on solubility and dissolution. The high polymer concentration and high screw speeds positively affected the dependent variables. However, higher temperatures had a negative effect. The lowest barrel temperature set near the Tg of the polymer, when combined with high polymer concentrations, resulted in high torques in HME and halted the extrusion process. Therefore, the temperature and polymer concentration should be selected to provide sufficient melt viscosities to aid the complex formation and extrusion process. Studies such as DSC and XRD revealed the amorphous conversion of IBU, while the inclusion complex formation was demonstrated by ATR and NMR studies. The dissolution of ternary inclusion complexes (TIC) produced from HME was found to be ≥85% released within 30 min. This finding implied the high solubility of IBU, according to the US FDA 2018 guidance for highly soluble compounds containing immediate-release solid oral dosage forms. Overall, the studies revealed the effect of various process parameters on the formation of CD inclusion complexes via HME.
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