ArticleAAPS PharmSciTech2021
Influence of Particle Size and Drug Load on Amorphous Solid Dispersions Containing pH-Dependent Soluble Polymers and the Weak Base Ketoconazole.
Article in AAPS PharmSciTech, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
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Who cites it
21 citing papers in PubMed.
- Unlocking the potential of alkaline polymethacrylates via ionic crosslinking in amorphous solid dispersions.International journal of pharmaceutics: X · 2026Article
- Formulation Design of a Hot-melt Extrusion-Based Amorphous Solid Dispersion to Optimize Palatability of Berberine Hydrochloride with In Vitro and In Vivo Evaluation.AAPS PharmSciTech · 2026Article
- Dissolution Amelioration by Small Amounts of HPMC in the Difficult-to-solve Drug Combination Baicalein-imperatorin Co-Amorphous System: Dispersion and Crystallization Inhibition.AAPS PharmSciTech · 2025Article
- Continuous Processing Strategies for Amorphous Solid Dispersions of Itraconazole: Impact of Polymer Selection and Manufacturing Techniques.Pharmaceutics · 2025Article
- Mechanistic Insights into Amorphous Solid Dispersions: Bridging Theory and Practice in Drug Delivery.Pharmaceutical research · 2025Review
- 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
- Exploring Immersion Coating as a Cost-Effective Method for Small-Scale Production of Enteric-Coated Gelatin Capsules.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Phase homogeneity in ternary amorphous solid dispersions and its impact on solubility, dissolution and supersaturation - Influence of processing and hydroxypropyl cellulose grade.International journal of pharmaceutics: X · 2023Article
- Evaluation of a Three-Fluid Nozzle Spraying Process for Facilitating Spray Drying of Hydrophilic Polymers for the Creation of Amorphous Solid Dispersions.Pharmaceutics · 2023Article
- Enteric coating of tablets containing an amorphous solid dispersion of an enteric polymer and a weakly basic drug: A strategy to enhance in vitro release.International journal of pharmaceutics · 2023Article
- Impact of Gastric pH Variations on the Release of Amorphous Solid Dispersion Formulations Containing a Weakly Basic Drug and Enteric Polymers.Molecular pharmaceutics · 2023Article
- Amorphous Solid Dispersions Layered onto Pellets-An Alternative to Spray Drying?Pharmaceutics · 2023Article
- Solubility Enhanced Formulation Approaches to Overcome Oral Delivery Obstacles of PROTACs.Pharmaceutics · 2023Article
- Subcellular Organelle-Targeted Nanostructured Lipid Carriers for the Treatment of Metastatic Breast Cancer.International journal of nanomedicine · 2023Article
- Enteric-Coated Cologrit Tablet Exhibit Robust Anti-Inflammatory Response in Ulcerative Colitis-like In-Vitro Models by Attuning NFκB-Centric Signaling Axis.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Boost of solubility and supersaturation of celecoxib via synergistic interactions of methacrylic acid-ethyl acrylate copolymer (1:1) and hydroxypropyl cellulose in ternary amorphous solid dispersions.International journal of pharmaceutics: X · 2022Article
- Commercially Available Enteric Empty Hard Capsules, Production Technology and Application.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Downstream Processing of Itraconazole:HPMCAS Amorphous Solid Dispersion: From Hot-Melt Extrudate to Tablet Using a Quality by Design Approach.Pharmaceutics · 2022Article
- Optimization of Spray-Drying Parameters for Formulation Development at Preclinical Scale.AAPS PharmSciTech · 2021Article
- Polyelectrolyte Matrices in the Modulation of Intermolecular Electrostatic Interactions for Amorphous Solid Dispersions: A Comprehensive Review.Pharmaceutics · 2021Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Among the great number of poorly soluble drugs in pharmaceutical development, most of them are weak bases. Typically, they readily dissolve in an acidic environment but are prone to precipitation at elevated pH. This was aimed to be counteracted by the preparation of amorphous solid dispersions (ASDs) using the pH-dependent soluble polymers methacrylic acid ethylacrylate copolymer (Eudragit L100-55) and hydroxypropylmethylcellulose acetate succinate (HPMCAS) via hot-melt extrusion. The hot-melt extruded ASDs were of amorphous nature and single phased with the presence of specific interactions between drug and polymer as revealed by X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), and Fourier-transform infrared spectroscopy (FT-IR). The ASDs were milled and classified into six particle size fractions. We investigated the influence of particle size, drug load, and polymer type on the dissolution performance. The best dissolution performance was achieved for the ASD made from Eudragit L100-55 at a drug load of 10%, whereby the dissolution rate was inversely proportional to the particle size. Within a pH-shift dissolution experiment (from pH 1 to pH 6.8), amorphous-amorphous phase separation occurred as a result of exposure to acidic medium which caused markedly reduced dissolution rates at subsequent higher pH values. Phase separation could be prevented by using enteric capsules (Vcaps Enteric®), which provided optimal dissolution profiles for the Eudragit L100-55 ASD at a drug load of 10%.
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