ArticlePharmaceutical research2018
Development of Fast-Dissolving Amorphous Solid Dispersion of Itraconazole by Melt Extrusion of its Mixture with Weak Organic Carboxylic Acid and Polymer.
Article in Pharmaceutical research, 2018. 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, 25 citations in OpenAlex.
- Drug Dissolution in Oral Drug Absorption: Workshop Report.The AAPS journal · 2023Article
- Challenges, current status and emerging strategies in the development of rapidly dissolving FDM 3D-printed tablets: An overview and commentary.ADMET & DMPK · 2023Review
- Chemical Stability Study of HMolecules (Basel, Switzerland) · 2022Article
- Tunable Drug Release from Fused Deposition Modelling (FDM) 3D-Printed Tablets Fabricated Using a Novel Extrudable Polymer.Pharmaceutics · 2022Article
- Citric Acid: A Multifunctional Pharmaceutical Excipient.Pharmaceutics · 2022Review
- Multivariate Design of 3D Printed Immediate-Release Tablets with Liquid Crystal-Forming Drug-Itraconazole.Materials (Basel, Switzerland) · 2020Article
- An update on the contribution of hot-melt extrusion technology to novel drug delivery in the twenty-first century: part II.Expert opinion on drug delivery · 2019Review
- Polyelectrolytes in Hot Melt Extrusion: A Combined Solvent-Based and Interacting Additive Technique for Solid Dispersions.Pharmaceutics · 2019Article
- Perspectives in solubility measurement and interpretation.ADMET & DMPK · 2019Review
Corrections and comments
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe purpose of this study was to explore the feasibility of developing amorphous solid dispersion (ASD) by inducing acid-base interaction at an elevated temperature using hot melt extrusion.
methodsItraconazole and glutaric acid, which do not form salt with each other, were selected as, respectively, model basic drug and weak organic acid. A 1:4:1w/w mixture of itraconazole, glutaric acid and a polymer, Kollidon®VA64, was melt extruded at 95°C. The ground extrudate was characterized by DSC and PXRD and then tested for dissolution at pH 1.2, followed by a change in pH to 5.5.
resultsDespite the high melting point of 168°C, itraconazole dissolved in glutaric acid at around the melting temperature of acid (~98°C), and physically stable ASD was produced when the formulation was extruded at 95°C. Capsules containing 100-mg equivalent of itraconazole dissolved rapidly at pH 1.2 producing highly supersaturated solution. When the pH was changed from 1.2 to 5.5, very fine suspensions, facilitated by the presence of Kollidon®VA64, was formed.
conclusionsPhysically stable ASD of itraconazole with high drug load was prepared by interaction with glutaric acid in a hot melt extruder. This may be used as a platform technology for the development ASD of most poorly water-soluble basic drugs.
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