ReviewEuropean journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences2021
Quality-by-design in hot melt extrusion based amorphous solid dispersions: An industrial perspective on product development.
Review in European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed.
- From triggers to interfaces: polymer-stabilized nano-co-crystals for robust mesalazine delivery in UC.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026Review
- Novel Hybrid Polymer-Lipid-Based Formulations for Enhanced Dissolution Rates of Poorly Water-Soluble Drugs: A Quality by Design (QbD) Approach via Hot Melt Extrusion.AAPS PharmSciTech · 2026Article
- Hidden Solid-State Transformation of Darunavir in Low-Temperature Hot-Melt-Extruded Granules: Implications for Pharmacy Compounding and Routine Quality Control.Pharmaceutics · 2026Article
- Simultaneous ultrasound-microwave assisted deep eutectic solvent extraction of essential oil from calamansi (Citrus × microcarpa) peel: optimization, volatile profiling, and antioxidant activities.Ultrasonics sonochemistry · 2026Article
- Advancing amorphous solid dispersions through empirical and hybrid modeling of drug-polymer solubility and miscibility: A case study using Ibuprofen.International journal of pharmaceutics: X · 2025Article
- Impact of Different Drying Processes on the Physico-Chemical Properties of Liquitablet Formulations Containing Lornoxicam.Pharmaceutics · 2025Article
- Hot Melt Extrusion Technology in Taste Masking.AAPS PharmSciTech · 2025Review
- Process Development for the Continuous Manufacturing of Carbamazepine-Nicotinamide Co-Crystals Utilizing Hot-Melt Extrusion Technology.Pharmaceutics · 2025Article
- Combining High-Throughput Screening and Machine Learning to Predict the Formation of Both Binary and Ternary Amorphous Solid Dispersion Formulations for Early Drug Discovery and Development.Pharmaceutical research · 2025Article
- Article
- Computational Support to Explore Ternary Solid Dispersions of Challenging Drugs Using Coformer and Hydroxypropyl Cellulose.Molecular pharmaceutics · 2024Article
- Customizable Three-Dimensional Printed Earring Tap for Treating Affections Caused by Aesthetic Perforations.Pharmaceutics · 2024Article
- The applications of machine learning to predict the forming of chemically stable amorphous solid dispersions prepared by hot-melt extrusion.International journal of pharmaceutics: X · 2023Article
- HPMCAS-Based Amorphous Solid Dispersions in Clinic: A Review on Manufacturing Techniques (Hot Melt Extrusion and Spray Drying), Marketed Products and Patents.Materials (Basel, Switzerland) · 2023Review
- Development of Diclofenac Sodium 3D Printed Cylindrical and Tubular-Shaped Tablets through Hot Melt Extrusion and Fused Deposition Modelling Techniques.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Advances in the development of amorphous solid dispersions: The role of polymeric carriers.Asian journal of pharmaceutical sciences · 2023Review
- Article
- Itraconazole Amorphous Solid Dispersion Tablets: Formulation and Compaction Process Optimization Using Quality by Design Principles and Tools.Pharmaceutics · 2022Article
- Article
- Review
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
An industrially feasible approach to overcome the solubility and bioavailability limitations of poorly soluble active pharmaceutical ingredients is the development of amorphous solid dispersions (ASDs) using hot-melt extrusion (HME) technique. The application of Quality by Design (QbD) had a profound impact on the development of HME-based ASDs. The formulation and process optimization of ASDs manufactured via HME techniques require an understanding of critical quality attributes, critical material attributes, critical process parameters, risk assessment tools, and experimental designs. The knowledge gained from each of these QbD elements helps ensure the consistency of product quality. The selection and implementation of appropriate Design of Experiments (DoE) methodology to screen and optimize the formulation and process variables remain a major challenge. This review provides a comprehensive overview on QbD concepts in HME-based ASDs with an emphasis on DoE methodologies. Further, the information provided in this review can assist researchers in selecting a suitable design with optimal experimental conditions. Specifically, this review has focused on the prediction of drug-polymer miscibility, the elements and sequence of QbD, and various screening and optimization designs, to provide insights into the formulation and process variables that are encountered routinely in the production of HME-based ASDs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.