ReviewAAPS PharmSciTech2020
Developing HME-Based Drug Products Using Emerging Science: a Fast-Track Roadmap from Concept to Clinical Batch.
Review in AAPS PharmSciTech, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
15 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
- Hidden Solid-State Transformation of Darunavir in Low-Temperature Hot-Melt-Extruded Granules: Implications for Pharmacy Compounding and Routine Quality Control.Pharmaceutics · 2026Article
- Exploring the pivotal role of hot melt extrusion technology in developing PLGA based novel drug delivery platforms for better therapeutic outcomes.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2026Review
- Data-driven full-chain quality control for Xiaoer Chiqiao Qingre granules: from process risk management to intelligent product testing.Chinese medicine · 2026Article
- The Increase in the Plasticity of Microcrystalline Cellulose Spheres' When Loaded with a Plasticizer.Pharmaceutics · 2024Article
- Transfer of a rational formulation and process development approach for 2D inks for pharmaceutical 2D and 3D printing.International journal of pharmaceutics: X · 2024Article
- Material-Sparing Feasibility Screening for Hot Melt Extrusion.Pharmaceutics · 2024Article
- Scope and Application of Hot Melt Extrusion in the Development of Controlled and Sustained Release Drug Delivery Systems.Current pharmaceutical design · 2024Review
- Tailored ASD destabilization - Balancing shelf life stability and dissolution performance with hydroxypropyl cellulose.International journal of pharmaceutics: X · 2023Article
- SEDEX-Self-Emulsifying Delivery Via Hot Melt Extrusion: A Continuous Pilot-Scale Feasibility Study.Pharmaceutics · 2022Article
- Downstream processing of spray-dried ASD with hypromellose acetate succinate - Roller compaction and subsequent compression into high ASD load tablets.International journal of pharmaceutics: X · 2021Article
- Towards predicting the product quality in hot-melt extrusion: Pilot plant scale extrusion.International journal of pharmaceutics: X · 2021Article
- Hot-Melt Extrusion: a Roadmap for Product Development.AAPS PharmSciTech · 2021Review
- Early mobilization intervention for patient rehabilitation after renal transplantation.American journal of translational research · 2021Article
- Towards predicting the product quality in hot-melt extrusion: Small scale extrusion.International journal of pharmaceutics: X · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This paper presents a rational workflow for developing enabling formulations, such as amorphous solid dispersions, via hot-melt extrusion in less than a year. First, our approach to an integrated product and process development framework is described, including state-of-the-art theoretical concepts, modeling, and experimental characterization described in the literature and developed by us. Next, lab-scale extruder setups are designed (processing conditions and screw design) based on a rational, model-based framework that takes into account the thermal load required, the mixing capabilities, and the thermo-mechanical degradation. The predicted optimal process setup can be validated quickly in the pilot plant. Lastly, a transfer of the process to any GMP-certified manufacturing site can be performed in silico for any extruder based on our validated computational framework. In summary, the proposed workflow massively reduces the risk in product and process development and shortens the drug-to-market time for enabling formulations.
Indexed as
Identifiers
What OpenQuestion holds
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.