ArticlePharmaceutics2024
Can 3D Printed Tablets Be Bioequivalent and How to Test It: A PBPK Model Based Virtual Bioequivalence Study for Ropinirole Modified Release Tablets.
Article in Pharmaceutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 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.
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Who cites it
4 citing papers in PubMed.
- Hot-Melt Pneumatic Extrusion-Based 3D-Printed Bilayer Tablets Enabling Sequential Release of Levocetirizine and Montelukast.Pharmaceutics · 2026Article
- Beyond Dysphagia in Parkinson's Disease: 3D Printing of Orally Disintegrating Tablets (ODTs) for Optimized Treatment.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Toward a harmonized regulatory framework for 3D-printed pharmaceutical products: the role of critical feedstock materials and process parameters.Drug delivery and translational research · 2025Review
- Revealing Three-Dimensional Printing Technology Advances for Oral Drug Delivery: Application to Central-Nervous-System-Related Diseases.Pharmaceutics · 2025Review
Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
As the field of personalized dosing develops, the pharmaceutical manufacturing industry needs to offer flexibility in terms of tailoring the drug release and strength to the individual patient's needs. One of the promising tools which have such capacity is 3D printing technology. However, manufacturing small batches of drugs for each patient might lead to huge test burden, including the need to conduct bioequivalence trials of formulations to support the change of equipment or strength. In this paper we demonstrate how to use 3D printing in conjunction with virtual bioequivalence trials based on physiologically based pharmacokinetic (PBPK) modeling. For this purpose, we developed 3D printed ropinirole formulations and tested their bioequivalence with the reference product Polpix. The Simcyp simulator and previously developed ropinirole PBPK model were used for the clinical trial simulations. The Weibull-fitted dissolution profiles of test and reference formulations were used as inputs for the model. The virtual bioequivalence trials were run using parallel design. The study power of 80% was reached using 125 individuals. The study demonstrated how to use PBPK modeling in conjunction with 3D printing to test the virtual bioequivalence of newly developed formulations. This virtual experiment demonstrated the bioequivalence of one of the newly developed formulations with a reference product available on a market.
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Registered trials
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