Optimising 3D printed medications for rare diseases: In-line mass uniformity testing in direct powder extrusion 3D printing DOI Creative Commons
Gloria Mora-Castaño, Lucía Rodríguez‐Pombo, Paola Carou‐Senra

et al.

International Journal of Pharmaceutics, Journal Year: 2024, Volume and Issue: 668, P. 124964 - 124964

Published: Nov. 16, 2024

Biotinidase deficiency is a rare inherited disorder characterized by biotin metabolism issues, leading to neurological and cutaneous symptoms that can be alleviated through administration. Three-dimensional (3D) printing (3DP) offers potential for personalized medicine production diseases, due its flexibility in designing dosage forms controlling release profiles. For such point-of-care applications, rigorous quality control (QC) measures are essential ensure precise dosing, optimal performance, product safety, especially low doses preclinical clinical studies. In this work, we addressed QC challenges integrating precision balance into direct powder extrusion pharmaceutical 3D printer (M3DIMAKER™) real-time, in-line mass uniformity testing, critical step. Small large capsule-shaped printlets (3D printed tablets) immediate- extended-release were printed. The integrated monitored registered each printlet's weight, identifying any deviations from acceptable limits. While all printlet batches met criteria, some small exhibited weight deviations. vitro studies showed immediate-release releasing 82% of within 45 min, compared 100% printlets. formulations, 35% the drug was released printlets, whereas 24% at same time point. integration process analytical technology tools 3DP shows promise enhancing scalability dosing point-of-care, demonstrating successful testing across different sizes

Language: Английский

3D Printing Direct Powder Extrusion in the Production of Drug Delivery Systems: State of the Art and Future Perspectives DOI Creative Commons
Ángela Aguilar-de-Leyva, Marta Casas, C Ferrero

et al.

Pharmaceutics, Journal Year: 2024, Volume and Issue: 16(4), P. 437 - 437

Published: March 22, 2024

The production of tailored, on-demand drug delivery systems has gained attention in pharmaceutical development over the last few years, thanks to application 3D printing technology field. Recently, direct powder extrusion (DPE) emerged among extrusion-based additive manufacturing techniques. It is a one-step procedure that allows processing powdered formulations. aim this systematic literature review analyze using DPE. A total 27 articles have been identified through scientific databases (Scopus, PubMed, and ScienceDirect). main characteristics three types printers based on DPE discussed. selection polymers auxiliary excipients, as well flowability mixture, rheological properties molten material, temperatures critical parameters for successful printing. wide range with varied geometries different release profiles intended oral, buccal, parenteral, transdermal routes produced. ability technique manufacture personalized, proven. For all these reasons, its implementation hospital settings near future seems promising.

Language: Английский

Citations

6
3D printing of pharmaceutical dosage forms: Recent advances and applications DOI Creative Commons

Auel Tobias,

Mentrup Aaron Felix Christofer,

Olivier Roy

et al.

Advanced Drug Delivery Reviews, Journal Year: 2024, Volume and Issue: unknown, P. 115504 - 115504

Published: Dec. 1, 2024

Language: Английский

Citations

6
Pharmaceutical 3D Printing Technology Integrating Nanomaterials and Nanodevices for Precision Neurological Therapies DOI Creative Commons
Jurga Bernatonienė,

Mindaugas Plieskis,

Kęstutis Petrikonis

et al.

Pharmaceutics, Journal Year: 2025, Volume and Issue: 17(3), P. 352 - 352

Published: March 9, 2025

Pharmaceutical 3D printing, combined with nanomaterials and nanodevices, presents a transformative approach to precision medicine for treating neurological diseases. This technology enables the creation of tailored dosage forms controlled release profiles, enhancing drug delivery across blood−brain barrier (BBB). The integration nanoparticles, such as poly lactic-co-glycolic acid (PLGA), chitosan, metallic nanomaterials, into 3D-printed scaffolds improves treatment efficacy by providing targeted prolonged release. Recent advances have demonstrated potential these systems in conditions like Parkinson’s disease, epilepsy, brain tumors. Moreover, printing allows multi-drug combinations personalized formulations that adapt individual patient needs. Novel approaches, including stimuli-responsive systems, on-demand dosing, theragnostics, provide new possibilities real-time monitoring disorders. Despite innovations, challenges remain terms scalability, regulatory approval, long-term safety. future perspectives this suggest its revolutionize treatments offering patient-specific therapies, improved penetration, enhanced outcomes. review discusses current state, applications, nanotechnology treatment, highlighting need further research overcome existing challenges.

Language: Английский

Citations

0
The Future of Medicine: How 3D Printing Is Transforming Pharmaceuticals DOI Creative Commons
Jurga Bernatonienė, Jolita Stabrauskiene, Jurga Andrėja Kazlauskaitė

et al.

Pharmaceutics, Journal Year: 2025, Volume and Issue: 17(3), P. 390 - 390

Published: March 19, 2025

Three-dimensional printing technology is transforming pharmaceutical manufacturing by shifting from conventional mass production to additive manufacturing, with a strong emphasis on personalized medicine. The integration of bioinks and AI-driven optimization further enhancing this innovation, enabling drug precise dosages, tailored drug-release profiles, unique multi-drug combinations that respond individual patient needs. This advancement significantly impacting healthcare accelerating development, encouraging innovative designs, treatment efficacy. Traditional follows one-size-fits-all approach, which often fails meet the specific requirements patients medical conditions. In contrast, 3D printing, coupled bioink formulations, allows for on-demand production, reducing dependency large-scale storage. AI-powered design process refine dosage forms, printability, release mechanisms, ensuring precision efficiency in manufacturing. These advancements have potential lower overall costs while improving adherence medication regimens. review explores potential, challenges, environmental benefits positioning it as key driver next-generation

Language: Английский

Citations

0
Sex-specific formulations of doxazosin mesylate via direct powder extrusion 3D printing DOI Creative Commons
Patricija Januskaite, Álvaro Goyanes, Mine Orlu

et al.

Drug Delivery and Translational Research, Journal Year: 2025, Volume and Issue: unknown

Published: April 22, 2025

Abstract Males and females are known to exhibit significant differences in drug pharmacokinetics pharmacodynamics, which still overlooked pharmaceutical research development. These disparities contribute adverse effects increased mortality females, highlighting the critical need for sex-specific formulations. Extended-release formulations of doxazosin mesylate, an alpha blocker used treat hypertension, have shown sex-based pharmacokinetics, leading heightened rendering current titration recommendations impractical. This study explored potential a 3D printing (3DP) technology, direct powder extrusion (DPE), producing personalised, doses mesylate. A simple three component formulation was made composed hydroxypropyl cellulose (HPC) polymer Klucel JF, D-mannitol, printlets varying (1, 2, 3 mg) were manufactured from single 1% w/w pharma-ink batch, enabling easy dose personalisation by adjusting printlet dimensions. The use supports technology’s ease pharmacy setting, eliminating frequent changes during compounding process. In vitro dissolution testing revealed extended release profile, influenced surface-area-to-volume (SA: V) ratios. Introducing channels larger standardized SA: V ratios, enhancing profile uniformity. Release kinetics followed Hixson-Crowell Korsmeyer-Peppas models, indicating diffusion swelling mechanisms. work highlights capability DPE 3DP creating personalized, extended-release oral dosage forms, supporting precise customization patient-specific therapy.

Language: Английский

Citations

0
Expediting 3D printed medication development using vacuum compression moulding DOI Creative Commons

Anna Kirstine Jørgensen,

Ye Chan Oh,

Hanxiang Li

et al.

Journal of Controlled Release, Journal Year: 2025, Volume and Issue: unknown, P. 113766 - 113766

Published: April 1, 2025

Language: Английский

Citations

0
Application of 3D printing on the design and development of pharmaceutical oral dosage forms DOI Creative Commons

Nicola Paccione,

Víctor Guarnizo-Herrero, Murugan Ramalingam

et al.

Journal of Controlled Release, Journal Year: 2024, Volume and Issue: 373, P. 463 - 480

Published: July 25, 2024

3D printing technologies confer an unparalleled degree of control over the material distribution on structures they produce, which has led them to become extremely attractive research topic in pharmaceutical dosage form development, especially for design personalized treatments. With fine tuning selection and careful design, these allow tailor not only amount drug administered but biopharmaceutical behaviour forms as well. While fused deposition modelling (FDM) is still most studied technology this area, others are gaining more relevance, many new exciting developed during 2022 2023. Considering that technologies, time, will join current manufacturing methods with ever-increasing knowledge topic, our review aims explore advantages limitations employed development oral forms, giving special focus important aspects governing resulting release profiles.

Language: Английский

Citations

1
Single-Step Extrusion Process for Formulation Development of Self-Emulsifying Granules for Oral Delivery of a BCS Class IV Drug DOI
Vineet Kulkarni, Santosh Bashyal, Varsha V. Nair

et al.

Molecular Pharmaceutics, Journal Year: 2024, Volume and Issue: unknown

Published: Oct. 8, 2024

This study aimed to develop and optimize formulations containinga BCS Class IV drug by improving its solubility permeability. Herein development of self-emulsifying solid lipid matrices was investigated as carrier systems for a model drug. Self-emulsifying delivery (SEDDS) have been extensively formulating drugs with poor water solubility. However, manufacturing SEDDS is challenging. These usually low drug-loading capacities, the incorporated tend recrystallize during storage, which severely impacts storage stability in vitro performance vivo. Moreover, they require greater amounts (>80%) carriers, cosolvents, surfactants, other excipients keep them from recrystallizing. turn again challenging high-dose it affects size final product (tablets capsules). Also, liquid nature formulation handling processability formulation, poses challenges packaging steps. In this work, we studied feasibility single-step extrusion process formulate granules relatively higher loading Ritonavir (RTV), Further, compared using these feedstock direct powder extrusion-based 3D printing opposed use physical blends. The solubility-permeability advantage also evaluated where showed about 27 20 fold increase apparent solublity permeability bulk drug, respectively. Combining capabilities HME form drug-loaded homogeneous continuous along application extruiosn (DPE) improves prospects such candidates.

Language: Английский

Citations

1
Twin Screw Melt Granulation of Simvastatin: Drug Solubility and Dissolution Rate Enhancement Using Polymer Blends DOI Creative Commons
Rasha M. Elkanayati, Indrajeet Karnik, Prateek Uttreja

et al.

Pharmaceutics, Journal Year: 2024, Volume and Issue: 16(12), P. 1630 - 1630

Published: Dec. 23, 2024

Background/Objectives: This study evaluates the efficacy of twin screw melt granulation (TSMG), and hot-melt extrusion (HME) techniques in enhancing solubility dissolution simvastatin (SIM), a poorly water-soluble drug with low bioavailability. Additionally, explores impact binary polymer blends on drug’s miscibility, solubility, vitro release profile. Methods: SIM was processed various polymeric combinations at 30% w/w load, 1:1 ratio blends, including Soluplus® (SOP), Kollidon® K12 (K12), VA64 (KVA), Kollicoat® IR (KIR). The solid dispersions were characterized using modulated differential scanning calorimetry (M-DSC), powder X-ray diffraction (PXRD), Fourier-transform infrared spectroscopy (FTIR). Dissolution studies compared developed formulations against marketed product. Results: SIM-SOP/KIR blend showed highest (34 µg/mL), achieving an approximately 5.5-fold enhancement over pure drug. that had significantly higher profiles than physical mixture (PM) (p < 0.01). their similar to formulation, 100% within 30 min. In contrast, SIM-K12/KIR formulation exhibited strong but limited slower rates, suggesting high miscibility does not necessarily correlate improved solubility. Conclusions: demonstrates effectiveness TSMG, HME as effective continuous manufacturing technologies for improving therapeutic drugs. It also emphasizes complexity polymer–drug interactions necessity carefully selecting compatible polymers optimize quality performance pharmaceutical formulations.

Language: Английский

Citations

1
Optimising 3D printed medications for rare diseases: In-line mass uniformity testing in direct powder extrusion 3D printing DOI Creative Commons
Gloria Mora-Castaño, Lucía Rodríguez‐Pombo, Paola Carou‐Senra

et al.

International Journal of Pharmaceutics, Journal Year: 2024, Volume and Issue: 668, P. 124964 - 124964

Published: Nov. 16, 2024

Biotinidase deficiency is a rare inherited disorder characterized by biotin metabolism issues, leading to neurological and cutaneous symptoms that can be alleviated through administration. Three-dimensional (3D) printing (3DP) offers potential for personalized medicine production diseases, due its flexibility in designing dosage forms controlling release profiles. For such point-of-care applications, rigorous quality control (QC) measures are essential ensure precise dosing, optimal performance, product safety, especially low doses preclinical clinical studies. In this work, we addressed QC challenges integrating precision balance into direct powder extrusion pharmaceutical 3D printer (M3DIMAKER™) real-time, in-line mass uniformity testing, critical step. Small large capsule-shaped printlets (3D printed tablets) immediate- extended-release were printed. The integrated monitored registered each printlet's weight, identifying any deviations from acceptable limits. While all printlet batches met criteria, some small exhibited weight deviations. vitro studies showed immediate-release releasing 82% of within 45 min, compared 100% printlets. formulations, 35% the drug was released printlets, whereas 24% at same time point. integration process analytical technology tools 3DP shows promise enhancing scalability dosing point-of-care, demonstrating successful testing across different sizes

Language: Английский

Citations

0