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Pharmaceutics
Special Issues
Advances in Hot Melt Extrusion Technology
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Advances in Hot Melt Extrusion Technology

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmaceutical Technology, Manufacturing and Devices".

Deadline for manuscript submissions: 30 September 2025 | Viewed by 2005

Special Issue Editors

Dr. Dinesh Nyavanandi

E-Mail Website
Guest Editor
Technical Operations, Cerevel Therapeutics, Cambridge, MA 02141, USA
Interests: hot melt extrusion; spray drying; continuous manufacturing; additive manufacturing; solid oral dosage forms; lipid based drug delivery systems; twin screw granulation; amorphous solid dispersions; implants; colon targeted drug delivery; gastro retentive formulations
Special Issues, Collections and Topics in MDPI journals
Dr. Valentyn Mohylyuk

E-Mail Website
Guest Editor
Leading Research Group, Riga Stradiņš University, LV-1007 Riga, Latvia
Interests: drug delivery and respective analytical methods; improving the solubility and bioavailability (BA) of poorly soluble drugs oral dosage forms (ODF); tailored drug release and improved customer properties of ODF; alcohol-resistant sustained-release ODF; abuse deterrent ODF; long-acting parenteral implants; hot-melt extrusion (HME); fluid-bed coating; loading of porous carriers; co-precipitation; easy-swallowing; taste-masked; delayed-, modified-release pellets & tablets; fluid-bed/pan-coating; matrix tablets; roll compaction (RC); continuous manufacturing of solid DF incl. continuous processing steps; emulsification congealing/polymerization; microfluidics; 3D-printing; compression-moulding

Special Issue Information

Dear Colleagues,

In recent years, hot melt extrusion (HME) has attracted the attention of researchers from the pharmaceutical industry and regulatory agencies due to its wide variety of applications in developing pharmaceutical medications. HME has been widely investigated in regard to improving the solubility and bioavailability of poorly soluble drug substances via amorphous solid dispersions, co-crystals, salts, co-amorphous systems, cyclodextrin complexation, solid crystal suspension, and lipid-based drug delivery systems. It is a single-step continuous manufacturing process that involves the application of thermal and mechanical shear, and it uses no solvent. Along with extrusion, the extruder is also suitable for the granulation process, referred to as twin-screw granulation (TSG). The extruder can also be coupled with an additive manufacturing process to fabricate patient-centric dosage forms. Along with the above-discussed application, the HME can also be employed for novel applications such as spheronization, co-extrusion, and injection molding. This Special Issue presents recent advancements, technical innovations, and practical applications of HME in drug formulation. Contributions exploring process optimization, material selection, characterization techniques, and clinical implications are invited, providing a comprehensive overview of HME's impact on modern pharmaceutics.

We encourage the submission of original research articles, comprehensive reviews, and case studies that explore the latest breakthroughs in HME. This Special Issue will be a vital resource for scientists, researchers, and industry professionals aiming to leverage HME for innovative pharmaceutical solutions. Join us in advancing the field by sharing your expertise and insights on this dynamic and rapidly evolving technology.

We look forward to receiving your contributions.

Dr. Dinesh Nyavanandi
Dr. Valentyn Mohylyuk
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • hot melt extrusion
  • solubility enhancement
  • amorphous solid dispersion
  • additive manufacturing
  • twin screw granulation
  • continuous manufacturing
  • lipid-based drug delivery systems
  • patient-centric dosage forms
  • fused deposition modeling 3D printing
  • bioavailability

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Published Papers (3 papers)

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Research

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23 pages, 7056 KiB  
Article
Feasibility of Hot Melt Extrusion in Converting Water-Based Nanosuspensions into Solid Dosage Forms
by Erasmo Ragucci, Marco Uboldi, Adam Sobczuk, Giorgio Facchetti, Alice Melocchi, Mauro Serratoni and Lucia Zema
Pharmaceutics 2025, 17(5), 662; https://doi.org/10.3390/pharmaceutics17050662 (registering DOI) - 17 May 2025
Abstract
Aim: In addition to numerous benefits provided by nanosuspensions (NSs) (e.g., enhanced saturation solubility, increased area for interaction with fluids), they suffer from major stability, handling and compliance issues. To overcome these challenges, we evaluated the feasibility of hot melt extrusion (HME) in [...] Read more.
Aim: In addition to numerous benefits provided by nanosuspensions (NSs) (e.g., enhanced saturation solubility, increased area for interaction with fluids), they suffer from major stability, handling and compliance issues. To overcome these challenges, we evaluated the feasibility of hot melt extrusion (HME) in transforming a cinnarizine-based NS, selected as a case study, into granules for oral intake. Methods: Thermoplastic polymers, in principle compatible with the thermal behavior of the selected drug and characterized by different interaction mechanisms with aqueous fluids, were used as carriers to absorb the NS and were processed by HME. Results: The extruded granules pointed out good physio-technological characteristics, a drug content > 85% with coefficient of variation (CV) < 5% and tunable in vitro performance coherent with the polymeric carriers they were composed of. Particle size as well as the solid state of cinnarizine was checked using several analytical techniques in combination (e.g., DSC, SEM, FT-IR, Raman). Depending on the composition of the granules, and specifically for formulations processed below 85 °C, the drug was found to remain crystalline and in the desired nanoscale. Conclusions: HME turned out to be a versatile process to transform, in a single-step, NSs into multi-particulate solid products for oral administration showing a variety of release profiles. Full article
(This article belongs to the Special Issue Advances in Hot Melt Extrusion Technology)
24 pages, 15011 KiB  
Article
Process Development for the Continuous Manufacturing of Carbamazepine-Nicotinamide Co-Crystals Utilizing Hot-Melt Extrusion Technology
by Lianghao Huang, Wen Ni, Yaru Jia, Minqing Zhu, Tiantian Yang, Mingchao Yu and Jiaxiang Zhang
Pharmaceutics 2025, 17(5), 568; https://doi.org/10.3390/pharmaceutics17050568 - 25 Apr 2025
Viewed by 296
Abstract
Objectives: Hot-melt extrusion (HME) offers a solvent-free, scalable approach for manufacturing pharmaceutical co-crystals (CCs), aligning with the industry’s shift to continuous manufacturing (CM). However, challenges like undefined yield optimization, insufficient risk management, and limited process analytical technology (PAT) integration hinder its industrial application. [...] Read more.
Objectives: Hot-melt extrusion (HME) offers a solvent-free, scalable approach for manufacturing pharmaceutical co-crystals (CCs), aligning with the industry’s shift to continuous manufacturing (CM). However, challenges like undefined yield optimization, insufficient risk management, and limited process analytical technology (PAT) integration hinder its industrial application. This study aimed to develop a proof-of-concept HME platform for CCs, assess process risks, and evaluate PAT-enabled monitoring to facilitate robust production. Methods: Using carbamazepine (CBZ) and nicotinamide (NIC) as model compounds, an HME platform compatible with PAT tools was established. A systematic risk assessment identified five key risk domains: materials, machinery, measurement, methods, and other factors. A Box–Behnken design of experiments (DoE) evaluated the impact of screw speed, temperature, and mixing sections on CC quality. Near-infrared (NIR) spectroscopy monitored CBZ-NIC co-crystal formation in real time during HME process. Results: DoE revealed temperature and number of mixing sections significantly influenced particle size (D50: 2.0–4.0 μm), while screw speed affected efficiency. NIR spectroscopy detected a unique CC absorption peak at 5008.3 cm⁻¹, enabling real-time structural monitoring with high accuracy (R² = 0.9999). Risk assessment highlighted material attributes, process parameters, and equipment design as critical factors affecting CC formation. All experimental batches yielded ≥ 94% pure CCs with no residual starting materials, demonstrating process reproducibility and robustness. Conclusions: Overall, this work successfully established a continuous hot-melt extrusion (HME) process for manufacturing CBZ-NIC co-crystals, offering critical insights into material, equipment, and process parameters while implementing robust in-line NIR monitoring for real-time quality control. Additionally, this work provides interpretable insights and serves as a basis for future machine learning (ML)-driven studies. Full article
(This article belongs to the Special Issue Advances in Hot Melt Extrusion Technology)
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Review

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26 pages, 2866 KiB  
Review
Enhancing Patient-Centric Drug Development: Coupling Hot Melt Extrusion with Fused Deposition Modeling and Pressure-Assisted Microsyringe Additive Manufacturing Platforms with Quality by Design
by Dinesh Nyavanandi, Preethi Mandati, Nithin Vidiyala, Prashanth Parupathi, Praveen Kolimi and Hemanth Kumar Mamidi
Pharmaceutics 2025, 17(1), 14; https://doi.org/10.3390/pharmaceutics17010014 - 25 Dec 2024
Viewed by 1050
Abstract
In recent years, with the increasing patient population, the need for complex and patient-centric medications has increased enormously. Traditional manufacturing techniques such as direct blending, high shear granulation, and dry granulation can be used to develop simple solid oral medications. However, it is [...] Read more.
In recent years, with the increasing patient population, the need for complex and patient-centric medications has increased enormously. Traditional manufacturing techniques such as direct blending, high shear granulation, and dry granulation can be used to develop simple solid oral medications. However, it is well known that “one size fits all” is not true for pharmaceutical medicines. Depending on the age, sex, and disease state, each patient might need a different dose, combination of medicines, and drug release pattern from the medications. By employing traditional practices, developing patient-centric medications remains challenging and unaddressed. Over the last few years, much research has been conducted exploring various additive manufacturing techniques for developing on-demand, complex, and patient-centric medications. Among all the techniques, nozzle-based additive manufacturing platforms such as pressure-assisted microsyringe (PAM) and fused deposition modeling (FDM) have been investigated thoroughly to develop various medications. Both nozzle-based techniques involve the application of thermal energy. However, PAM can also be operated under ambient conditions to process semi-solid materials. Nozzle-based techniques can also be paired with the hot melt extrusion (HME) process for establishing a continuous manufacturing platform by employing various in-line process analytical technology (PAT) tools for monitoring critical process parameters (CPPs) and critical material attributes (CMAs) for delivering safe, efficacious, and quality medications to the patient population without compromising critical quality attributes (CQAs). This review covers an in-depth discussion of various critical parameters and their influence on product quality, along with a note on the continuous manufacturing process, quality by design, and future perspectives. Full article
(This article belongs to the Special Issue Advances in Hot Melt Extrusion Technology)
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