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Pharmaceutics
Special Issues
Advances in Granulation Processes in Pharmaceutical Formulation Systems
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Advances in Granulation Processes in Pharmaceutical Formulation Systems

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

Deadline for manuscript submissions: 31 July 2025 | Viewed by 2254

Special Issue Editors

Prof. Dr. Krunoslav Žižek

E-Mail Website
Guest Editor
Faculty of Chemical Engineering and Technology, University of Zagreb, 10000 Zagreb, Croatia
Interests: drug formulation; fast disintegrating tablets; mini-tablets; mechanochemical activation of drug; spray drying; granulation; population balance modelling
Prof. Dr. Rachel Smith

E-Mail Website
Guest Editor
Department of Chemical and Biological Engineering, The University of Sheffield, Sheffield S10 2TN, UK
Interests: powders; particles; granulation; mechanistic modelling; process; population balance modelling; discrete element modelling; dissolution; disintegration
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Pharmaceutics is pleased to present a Special Issue entitled “Advances in Granulation Processes in Pharmaceutical Formulation Systems”. This issue will cover cutting-edge research and new insights into the granulation process, with a focus on process optimization, scale-up challenges, and modelling related to drug formulation.

Granulation is the process of agglomerating fine particles into larger granules. Joining particles together improves flowability and compressibility and reduces unwanted segregation, leading to the uniform distribution of drugs, controllable drug release, consistent drug delivery, and reduced dosage form defects. The objective of this powerful technology is to formulate drugs with high quality and performance with increased productivity. The aim of this issue is to address the challenges faced by many formulators today, as well as the advances and potential technological improvements in wet, dry, and melted granulation in regard to designing a more effective drug product.

This issue will reveal the current state of granulation technology and perspectives on its future, focusing on the tremendous importance of this particle design process for drug product formulation. We invite researchers from academia and experts from the industry to share their innovations, achievements, and great scientific results related to pharmaceutical granulation.

We look forward to receiving your contributions.

Prof. Dr. Krunoslav Žižek
Prof. Dr. Rachel Smith
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

  • granulation
  • drug formulation
  • tableting
  • process modelling
  • process optimization
  • scale-up

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Published Papers (3 papers)

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Research

17 pages, 4844 KiB  
Article
Granulation Methods and the Mechanisms for Improving Hardness of Loxoprofen Sodium Hydrate-Containing Tablets
by Aya Kuwata, Agata Ishikawa, Tetsuo Ono and Etsuo Yonemochi
Pharmaceutics 2025, 17(4), 455; https://doi.org/10.3390/pharmaceutics17040455 - 1 Apr 2025
Viewed by 359
Abstract
Objectives: We investigated the compression mechanisms for loxoprofen sodium (LXP), which is known to occur as a dihydrate, and identified parameters that influence the tablet hardness of LXP tablets prepared by the wet granulation method. Method: LXP granules were prepared with water or [...] Read more.
Objectives: We investigated the compression mechanisms for loxoprofen sodium (LXP), which is known to occur as a dihydrate, and identified parameters that influence the tablet hardness of LXP tablets prepared by the wet granulation method. Method: LXP granules were prepared with water or ethanol as the solvent, dried under various conditions and sieved for particle size control, with 1% Mg-st added before tablet compression. Results: The findings indicated that both the granulation solvent and drying temperature significantly impacted the tablet hardness. Granules prepared with ethanol exhibited higher hardness as compared with those prepared with water. The tablet hardness varied with varying drying temperatures. Discussion: Principal component analysis (PCA) identified positive correlations between the tablet hardness and the surface free energy (SFE), polar component (γ(p)), and cohesion, and a negative correlation with the dispersive component (γ(d)). Granules prepared with ethanol exhibited a higher γ(p), likely due to the differing solubility in ethanol and water, leading to enhanced interparticle binding. This study confirmed that use of the eutectic mixture of LXP and Mg-st exerted no significant influence. Crystal structure analysis indicated that the hydration states varied according to the drying temperature, suggesting the higher γ(p) in anhydrous forms, due to the lower hydrophobicity, contributed to increased tablet hardness. Conclusion: This research offers insights for optimizing the formulation conditions to improve the LXP tablet hardness. Appropriate selection of the solvent and drying temperature mitigates tablet hardness issues, while assessment of SFE can help in the selection of suitable additives. Full article
(This article belongs to the Special Issue Advances in Granulation Processes in Pharmaceutical Formulation Systems)
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17 pages, 6271 KiB  
Article
Experimental and Numerical Study to Enhance Granule Control and Quality Predictions in Pharmaceutical Granulations
by Maroua Rouabah, Inès Esma Achouri, Sandrine Bourgeois, Stéphanie Briançon and Claudia Cogné
Pharmaceutics 2025, 17(3), 364; https://doi.org/10.3390/pharmaceutics17030364 - 13 Mar 2025
Viewed by 573
Abstract
Background/Objectives: The pharmaceutical industry demands stringent regulation of product characteristics and strives to ensure the reproducibility of granules manufactured via the wet granulation process. A systematic model employing the discrete element method (DEM) was developed herein to gain insights into and better control [...] Read more.
Background/Objectives: The pharmaceutical industry demands stringent regulation of product characteristics and strives to ensure the reproducibility of granules manufactured via the wet granulation process. A systematic model employing the discrete element method (DEM) was developed herein to gain insights into and better control this process. Methods: The model comprehensively simulates particle behavior during granulation by considering the intrinsic properties of the powder material, the specific geometry of the granulation equipment, and various operational conditions, including impeller speed and chopper use. Notably, this approach can simulate dynamic interactions among particles and integrate complex phenomena, such as cohesion, which is crucial for predicting the formation and quality of granules. Results: To further support process optimization, an EDEMpy artificial intelligence (AI) tool was developed as a posttreatment routine to monitor and analyze agglomerate size distributions, proving essential for assessing the efficiency of the granulation process and the quality of resulting granules. The DEM model was evaluated by comparing its output with experimental data collected from a 0.5 L high-shear granulator. The model reproduced the granule growth kinetics observed experimentally, confirming the agreement between the experimental and numerical analyses. Conclusions: This underscores the model’s potential in predicting and controlling granule quality in wet granulation processes, enhancing the precision and efficiency of pharmaceutical manufacturing. Full article
(This article belongs to the Special Issue Advances in Granulation Processes in Pharmaceutical Formulation Systems)
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20 pages, 8955 KiB  
Article
Multivariate Data Analysis to Assess Process Evolution and Systematic Root Causes Investigation in Tablet Manufacturing at an Industrial Scale—A Case Study Focused on Improving Tablet Hardness
by Rita Mathe, Tibor Casian and Ioan Tomuta
Pharmaceutics 2025, 17(2), 213; https://doi.org/10.3390/pharmaceutics17020213 - 7 Feb 2025
Viewed by 870
Abstract
Background/Objectives: Only a few studies performed at industrial scale in non-simulated conditions have investigated the effect of input variability from the product’s lifecycle on product quality. The purpose of this work was to identify the root causes for the low and variable [...] Read more.
Background/Objectives: Only a few studies performed at industrial scale in non-simulated conditions have investigated the effect of input variability from the product’s lifecycle on product quality. The purpose of this work was to identify the root causes for the low and variable hardness of core tablets prepared using high-shear wet granulation through batch statistical modeling and to verify the short- and long-term effectiveness of the improvement actions. Methods: The novelty of this study is the use of multivariate methods for the complex assessment of a wide data set belonging to two proportional composition strengths, manufactured at an industrial scale, with different tablet shapes and sizes, with the aim of identifying inter-related active ingredient and process variables with the highest impact on hardness value and for defining optimal processing conditions leading to a robust product. Results: Four main variables affecting the output variable were identified: API particle size, nozzle type used for granulation, wet discharge, and drying intensity. These were included in an updated control strategy (3 out of 4 variables having to be within the desired ranges: API d0.5 < 45 microns; granulation nozzle that ensures liquid dispersion into droplets; gentle wet discharge and drying processes). In the case of the product studied, the newly defined process conditions could even accommodate d0.5 up to 70 microns and still ensure adequate core tablet hardness (at least 30% above the lower specification limit) for the successive film-coating step. Conclusions: Besides the beneficial impact of reducing the risk for out-of-specification hardness results, this study also offered the benefit of cost avoidance and yield improvement. The improvement was confirmed through the significant average hardness increase (15–20%) and between-batch variability decrease, leading to decent sigma quality levels (2.5) for the control phase batches. Full article
(This article belongs to the Special Issue Advances in Granulation Processes in Pharmaceutical Formulation Systems)
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