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Pharmaceutics
Special Issues
Advances in Analysis and Modeling of Solid Drug Product
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Advances in Analysis and Modeling of Solid Drug Product

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".

Deadline for manuscript submissions: 31 October 2025 | Viewed by 2330

Special Issue Editors

Prof. Dr. Ashish Kumar

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Guest Editor
Pharmaceutical Engineering Research Group (PharmaEng), Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg, B-9000 Ghent, Belgium
Interests: pharmaceutical engineering; process and equipment design; (bio-)pharmaceutical plant design
Special Issues, Collections and Topics in MDPI journals
Dr. Kensaku Matsunami

E-Mail Website
Guest Editor
Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN, USA
Interests: process systems engineering; pharmaceutical engineering; mechanistic modeling; data-driven modeling; continuous manufacturing; process design; process control; particle technology

Special Issue Information

Dear Colleagues,

Solid drug products are traditional but still the most popular dosage forms, requiring further research. In the last couple of years, there have been huge advances in experimental analysis and modeling of solid drug product manufacturing processes. High attention to digitalization has triggered research of real-time release testing and process control, leading to the new concept of Pharma 4.0. Significant improvement in computational power has also contributed to the progress of modeling studies, e.g., mechanistic, data-driven, and hybrid modeling.

Moreover, pharmaceutical science and engineering have joined forces, leading to exciting breakthroughs in solid drug product manufacturing. Experts are developing and using Process Analytical Technology (PAT) tools to bring new fundamental insights regarding the process while monitoring and improving production by use of advanced process control (APC). PAT uses sensors and instruments to monitor every step of manufacturing, measuring important details. This helps them understand the process better, make quick adjustments for the best quality, and support real-time release testing (RTRT) of the drug product. For example, it can even keep an eye on granule size during a critical stage like wet granulation and provide instant feedback for improvements.

The Special Issue aims to bring state-of-the-art research, critical reviews, and perspectives related to the current status and challenges in the analysis and modeling of solid drug product manufacturing processes. Research areas may include (but are not limited to) the following: design of experiments, data-driven modeling/analysis, mechanistic modeling, hybrid modeling, uncertainty analysis, and real-time monitoring/release testing. In this Special Issue, original research articles and reviews are welcome. We look forward to receiving your contributions.

Prof. Dr. Ashish Kumar
Dr. Kensaku Matsunami
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

  • design-of-experiments (DoE)
  • data-driven modeling/analysis
  • mechanistic modeling
  • hybrid modeling
  • uncertainty analysis
  • real-time monitoring/release testing
  • digitalization

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Published Papers (3 papers)

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Research

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21 pages, 1565 KiB  
Article
Merging Real-Time NIR and Process Parameter Measurements in a Fluidized Bed Granulation Process to Predict Particle Size
by Ozren Jovic, Marcus O’Mahony, Samuel Solomon, David Egan, Chris O’Callaghan, Caroline McCormack, Ian Jones, Patrick Cronin, Gavin M. Walker and Rabah Mouras
Pharmaceutics 2025, 17(6), 720; https://doi.org/10.3390/pharmaceutics17060720 - 29 May 2025
Viewed by 434
Abstract
Background/Objectives: Controlling the critical quality attributes (CQAs), such as granule moisture level and particle size distribution, that impact product performance is essential for ensuring product quality in medicine manufacture. Oral solid dosage forms, such as tablets, often require appropriate powder flow for [...] Read more.
Background/Objectives: Controlling the critical quality attributes (CQAs), such as granule moisture level and particle size distribution, that impact product performance is essential for ensuring product quality in medicine manufacture. Oral solid dosage forms, such as tablets, often require appropriate powder flow for compaction and filling. Spray-dried fluidized bed granulation (FBG) is a key unit operation in the preparation of granulated powders. The determination of particle sizes in FBG using near-infrared spectroscopy (NIR) has been considered in the literature. Herein, for the first time, NIR is combined with process parameters to achieve improved prediction of the particle sizes in FBG. Methods: An inline model for particle size determination using both NIR and FBG process parameters was developed using the partial least square (PLS) method, or ‘merged-PLS model’. The particle size was predicted at the end point of the process, i.e., the last 10% of the particle-size data for each batch run. An additional two analyses included a merged-PLS model with 12 batches: (1) where nine batches were training and three batches were a test set; and (2) where 11 batches were training and one was a test batch. Results: For all considered particle size fractions, Dv10, Dv25, Dv50, Dv75, and Dv90, an improved root-mean-squared error of prediction (RMSEP) is obtained for the merged-PLS model compared to the NIR-only PLS model and compared to the process parameters alone model. Improved RMSEP is also achieved for the additional two analyses. Conclusions: The improved prediction performance of endpoint particle sizes by the merged-PLS model can help to enhance both the process understanding and the overall control of the FBG process. Full article
(This article belongs to the Special Issue Advances in Analysis and Modeling of Solid Drug Product)
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21 pages, 1518 KiB  
Article
Design of Experiment Approach for Enhancing the Dissolution Profile and Robustness of Loratadine Tablet Using D-α-Tocopheryl Polyethylene Glycol 1000 Succinate
by Alhasan A. Jabbar, Israa Al-Ani, Ramadan I. Al-Shdefat, Nadia Ghazal, Anwar Jaffal and Mohamed H. Fayed
Pharmaceutics 2025, 17(3), 380; https://doi.org/10.3390/pharmaceutics17030380 - 17 Mar 2025
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Abstract
Background: Formulating poorly water-soluble drugs poses significant challenges due to their limited solubility and bioavailability. Loratadine (LTD), classified as a BCS II molecule, exhibits notably low solubility, leading to reduced bioavailability. Objective: This study aims to enhance the dissolution rate of LTD through [...] Read more.
Background: Formulating poorly water-soluble drugs poses significant challenges due to their limited solubility and bioavailability. Loratadine (LTD), classified as a BCS II molecule, exhibits notably low solubility, leading to reduced bioavailability. Objective: This study aims to enhance the dissolution rate of LTD through the utilization of the wet granulation process using Tocopheryl polyethylene glycol 1000 succinate (TPGS). Methods: A Design-of-Experiment methodology was adopted to investigate and optimize the formulation variables for preparing an oral delivery system of LTD with improved dissolution properties. The levels of TPGS (2–6% w/w), as a surfactant, and sodium starch glycolate (SSG; 2–8% w/w), as a super-disintegrant, were established as independent variables in the formulations. Loratadine was granulated in the presence of TPGS, and the resultant granules were subsequently compressed into tablets. The granules and tablets produced were then subjected to characterization. Results: ANOVA analysis indicated that both TPGS and SSG had a significant (p < 0.05) influence on the critical characteristics of the obtained granules and tablets, with TPGS showing a particularly notable effect. The optimal concentrations of TPGS and SSG for the development of LTD tablets with the necessary quality attributes were identified as 5.0% w/w and 2.0% w/w, respectively, through optimization utilizing the desirability function. The tablets produced at these optimized concentrations displayed favorable properties concerning their mechanical strength (5.72 ± 0.32 KP), disintegration time (7.11 ± 1.08 min.), and release profile (86.21 ± 1.61%). Conclusions: In conclusion, incorporating TPGS in the granulation process shows promise in improving the dissolution profile of poorly water-soluble drugs and demonstrated formulation robustness. Full article
(This article belongs to the Special Issue Advances in Analysis and Modeling of Solid Drug Product)
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Review

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26 pages, 889 KiB  
Review
Cutting-Edge Approaches in the Co-Amorphization Process
by Azza A. K. Mahmoud, Géza Regdon, Jr. and Katalin Kristó
Pharmaceutics 2025, 17(7), 850; https://doi.org/10.3390/pharmaceutics17070850 - 29 Jun 2025
Viewed by 424
Abstract
Background: Recently, the co-amorphization method has been widely used to refine the bioavailability characteristics of poorly soluble drugs in addition to overcoming the drawbacks of other traditional amorphization techniques. Objectives: The main aim of this systematic review is to present an extensive outline [...] Read more.
Background: Recently, the co-amorphization method has been widely used to refine the bioavailability characteristics of poorly soluble drugs in addition to overcoming the drawbacks of other traditional amorphization techniques. Objectives: The main aim of this systematic review is to present an extensive outline of different co-former classes, co-former selection, and evaluation of produced co-amorphous systems. Methods: The systematic research was carried out based on three different databases, including PubMed, Scopus, and Web of Science time using co-amorphous, co-former, and drug as keywords. The selected papers were written in the English language and published between 2016 and 2024, and they focused on the co-amorphous systems, while articles discussing other amorphization techniques and crystallization processes were excluded. Results: 127 peer-reviewed articles were selected and summarized. Conclusions: This paper revealed that amino acid is the most commonly used co-former, specifically arginine with acidic drugs and tryptophan with acidic and basic drugs, and it reported other co-formers that were used and different co-amorphous systems with their dissolution behaviour and stabilities, and different computational tools that were applied in the selection of co-former and process result evaluation. Full article
(This article belongs to the Special Issue Advances in Analysis and Modeling of Solid Drug Product)
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