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Pharmaceutics
Special Issues
Aspects and Implementation of Pharmaceutical Quality by Design, 2nd Edition
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Aspects and Implementation of Pharmaceutical Quality by Design, 2nd Edition

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

Deadline for manuscript submissions: 30 June 2025 | Viewed by 3661

Special Issue Editors

Dr. Tamás Sovány

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Guest Editor
Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös u. 6., H-6720 Szeged, Hungary
Interests: solid state characterisation; drug-matrix interactions; tablet compression; extrusion-spheronization; printing technologies; inorganic nanocarriers; protein delivery; artificial neural networks; quality by design
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Ildikó Csóka

E-Mail Website
Guest Editor
Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, H-6720 Szeged, Hungary
Interests: quality by design-based formulation strategies; regulatory science; patient centeredness in dosage form design; alternative administration routes; nose-to-brain delivery
Special Issues, Collections and Topics in MDPI journals
Dr. Katalin Kristó

E-Mail Website
Guest Editor
Institute of Pharmaceutical Technology and Regulatoy Affairs, University of Szeged, Eötvös u. 6., H-6720 Szeged, Hungary
Interests: buccal polymer films; mucoadhesion; proteins; quality by design; permeation enhancing
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

The introduction of the Quality by Design concept in 2004 has provoked a paradigm shift in the pharmaceutical industry, as well as a new era in pharmaceutical research and development. This concept offers a higher flexibility of production and a reduction in manufacturing costs through the application of a complex risk-based approach from the beginning of the early development phase until the end of the product lifecycle.

Quality by Design is a highly multidisciplinary field, as the implementation of the many aspects of this complex approach requires the use of versatile methodology and a wide range of tools for understanding the patient’s needs, achieved through the proper design of experiments to advanced process analytical technologies, multivariate data analysis, and machine learning. The papers in the previous volume of this SI （https://www.mdpi.com/journal/pharmaceutics/special_issues/quality_design）mostly focused on process and formula optimization. The aim of this current volume is to extend the range of papers and involve more studies on the identification and fulfilment of patient needs, as well as on the application and development of analytical methods for an improved control strategy.

Dr. Tamás Sovány
Prof. Dr. Ildikó Csóka
Dr. Katalin Kristó
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

  • quality by design
  • identification of patient needs
  • process optimization
  • design of experiments
  • multivariate data analysis
  • machine learning
  • process analytical technologies
  • control strategy

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Published Papers (3 papers)

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Research

19 pages, 7939 KiB  
Article
Enhancing Process Control and Quality in Amorphous Solid Dispersions Using In-Line UV–Vis Monitoring of L* as a Real-Time Response
by Mariana Bezerra, Juan Almeida, Matheus de Castro, Martin Grootveld and Walkiria Schlindwein
Pharmaceutics 2025, 17(2), 151; https://doi.org/10.3390/pharmaceutics17020151 - 23 Jan 2025
Viewed by 758
Abstract
Background: This study demonstrates the application of the sequential design of experiments (DoE) approach within the quality by design (QbD) framework to optimize extrusion processes through screening, optimization, and robustness testing. Methods: An in-line UV–Vis process analytical technology (PAT) system was successfully employed [...] Read more.
Background: This study demonstrates the application of the sequential design of experiments (DoE) approach within the quality by design (QbD) framework to optimize extrusion processes through screening, optimization, and robustness testing. Methods: An in-line UV–Vis process analytical technology (PAT) system was successfully employed to monitor critical quality attributes (CQAs) of piroxicam amorphous solid dispersion (ASD) extrusion products, specifically lightness (L*). Results: L* measurement proved highly effective for ensuring the quality and uniformity of ASDs, offering real-time insights into their physical appearance and process stability. Small variations in L* acted as early indicators of processing issues, such as phase separation or bubble formation, enabling timely intervention. This straightforward and rapid technique supports real-time process monitoring and control, allowing automated adjustments to maintain product consistency and quality. By adopting this strategy, manufacturers can minimize variability, reduce waste, and ensure adherence to quality target product profiles (QTPPs). Conclusions: Overall, this study highlights the value of in-line UV–Vis spectroscopy as a PAT tool in hot melt extrusion, enhancing CQA assessment and advancing the efficiency and reliability of ASD manufacturing. Full article
(This article belongs to the Special Issue Aspects and Implementation of Pharmaceutical Quality by Design, 2nd Edition)
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22 pages, 3321 KiB  
Article
Quality by Design-Based Methodology for Development of Titanate Nanotubes Specified for Pharmaceutical Applications Based on Risk Assessment and Artificial Neural Network Modeling
by Ranim Saker, Géza Regdon, Jr., Krisztina Ludasi and Tamás Sovány
Pharmaceutics 2025, 17(1), 47; https://doi.org/10.3390/pharmaceutics17010047 - 1 Jan 2025
Viewed by 1390
Abstract
Background: Nanotechnology has been the main area of focus for research in different disciplines, such as medicine, engineering, and applied sciences. Therefore, enormous efforts have been made to insert the use of nanoparticles into the daily routines of different platforms due to their [...] Read more.
Background: Nanotechnology has been the main area of focus for research in different disciplines, such as medicine, engineering, and applied sciences. Therefore, enormous efforts have been made to insert the use of nanoparticles into the daily routines of different platforms due to their impressive performance and the huge potential they could offer. Among numerous types of nanomaterials, titanate nanotubes have been widely recognised as some of the most promising nanocarriers due to their outstanding profile and brilliant design. Their implementation in pharmaceutical applications is of huge interest nowadays as it could be of fundamental importance in the development of the pharmaceutical industry and therapeutic systems. Methods: In the present work, a risk assessment-based procedure was developed and completed using ANN-based modeling to enable the design and fabrication of titanate nanotube-based drug delivery systems with desired properties, based on the critical analysis and evaluation of data collected from published articles regarding titanate nanotube preparation using the hydrothermal treatment method. Results: This analysis is presented as an integrated pathway for titanate nanotube preparation and utilization in a proper way that meets the strict requirements of pharmaceutical systems (quality, safety, and efficacy). Furthermore, a reasonable estimation of the factors affecting titanate nanotube preparation and transformation from traditional uses to novel pharmaceutical ones was established with the aid of a quality by design approach and risk assessment tools, mainly an Ishikawa diagram, a risk estimation matrix, and Pareto analysis. Conclusions: To the best of our knowledge, this is the first article using the QbD approach to suggest a systematic method for the purpose of upgrading TNT use to the pharmaceutical domain. Full article
(This article belongs to the Special Issue Aspects and Implementation of Pharmaceutical Quality by Design, 2nd Edition)
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22 pages, 5873 KiB  
Article
Quality by Design Approach for the Formulation and Evaluation of Stem Cells Derived Rosmarinic Acid-Loaded Nanofibers as an Anti-Wrinkle Patch: In Vitro and In Vivo Characterizations
by Rehab Abdelmonem, Ahmed Bakr, Ingy Badawy, Ahmed Ibrahim Abd El Maksoud and Reem T. Attia
Pharmaceutics 2024, 16(12), 1598; https://doi.org/10.3390/pharmaceutics16121598 - 16 Dec 2024
Viewed by 1010
Abstract
Background/Objectives: Skin wrinkles result from a myriad of multifaceted processes involving intrinsic and extrinsic aging. To combat this effect, plant stem cells offer a renewable and eco-friendly source for various industries, including cosmeceuticals. Salvia miltiorrhiza (SM), which contains the bioactive compound Rosmarinic acid [...] Read more.
Background/Objectives: Skin wrinkles result from a myriad of multifaceted processes involving intrinsic and extrinsic aging. To combat this effect, plant stem cells offer a renewable and eco-friendly source for various industries, including cosmeceuticals. Salvia miltiorrhiza (SM), which contains the bioactive compound Rosmarinic acid (RA) and has been proposed for its anti-wrinkle effect. Methods: In the present study, calli from SM were cultured and Quality by Design (QbD) was implemented to investigate the effect of different types and concentrations of elicitors; jasmonic acid (JA) and salicylic acid (SA). Both raised RA levels yet, jasmonic acid (50 µM) has resulted in the highest yield for RA, at 16 mg/g. A nanofiber patch was prepared and characterized in-vitro by the release percentage, drug content, swelling degree, scanning electron microscope, and surface roughness. Then, the anti-wrinkle effect of the patch was tested in a UV wrinkle-induced mouse model. Results: Interestingly, after treatment, there were visibly fewer wrinkles, and the skin was softer than in the untreated control group. This study suggests that the treatment exerted its effect through the Nrf2/Keap1 pathway, which plays a crucial role in cellular antioxidant protective processes. By activating this pathway through boosting Nrf2 and diminishing Keap1 cellular content, the nanofiber patch enhances the production of antioxidant enzymes, such as superoxide dismutase and glutathione peroxidase, enhancesglutathione, and reduces the skin lipid peroxidation, collectively indicating enhanced skin quality. Conclusions: In conclusion, this study highlights the importance of this formula as an anti-wrinkle treatment, and future clinical studies are recommended to further unveil the potential of this formula. Full article
(This article belongs to the Special Issue Aspects and Implementation of Pharmaceutical Quality by Design, 2nd Edition)
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