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Pharmaceutics
Special Issues
Impact of Raw Material Properties on Solid Dosage Form Processes
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Impact of Raw Material Properties on Solid Dosage Form Processes

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

Deadline for manuscript submissions: 31 January 2025 | Viewed by 3744

Special Issue Editors

Prof. Dr. Valérie Vanhoorne

E-Mail Website
Guest Editor
Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg, B-9000 Ghent, Belgium
Interests: pharmaceutical technology; continuous manufacturing; 3D printing; additive manufacturing; pellets; twin-screw granulation; direct compression; material science
Special Issues, Collections and Topics in MDPI journals
Dr. Fanny Stauffer

E-Mail Website
Guest Editor
UCB Pharma, Chemin du Foriest 1, 1420 Braine l’Alleud, Belgium
Interests: pharmaceutical technology; continuous manufacturing; twin-screw granulation; material science; modelling

Special Issue Information

Dear Colleagues,

The interlink between raw material properties and drug product performance has been a growing research topic in the last few years. Advances in the definition of a manufacturing classification system allowed rationalizing drug product process selection based on raw material properties. Such initiatives, however, rely on powder characterizations predictive of the behaviour of the powder during manufacturing at the pilot or commercial scale. It also implies that the raw material properties driving the process are well identified and that the desired ranges have been defined. Hence, it is key to understand the impact of the raw materials’ properties for each unit of operation as well as the integrated manufacturing process. Based on this knowledge, it becomes possible to design raw materials with the desired properties in order to make it amenable for a preferred process (e.g., a greener process) to improve the drug product process robustness and the drug product quality. Finally, there will always be a natural variability in the raw materials’ physical properties. New approaches are being developed to understand batch-to-batch variability and define critical material attributes for a specific product.

This Special Issue aims to approach this complex topic in a transversal way, allowing a comprehensible view of the current landscape.

Prof. Dr. Valérie Vanhoorne
Dr. Fanny Stauffer
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

  • pharmaceutical technology
  • material science
  • powder
  • drug product process development
  • quality-by-design

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Published Papers (2 papers)

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20 pages, 2426 KiB  
Article
Evaluation of Polyvinyl Alcohol as Binder during Continuous Twin Screw Wet Granulation
by Phaedra Denduyver, Gudrun Birk, Alessandra Ambruosi, Chris Vervaet and Valérie Vanhoorne
Pharmaceutics 2024, 16(7), 854; https://doi.org/10.3390/pharmaceutics16070854 - 25 Jun 2024
Viewed by 1095
Abstract
Binder selection is a crucial step in continuous twin-screw wet granulation (TSWG), as the material experiences a much shorter residence time (2–40 s) in the granulator barrel compared to batch-wise granulation processes. Polyvinyl alcohol (PVA) 4-88 was identified as an effective binder during [...] Read more.
Binder selection is a crucial step in continuous twin-screw wet granulation (TSWG), as the material experiences a much shorter residence time (2–40 s) in the granulator barrel compared to batch-wise granulation processes. Polyvinyl alcohol (PVA) 4-88 was identified as an effective binder during TSWG, but the potential of other PVA grades—differing in polymerization and hydrolysis degree—has not yet been studied. Therefore, the aim of the current study was to evaluate the potential of different PVA grades as a binder during TSWG. The breakage and drying behavior during the fluidized bed drying of drug-loaded granules containing the PVA grades was also studied. Three PVA grades (4-88, 18-88, and 40-88) were characterized and their attributes were compared to previously investigated binders by Vandevivere et al. through principal component analysis. Three binder clusters could be distinguished according to their attributes, whereby each cluster contained a PVA grade and a previously investigated binder. PVA 4-88 was the most effective binder of the PVA grades for both a good water-soluble and water-insoluble formulation. This could be attributed to its high total surface energy, low viscosity, good wettability of hydrophilic and hydrophobic surfaces, and good wettability by water of the binder. Compared to the previously investigated binders, all PVA grades were more effective in the water-insoluble formulation, as they yielded strong granules (friability below 30%) at lower L/S-ratios. This was linked to the high dispersive surface energy of the high-energy sites on the surface of PVA grades and their low surface tension. During fluidized bed drying, PVA grades proved suitable binders, as the acetaminophen (APAP) granules were dried within a short time due to the low L/S-ratio, at which high-quality granules could be produced. In addition, no attrition occurred, and strong tablets were obtained. Based on this study, PVA could be the preferred binder during twin screw granulation due to its high binder effectiveness at a low L/S-ratio, allowing efficient downstream processing. However, process robustness must be controlled by the included excipients, as PVA grades are operating in a narrow L/S-ratio range. Full article
(This article belongs to the Special Issue Impact of Raw Material Properties on Solid Dosage Form Processes)
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22 pages, 5427 KiB  
Article
Understanding the Interaction of Thermal, Rheological, and Mechanical Parameters Critical for the Processability of Polyvinyl Alcohol-Based Systems during Hot Melt Extrusion
by Florian Hess, Thomas Kipping, Werner Weitschies and Julius Krause
Pharmaceutics 2024, 16(4), 472; https://doi.org/10.3390/pharmaceutics16040472 - 28 Mar 2024
Cited by 2 | Viewed by 1855
Abstract
Hot melt extrusion (HME) is a common manufacturing process used in the pharmaceutical industry to improve the solubility of poorly soluble active pharmaceutical ingredients (API). The goal is to create an amorphous solid dispersion (ASD) where the amorphous form of the API is [...] Read more.
Hot melt extrusion (HME) is a common manufacturing process used in the pharmaceutical industry to improve the solubility of poorly soluble active pharmaceutical ingredients (API). The goal is to create an amorphous solid dispersion (ASD) where the amorphous form of the API is stabilized within a polymer matrix. Traditionally, the development of pharmaceutically approved polymers has focused on requirements such as thermal properties, solubility, drug–polymer interactions, and biocompatibility. The mechanical properties of the material have often been neglected in the design of new polymers. However, new downstream methods require more flexible polymers or suitable plasticizer polymer combinations. In this study, two grades of the polymer polyvinyl alcohol (PVA), which is already established for HME, are investigated in terms of their mechanical, rheological, and thermal properties. The mechanical properties of the extruded filaments were tested by the three-point bending test. The rheological behavior was analyzed by oscillating plate measurements. Thermal analysis was performed by differential scanning calorimetry (DSC). In addition, the solid and liquid plasticizers mannitol, sorbitol, triacetin, triethyl citrate, polyethylene glycol, and glycerol were evaluated for use with PVA and their impact on the polymer properties was elaborated. Finally, the effects of the plasticizers are compared to each other, and the correlations are analyzed statistically using principal component analysis (PCA). Thereby, a clear ranking of the plasticizer effects was established, and a deeper understanding of the polymer–plasticizer interactions was created. Full article
(This article belongs to the Special Issue Impact of Raw Material Properties on Solid Dosage Form Processes)
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