Novel Applications of Modern Excipients in Advanced Pharmaceutical Products, 2nd Edition

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 June 2026 | Viewed by 1476

Special Issue Editors


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Department of Pharmaceutical Technology, Faculty of Pharmacy, Medical University of Gdansk, al. gen. J. 12 Hallera 107, 80-416 Gdansk, Poland
Interests: pharmaceutical technology; oral dosage forms; skin penetration and permeation
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Chemische Fabrik Budenheim KG, Rheinstrasse 27, 55257 Budenheim, Germany
Interests: pharmaceutical technology; formulation development; direct compression; excipients; OSDF; improvement of drug solubility; pharmaceutical analysis
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Guest Editor
Chemische Fabrik Budenheim KG, Rheinstrasse 27, 55257 Budenheim, Germany
Interests: pharmaceutical technology; formulation development; co-processed excipients; OSDF; continous manufacturing
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Practically every pharmaceutical product, whether in solid or liquid form, contains at least one excipient in addition to one or more active ingredients. Excipients are inert components, other than drug substances, which do not exert a pharmacological effect in the doses used. Nevertheless, they are essential in pharmaceutical formulations, ensuring easy and safe drug administration. Although most excipients are considered inert, they are often used for specific purposes. For example, in the field of technology of oral solid dosage forms, they facilitate technological processes such as granulation, tabletting, encapsulation, and give the final drug product the required physical properties, guaranteeing stability and efficacy.

Most scientists and formulation experts concentrate on drug substances, which are the most important components of medicinal preparations. In this Special Issue, we would like to more closely examine various excipients used in pharmaceutical technology, their solubility, rheological and functional characteristics, as well as their impact on the final product. Furthermore, we would like to explore the impact of origin and the method of production on their structure, morphology and physical, chemical, or functional characteristics. An interesting aspect is the constantly evolving quality and safety requirements (e.g., regarding nitrosamine or elemental impurities) as well as market trends (e.g., the demand for vegan, non-GMO, lactose-free products) and how contemporary excipients are responding to them.

Prof. Dr. Krzysztof Cal
Dr. Daniel Zakowiecki
Dr. Tobias Heß
Guest Editors

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Keywords

  • pharmaceutical excipients
  • inactive ingredients
  • preformulation/formulation
  • drug-excipient compatibility
  • particle size, shape and morphology
  • oral solid dosage forms
  • solubility/dissolution rate
  • chemical and physical stability
  • manufacturing process

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Published Papers (2 papers)

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Research

16 pages, 4234 KB  
Article
Comparative Evaluation of Glidants for Enhancing the Flowability of Poorly Flowing Powdered Materials with Varying Particle Sizes and Morphologies
by Daniel Zakowiecki, Peter Edinger, Michael Wagner, Tobias Hess, Dariusz Lipiak and Krzysztof Cal
Pharmaceutics 2026, 18(6), 721; https://doi.org/10.3390/pharmaceutics18060721 (registering DOI) - 11 Jun 2026
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Abstract
Background: An increasing number of commercially available drug substances and bioactive ingredients are characterized by poor flowability. Inadequate flow properties may lead to material blockage during transport within production lines, as well as the formation of air voids within the bulk. Such [...] Read more.
Background: An increasing number of commercially available drug substances and bioactive ingredients are characterized by poor flowability. Inadequate flow properties may lead to material blockage during transport within production lines, as well as the formation of air voids within the bulk. Such phenomena can disrupt the technological process and may even result in batches that fail to meet quality requirements. Therefore, ensuring adequate powder flow is of utmost importance in the manufacture of health-related products. Methods: Binary mixtures were prepared using one of four model substances (ibuprofen, metamizole sodium, mefenamic acid, or sunflower lecithin) combined with a glidant (colloidal silica, precipitated silica, or tricalcium phosphate). The glidant content ranged from 0.5 to 10.0% w/w depending on the model substance, and mixing was carried out for 5–30 min. The resulting binary mixtures were evaluated for flow properties using the angle of repose method, and in selected cases, bulk density was also determined. Results/Conclusions: The study demonstrated that powder flow improvement depended not only on the glidant but primarily on the properties of the host material (particle size, shape, and bulk density). Coarser powders such as ibuprofen responded well to low glidant levels, although excessive silicon dioxide caused oversilication. Metamizole sodium showed progressively better flow with increasing particle size and density, and tribasic calcium phosphate further improved performance, particularly with longer mixing times. Very fine or cohesive powders, such as mefenamic acid and sunflower lecithin, showed limited response to silica-based glidants, whereas tribasic calcium phosphate proved more effective and additionally increased bulk density. Overall, no universal glidant strategy was identified; effective flow enhancement requires a tailored approach based on specific powder characteristics. Full article
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31 pages, 4413 KB  
Article
Microwave-Assisted Wet Granulation for Engineering Rice Starch–Mannitol Co-Processed Excipients for Direct Compression of Orally Disintegrating Tablets
by Karnkamol Trisopon and Phennapha Saokham
Pharmaceutics 2026, 18(2), 153; https://doi.org/10.3390/pharmaceutics18020153 - 25 Jan 2026
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Abstract
Background/Objectives: Enhancing excipient functionality through environmentally friendly and scalable processing methods is essential for improving the manufacturability and performance of orally disintegrating tablets (ODTs). Microwave-assisted wet granulation enables controlled microstructural modification without chemical alteration of excipient components. This study aimed to develop [...] Read more.
Background/Objectives: Enhancing excipient functionality through environmentally friendly and scalable processing methods is essential for improving the manufacturability and performance of orally disintegrating tablets (ODTs). Microwave-assisted wet granulation enables controlled microstructural modification without chemical alteration of excipient components. This study aimed to develop and evaluate a rice starch (RS)–mannitol co-processed excipient using microwave-assisted wet granulation for direct compression of ODTs. Methods: RS and mannitol were co-processed by wet granulation followed by microwave treatment under varying power levels and irradiation times. The effects of processing conditions on granule morphology, solid-state properties, porosity, powder flow, compressibility, wettability, and disintegration behavior were systematically investigated. The optimized excipient was further evaluated in ODT formulations containing chlorpheniramine maleate and piroxicam and benchmarked against a commercial co-processed excipient (Starlac®). Results: Microwave treatment generated internal vapor pressure that promoted pore formation and particle agglomeration, resulting in enhanced powder flowability (compressibility index 8.4–10.8%). Partial crystallinity reduction and microstructural modification improved compressibility and surface wettability compared with non-microwave-treated materials. The optimized formulation (MW-RM-H-30) exhibited rapid wetting (25 s), high water absorption (90.5%), low contact angle (42°), and fast tablet disintegration (31 s). ODTs prepared with MW-RM-H-30 showed rapid disintegration (42 s for chlorpheniramine maleate and 32 s for piroxicam) and dissolution behavior comparable to Starlac®. Conclusions: Microwave-assisted wet granulation provides an efficient, scalable, and environmentally friendly strategy for engineering starch-based co-processed excipients with enhanced functionality for direct compression ODT applications. The developed excipient demonstrates strong potential for solid dosage form manufacturing. Full article
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