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Pharmaceutics
Special Issues
Commemorative Issue in Honor of Professor Guy Van den Mooter
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Commemorative Issue in Honor of Professor Guy Van den Mooter

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

Deadline for manuscript submissions: closed (31 December 2021) | Viewed by 13398

Special Issue Editor

Prof. Dr. Amrit Paudel

E-Mail Website
Guest Editor
Graz University of Technology & Research Center Pharmaceutical Engineering (RCPE), Graz, Austria
Interests: drug delivery; solid-state pharmaceutics; stability; amorphous drugs; pharmaceutical material science; pulmonary drug delivery; poorly soluble drug formulations; biopharmaceutics
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

It is my pleasure to invite you to contribute a research or review article to a Special Issue in honor of Professor Guy Van den Mooter (born on May 8th, 1964). Guy is a Professor at the Drug Delivery and Disposition, Faculty of Pharmaceutical Sciences, University of Leuven, Leuven, Belgium. He graduated in pharmacy and industrial pharmacy from the University of Leuven and received his PhD from the same university in 1994. He worked as a pharmaceutical development scientist at Janssen Pharmaceutica (Belgium) until 1996. From 1997 until 1999, he was a post-doctoral researcher in the laboratory for Pharmacotechnology and Biopharmacy (University of Leuven). In 1999, he was appointed assistant professor and in 2009 full professor at the University of Leuven. He coordinates and teaches courses of pharmaceutical technology, physical pharmacy, and industrial pharmacy to students of undergraduate and graduate programs.

Prof Van den Mooter is one of the most cited researchers in the field of poorly soluble drug formulations. His group is considered, by both academia and industry, to be highly specialized, and he is deemed a world-class expert in amorphous solid dispersions (ASDs). His over 200 published works have received more than 18,000 citations, with an h-index of 76 as of January 2021. Overall, his scientific contributions broadly cover highly innovative approaches of formulating poorly soluble drugs such as ASDs, nanocrystalline formulations, self-emulsifying systems, cyclodextrin complexes, mesoporous silica, etc. Additionally, in the area of advanced drug delivery, his group has contributed high-impact publications in colon targeting, PLGA microspheres, controlled release formulations, etc. His insightful papers include process technologies such as spray drying and electrospray drying, hot melt extrusion, nanomilling, and others. In recent years, his group has published excellent papers on protein formulation development using spray drying and on cleverly using protein as the solubilizing excipient for poorly soluble drugs. He is a well-respected expert in the field of preformulation and solid-state characterization, such as polymorphism, amorphous pharmaceuticals, crystal hydrates, phase transitions, etc. His key analytical expertise includes thermal analysis and calorimetry, solid-state spectroscopy, X-ray diffraction, moisture sorption, etc. In addition, the translational aspect of Prof Van den Mooter´s research is reflected in the several national and international patents that he holds on innovative drug formulations and his extensive collaborations with academia and pharmaceutical industries. In 2007, he founded FORMAC Pharmaceuticals N.V., a drug delivery and development company. He is the recipient of several awards and member of the Belgian Pharmacopeia commission and member of the Editorial Boards of the Journal of Pharmaceutical Sciences, Journal of Pharmacy and Pharmacology, and International Journal of Pharmaceutics. He is an Editor for Pharmaceutics, Molecules, and Section Editor of the European Journal of Pharmaceutical Sciences.

To celebrate Prof Van den Mooter´s significant and important contributions to the field of pharmaceutics and drug delivery, we aim to dedicate this Special Issue of Pharmaceutics in his honor. He is a keen scientist, whose numerous research areas have been profoundly multidisciplinary. To cover his inspirational research works accomplished across his outstanding career, we invite contributions in the wide area of pharmaceutics disciplines encompassing preformulation, formulation, solid-state analysis and characterization, pharmaceutical technology, advanced drug delivery, and diverse poorly soluble drug formulation approaches. We welcome in this Special Issue submissions of previously unpublished original research works or reviews in these areas.

Prof. Dr. Amrit Paudel
Guest Editor

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

  • preformulation
  • formulation
  • solid-state analysis and characterization
  • amorphous solid dispersion
  • lipid-based formulation
  • self-emulsifying systems
  • cyclodextrin complexes
  • mesoporous silica-based formulations
  • nanocrystals
  • protein solid formulation
  • spray drying
  • electrospray drying
  • hot melt extrusion
  • milling
  • thermal analysis
  • polymorphism
  • glass transition
  • disordered pharmaceuticals

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Published Papers (3 papers)

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Research

13 pages, 3037 KiB  
Article
Factors Influencing the Crystallization-Onset Time of Metastable ASDs
by Friederike Wolbert, Ineke-Katharina Fahrig, Tobias Gottschalk, Christian Luebbert, Markus Thommes and Gabriele Sadowski
Pharmaceutics 2022, 14(2), 269; https://doi.org/10.3390/pharmaceutics14020269 - 23 Jan 2022
Cited by 14 | Viewed by 3911
Abstract
In formulation development, amorphous solid dispersions (ASD) are considered to improve the bioavailability of poorly water-soluble active pharmaceutical ingredients (APIs). However, the crystallization of APIs often limits long-term stability and thus the shelf life of ASDs. It has already been shown earlier that [...] Read more.
In formulation development, amorphous solid dispersions (ASD) are considered to improve the bioavailability of poorly water-soluble active pharmaceutical ingredients (APIs). However, the crystallization of APIs often limits long-term stability and thus the shelf life of ASDs. It has already been shown earlier that the long-term stability of ASDs strongly depends on the storage conditions (relative humidity, temperature), the manufacturing methods, and the resulting particle sizes. In this work, ASDs composed of the model APIs Griseofulvin (GRI) or Itraconazole (ITR) and the polymers poly (vinylpyrrolidone-co-vinyl acetate) (PVPVA) or Soluplus® were manufactured via spray drying and hot-melt extrusion. Each API/polymer combination was manufactured using the two manufacturing methods with at least two different API loads and two particle-size distributions. It was a priori known that these ASDs were metastable and would crystallize over time, even in the dry stage. The amount of water absorbed by the ASD from humid air (40 °C/75% relative humidity), the solubility of the API in the ASD at humid conditions, and the resulting glass-transition temperature were predicted using the Perturbed-Chain Statistical Associating Fluid Theory (PC-SAFT) and the Gordon–Taylor approach, respectively. The onset of crystallization was determined via periodic powder X-ray diffraction (PXRD) measurements. It was shown that simple heuristics such as “larger particles always crystallize later than smaller particles” are correct within one manufacturing method but cannot be transferred from one manufacturing method to another. Moreover, amorphous phase separation in the ASDs was shown to also influence their crystallization kinetics. Counterintuitively, phase separation accelerated the crystallization time, which could be explained by the glass-transition temperatures of the evolving phases. Full article
(This article belongs to the Special Issue Commemorative Issue in Honor of Professor Guy Van den Mooter)
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22 pages, 2965 KiB  
Article
Influence of Print Settings on the Critical Quality Attributes of Extrusion-Based 3D-Printed Caplets: A Quality-by-Design Approach
by Silke Henry, Lotte De Wever, Valérie Vanhoorne, Thomas De Beer and Chris Vervaet
Pharmaceutics 2021, 13(12), 2068; https://doi.org/10.3390/pharmaceutics13122068 - 3 Dec 2021
Cited by 18 | Viewed by 4455
Abstract
Extrusion-based 3D-printing is an easy-to-use, cheap manufacturing technique that could be used to produce tailored precision medicines. The technique has an almost unlimited versatility since a multitude of print parameters can easily be adapted. Unfortunately, little is known of the effect of these [...] Read more.
Extrusion-based 3D-printing is an easy-to-use, cheap manufacturing technique that could be used to produce tailored precision medicines. The technique has an almost unlimited versatility since a multitude of print parameters can easily be adapted. Unfortunately, little is known of the effect of these print parameters on the critical quality attributes of the resulting printlets. In this study, practical guidelines and means to adapt certain parameters in order to achieve the desired outcome (e.g., acceptable visual quality and flexible dosing) are stipulated for medical 3D-printing using a design-of-experiments approach. The current study aims at elucidating the effect of five print parameters (infill, overlap, number of shells, layer height and layer pattern) on the mechanical properties, dimensions, weight, porosity and dissolution characteristics of a fixed-size caplet consisting of Eudragit EPO (69.3%), Polyox WSR N10 (29.7%) and zolpidem hemitartrate (1%). In terms of the mechanical properties, 3D-printed caplets possessed anisotropy where the vertical compression strength and Brinell hardness exceeded the diametral strength. In general, all 3D-printed caplets possessed acceptable mechanical strength except for a small region of the knowledge space. Dimensional analysis revealed small, statistical significant differences between different runs, although the clinical relevance of this variation is likely negligible. The weight or dose of a caplet can be varied mainly using the infill and overlap and, to a lesser extent, via the layer height and number of shells. The impact on porosity was complicated as this was influenced by many factors and their interactions. Infill was the only statistically relevant factor influencing the dissolution rate of the current formulation. This study unravels the importance of the print parameter overlap, which is a regularly neglected parameter. We also discovered that small dose variations while maintaining the same dissolution profile were possible via modifying the overlap or number of shells. However, large dose variations without affecting the dissolution behaviour could only be accomplished by size modifications of the printlet. Full article
(This article belongs to the Special Issue Commemorative Issue in Honor of Professor Guy Van den Mooter)
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23 pages, 3070 KiB  
Article
Development of a 3D-Printed Dosing Platform to Aid in Zolpidem Withdrawal Therapy
by Silke Henry, Lien De Vadder, Milan Decorte, Susanna Francia, Magali Van Steenkiste, Jan Saevels, Valérie Vanhoorne and Chris Vervaet
Pharmaceutics 2021, 13(10), 1684; https://doi.org/10.3390/pharmaceutics13101684 - 14 Oct 2021
Cited by 19 | Viewed by 4128
Abstract
The long-term use of benzodiazepine receptor agonists (BZRAs) is associated with multiple side effects, such as increased sedation, hangover or an elevated risk of dependency and abuse. Unfortunately, the long-term use of BZRAs is reaching worrying intake rates, and therefore, the need for [...] Read more.
The long-term use of benzodiazepine receptor agonists (BZRAs) is associated with multiple side effects, such as increased sedation, hangover or an elevated risk of dependency and abuse. Unfortunately, the long-term use of BZRAs is reaching worrying intake rates, and therefore, the need for action is high. It was demonstrated already that the overall willingness of patients for deprescription increased when a slow dose reduction scheme with the possibility for dose increase, if needed, is employed. The current study aims to develop a flexible dosing platform of zolpidem hemitartrate (ZHT) to facilitate such withdrawal therapy. As this is the first report on the extrusion and 3D printing of ZHT, its thermal behaviour and sensitivity towards photolytic degradation was characterised. It was shown that ZHT possesses multiple polymorphs and was especially prone to oxidative photolysis. Next, a variety of immediate release polymers (Eudragit EPO, Kollidon VA64, Kollidon 12PF and Soluplus) were blended and extruded with Polyox WSR N10 to investigate their feedability and printability by mechanical and rheological analysis. The addition of PEO was shown to enable printing of these brittle pharmaceutical polymers, although the processing temperature was deemed critical to avoid surface defects on the resulting filaments. An EPO(70)PEO(30) system was selected based on its suitable mechanical properties and low hygroscopicity favoring ZHT stability. The matrix was blended with 1% or 10% API. The effect of certain printing parameters (caplet size, nozzle diameter, % overlap) on dissolution behaviour and caplet weight/dimensions/quality was assessed. A flexible dosing platform capable of delivering <1 mg and up to 10 mg of ZHT was created. Either caplet modification (incorporation of channels) or disintegrant addition (Primojel, Explotab, Ac-Di-Sol, Primellose and Polyplasdone-XL) failed to achieve an immediate release profile. This study provides the first report of a 3D-printed flexible dosing platform containing ZHT to aid in withdrawal therapy. Full article
(This article belongs to the Special Issue Commemorative Issue in Honor of Professor Guy Van den Mooter)
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