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Pharmaceutics
Special Issues
Pharmaceutical Solids: Advanced Manufacturing and Characterization
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Pharmaceutical Solids: Advanced Manufacturing and Characterization

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmaceutical Technology, Manufacturing and Devices".

Deadline for manuscript submissions: closed (20 April 2024) | Viewed by 5702

Special Issue Editor

Dr. Vivek Verma

E-Mail Website
Guest Editor
Department of Chemical Engineering, Imperial College London, London SW7 2AZ, UK
Interests: (bio)pharmaceutical crystallisation; pharmaceutical formulations; secondary processing of powders; process analytical techniques; spray drying

Special Issue Information

Dear Colleagues,

Pharmaceutical solids play a pivotal role in drug development and delivery. Advanced manufacturing and characterization techniques are indispensable for ensuring the quality, safety, effectiveness, and swift time-to-market of these products. In recent times, significant progress has been made in the realm of pharmaceutical solid manufacturing and characterization, resulting in enhanced drug formulations, delivery systems, and overall patient well-being. Novel manufacturing and characterization technologies hold the potential to optimize pharmaceutical production and offer advantages to patients. However, the widespread adoption of these innovative pharmaceutical manufacturing technologies has encountered obstacles, as stakeholders highlight potential barriers to their implementation. This Special Issue, titled "Pharmaceutical Solids: Advanced Manufacturing and Characterization", aims to showcase the cutting-edge advancements in all facets of pharmaceutical solids manufacturing and characterization. The goal is to introduce new tools that address drug shortages and other challenges, ultimately contributing to improved pharmaceutical quality.

Dr. Vivek Verma
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

  • hot melt extrusion (HME)
  • nanotechnology (nanoparticles and nanosuspensions, nanoprecipitation and nano emulsification)
  • three-dimensional printing
  • spray drying including supercritical CO2-assisted spray drying
  • quality-by-design (QbD) approach
  • continuous manufacturing
  • artificial intelligence and machine learning
  • template/surface assisted crystallisation
  • microwave assisted manufacturing
  • sono precipitation
  • mechanochemistry
  • advanced characterizations such as X-Ray Diffraction (XRD), Differential Scanning Calorimetry (DSC), Scanning Electron Microscopy (SEM), Raman Spectroscopy, Dynamic Vapor Sorption (DVS), Inverse Gas Chromatography (IGC), Quartz Crystal Microbalance (QCM), scanning white light interferometry, TOF-SIMS, XPS, Solid State Nuclear Magnetic Resonance, in situ PXRD, TEM, and SEM, SEM-Raman, and other solid state characterizations
  • hyperspectral imaging, MRI characterization of solid pharmaceutical dosage forms, X-ray tomography and terahertz pulsed spectroscopy and imaging, NIR spectroscopy
  • Process Analytical Technology (PAT)

Published Papers (5 papers)

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Research

18 pages, 2826 KiB  
Article
Novel Dry Hyaluronic Acid–Vancomycin Complex Powder for Inhalation, Useful in Pulmonary Infections Associated with Cystic Fibrosis
by María S. Magi, Yanina de Lafuente, Eride Quarta, María C. Palena, Perla del R. Ardiles, Paulina L. Páez, Fabio Sonvico, Francesca Buttini and Alvaro F. Jimenez-Kairuz
Pharmaceutics 2024, 16(4), 436; https://doi.org/10.3390/pharmaceutics16040436 - 22 Mar 2024
Viewed by 720
Abstract
Polyelectrolyte–drug complexes are interesting alternatives to improve unfavorable drug properties. Vancomycin (VAN) is an antimicrobial used in the treatment of methicillin-resistant Staphylococcus aureus pulmonary infections in patients with cystic fibrosis. It is generally administered intravenously with a high incidence of adverse side effects, [...] Read more.
Polyelectrolyte–drug complexes are interesting alternatives to improve unfavorable drug properties. Vancomycin (VAN) is an antimicrobial used in the treatment of methicillin-resistant Staphylococcus aureus pulmonary infections in patients with cystic fibrosis. It is generally administered intravenously with a high incidence of adverse side effects, which could be reduced by intrapulmonary administration. Currently, there are no commercially available inhalable formulations containing VAN. Thus, the present work focuses on the preparation and characterization of an ionic complex between hyaluronic acid (HA) and VAN with potential use in inhalable formulations. A particulate–solid HA-VAN25 complex was obtained by spray drying from an aqueous dispersion. FTIR spectroscopy and thermal analysis confirmed the ionic interaction between HA and VAN, while an amorphous diffraction pattern was observed by X-ray. The powder density, geometric size and morphology showed the suitable aerosolization and aerodynamic performance of the powder, indicating its capability of reaching the deep lung. An in vitro extended-release profile of VAN from the complex was obtained, exceeding 24 h. Microbiological assays against methicillin-resistant and -sensitive reference strains of Staphylococcus aureus showed that VAN preserves its antibacterial efficacy. In conclusion, HA-VAN25 exhibited interesting properties for the development of inhalable formulations with potential efficacy and safety advantages over conventional treatment. Full article
(This article belongs to the Special Issue Pharmaceutical Solids: Advanced Manufacturing and Characterization)
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20 pages, 3201 KiB  
Article
Natural Stabilizers and Nanostructured Lipid Carrier Entrapment for Photosensitive Compounds, Curcumin and Capsaicin
by Wipanan Jandang, Chadarat Ampasavate and Kanokwan Kiattisin
Pharmaceutics 2024, 16(3), 412; https://doi.org/10.3390/pharmaceutics16030412 - 17 Mar 2024
Viewed by 803
Abstract
Capsaicin and curcumin, the active components of chili and turmeric, are prone to instability when exposed to light. Therefore, this research aimed to enhance the photostability of both extracts via the use of antioxidants, natural sunscreen, and nanostructured lipid carriers (NLCs). NLCs were [...] Read more.
Capsaicin and curcumin, the active components of chili and turmeric, are prone to instability when exposed to light. Therefore, this research aimed to enhance the photostability of both extracts via the use of antioxidants, natural sunscreen, and nanostructured lipid carriers (NLCs). NLCs were chosen for this this study due to their advantages in terms of stability, drug loading capacity, occlusive effect, skin penetration, and controlled release. The photostability of each extract and extracts mixed with antioxidants, including grape seed extract, tea extract, and chlorogenic acid, were determined. Chlorogenic acid can enhance the photostability of capsaicin from 6.79 h to 16.50 h, while the photostability of curcumin increased from 9.63 h to 19.25 h. In addition, the use of natural sunscreen (sunflower oil) also increased the photostability of capsaicin and curcumin. The mixed extracts were then loaded into NLCs. The particle size of the formulation was 153.73 nm with a PDI value of 0.25. It exhibited high entrapment efficiency (more than 95%). In addition, it effectively reduced the decomposition of capsaicin and curcumin. Importantly, the natural stabilizers chosen for NLC fabrication significantly improved the photostability of curcumin and capsaicin by 600% and 567% compared to the unstabilized counterparts. This improvement contributes to the sustainability and bioavailability of these compounds in both cosmeceutical and pharmaceutical products. Full article
(This article belongs to the Special Issue Pharmaceutical Solids: Advanced Manufacturing and Characterization)
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21 pages, 9487 KiB  
Article
The Effect of Formulation Variables on the Manufacturability of Clopidogrel Tablets via Fluidized Hot-Melt Granulation—From the Lab Scale to the Pilot Scale
by Béla Kovács, Erzsébet-Orsolya Tőkés, Éva Katalin Kelemen, Katalin Zöldi, Francisc Boda, Edit Suba, Boglárka Kovács-Deák and Tibor Casian
Pharmaceutics 2024, 16(3), 391; https://doi.org/10.3390/pharmaceutics16030391 - 13 Mar 2024
Viewed by 752
Abstract
Solid pharmaceutical formulations with class II active pharmaceutical ingredients (APIs) face dissolution challenges due to limited solubility, affecting in vivo behavior. Robust computational tools, via data mining, offer valuable insights into product performance, complementing traditional methods and aiding in scale-up decisions. This study [...] Read more.
Solid pharmaceutical formulations with class II active pharmaceutical ingredients (APIs) face dissolution challenges due to limited solubility, affecting in vivo behavior. Robust computational tools, via data mining, offer valuable insights into product performance, complementing traditional methods and aiding in scale-up decisions. This study utilizes the design of experiments (DoE) to understand fluidized hot-melt granulation manufacturing technology. Exploratory data analysis (MVDA) highlights similarities and differences in tablet manufacturability and dissolution profiles at both the lab and pilot scales. The study sought to gain insights into the application of multivariate data analysis by identifying variations among batches produced at different manufacturing scales for this technology. DoE and MVDA findings show that the granulation temperature, time, and Macrogol type significantly impact product performance. These factors, by influencing particle size distribution, become key predictors of product quality attributes such as resistance to crushing, disintegration time, and early-stage API dissolution in the profile. Software-aided data mining, with its multivariate and versatile nature, complements the empirical approach, which is reliant on trial and error during product scale-up. Full article
(This article belongs to the Special Issue Pharmaceutical Solids: Advanced Manufacturing and Characterization)
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15 pages, 7305 KiB  
Article
Customizable Three-Dimensional Printed Earring Tap for Treating Affections Caused by Aesthetic Perforations
by Ludmila A. G. Pinho, Ana Luiza Lima, Yong Chen, Livia L. Sa-Barreto, Ricardo N. Marreto, Guilherme M. Gelfuso, Tais Gratieri and Marcilio Cunha-Filho
Pharmaceutics 2024, 16(1), 77; https://doi.org/10.3390/pharmaceutics16010077 - 05 Jan 2024
Viewed by 1063
Abstract
This work aimed to develop a three-dimensional (3D) wearable drug-loaded earring tap to treat affections caused by aesthetic perforations. The initial phase involved a combination of polymers to prepare filaments for fused deposition modeling (FDM) 3D printing using a centroid mixture design. Optimized [...] Read more.
This work aimed to develop a three-dimensional (3D) wearable drug-loaded earring tap to treat affections caused by aesthetic perforations. The initial phase involved a combination of polymers to prepare filaments for fused deposition modeling (FDM) 3D printing using a centroid mixture design. Optimized filament compositions were used in the second phase to produce 3D printed earring taps containing the anti-inflammatory naringenin. Next, samples were assessed via physicochemical assays followed by in vitro skin permeation studies with porcine ear skin. Two filament compositions were selected for the study’s second phase: one to accelerate drug release and another with slow drug dissolution. Both filaments demonstrated chemical compatibility and amorphous behavior. The use of the polymer blend to enhance printability has been confirmed by rheological analysis. The 3D devices facilitated naringenin skin penetration, improving drug recovery from the skin’s most superficial layer (3D device A) or inner layers (3D device B). Furthermore, the devices significantly decreased transdermal drug delivery compared to the control containing the free drug. Thus, the resulting systems are promising for producing 3D printed earring taps with topical drug delivery and reinforcing the feasibility of patient-centered drug administration through wearable devices. Full article
(This article belongs to the Special Issue Pharmaceutical Solids: Advanced Manufacturing and Characterization)
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12 pages, 2724 KiB  
Article
The Cocrystal of Ubiquinol: Improved Stability and Bioavailability
by Qi Zhang, Mengyuan Xia, Chenxuan Zheng, Yinghong Yang, Junjie Bao, Wenjuan Dai and Xuefeng Mei
Pharmaceutics 2023, 15(10), 2499; https://doi.org/10.3390/pharmaceutics15102499 - 20 Oct 2023
Cited by 2 | Viewed by 1600
Abstract
Coenzyme Q10 (CoQ10) exists in two forms, an oxidized form and a reduced form. Ubiquinol is the fully reduced form of CoQ10. Compared to the oxidized form, ubiquinol has a much higher biological absorption and better therapeutic effect. However, ubiquinol has an important [...] Read more.
Coenzyme Q10 (CoQ10) exists in two forms, an oxidized form and a reduced form. Ubiquinol is the fully reduced form of CoQ10. Compared to the oxidized form, ubiquinol has a much higher biological absorption and better therapeutic effect. However, ubiquinol has an important stability problem which hampers its storage and formulation. It can be easily transformed into its oxidized form—ubiquinone—even at low temperature. In this work, we designed, synthesized, and characterized a new cocrystal of ubiquinol with vitamin B3 nicotinamide (UQ-NC). Compared to the marketed ubiquinol form, the cocrystal exhibited an excellent stability, improved dissolution properties, and higher bioavailability. The cocrystal remained stable for a long period, even when stored under stressed conditions. In the dissolution experiments, the cocrystal generated 12.6 (in SIF) and 38.3 (in SGF) times greater maximum ubiquinol concentrations above that of the marketed form. In addition, in the PK studies, compared to the marketed form, the cocrystal exhibited a 2.2 times greater maximum total coenzyme Q10 concentration and a 4.5 times greater AUC than that of the marketed form. Full article
(This article belongs to the Special Issue Pharmaceutical Solids: Advanced Manufacturing and Characterization)
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