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Materials and Devices for Drug Delivery—Applications and Methods of Evaluation

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A special issue of Materials (ISSN 1996-1944). This special issue belongs to the section "Biomaterials".

Deadline for manuscript submissions: closed (20 June 2023) | Viewed by 8418

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Special Issue Editors

Dr. Piotr Kulinowski

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Guest Editor

Institute of Technology, Pedagogical University of Krakow, ul. Podchorążych 2, 30-084 Kraków, Poland
Interests: controlled release; additive manufacturing; magnetic resonance imaging; personalized medicine

Prof. Dr. Przemysław Dorożyński

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Guest Editor

Department of Drug Technology and Pharmaceutical Biotechnology, Warsaw Medical University, 02-091 Warszawa, Poland
Interests: controlled drug delivery; novel excipients; manufacturing technologies; pharmaceutical analysis

Special Issue Information

Dear Colleagues,

The improvement of the therapeutic effect of a given drug has been in the scientific focus for decades. However, the current development of manufacturing and analytical methods of pharmaceutical formulations has changed the view and approach to new solutions in drug delivery. In particular, targeted/local drug delivery and personalized therapy require dedicated materials and devices. For this reason, there is a strong demand for novel solutions in this area, as well as innovative approaches to the use of existing ones. Various technologies can be used to achieve the desired functional properties, e.g., various methods of additive manufacturing.

Knowledge of mechanisms of drug delivery with controlled release kinetics is crucial for the rational design of drug delivery systems. A key issue is evaluation toward functional properties and working mechanisms in vitro or/and in vivo. Special attention should be paid to the physicochemical basis of action and drug delivery using various analytical methods, including imaging modalities (e.g., chemical imaging, magnetic resonance imaging), and to links between mechanisms and functional properties of drug delivery systems.

As the editors of this Special Issue, we are inviting research and review papers covering as broad as possible a spectrum of materials and devices dedicated to wide application in drug delivery from systemic delivery to targeted/local drug delivery and personalized therapy. Papers concerning analytical aspects of drug delivery in terms of internal structure of dosage forms, their mechanism of action or accompanying physicochemical phenomena are also welcome.

Dr. Piotr Kulinowski
Prof. Dr. Przemysław Dorożyński
Guest Editors

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Keywords

personalized medicines
systemic drug delivery
targeted drug delivery
Medicinal product
Medical device
Novel manufacturing methodologies
Integrated/multimodal methods of pharmaceutical formulation analysis
Novel materials in drug delivery
Rational design of drug delivery systems
Programmable drug release
Improved therapeutic effect

Published Papers (5 papers)

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Research

14 pages, 13380 KiB

Open AccessArticle

Paraffin–Peloid Formulations from Copahue: Processing, Characterization, and Application

by Micaela A. Sanchez, Miria T. Baschini, Manuel Pozo, Betina R. Gramisci, María E. Roca Jalil and María L. Vela

Materials 2023, 16(14), 5062; https://doi.org/10.3390/ma16145062 - 18 Jul 2023

Cited by 1 | Viewed by 800

Abstract

The Copahue Thermal Center, situated in Neuquén, Argentina, produces natural and matured peloids, which are employed in the prevention and treatment of various osteoarticular and dermatological disorders. The presence of sulfur as a constituent and its thermotherapeutic potential constitute the primary strengths of these peloids. Nevertheless, accessing Copahue is challenging due to its distance from densely populated centers and the snow cover during the winter months in the southern hemisphere. Therefore, in order to propose a material that can be utilized year-round in any location, a mudpack was obtained by combining medicinal paraffin with dehydrated Copahue peloids, with concentrations evaluated up to 10% w/w. This mudpack was analyzed through X-ray diffraction, which detected the presence of sulfur, the most important component of Copahue’s peloids. Through IR spectroscopy, the signals that identify medicinal paraffin were clearly observed, and for concentrations of 6% and 10% peloid in the material, it was possible to detect the presence of mineral clay components associated with Si-O stretching vibrations at around 1041 cm⁻¹. The low values of luminosity and grey tonality obtained for the mudpack contributed to patient acceptability and the absorption of electromagnetic radiation. The experimental cooling rate, calculated using the ratio of the temperature variation (∆T) with respect to the time variation (∆t) in each interval of the experimental curve, was determined to be 0.6 °C·min⁻¹ for both paraffin and the mudpack. However, for peloids, higher values ranging from 0.6 to 4.8 °C·min⁻¹ were obtained. This suggests that the mudpack mixtures have a slower heat release, which is a desirable property for their use as a thermotherapeutic agent. Considering the reusability of the mudpack, its stability was evaluated after 10 cycles of cooling and heating through XRD, DSC, and FTIR tests, resulting in a system that retains its properties. The formulation of the obtained mudpack is promising for the development of these materials on a larger scale. Full article

(This article belongs to the Special Issue Materials and Devices for Drug Delivery—Applications and Methods of Evaluation)

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16 pages, 4487 KiB

Open AccessArticle

Development of Composite, Reinforced, Highly Drug-Loaded Pharmaceutical Printlets Manufactured by Selective Laser Sintering—In Search of Relevant Excipients for Pharmaceutical 3D Printing

by Piotr Kulinowski, Piotr Malczewski, Marta Łaszcz, Ewelina Baran, Bartłomiej Milanowski, Mateusz Kuprianowicz and Przemysław Dorożyński

Materials 2022, 15(6), 2142; https://doi.org/10.3390/ma15062142 - 14 Mar 2022

Cited by 18 | Viewed by 3094

Abstract

3D printing by selective laser sintering (SLS) of high-dose drug delivery systems using pure brittle crystalline active pharmaceutical ingredients (API) is possible but impractical. Currently used pharmaceutical grade excipients, including polymers, are primarily designed for powder compression, ensuring good mechanical properties. Using these excipients for SLS usually leads to poor mechanical properties of printed tablets (printlets). Composite printlets consisting of sintered carbon-stained polyamide (PA12) and metronidazole (Met) were manufactured by SLS to overcome the issue. The printlets were characterized using DSC and IR spectroscopy together with an assessment of mechanical properties. Functional properties of the printlets, i.e., drug release in USP3 and USP4 apparatus together with flotation assessment, were evaluated. The printlets contained 80 to 90% of Met (therapeutic dose ca. 600 mg), had hardness above 40 N (comparable with compressed tablets) and were of good quality with internal porous structure, which assured flotation. The thermal stability of the composite material and the identity of its constituents were confirmed. Elastic PA12 mesh maintained the shape and structure of the printlets during drug dissolution and flotation. Laser speed and the addition of an osmotic agent in low content influenced drug release virtually not changing composition of the printlet; time to release 80% of Met varied from 0.5 to 5 h. Composite printlets consisting of elastic insoluble PA12 mesh filled with high content of crystalline Met were manufactured by 3D SLS printing. Dissolution modification by the addition of an osmotic agent was demonstrated. The study shows the need to define the requirements for excipients dedicated to 3D printing and to search for appropriate materials for this purpose. Full article

(This article belongs to the Special Issue Materials and Devices for Drug Delivery—Applications and Methods of Evaluation)

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17 pages, 3880 KiB

Open AccessArticle

In Vitro Wound Dressing Stack Model as a First Step to Evaluate the Behavior of Dressing Materials in Wound Bed—An Assessment of Mass Transport Phenomena in Hydrogel Wound Dressings

by Ewelina Baran, Anna Górska, Artur Birczyński, Wiktor Hudy, Wojciech Kulinowski, Witold Jamróz, Władysław P. Węglarz and Piotr Kulinowski

Materials 2021, 14(24), 7702; https://doi.org/10.3390/ma14247702 - 13 Dec 2021

Cited by 1 | Viewed by 2643

Abstract

Wound dressings when applied are in contact with wound exudates in vivo or with acceptor fluid when testing drug release from wound dressing in vitro. Therefore, the assessment of bidirectional mass transport phenomena in dressing after application on the substrate is important but has never been addressed in this context. For this reason, an in vitro wound dressing stack model was developed and implemented in the 3D printed holder. The stack was imaged using magnetic resonance imaging, i.e., relaxometric imaging was performed by means of T₂ relaxation time and signal amplitude 1D profiles across the wound stack. As a substrate, fetal bovine serum or propylene glycol were used to simulate in vivo or in vitro cases. Multi-exponential analysis of the spatially resolved magnetic resonance signal enabled to distinguish components originating from water and propylene glycol in various environments. The spatiotemporal evolution of these components was assessed. The components were related to mass transport (water, propylene glycol) in the dressing/substrate system and subsequent changes of physicochemical properties of the dressing and adjacent substrate. Sharp changes in spatial profiles were detected and identified as moving fronts. It can be concluded that: (1) An attempt to assess mass transport phenomena was carried out revealing the spatial structure of the wound dressing in terms of moving fronts and corresponding layers; (2) Moving fronts, layers and their temporal evolution originated from bidirectional mass transport between wound dressing and substrate. The setup can be further applied to dressings containing drugs. Full article

(This article belongs to the Special Issue Materials and Devices for Drug Delivery—Applications and Methods of Evaluation)

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18 pages, 3502 KiB

Open AccessArticle

Hydration Patterns in Sodium Alginate Polymeric Matrix Tablets—The Result of Drug Substance Incorporation

by Ewelina Juszczyk, Piotr Kulinowski, Ewelina Baran, Artur Birczyński, Jolanta Klaja, Dorota Majda, Encarna Garcia-Montoya, Władysław P. Węglarz and Przemysław Dorożyński

Materials 2021, 14(21), 6531; https://doi.org/10.3390/ma14216531 - 29 Oct 2021

Cited by 4 | Viewed by 1794

Abstract

The purpose was to show, using destructive/nondestructive methods, that the interplay between water, tablet structure, and composition determine the unique spatiotemporal hydration pattern of polymer-based matrices. The tablets containing a 1:1 w/w mixture of sodium alginate with salicylic acid (ALG/SA) or sodium salicylate (ALG/SNA) were studied using Karl Fischer titration, differential scanning calorimetry, X-ray microtomography, and magnetic resonance imaging. As the principal results, matrix specific features were detected, e.g., “locking” of the internal part of the matrix (ALG/SA); existence of lamellar region associated with detection of free/freezing water (ALG/SA); existence of water penetrating the matrix forming specific region preceding infiltration layer (ALG/SNA); switch in the onset temperature of endothermic water peak associated with an increase in the fraction of non-freezing water weight per dry matrix weight in the infiltration layer (ALG/SNA). The existence of complicated spatiotemporal hydration patterns influenced by matrix composition and molecular properties of constituents has been demonstrated. Full article

(This article belongs to the Special Issue Materials and Devices for Drug Delivery—Applications and Methods of Evaluation)

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13 pages, 2882 KiB

Open AccessArticle

Spatiotemporal Analysis of Hydration Mechanism in Sodium Alginate Matrix Tablets

by Ewelina Juszczyk, Piotr Kulinowski, Ewelina Baran, Artur Birczyński, Dorota Majda, Encarna García-Montoya, Pilar Pérez-Lozano, Josep Maria Suñé-Negre, Władysław P. Węglarz and Przemysław Dorożyński

Materials 2021, 14(3), 646; https://doi.org/10.3390/ma14030646 - 30 Jan 2021

Cited by 6 | Viewed by 1911

Abstract

Methods of spatiotemporal characterization of nonequilibrated polymer based matrices are still immature and imperfect. The purpose of the study was to develop the methodology for the spatiotemporal characterization of water transport and properties in alginate tablets under hydration. The regions of low water content were spatially and temporally sampled using Karl Fisher and Differential Scanning Callorimetry (spatial distribution of freezing/nonfreezing water) with spatial resolution of 1 mm. In the regions of high water content, where sampling was infeasible due to gel/sol consistency, magnetic resonance imaging (MRI) enabled characterization with an order of magnitude higher spatial resolution. The minimally hydrated layer (MHL), infiltration layer (IL) and fully hydrated layer (FHL) were identified in the unilaterally hydrated matrices. The MHL gained water from the first hour of incubation (5–10% w/w) and at 4 h total water content was 29–39% with nonfreezing pool of 28–29%. The water content in the IL was 45–47% and at 4 h it reached ~50% with the nonfreezing pool of 28% and T₂ relaxation time < 10 ms. The FHL consisted of gel and sol layer with water content of 85–86% with a nonfreezing pool of 11% at 4 h and T₂ in the range 20–200 ms. Hybrid destructive/nondestructive analysis of alginate matrices under hydration was proposed. It allowed assessing the temporal changes of water distribution, its mobility and interaction with matrices in identified layers. Full article

(This article belongs to the Special Issue Materials and Devices for Drug Delivery—Applications and Methods of Evaluation)

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