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Pharmaceutics
Special Issues
Protein-Based Formulations for Biomedical and Pharmaceutical Applications
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Protein-Based Formulations for Biomedical and Pharmaceutical Applications

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Drug Delivery and Controlled Release".

Deadline for manuscript submissions: closed (15 March 2022) | Viewed by 12787

Special Issue Editors

Dr. Donato Cosco

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Guest Editor
Department of Health Sciences, University "Magna Graecia" of Catanzaro, Campus "S. Venuta", Building of BioSciences, I-88100 Catanzaro, Italy
Interests: drug delivery; liposomes; pharmaceutical technology; polymeric micro/nanoparticles; selective targeting
Special Issues, Collections and Topics in MDPI journals
Dr. Agnese Gagliardi

E-Mail Website
Guest Editor
Department of Health Sciences, University “Magna Græcia” of Catanzaro, Campus Universitario “S. Venuta”, I-88100 Catanzaro, Italy
Interests: colloidal systems; pharmaceutical technology; polymeric nanoparticles; zein protein

Special Issue Information

Dear Colleagues,

In the last decade, proteins have been widely used in the development of various innovative formulations used as drug delivery systems as a consequence of their great availability, high biocompatibility and biodegradability, as well as thanks to the opportunity to be functionalized. Their peculiar characteristics can be used to obtain systems able to retain hydrophilic and poorly soluble compounds, avoiding the use of harmful organic solvents and crosslinkers. According to their source of origin (animal or vegetal), proteins are characterized by different physico-chemical characteristics, e.g., conformation, molecular weight, isoelectric point, flexibility, polarity, charge, solubility, and interactions. Moreover, the use of a single protein or a blend of different compounds, as well as the preparation techniques, influence the properties of the obtained formulation.

The aim of this Special Issue is to describe advancements concerning the development of innovative protein-based systems used for biomedical and pharmaceutical applications.

All researchers working in the field are cordially invited to contribute. Original research papers, brief communication reports, as well as review articles, are all welcome.

Prof. Dr. Donato Cosco
Dr. Agnese Gagliardi
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

  • biopolymers
  • colloidal systems
  • drug delivery
  • films
  • gels
  • proteins

Published Papers (4 papers)

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Research

18 pages, 4997 KiB  
Communication
Influence of the Dispersion Medium and Cryoprotectants on the Physico-Chemical Features of Gliadin- and Zein-Based Nanoparticles
by Silvia Voci, Agnese Gagliardi, Maria Cristina Salvatici, Massimo Fresta and Donato Cosco
Pharmaceutics 2022, 14(2), 332; https://0-doi-org.brum.beds.ac.uk/10.3390/pharmaceutics14020332 - 30 Jan 2022
Cited by 12 | Viewed by 2325
Abstract
The evaluation of the physico-chemical features of nanocarriers is fundamental because the modulation of these parameters can influence their biological and in vivo fate. This work investigated the feasibility of saline, 5% w/v glucose and phosphate-buffered saline solution, as polar media [...] Read more.
The evaluation of the physico-chemical features of nanocarriers is fundamental because the modulation of these parameters can influence their biological and in vivo fate. This work investigated the feasibility of saline, 5% w/v glucose and phosphate-buffered saline solution, as polar media for the development of nanoparticles made up of two vegetal proteins, zein from corn and gliadin from wheat, respectively. The physico-chemical features of the various systems were evaluated using dynamic and multiple light scattering techniques, and the results demonstrate that the 5% w/v glucose solution is a feasible medium to be used for their development. Moreover, the best formulations were characterized by the aforementioned techniques following the freeze-drying procedure. The aggregation of the zein nanoparticles prepared in water or glucose solution was prevented by using various cryoprotectants. Mannose confirmed its crucial role in the cryopreservation of the gliadin nanosystems prepared in both water and glucose solution. Sucrose and glucose emerged as additional useful excipients when they were added to gliadin nanoparticles prepared in a 5% glucose solution. Specifically, their protective effect was in the following order: mannose > sucrose > glucose. The results obtained when using specific aqueous media and cryoprotectants permitted us to develop stable zein or gliadin nanoparticles as suspension or freeze-dried formulations. Full article
(This article belongs to the Special Issue Protein-Based Formulations for Biomedical and Pharmaceutical Applications)
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14 pages, 12732 KiB  
Article
A General Small-Angle X-ray Scattering-Based Screening Protocol for Studying Physical Stability of Protein Formulations
by Fangrong Zhang, Gesa Richter, Benjamin Bourgeois, Emil Spreitzer, Armin Moser, Andreas Keilbach, Petra Kotnik and Tobias Madl
Pharmaceutics 2022, 14(1), 69; https://0-doi-org.brum.beds.ac.uk/10.3390/pharmaceutics14010069 - 28 Dec 2021
Cited by 3 | Viewed by 2370
Abstract
A fundamental step in developing a protein drug is the selection of a stable storage formulation that ensures efficacy of the drug and inhibits physiochemical degradation or aggregation. Here, we designed and evaluated a general workflow for screening of protein formulations based on [...] Read more.
A fundamental step in developing a protein drug is the selection of a stable storage formulation that ensures efficacy of the drug and inhibits physiochemical degradation or aggregation. Here, we designed and evaluated a general workflow for screening of protein formulations based on small-angle X-ray scattering (SAXS). Our SAXS pipeline combines automated sample handling, temperature control, and fast data analysis and provides protein particle interaction information. SAXS, together with different methods including turbidity analysis, dynamic light scattering (DLS), and SDS-PAGE measurements, were used to obtain different parameters to provide high throughput screenings. Using a set of model proteins and biopharmaceuticals, we show that SAXS is complementary to dynamic light scattering (DLS), which is widely used in biopharmaceutical research and industry. We found that, compared to DLS, SAXS can provide a more sensitive measure for protein particle interactions, such as protein aggregation and repulsion. Moreover, we show that SAXS is compatible with a broader range of buffers, excipients, and protein concentrations and that in situ SAXS provides a sensitive measure for long-term protein stability. This workflow can enable future high-throughput analysis of proteins and biopharmaceuticals and can be integrated with well-established complementary physicochemical analysis pipelines in (biopharmaceutical) research and industry. Full article
(This article belongs to the Special Issue Protein-Based Formulations for Biomedical and Pharmaceutical Applications)
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19 pages, 3522 KiB  
Article
Zein-Based Nanoparticles as Oral Carriers for Insulin Delivery
by Cristian Reboredo, Carlos J. González-Navarro, Ana Luisa Martínez-López, Cristina Martínez-Ohárriz, Bruno Sarmento and Juan M. Irache
Pharmaceutics 2022, 14(1), 39; https://0-doi-org.brum.beds.ac.uk/10.3390/pharmaceutics14010039 - 24 Dec 2021
Cited by 23 | Viewed by 5037
Abstract
Zein, the major storage protein from corn, has a GRAS (Generally Regarded as Safe) status and may be easily transformed into nanoparticles, offering significant payloads for protein materials without affecting their stability. In this work, the capability of bare zein nanoparticles (mucoadhesive) and [...] Read more.
Zein, the major storage protein from corn, has a GRAS (Generally Regarded as Safe) status and may be easily transformed into nanoparticles, offering significant payloads for protein materials without affecting their stability. In this work, the capability of bare zein nanoparticles (mucoadhesive) and nanoparticles coated with poly(ethylene glycol) (mucus-permeating) was evaluated as oral carriers of insulin (I-NP and I-NP-PEG, respectively). Both nanocarriers displayed sizes of around 270 nm, insulin payloads close to 80 µg/mg and did not induce cytotoxic effects in Caco-2 and HT29-MTX cell lines. In Caenorhabditis elegans, where insulin decreases fat storage, I-NP-PEG induced a higher reduction in the fat content than I-NP and slightly lower than the control (Orlistat). In diabetic rats, nanoparticles induced a potent hypoglycemic effect and achieved an oral bioavailability of 4.2% for I-NP and 10.2% for I-NP-PEG. This superior effect observed for I-NP-PEG would be related to their capability to diffuse through the mucus layer and reach the surface of enterocytes (where insulin would be released), whereas the mucoadhesive I-NP would remain trapped in the mucus, far away from the absorptive epithelium. In summary, PEG-coated zein nanoparticles may be an interesting device for the effective delivery of proteins through the oral route. Full article
(This article belongs to the Special Issue Protein-Based Formulations for Biomedical and Pharmaceutical Applications)
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12 pages, 1820 KiB  
Article
Entrapment of Hydrophilic and Hydrophobic Molecules in Beads Prepared from Isolated Denatured Whey Protein
by Joanne Heade, Robert Kent, Sinead B. Bleiel and David J. Brayden
Pharmaceutics 2021, 13(7), 1001; https://0-doi-org.brum.beds.ac.uk/10.3390/pharmaceutics13071001 - 01 Jul 2021
Cited by 1 | Viewed by 2317
Abstract
The oral route of administration is by far the most convenient route, especially in the treatment of chronic conditions. However, many therapeutics present formulation difficulties which make them unsuitable for oral delivery. Recently, we synthesized a denatured whey protein isolate (dWPI) bead entrapped [...] Read more.
The oral route of administration is by far the most convenient route, especially in the treatment of chronic conditions. However, many therapeutics present formulation difficulties which make them unsuitable for oral delivery. Recently, we synthesized a denatured whey protein isolate (dWPI) bead entrapped with insulin. Our present goal was to assess the suitability of this delivery system to the delivery of other potential molecules, both hydrophilic and hydrophobic. Beads of 1.2–1.5 mm in diameter were entrapped with four payloads representing a range of solubilities. The water-soluble payloads were sodium fluorescein (SF) and FITC dextran 4000 Da (FD4), while the hydrophobic ones were Fast Green and curcumin. Encapsulation efficiency (EE) was 73%, 84%, 70%, and 83% for SF, FD4, Fast Green, and curcumin-loaded beads, respectively. The corresponding loading capacity for each bead was 0.07%, 1.1%, 0.75%, and 1.1%, respectively. Each payload produced different release profiles in simulated gastric fluid (SGF) and simulated intestinal fluids (SIF). SF released steadily in both SGF and SIF. FD4 and curcumin release was not substantial in any buffers, while Fast Green release was low in SGF and high in SIF. The differences in release behaviour were likely due to the varying properties of the payloads. The effect of proteolysis on beads suggested that enzymatic degradation of the whey bead may promote payload release. The beads swelled rapidly in SGF compared to SIF, which likely contributed to the release from the beads, which was largely governed by solvent diffusion and polymer relaxation. Our results offer a systematic examination of the behaviour of hydrophilic and hydrophobic payloads in a dWPI delivery system. These beads may be further designed to orally deliver poorly permeable macromolecules and poorly soluble small molecules of pharmaceutical interest. Full article
(This article belongs to the Special Issue Protein-Based Formulations for Biomedical and Pharmaceutical Applications)
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