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Pharmaceuticals
Special Issues
Pharmaceutical Formulation Characterization Design
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Pharmaceutical Formulation Characterization Design

A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Pharmaceutical Technology".

Deadline for manuscript submissions: 5 January 2025 | Viewed by 3321

Special Issue Editors

Dr. Tamás Sovány

E-Mail Website
Guest Editor
Institute of Pharmaceutical Technology and Regulatoy Affairs, University of Szeged, Eötvös u.6., 6720 Szeged, Hungary
Interests: solid dosage forms; tablets; quality by design; factorial design; artificial neural network
Special Issues, Collections and Topics in MDPI journals
Dr. Katalin Kristó

E-Mail Website
Guest Editor
Institute of Pharmaceutical Technology and Regulatoy Affairs, University of Szeged, Eötvös u. 6., H-6720 Szeged, Hungary
Interests: buccal polymer films; mucoadhesion; proteins; quality by design; permeation enhancing
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear colleagues,

This Special Issue in "Pharmaceuticals" is dedicated to reporting the latest scientific results in the field of "Formulation Characterization Design". At present, it is very important that, before the industrial production of pharmaceuticals, a given pharmaceutical form is extensively tested, which includes various structural tests, physical tests, and pharmacokinetic tests. It is necessary to find out whether there is any change in the active ingredient during pharmaceutical technological processes and whether this could influence the development of the effect. It is necessary to understand the relationships between different structural properties, the dissolution profile, and effect development in order to be able to design medicines more efficiently based on new knowledge. Appropriate planning is also very important, and this can be achieved primarily through risk analysis, the Quality by Design (QbD) approach, and the use of factorial experimental design (DoE). It is possible to determine the design space, which provides accurate information provides information about the Critical Process Parameter (CPP) values, within which the product with the quality target product profile (QTPP) will be suitable. Based on these, we can gain new knowledge and connections that are essential for efficient production later on. This Special Issue primarily publishes results related to the above-mentioned topic or some part of it, mainly in the field of solid dosage form formulation or intermediate products that can be used in them.

Dr. Tamás Sovány
Dr. Katalin Kristó
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. Pharmaceuticals 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

  • quality by design
  • factorial design
  • design space
  • solid dosage forms
  • risk assessment
  • critical process parameters
  • quality target product profile

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Published Papers (4 papers)

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Research

20 pages, 2396 KiB  
Article
Modelling of Cetylpyridinium Chloride Availability in Complex Mixtures for the Prediction of Anti-Microbial Activity Using Diffusion Ordered Spectroscopy, Saturation Transfer Difference and 1D NMR
by Cameron Robertson, Sayoni Batabyal, Darren Whitworth, Tomris Coban, Angharad Smith, Alessandra Montesanto, Robert Lucas and Adam Le Gresley
Pharmaceuticals 2024, 17(12), 1570; https://doi.org/10.3390/ph17121570 - 22 Nov 2024
Abstract
Background/Objectives: A range of NMR techniques, including diffusion ordered spectroscopy (DOSY) were used to characterise complex micelles formed by the anti-microbial cationic surfactant cetylpyridium chloride and to quantify the degree of interaction between cetylpyridium chloride and hydroxyethyl cellulose in a variety of commercially [...] Read more.
Background/Objectives: A range of NMR techniques, including diffusion ordered spectroscopy (DOSY) were used to characterise complex micelles formed by the anti-microbial cationic surfactant cetylpyridium chloride and to quantify the degree of interaction between cetylpyridium chloride and hydroxyethyl cellulose in a variety of commercially relevant formulations as a model for the disk retention assay. Methods: This NMR-derived binding information was then compared with the results of formulation analysis by traditional disk retention assay (DRA) and anti-microbial activity assays to assess the suitability of these NMR techniques for the rapid identification of formulation components that could augment or retard antimicrobial activity DRA. Results: NMR showed a strong ability to predict anti-microbial activity for a diverse range of formulations containing cetylpyridinium chloride (CPC). Conclusions: This demonstrates the value of this NMR-based approach as a rapid, relatively non-destructive method for screening commercial experimental anti-microbial formulations for efficacy and further helps to understand the interplay of excipients and active ingredients. Full article
(This article belongs to the Special Issue Pharmaceutical Formulation Characterization Design)
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10 pages, 1465 KiB  
Article
Optical Microscopy as a Tool for Assessing Parenteral Nutrition Solution Stability: A Proof of Concept
by Luis Otero-Millán, Brais Bea-Mascato, Jose Luis Legido Soto, María Carmen Martín de la Cruz, Noemi Martínez-López-De-Castro and Natividad Lago-Rivero
Pharmaceuticals 2024, 17(10), 1330; https://doi.org/10.3390/ph17101330 - 5 Oct 2024
Viewed by 553
Abstract
Background/Objectives: Parenteral nutrition (PN) is used when enteral feeding is not possible. It is a complex mixture of nutrients that must meet a patient’s needs but can face stability issues, such as lipid emulsion destabilisation and precipitate formation. Stability studies are complex, [...] Read more.
Background/Objectives: Parenteral nutrition (PN) is used when enteral feeding is not possible. It is a complex mixture of nutrients that must meet a patient’s needs but can face stability issues, such as lipid emulsion destabilisation and precipitate formation. Stability studies are complex, and the methodologies used are very varied in the literature. In addition, many studies are outdated and use outdated components. This study conducts a stability analysis of PN solutions using optical microscopy. Methods: Samples were prepared according to clinical practice standards and previous studies. We used a counting chamber for optical microscopic observations and different storage conditions (RT, 4 °C 1–14 days). Results: Precipitates larger than 5 µm were found in 8 out of 14 samples after 14 days of storage at room temperature, and none were observed in refrigerated samples. More lipid globules larger than 5 µm were detected in samples stored at room temperature than in those stored in a refrigerator after 14 days. Additionally, the number of large globules generally increased from day 1 to day 14 in most samples. Conclusions: The observed precipitates were probably calcium oxalate crystals, the formation of which is possible in PN but is not expected under the usual storage conditions in a hospital environment. Prolonged storage time and storage at room temperature increases the formation of these precipitates. These findings highlight the importance of using filters during both the preparation and administration of PN to prevent large particles from reaching patients. Full article
(This article belongs to the Special Issue Pharmaceutical Formulation Characterization Design)
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18 pages, 1778 KiB  
Article
In Vitro Study of Cyano-Phycocyanin Release from Hydrogels and Ex Vivo Study of Skin Penetration
by Daiva Galinytė, Jurga Bernatoniene, Modestas Žilius, Kristina Rysevaitė-Kyguolienė, Arūnas Savickas, Jūratė Karosienė, Vitalis Briedis, Dainius Haroldas Pauža and Nijolė Savickienė
Pharmaceuticals 2024, 17(9), 1224; https://doi.org/10.3390/ph17091224 - 17 Sep 2024
Viewed by 917
Abstract
Background: This study explored the most suitable materials for incorporating cyano-phycocyanin (C-PC) into hydrogels, focusing on maintaining the C-PC’s long-term structural integrity and stabilityNext, the release of C-PC from the hydrogels and its skin penetration were investigated. Methods: A series of 1% ( [...] Read more.
Background: This study explored the most suitable materials for incorporating cyano-phycocyanin (C-PC) into hydrogels, focusing on maintaining the C-PC’s long-term structural integrity and stabilityNext, the release of C-PC from the hydrogels and its skin penetration were investigated. Methods: A series of 1% (w/w) C-PC hydrogels was prepared using various gelling agents and preservatives. Spectrophotometric measurements compared the amount of C-PC in the hydrogels to the initially added amount. After selecting the most suitable gelling agent and preservative, two C-PC hydrogels, with and without propylene glycol (PG) (Sigma-Aldrich, St. Louis, MO, USA), were produced for further testing. In vitro release studies utilized modified Franz-type diffusion cells, while ex vivo skin-permeation studies employed Bronaugh-type cells and human skin. Confocal laser scanning microscopy analyzed C-PC accumulation in the skin. Results: The findings demonstrated that sodium alginate (Sigma-Aldrich, St. Louis, MO, USA), hydroxyethyl cellulose (HEC) (Sigma-Aldrich, St. Louis, MO, USA), and SoligelTM (Givaudan, Vernier, Switzerland) are effective biopolymers for formulating hydrogels while maintaining C-PC stability. After 6 h, C-PC release from the hydrogel containing PG was approximately 10% or 728.07 (±19.35) μg/cm2, significantly higher than the nearly 7% or 531.44 (±26.81) μg/cm2 release from the hydrogel without PG (p < 0.05). The ex vivo qualitative skin-permeation study indicated that PG enhances C-PC penetration into the outermost skin layer. Conclusion: PG’s ability to enhance the release of C-PC from the hydrogel, coupled with its capacity to modify the skin barrier ex vivo, facilitates the penetration of C-PC into the stratum corneum. Full article
(This article belongs to the Special Issue Pharmaceutical Formulation Characterization Design)
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32 pages, 7235 KiB  
Article
pH-Sensitive In Situ Gel of Mirtazapine Invasomes for Rectal Drug Delivery: Protruded Bioavailability and Anti-Depressant Efficacy
by Essam M. Eissa, Amani M. El Sisi, Marina A. Bekhet, Fatma I. Abo El-Ela, Rasha M. Kharshoum, Adel A. Ali, Majed Alrobaian and Ahmed M. Abdelhaleem Ali
Pharmaceuticals 2024, 17(8), 978; https://doi.org/10.3390/ph17080978 - 24 Jul 2024
Cited by 1 | Viewed by 1231
Abstract
The present research emphasizes fabrication alongside the assessment of an innovative nano-vesicular membranous system known as invasomes (NVMs) laden with Mirtazapine for rectal administration. This system could circumvent the confines of orally administered counterparts regarding dose schedules and bioavailability. Mirtazapine invasomes were tailored [...] Read more.
The present research emphasizes fabrication alongside the assessment of an innovative nano-vesicular membranous system known as invasomes (NVMs) laden with Mirtazapine for rectal administration. This system could circumvent the confines of orally administered counterparts regarding dose schedules and bioavailability. Mirtazapine invasomes were tailored by amalgamating phospholipid, cineole, and ethanol through a thin-film hydration approach rooted in the Box–Behnken layout. Optimization of composition parameters used to fabricate desired NVMs’ physicochemical attributes was undertaken using the Design-Expert® program. The optimal MRZ-NVMs were subsequently transformed to a pH-triggered in situ rectal gel followed by animal pharmacodynamic and pharmacokinetic investigations relative to rectal plain gel and oral suspension. The optimized NVMs revealed a diameter size of 201.3 nm, a z potential of −28.8 mV, an entrapment efficiency of 81.45%, a cumulative release within 12 h of 67.29%, and a cumulative daily permeated quantity of 468.68 µg/cm2. Compared to the oral suspension, pharmacokinetic studies revealed a 2.85- and 4.45-fold increase in calculated rectal bioavailability in circulation and brain, respectively. Pharmacodynamic and immunohistopathology evaluations exposed superior MRZ-NVMs attributed to the orally administered drug. Consequently, rectal MRZ-NVMs can potentially be regarded as a prospective nanoplatform with valuable pharmacokinetics and tolerability assets. Full article
(This article belongs to the Special Issue Pharmaceutical Formulation Characterization Design)
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