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Studies of the Dosage Form and Stability of the Drug...
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Studies of the Dosage Form and Stability of the Drug by Various Techniques, 2nd Edition

A special issue of Processes (ISSN 2227-9717). This special issue belongs to the section "Pharmaceutical Processes".

Deadline for manuscript submissions: closed (31 December 2025) | Viewed by 4788

Special Issue Editor

Prof. Dr. Alina Pyka

E-Mail Website
Guest Editor
Department of Analytical Chemistry, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, Jagiellońska 4, 41-200 Sosnowiec, Poland
Interests: chromatography; liquid chromatography; gas chromatography; thin layer chromatography; spectrophotometry; densitometry; organic compounds analysis; QSAR; QSRR; QSPR; pharmaceutical analysis; purity of pharmaceutical preparations
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

This is the second volume of the Special Issue titled "Studies of the Dosage Form and Stability of the Drug by Various Techniques", which was highly successful. In the first volume, we published 11 articles. (https://www.mdpi.com/journal/processes/special_issues/Stability_Drug).

Stability determines the shelf life of drugs, during which their pharmacological activities do not decline and any degradation products are nontoxic. The medicinal product remains stable if the declared content of the drug substance does not differ by more than 5%, if the decomposition products and microbiological contamination are within the acceptable standards, and if there are no changes in the appearance and physical properties of the preparation or drug substance release. Ensuring the stability of a medicinal product begins at the stage of drug substance synthesis, then during technological processes (granulation, tableting), packaging (placing in immediate packaging), distribution (wholesalers, pharmacies), and administration to the patient.

This Special Issue, titled “Studies of the Dosage Form and Stability of the Drug by Various Techniques, 2nd Edition”, aims to curate novel advances in the development and application of different analytical techniques in drug analyses. Topics of interest include, but are not limited to:

  • The dosage form of the drug and its stability;
  • Physical factors influencing the shelf life of medicinal products;
  • Chemical factors influencing the shelf life of medicinal products;
  • Microbiological factors influencing the shelf life of medicinal products;
  • Stabilization treatments during drug preparation;
  • Drug stability study;
  • Drug purity testing;
  • The use of new media in the formulation of a dosage form with model substances;
  • The influence of the composition of the tablet mass on the availability of micro- and macro-elements;
  • The determination of the active substance in medicinal products;
  • Drug quality assessment;
  • Dosage form technology.

Prof. Dr. Alina Pyka-Pająk
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 250 words) can be sent to the Editorial Office for assessment.

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. Processes is an international peer-reviewed open access semimonthly 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 2400 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

  • drug analysis
  • drug stability
  • dosage form
  • analytical methods

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Further information on MDPI's Special Issue policies can be found here.

Published Papers (4 papers)

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Research

26 pages, 5269 KB  
Article
Development and Optimization of Resveratrol-Loaded NLCs via Low-Energy Methods: A Promising Alternative to Conventional High-Energy or Solvent-Based Techniques
by Nicoly T. R. Britto, Lilian R. S. Montanheri, Juliane N. B. D. Pelin, Raquel A. G. B. Siqueira, Matheus de Souza Alves, Tereza S. Martins, Ian W. Hamley, Patrícia S. Lopes, Vânia R. Leite-Silva and Newton Andreo-Filho
Processes 2026, 14(2), 393; https://doi.org/10.3390/pr14020393 - 22 Jan 2026
Cited by 1 | Viewed by 825
Abstract
High-energy methods dominate the development of lipid nanoparticles but often require specialized equipment that increases production costs. Low-energy approaches, particularly those free of organic solvents, offer a promising alternative. This study aimed to obtain nanostructured lipid carriers (NLCs) using a solvent-free, low-energy process [...] Read more.
High-energy methods dominate the development of lipid nanoparticles but often require specialized equipment that increases production costs. Low-energy approaches, particularly those free of organic solvents, offer a promising alternative. This study aimed to obtain nanostructured lipid carriers (NLCs) using a solvent-free, low-energy process combining microemulsification and phase inversion. Cetearyl alcohol and PEG-40 hydrogenated castor oil were selected as the solid lipid and surfactant, respectively; the formulation and process were optimized through a Box–Behnken Design. Incorporation of the ionic surfactant extended colloidal stability, while the poloxamer in the aqueous phase enhanced steric stabilization. Resveratrol was efficiently encapsulated (E.E. = 98%), contributing to reduced particle size (291 nm), improved homogeneity (PDI = 0.25), and positive surface charge (+43 mV). Scale-up yielded stable particles carrying resveratrol with a mean size of 507 nm, PDI = 0.24, and ZP = +52 mV. The optimized formulation remained stable for 90 days at 8 °C. In vitro release demonstrated a sustained and controlled release profile, with significantly lower resveratrol release compared to the free compound. Thermal analysis confirmed drug incorporation within the lipid matrix, while transmission electron microscopy (TEM) revealed spherical particles (~200 nm) and SAXS indicated a nanostructure of ~50 nm. Overall, this study demonstrates that solvent-free, low-energy processing can produce stable and scalable NLC formulations, successfully encapsulating resveratrol with favorable physicochemical properties and controlled release behavior. These findings highlight a simple, cost-effective strategy for developing lipid-based nanocarriers with potential applications in drug delivery. Full article
(This article belongs to the Special Issue Studies of the Dosage Form and Stability of the Drug by Various Techniques, 2nd Edition)
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11 pages, 1639 KB  
Article
Application of EPR Spectroscopy to Determine the Influence of Simvastatin Concentration on Free Radicals in G-361 Human Melanoma malignum Cells
by Ewa Chodurek, Magdalena Zdybel and Barbara Pilawa
Processes 2025, 13(8), 2578; https://doi.org/10.3390/pr13082578 - 14 Aug 2025
Viewed by 664
Abstract
Free radicals in G-361 human melanoma malignum control cells and the cells cultured with simvastatin were examined by EPR spectroscopy. The proliferation of the cells was determined. The aim of this work was to examine the influence of simvastatin used at different concentrations [...] Read more.
Free radicals in G-361 human melanoma malignum control cells and the cells cultured with simvastatin were examined by EPR spectroscopy. The proliferation of the cells was determined. The aim of this work was to examine the influence of simvastatin used at different concentrations in the G-361 cell culture on its free radicals. The concentrations of simvastatin—0.1 μM, 1 μM, 3 μM, and 5 μM—were tested. EPR spectra of free radicals were measured by an X-band (9.3 GHz) spectrometer. Amplitudes, integral intensities, linewidths, and g factors were determined. Melanin biopolymers are the main source of o-semiquinone free radicals in G-361 human melanoma malignum cells, for which the EPR lines show characteristic g values of 2.0046–2.0059, but also, free radicals occurring in other cellular structures may contribute to these signals. The amount of free radicals decreases after interactions of simvastatin with the G-361 cells, and this effect depends on the concentration of simvastatin. The highest amounts of free radicals exist in G-361 cells cultured with simvastatin at concentrations of 3 μM and 5 μM. The relatively lower amounts of free radicals occur in G-361 cells cultured with simvastatin at concentrations of 0.1 μM and 1 μM. The fast spin–lattice relaxation processes exist in the control G-361 cells and in the cells cultured with simvastatin, regardless of simvastatin concentration. Full article
(This article belongs to the Special Issue Studies of the Dosage Form and Stability of the Drug by Various Techniques, 2nd Edition)
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13 pages, 881 KB  
Article
Free Radical Formation in a Pharmaceutical Product Containing Bisoprolol Fumarate Stored Under Different Physical Conditions
by Kacper Sobczak, Barbara Pilawa, Magdalena Zdybel and Ewa Chodurek
Processes 2025, 13(6), 1742; https://doi.org/10.3390/pr13061742 - 1 Jun 2025
Viewed by 1456
Abstract
The pharmaceutical product is a powdered tablets containing bisoprolol fumarate that is used in the treatment of circulatory system diseases. They were examined by X-band (9.3 GHz) electron paramagnetic resonance spectroscopy. The aim of this work was to determine the influence of the [...] Read more.
The pharmaceutical product is a powdered tablets containing bisoprolol fumarate that is used in the treatment of circulatory system diseases. They were examined by X-band (9.3 GHz) electron paramagnetic resonance spectroscopy. The aim of this work was to determine the influence of the physical conditions of storage on the properties and content of free radicals in this pharmaceutical product. The product was subjected to a temperature of 50 °C, UVA radiation, and UVA radiation and then a temperature of 50 °C. The amplitude, integral intensity, linewidth of EPR lines, and g factor, were analyzed. Free radicals were formed in all tested samples; thus, the product containing bisoprolol fumarate should not be stored at a temperature of 50 °C, and it should be protected from UVA radiation, which is in line with the manufacturer’s requirements. The content of free radicals in the examined product was highest after treatment at a temperature of 50 °C. The lowest free radical content characterized the product after the interaction of both UVA radiation and a temperature of 50 °C. EPR lines were not microwave saturated below a power of 70 mW, which indicates fast spin-lattice relaxation processes in the product. It has been demonstrated that free radical formation in the product containing bisoprolol fumarate depends on the type of physical factor. Full article
(This article belongs to the Special Issue Studies of the Dosage Form and Stability of the Drug by Various Techniques, 2nd Edition)
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14 pages, 2524 KB  
Article
The Effect of the Higher Temperature and UVA Radiation on the Pharmaceutical Preparation Containing Spironolactone—EPR Examination
by Ewa Burek, Barbara Pilawa, Magdalena Zdybel and Ewa Chodurek
Processes 2025, 13(6), 1696; https://doi.org/10.3390/pr13061696 - 28 May 2025
Viewed by 1095
Abstract
Electron paramagnetic resonance (EPR) examination of the effect of storage conditions on properties and contents of free radicals formed in the pharmaceutical preparation containing spironolactone, taking into account physical factors such as UVA radiation and the higher temperature, was conducted. The changes in [...] Read more.
Electron paramagnetic resonance (EPR) examination of the effect of storage conditions on properties and contents of free radicals formed in the pharmaceutical preparation containing spironolactone, taking into account physical factors such as UVA radiation and the higher temperature, was conducted. The changes in amplitude (A), integral intensity (I) and EPR linewidth (ΔBpp) of the EPR spectra and free radical contents were determined. It was obtained that free radicals are formed during storage of this preparation under three different treatments: 50 °C, under UVA radiation, and under UVA radiation and a temperature of 50 °C. During storage, the preparation containing spironolactone should be protected from temperatures 50 °C and from UVA radiation. A higher content of free radicals is formed in the tested preparation exposed to both UVA and a temperature of 50 °C, than in the preparation exposed only to UVA or only to a temperature of 50 °C. Similar integral intensities (I) were obtained for the tested preparation exposed to a temperature of 50 °C or exposed to UVA radiation. Fast spin-lattice relaxation processes occur in all tested pharmaceutical preparation samples containing spironolactone. The usefulness of EPR spectral analysis in the study of free radicals formed in pharmaceutical preparations has been confirmed. Full article
(This article belongs to the Special Issue Studies of the Dosage Form and Stability of the Drug by Various Techniques, 2nd Edition)
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