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: 31 December 2025 | Viewed by 897

Special Issue Editor


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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: liquid chromatography; spectrophotometry; densitometry; organic compounds analysis; QSAR; QSRR; QSPR; pharmaceutical analysis; purity of pharmaceutical preparations
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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

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Keywords

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

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Published Papers (2 papers)

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Research

13 pages, 881 KiB  
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 270
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
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14 pages, 2524 KiB  
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 216
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
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