Search for Articles:
Title / Keyword
Author / Affiliation / Email
Journal
Article Type
 
 
Advanced Search
 
Section
Special Issue
Volume
Issue
Number
Page
 
7.7
4.8
Journals
Pharmaceuticals
Special Issues
Advances in Drug Analysis and Drug Development, 2nd Edition
share announcement

Advances in Drug Analysis and Drug Development, 2nd Edition

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

Deadline for manuscript submissions: 26 January 2026 | Viewed by 2763

Special Issue Editors

Dr. Daniela Amidžić Klarić

E-Mail Website
Guest Editor
Faculty of Pharmacy of Biochemistry, University of Zagreb, A. Kovačića 1, 10000 Zagreb, Croatia
Interests: pharmaceutical analysis, supplement analysis; sample preparation; atomic spectroscopy; chromatography; food analytical chemistry; food control; bioactive compounds; metals
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Ana Mornar

E-Mail Website
Guest Editor
Faculty of Pharmacy of Biochemistry, University of Zagreb, A. Kovačića 1, 10000 Zagreb, Croatia
Interests: drug development; sample preparation; pharmaceutical analysis; bioanalysis; biopharmaceutical analysis; food analysis; chromatography; mass spectrometry
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

The different phases of drug development include preclinical and clinical drug development. During this long-term process, a large number of different compounds (active pharmaceutical substances, excipients, impurities, and metabolites) are monitored, and the development of new analytical methods facilitates their implementation.

This Special Issue of Pharmaceuticals will showcase a collection of research articles, short communications, and reviews addressing original and novel analytical methods for the evaluation of active substances in various dosage forms during drug development.

From an analytical point of view, a specific challenge involves the identification and determination of metabolites as the products of drug metabolism and other endogenous compounds. We welcome contributions on green and sustainable analytical procedures and methods, including the pretreatment of different dosage forms and biological materials as samples.

The scope of this Special Issue includes, but is not limited to, the following topics:

  • Advances in instrumental analysis in drug development;
  • Preformulation and pharmaceutical formulation studies;
  • Preclinical and clinical evaluations of formulation technologies;
  • The pharmacokinetic analysis of active substances and metabolites;
  • Innovative processing and analytical technologies;
  • Extractable and leachable testing in pharmaceutical analysis;
  • Bioanalysis of nano-drug delivery systems;
  • Lab-on-a-chip technology;
  • High-throughput screening in preformulation studies;
  • Validation and regulatory aspects of pharmaceutical analysis.

We are looking forward to hearing from you.

Dr. Daniela Amidžić Klarić
Prof. Dr. Ana Mornar
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 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. 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

  • analytical methodology
  • chromatographic techniques
  • spectrometric techniques
  • thermal analysis techniques
  • sample preparation
  • drug stability
  • compatibility study
  • bioavailability studies
  • therapeutic drug monitoring
  • quality by design in pharmaceutical analysis

Benefits of Publishing in a Special Issue

  • Ease of navigation: Grouping papers by topic helps scholars navigate broad scope journals more efficiently.
  • Greater discoverability: Special Issues support the reach and impact of scientific research. Articles in Special Issues are more discoverable and cited more frequently.
  • Expansion of research network: Special Issues facilitate connections among authors, fostering scientific collaborations.
  • External promotion: Articles in Special Issues are often promoted through the journal's social media, increasing their visibility.
  • Reprint: MDPI Books provides the opportunity to republish successful Special Issues in book format, both online and in print.

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

Published Papers (3 papers)

Download All Papers
Order results
Result details
Show export options expand_more Show export options expand_less
Select all
Export citation of selected articles as:

Research

21 pages, 2981 KB  
Article
Impact of Ethanol on Electrostatic Behaviour of Fluorocarbon Pharmaceutical Propellants
by Lochana Ranatunge, Manoochehr Rasekh, Hussein Ahmad and Wamadeva Balachandran
Pharmaceuticals 2025, 18(11), 1755; https://doi.org/10.3390/ph18111755 - 18 Nov 2025
Viewed by 315
Abstract
Background/Objectives: Triboelectrification in fluid systems, and specifically in hydrofluorocarbon (HFC)-based propellants, used in pressurised metered-dose inhalers (pMDIs) remains understudied despite its impact on aerosol behaviour and does delivery. This study investigates how ethanol concentration affects charge generation and dissipation in HFC-152a (1,1-difluoroethane; R152a) [...] Read more.
Background/Objectives: Triboelectrification in fluid systems, and specifically in hydrofluorocarbon (HFC)-based propellants, used in pressurised metered-dose inhalers (pMDIs) remains understudied despite its impact on aerosol behaviour and does delivery. This study investigates how ethanol concentration affects charge generation and dissipation in HFC-152a (1,1-difluoroethane; R152a) flowing through low-density polyethylene (LDPE) tubing, a common valve-stem material in pMDIs. Methods: Controlled experiments measured electrical current, charge accumulation, and flow stability for HFC-152a with varying ethanol concentrations in LDPE tubing. Statistical analysis (two-way ANOVA, p < 0.05) assessed the effects of the propellant and material. Comparative tests include R134a (1,1,1,2-tetrafluoroethane) and R227ea (1,1,1,2,3,3,3-heptafluoropropane), and the tubing materials are polybutylene terephthalate (PBT), polyvinyl chloride (VINYL), polyoxymethylene (POM), and LDPE. Results: Increasing ethanol concentration produced larger measured currents, reduced net charge accumulation, and improved flow stability; these effects are attributed to ethanol’s higher dielectric constant and conductivity enhancing charge mobility and dissipation. Significant propellant x material interactions were found (p < 0.05): R152a generated the largest responses with PBT and VINYL (~16 nA and ~5.6 nA, respectively), R227ea showed higher responses with POM and LDPE (~8 nA), and R134a delivered the highest flow rates across materials but exhibited limited electrical responsiveness. Conclusions: Ethanol addition mitigates undesirable electrostatic effects in HFC-based propellants by promoting charge dissipation. The results demonstrate the strong material dependence of triboelectric behaviour and underline the importance of optimising propellant–polymer pairings to minimise the electrostatic adhesion of aerosolised particles and improve pMDI drug delivery performance. Full article
(This article belongs to the Special Issue Advances in Drug Analysis and Drug Development, 2nd Edition)
►▼ Show Figures

Figure 1

13 pages, 502 KB  
Article
Determination of Nitrosamine Drug Substance-Related Impurities Derived from Nortriptyline and Sertraline Using LC-MS/MS: A Comparative Evaluation of Chromatographic Separation and Pharmaceutical Application
by Minki Shim, Ji Yeon Kim, Seungjin Jung, Minkyeong Hong, Sang Beom Han and Dong-Kyu Lee
Pharmaceuticals 2025, 18(11), 1673; https://doi.org/10.3390/ph18111673 - 5 Nov 2025
Viewed by 748
Abstract
Background/Objectives: Nitrosamine drug substance-related impurities (NDSRIs) are a class of potent genotoxic impurities that pose a critical risk to patient safety, thereby necessitating the stringent control of pharmaceutical products. Nortriptyline (NORT) and sertraline (SERT) are two widely prescribed antidepressants that form highly [...] Read more.
Background/Objectives: Nitrosamine drug substance-related impurities (NDSRIs) are a class of potent genotoxic impurities that pose a critical risk to patient safety, thereby necessitating the stringent control of pharmaceutical products. Nortriptyline (NORT) and sertraline (SERT) are two widely prescribed antidepressants that form highly potent NDSRIs, N-nitroso-nortriptyline (NNORT) and N-nitroso-sertraline (NSERT), respectively. Despite these risks, a substantial gap exists in terms of the validated analytical methods for surveillance. Accordingly, this study addressed this need by developing a liquid chromatography–tandem mass spectrometry method for the quantification of NNORT and NSERT in drug products. Methods: A comparative evaluation of two reversed-phase columns (general-purpose C18 column and phenyl-hexyl column) was performed to achieve optimal chromatographic resolution of the parent active pharmaceutical ingredients (APIs). Results: The phenyl-hexyl column demonstrated superior separation for both NDSRI/API pairs by leveraging π-π interactions to markedly enhance the resolution. This was particularly critical for SERT. The method was fully validated according to the International Council for Harmonization guideline Q2(R1) and demonstrated excellent linearity (r2 = 0.998 for both NNORT and NSERT) with limits of quantitation of 20 ng/g for NNORT and 125 ng/g for NSERT. Accuracy was confirmed with recoveries of 96.6–99.4% for NNORT and 98.6–99.4% for NSERT, and precision was acceptable, with relative standard deviation below 3.9% and 1.9%, respectively. The application of this method to commercial products subjected to accelerated stress testing revealed NNORT formation in NORT products with an average concentration of 190 ng/g, as well as NSERT formation in SERT products resulted in an average concentration of 172 ng/g. Conclusions: This validated method provides a reliable tool for routine quality control, thereby enabling pharmaceutical manufacturers and regulatory agencies to ensure safety and compliance with widely used antidepressant medications. Full article
(This article belongs to the Special Issue Advances in Drug Analysis and Drug Development, 2nd Edition)
►▼ Show Figures

Graphical abstract

17 pages, 1812 KB  
Article
Systemic Metabolic Alterations Induced by Etodolac in Healthy Individuals
by Rajaa Sebaa, Reem H. AlMalki, Hatouf Sukkarieh, Lina A. Dahabiyeh, Maha Al Mogren, Tawfiq Arafat, Ahmed H. Mujamammi, Essa M. Sabi and Anas M. Abdel Rahman
Pharmaceuticals 2025, 18(8), 1155; https://doi.org/10.3390/ph18081155 - 4 Aug 2025
Viewed by 1280
Abstract
Background/Objective: Pharmacological interventions often exert systemic effects beyond their primary targets, underscoring the need for a comprehensive evaluation of their metabolic impact. Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that alleviates pain, fever, and inflammation by inhibiting cyclooxygenase-2 (COX-2), thereby reducing prostaglandin synthesis. [...] Read more.
Background/Objective: Pharmacological interventions often exert systemic effects beyond their primary targets, underscoring the need for a comprehensive evaluation of their metabolic impact. Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that alleviates pain, fever, and inflammation by inhibiting cyclooxygenase-2 (COX-2), thereby reducing prostaglandin synthesis. While its pharmacological effects are well known, the broader metabolic impact and potential mechanisms underlying improved clinical outcomes remain underexplored. Untargeted metabolomics, which profiles the metabolome without prior selection, is an emerging tool in clinical pharmacology for elucidating drug-induced metabolic changes. In this study, untargeted metabolomics was applied to investigate metabolic changes following a single oral dose of etodolac in healthy male volunteers. By analyzing serial blood samples over time, we identified endogenous metabolites whose concentrations were positively or inversely associated with the drug’s plasma levels. This approach provides a window into both therapeutic pathways and potential off-target effects, offering a promising strategy for early-stage drug evaluation and multi-target discovery using minimal human exposure. Methods: Thirty healthy participants received a 400 mg dose of Etodolac. Plasma samples were collected at five time points: pre-dose, before Cmax, at Cmax, after Cmax, and 36 h post-dose (n = 150). Samples underwent LC/MS-based untargeted metabolomics profiling and pharmacokinetic analysis. A total of 997 metabolites were significantly dysregulated between the pre-dose and Cmax time points, with 875 upregulated and 122 downregulated. Among these, 80 human endogenous metabolites were identified as being influenced by Etodolac. Results: A total of 17 metabolites exhibited time-dependent changes closely aligned with Etodolac’s pharmacokinetic profile, while 27 displayed inverse trends. Conclusions: Etodolac influences various metabolic pathways, including arachidonic acid metabolism, sphingolipid metabolism, and the biosynthesis of unsaturated fatty acids. These selective metabolic alterations complement its COX-2 inhibition and may contribute to its anti-inflammatory effects. This study provides new insights into Etodolac’s metabolic impact under healthy conditions and may inform future therapeutic strategies targeting inflammation. Full article
(This article belongs to the Special Issue Advances in Drug Analysis and Drug Development, 2nd Edition)
►▼ Show Figures

Figure 1

Show export options expand_more Show export options expand_less
Select all
Export citation of selected articles as:
 
Displaying articles 1-3
Back to TopTop