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Pharmaceutical Analysis and Drug Stability Evaluation
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Pharmaceutical Analysis and Drug Stability Evaluation

A special issue of Molecules (ISSN 1420-3049). This special issue belongs to the section "Medicinal Chemistry".

Deadline for manuscript submissions: closed (1 September 2021) | Viewed by 20047

Special Issue Editors

Prof. Dr. Adriana Violeta Ledeți

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Guest Editor
Department of Analytical Chemistry, Faculty of Pharmacy, “Victor Babeş” University of Medicine and Pharmacy, 2 Eftimie Murgu Square, 300041 Timisoara, Romania
Interests: drug stability and stabilization techniques; instrumental analysis of active pharmaceutical ingredients; heterogenous degradation of drugs; solid-state kinetics; supramolecular systems with increased biopharmaceutical profile
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Laura Sbârcea

E-Mail Website
Guest Editor
Department of Drug Analysis, Faculty of Pharmacy, “Victor Babeş” University of Medicine and Pharmacy, 2 Eftimie Murgu Square, 300041 Timisoara, Romania
Interests: drug solubility; cyclodextrin-based delivery systems; drug analysis and quality control; drug stability; drug–drug interactions; drug-excipient interactions
Special Issues, Collections and Topics in MDPI journals
Dr. Denisa Laura Ivan

E-Mail Website
Guest Editor
Department of Analytical Chemistry , Faculty of Pharmacy, “Victor Babeş” University of Medicine and Pharmacy, 2 Eftimie Murgu Square, 300041 Timisoara, Romania
Interests: stability of drugs and compounds with potential biological activity; instrumental analysis of drugs as pure APIs and in pharmaceutical dosage forms
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

It is well-known that pharmaceutical analysis plays an essential role in the development of new dosage forms, not only for the original formulations newly developed by pharmaceutical giants, but also for the release of generics.

The development of new pharmaceutical formulations is correlated not only with the pharmacological effect of the bioactive molecule, but also with the physico-chemical profile of the compound, which must be rigorously analyzed. Since this profile determines the stability and reactivity of the drug, its interactions with excipients and solubility are of the utmost importance, necessitating the performance of in-depth analyses that reveal these parameters. Furthermore, a comprehensive physico-chemical profile gives clear indications regarding the technological processes that must be chosen during the preformulation and formulation stages. The adequate selection of these steps has a direct influence on the bioavailability of the active pharmaceutical ingredient when administered as the designed dosage form.

Preformulation studies are essential in revealing the possible impediments that may occur before or during the production of the final pharmaceutical formulation. These offer adequate solutions to avoid these issues, no matter the type of the pharmaceutical form (liquid, semi-solid, or solid, with systemic or local action). In the preformulation phase, a series of properties are analyzed regarding the active substance, the possible and selected excipients, and the active substance–excipient mixtures, such as stability in solution or in solid state (both in ambient conditions and under thermal stress), dissolution profile, the formation of binary adducts (salts, cocrystals, or supramolecular assemblies), and these tests are performed using advanced instrumental techniques.

This Special Issue is focused on original research papers that cover pharmaceutical analysis and drug stability evaluation in the preformulation and/or formulation stage for active pharmaceutical ingredients that are no longer protected by patents. The performed studies should be based on advanced instrumental techniques and the results revealed in order to offer viable solutions for the development of new generic dosage forms, with increased stability and longer shelf-life, facilitating the access of patients to cheaper therapeutic alternatives with the same biological effects as the original formulations. Scientists that are focused on this domain are encouraged to submit their research results for publication in this Special Issue. Additionally, review papers that present an in-depth analysis of the state of the art in the preformulation/formulation of a certain active pharmaceutical ingredient are also eligible.

Prof. Dr. Adriana Violeta Ledeți
Dr. Laura Sbârcea
Dr. Denisa Laura Cîrcioban
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. Molecules 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 2700 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 stability and stabilization techniques
  • instrumental analysis of active pharmaceutical ingredients
  • heterogenous degradation of drugs
  • solid-state kinetics
  • supramolecular systems with increased biopharmaceutical profile

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Related Special Issue

Published Papers (4 papers)

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Research

14 pages, 10219 KiB  
Article
Warfarin Sodium Stability in Oral Formulations
by Evangelia Dimitrokalli, Stefani Fertaki, Michail Lykouras, Petros Kokkinos, Malvina Orkoula and Christos Kontoyannis
Molecules 2021, 26(21), 6631; https://doi.org/10.3390/molecules26216631 - 1 Nov 2021
Cited by 6 | Viewed by 4945
Abstract
Warfarin sodium is a low-dose pharmaceutical blood thinner that exists in two forms: the clathrate form and the amorphous form. In commercially available warfarin sodium oral suspension, the active pharmaceutical ingredient (API) is added in the amorphous state. This study investigates the apparent [...] Read more.
Warfarin sodium is a low-dose pharmaceutical blood thinner that exists in two forms: the clathrate form and the amorphous form. In commercially available warfarin sodium oral suspension, the active pharmaceutical ingredient (API) is added in the amorphous state. This study investigates the apparent instability of the commercially available warfarin liquid oral formulation using Raman and IR spectroscopy, X-ray diffraction, differential scanning calorimetry, UV spectroscopy, and optical microscopy. Warfarin, not its sodium salt, was identified as the undissolved solid existing in the suspension. This was found to be due to the dissociation of sodium salt and the protonation of the warfarin ion in the liquid phase, which triggered the crystallization of the sparingly soluble unsalted form. The coexistence of protonated and unprotonated warfarin ions in the supernatant, as detected by Raman and UV spectroscopy, confirmed this assumption. Study of the dissolution of warfarin sodium amorphous salt and crystalline sodium clathrate in the placebo and pure water verified the results. The effect of pH and temperature on warfarin precipitation was also explored. Full article
(This article belongs to the Special Issue Pharmaceutical Analysis and Drug Stability Evaluation)
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15 pages, 25592 KiB  
Article
Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles
by Jesús Alberto Afonso Urich, Viktoria Marko, Katharina Boehm, Raymar Andreína Lara García, Dalibor Jeremic and Amrit Paudel
Molecules 2021, 26(21), 6597; https://doi.org/10.3390/molecules26216597 - 31 Oct 2021
Cited by 2 | Viewed by 2956
Abstract
A novel and efficient stability-indicating, reverse phase ultra-performance liquid chromatographic (UPLC®) analytical method was developed and validated for the determination of hexoprenaline in an injectable dosage form. The development of the method was performed using analytical quality by design (AQbD) principles, [...] Read more.
A novel and efficient stability-indicating, reverse phase ultra-performance liquid chromatographic (UPLC®) analytical method was developed and validated for the determination of hexoprenaline in an injectable dosage form. The development of the method was performed using analytical quality by design (AQbD) principles, which are aligned with the future requirements from the regulatory agencies using AQbD principles. The method was developed by assessing the impact of ion pairing, the chromatographic column, pH and gradient elution. The development was achieved with a Waters Acquity HSS T3 (50 × 2.1 mm i.d., 1.8 µm) column at ambient temperature, using sodium dihydrogen phosphate 5 mM + octane-1-sulphonic acid sodium salt 10 mM buffer pH 3.0 (Solution A) and acetonitrile (Solution B) as mobile phases in gradient elution (t = 0 min, 5% B; t = 1 min, 5% B; t = 5 min, 50% B; t = 7 min, 5% B; t = 10 min, 5% B) at a flow rate of 0.5 mL/min and UV detection of 280 nm. The linearity was proven for hexoprenaline over a concentration range of 3.50–6.50 µg/mL (R2 = 0.9998). Forced degradation studies were performed by subjecting the samples to hydrolytic (acid and base), oxidative, and thermal stress conditions. Standard solution stability was also performed. The proposed validated method was successfully used for the quantitative analysis of bulk, stability and injectable dosage form samples of the desired drug product. Using the AQbD principles, it is possible to generate methodologies with enhanced knowledge, which can eventually lead to a reduced regulatory risk, high quality data and lower operational costs. Full article
(This article belongs to the Special Issue Pharmaceutical Analysis and Drug Stability Evaluation)
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17 pages, 3238 KiB  
Article
Stability of Metronidazole and Its Complexes with Silver(I) Salts under Various Stress Conditions
by Małgorzata Starek, Monika Dąbrowska, Joanna Chebda, Dominik Żyro and Justyn Ochocki
Molecules 2021, 26(12), 3582; https://doi.org/10.3390/molecules26123582 - 11 Jun 2021
Cited by 11 | Viewed by 6127
Abstract
Metronidazole is a drug widely used in the prevention and treatment of bacterial infections. Due to its possibility of the formation of stable metal complexes, it was decided to broaden its activity spectrum by introducing the silver(I) coordination compounds i.e., [Ag(MTZ)2NO [...] Read more.
Metronidazole is a drug widely used in the prevention and treatment of bacterial infections. Due to its possibility of the formation of stable metal complexes, it was decided to broaden its activity spectrum by introducing the silver(I) coordination compounds i.e., [Ag(MTZ)2NO3] and [(Ag(MTZ)2)2]SO4, which have significant antibacterial properties. The paper presents a description of a new qualitative and quantitative analysis of metronidazole in bulk and possible pharmaceutical preparations by thin-layer chromatography with densitometric detection. Optimal separation conditions were selected, and the analytical procedure was validated according to the ICH guidelines. The obtained data indicate that the method is sufficiently sensitive, precise, and accurate. The stability of the metronidazole solutions obtained from tablets, pure metronidazole, and its silver(I) complexes was tested. The research was carried out in various environments, at different temperatures, in H2O2 solution, and during exposure to radiation (UV, sunlight). The greatest degradation was found in the alkaline environment and at higher temperatures. The silver(I) complexes exhibited relatively high stability under analyzed conditions that are higher than standard metronidazole solutions and tablets. The observations were confirmed by the kinetic and thermodynamic analysis. The described studies of new metronidazole silver(I) complexes increase the potential for their application in infections both in humans and animals. Full article
(This article belongs to the Special Issue Pharmaceutical Analysis and Drug Stability Evaluation)
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12 pages, 3212 KiB  
Article
Chloroquine and Hydroxychloroquine Interact Differently with ACE2 Domains Reported to Bind with the Coronavirus Spike Protein: Mediation by ACE2 Polymorphism
by Riadh Badraoui, Mohd Adnan, Fevzi Bardakci and Mousa M. Alreshidi
Molecules 2021, 26(3), 673; https://doi.org/10.3390/molecules26030673 - 28 Jan 2021
Cited by 41 | Viewed by 4563
Abstract
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection inducing coronavirus disease 2019 (COVID-19) is still an ongoing challenge. To date, more than 95.4 million have been infected and more than two million deaths have been officially reported by the WHO. Angiotensin-converting enzyme [...] Read more.
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection inducing coronavirus disease 2019 (COVID-19) is still an ongoing challenge. To date, more than 95.4 million have been infected and more than two million deaths have been officially reported by the WHO. Angiotensin-converting enzyme (ACE) plays a key role in the disease pathogenesis. In this computational study, seventeen coding variants were found to be important for ACE2 binding with the coronavirus spike protein. The frequencies of these allele variants range from 3.88 × 10−3 to 5.47 × 10−6 for rs4646116 (K26R) and rs1238146879 (P426A), respectively. Chloroquine (CQ) and its metabolite hydroxychloroquine (HCQ) are mainly used to prevent and treat malaria and rheumatic diseases. They are also used in several countries to treat SARS-CoV-2 infection inducing COVID-19. Both CQ and HCQ were found to interact differently with the various ACE2 domains reported to bind with coronavirus spike protein. A molecular docking approach revealed that intermolecular interactions of both CQ and HCQ exhibited mediation by ACE2 polymorphism. Further explorations of the relationship and the interactions between ACE2 polymorphism and CQ/HCQ would certainly help to better understand the COVID-19 management strategies, particularly their use in the absence of specific vaccines or drugs. Full article
(This article belongs to the Special Issue Pharmaceutical Analysis and Drug Stability Evaluation)
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