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7.9
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Pharmaceutics
Special Issues
Recent Advances in Physicochemical Stability of Drugs
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Recent Advances in Physicochemical Stability of Drugs

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Biopharmaceutics".

Deadline for manuscript submissions: closed (20 June 2023) | Viewed by 8460

Special Issue Editor

Prof. Dr. Valérie Sautou

E-Mail Website
Guest Editor
Université Clermont Auvergne, CHU Clermont Ferrand, Clermont Auvergne INP, CNRS, ICCF, F-63000 Clermont-Ferrand, France
Interests: pharmaceutical technology; physicochemical stability studies; medical devices; drug packaging; content–container interactions; leachables; drug sorption

Special Issue Information

Dear Colleagues,

Physicochemical stability studies are a key step in validating the quality, safety, and efficacy of medications, whether in the pharmaceutical laboratories or in hospitals (pharmaceutical preparations). These studies can be complex and/or time-consuming, for example for biomedicines such as monoclonal antibodies. The analyses used to verify the physicochemical stability of medications require the development and implementation of effective and appropriate techniques. In addition, certain active ingredients or excipients used in the formulation of medications may interact with packaging articles and/or medical administration devices. These container–content interactions (adsorption, absorption, permeation, release) are still little studied, despite the fact that they can, in certain cases, have a profound impact on the stability of the medications.

This Special Issue is, therefore, dedicated to the following topics:

  • Physicochemical stability studies of drugs with an innovative aspect to its active ingredient, its formulation, or its galenic form;
  • Content–container interaction studies (on methodological and practical aspects) and mechanistic studies;
  • Innovative analytical techniques used to study physicochemical instabilities, as well as the interactions at the material–drug interface;
  • Simulation models on the prediction of the physicochemical instability of an active ingredient or an excipient, and their interactions with biomaterials or materials for pharmaceutical use.

Prof. Dr. Valérie Sautou
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 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. Pharmaceutics 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

  • physicochemical stability
  • content-container interactions
  • in silico modelling
  • predictive models
  • analytical technology

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Published Papers (4 papers)

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Research

11 pages, 2372 KiB  
Article
Storage Stability of Atheroglitatide, an Echogenic Liposomal Formulation of Pioglitazone Targeted to Advanced Atheroma with a Fibrin-Binding Peptide
by Melvin E. Klegerman, Tao Peng, Shao-Ling Huang, Brion Frierson, Melanie R. Moody, Hyunggun Kim and David D. McPherson
Pharmaceutics 2023, 15(9), 2288; https://doi.org/10.3390/pharmaceutics15092288 - 6 Sep 2023
Viewed by 1042
Abstract
We have conducted a stability study of a complex liposomal pharmaceutical product, Atheroglitatide (AGT), stored at three temperatures, 4, 24, and 37 °C, for up to six months. The six parameters measured were functions of liposomal integrity (size and number), drug payload (loading [...] Read more.
We have conducted a stability study of a complex liposomal pharmaceutical product, Atheroglitatide (AGT), stored at three temperatures, 4, 24, and 37 °C, for up to six months. The six parameters measured were functions of liposomal integrity (size and number), drug payload (loading efficiency), targeting peptide integrity (conjugation efficiency and specific avidity), and echogenicity (ultrasound-dependent controlled drug release), which were considered most relevant to the product’s intended use. At 4 °C, liposome diameter trended upward, indicative of aggregation, while liposome number per mg lipid and echogenicity trended downward. At 24 °C, peptide conjugation efficiency (CE) and targeting efficiency (TE, specific avidity) trended downward. At 37 °C, CE and drug (pioglitazone) loading efficiency trended downward. At 4 °C, the intended storage temperature, echogenicity, and liposome size reached their practical tolerance limits at 6 months, fixing the product expiration at that point. Arrhenius analysis of targeting peptide CE and drug loading efficiency decay at the higher temperatures indicated complete stability of these characteristics at 4 °C. The results of this study underscore the storage stability challenges presented by complex nanopharmaceutical formulations. Full article
(This article belongs to the Special Issue Recent Advances in Physicochemical Stability of Drugs)
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20 pages, 4448 KiB  
Article
Robust Inclusion Complex of Topotecan Comprised within a Rhodamine-Labeled β-Cyclodextrin: Competing Proton and Energy Transfer Processes
by Maria Rosaria Di Nunzio and Abderrazzak Douhal
Pharmaceutics 2023, 15(6), 1620; https://doi.org/10.3390/pharmaceutics15061620 - 30 May 2023
Cited by 2 | Viewed by 1610
Abstract
Monitoring the biological fate of medicaments within the environments of cancer cells is an important challenge which is nowadays the object of intensive studies. In this regard, rhodamine-based supramolecular systems are one of the most suitable probes used in drug delivery thanks to [...] Read more.
Monitoring the biological fate of medicaments within the environments of cancer cells is an important challenge which is nowadays the object of intensive studies. In this regard, rhodamine-based supramolecular systems are one of the most suitable probes used in drug delivery thanks to their high emission quantum yield and sensitivity to the environment which helps to track the medicament in real time. In this work, we used steady-state and time-resolved spectroscopy techniques to investigate the dynamics of the anticancer drug, topotecan (TPT), in water (pH ~6.2) in the presence of a rhodamine-labeled methylated β-cyclodextrin (RB-RM-βCD). A stable complex of 1:1 stoichiometry is formed with a Keq value of ~4 × 104 M−1 at room temperature. The fluorescence signal of the caged TPT is reduced due to: (1) the CD confinement effect; and (2) a Förster resonance energy transfer (FRET) process from the trapped drug to the RB-RM-βCD occurring in ~43 ps with 40% efficiency. These findings provide additional knowledge about the spectroscopic and photodynamic interactions between drugs and fluorescent functionalized CDs, and may lead to the design of new fluorescent CD-based host–guest nanosystems with efficient FRET to be used in bioimaging for drug delivery monitoring. Full article
(This article belongs to the Special Issue Recent Advances in Physicochemical Stability of Drugs)
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14 pages, 1644 KiB  
Article
Pharmaceutical Oral Formulation of Methionine as a Pediatric Treatment in Inherited Metabolic Disease
by Benjamin Querin, Arnaud Schweitzer-Chaput, Salvatore Cisternino, Sylvain Auvity, Anne-Sophie Fauqueur, Abdel Negbane, Alice Hadchouel, Joël Schlatter and Camille Cotteret
Pharmaceutics 2023, 15(3), 957; https://doi.org/10.3390/pharmaceutics15030957 - 16 Mar 2023
Cited by 1 | Viewed by 2686
Abstract
L-Methionine (Met) is an essential alpha-amino acid playing a key role in several metabolic pathways. Rare inherited metabolic diseases such as mutations affecting the MARS1 gene encoding methionine tRNA synthetase (MetRS) can cause severe lung and liver disease before the age of two [...] Read more.
L-Methionine (Met) is an essential alpha-amino acid playing a key role in several metabolic pathways. Rare inherited metabolic diseases such as mutations affecting the MARS1 gene encoding methionine tRNA synthetase (MetRS) can cause severe lung and liver disease before the age of two years. Oral Met therapy has been shown to restore MetRS activity and improve clinical health in children. As a sulfur-containing compound, Met has a strongly unpleasant odor and taste. The objective of this study was to develop an optimized pediatric pharmaceutical formulation of Met powder, to be reconstituted with water, to obtain a stable oral suspension. Organoleptic characteristics and physicochemical stability of the powdered Met formulation and suspension were evaluated at three storage temperatures. Met quantification was assessed by a stability-indicating chromatographic method as well as microbial stability. The use of a specific fruit flavor (e.g., strawberry) with sweeteners (e.g., sucralose) was considered acceptable. No drug loss, pH changes, microbiological growth, or visual changes were observed at 23 ± 2 °C and 4 ± 2 °C with the powder formulation for 92 days, and the reconstituted suspension for at least 45 days. The developed formulation facilitates the preparation, administration, the dose adjustment and palatability of Met treatment in children. Full article
(This article belongs to the Special Issue Recent Advances in Physicochemical Stability of Drugs)
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16 pages, 1928 KiB  
Article
Physicochemical Stability of Generic Thiotepa Concentrate and Ready-to-Administer Infusion Solutions for Conditioning Treatment
by Helen Linxweiler, Judith Thiesen and Irene Krämer
Pharmaceutics 2023, 15(2), 309; https://doi.org/10.3390/pharmaceutics15020309 - 17 Jan 2023
Cited by 1 | Viewed by 2506
Abstract
The objective of this study was to determine the physicochemical in-use stability of recently approved Thiotepa Riemser concentrate in the original vial and diluted ready-to-administer (RTA) infusion solutions in prefilled glucose 5% and 0.9% NaCl polyolefin bags. Thiotepa Riemser 10 mg/mL concentrates and [...] Read more.
The objective of this study was to determine the physicochemical in-use stability of recently approved Thiotepa Riemser concentrate in the original vial and diluted ready-to-administer (RTA) infusion solutions in prefilled glucose 5% and 0.9% NaCl polyolefin bags. Thiotepa Riemser 10 mg/mL concentrates and infusion solutions (1 mg/mL, 2 mg/mL, 3 mg/mL) were prepared in triplicate and stored at 2–8 °C or 25 °C for 14 days. Thiotepa concentrations were determined using a stability-indicating RP-HPLC assay. In parallel, pH and osmolality were measured. Sub-visible particles were counted on day 0 and 14. Thiotepa Riemser concentrate was revealed to be stable for 14 days when stored at 2–8 °C, or for 24 h when stored at 25 °C. Thiotepa concentrations in infusion solutions stored at 2–8 °C remained above 95% of the initial concentrations for at least 14 days, regardless of the type of vehicle solution. When stored at 25 °C, thiotepa infusion solutions in glucose 5% proved to be physicochemically stable for 3 days (1 mg/mL), 5 days (2 mg/mL) or 7 days (3 mg/mL). Thiotepa infusion solutions in 0.9% NaCl remained physicochemically stable for 5 days (1 mg/mL) or 7 days (2 mg/mL, 3 mg/mL). At these points in time, the specification limit of ≤0.6% monochloro-adduct was fulfilled. In parallel, an elevation of the pH values was registered. Thiotepa concentrates and infusion solutions should be stored at 2–8 °C due to temperature-dependent physicochemical stability, and for microbiological reasons. Glucose 5% infusion solution is recommended as a diluent, and stability-improving nominal 2 mg/mL to 3 mg/mL thiotepa concentrations should be obtained. Full article
(This article belongs to the Special Issue Recent Advances in Physicochemical Stability of Drugs)
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