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7.9
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Journals
Pharmaceutics
Special Issues
Physical and Chemical Stability of Drug Formulation
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Physical and Chemical Stability of Drug Formulation

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".

Deadline for manuscript submissions: 25 January 2025 | Viewed by 1178

Special Issue Editors

Dr. Philippe-Henri Secretan

E-Mail Website
Guest Editor
Laboratoire et Matériaux et Santé, Université Paris-Saclay, 92296 Châtenay-Malabry, France
Interests: intrinsic stability; physico-chemical characterization; preformulation; structural elucidation; degradation pathways; drug development
Special Issues, Collections and Topics in MDPI journals
Dr. Hassane Sadou Yayé

E-Mail Website
Guest Editor
Department of Pharmacy, Hôpitaux Universitaires Pitié-Salpêtrière, AP-HP, 75013 Paris, France
Interests: drug stability

Special Issue Information

Dear Colleagues,

Throughout their lifecycle, drug substances are exposed to a wide range of physicochemical factors that can cause transformations, which can significantly impact the efficacy and safety of therapy. For the drug substance alone, this includes solid state transformation, such as polymorphic changes, as well as degradation due to exposure to natural light, solvolysis, and oxidation. In drug products, the presence of excipients can induce drug substance degradation or limit its decay.

This Special Issue aims to gather research on mechanisms of drug substance transformation, as well as innovative strategies to reduce its occurrence.

The editors welcome original research articles and reviews on the following topics.

Dr. Philippe-Henri Secretan
Dr. Hassane Sadou Yayé
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. 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

  • drug stability
  • solid state
  • stress testing
  • degradation pathways
  • structural elucidation
  • preformulation

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Published Papers (1 paper)

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Research

24 pages, 3085 KiB  
Article
Comprehensive Analysis of Cetuximab Critical Quality Attributes: Impact of Handling on Antigen-Antibody Binding
by Alicia Torres-García, Anabel Torrente-López, Jesús Hermosilla, Amparo Hernández, Antonio Salmerón-García, José Cabeza and Natalia Navas
Pharmaceutics 2024, 16(9), 1222; https://doi.org/10.3390/pharmaceutics16091222 - 19 Sep 2024
Viewed by 928
Abstract
Background/Objectives: Cetuximab, formulated in Erbitux® (5 mg/mL), is a therapeutic monoclonal antibody (mAb) widely used in several cancer treatments. Currently, there is insufficient knowledge about the behavior of cetuximab with regard to the risk associated with its routine handling or unintentional mishandling [...] Read more.
Background/Objectives: Cetuximab, formulated in Erbitux® (5 mg/mL), is a therapeutic monoclonal antibody (mAb) widely used in several cancer treatments. Currently, there is insufficient knowledge about the behavior of cetuximab with regard to the risk associated with its routine handling or unintentional mishandling in hospitals. Forced degradation studies can simulate these conditions and provide insights into the biophysical and biochemical properties of mAbs. Methods: In this study, we conducted a deep physicochemical and functional characterization of the critical quality attributes of cetuximab in control samples and under controlled degraded conditions, including freeze–thaw cycles, heat, agitation, and light exposure. To achieve this purpose, we used a set of proper analytical techniques, including CD, IT-FS, DLS, SE/UHPLC-UV, UHPLC-MS/MS, and ELISA, to check functionality based on antigen–antibody binding. Results: The results revealed that light exposure was the stress stimuli with the greatest impact on the drug product, leading to the formation of non-natural oligomers, fragmentation, and oxidation of methionine residues. Additionally, cetuximab (Erbitux®, 5 mg/mL) showed a tendency to aggregate when submitted to 60 °C for 1 h. In terms of functionality, cetuximab (Erbitux®, 5 mg/mL) samples were found to be affected when subjected to freeze–thaw cycles, 60 °C (1 h), and when exposed to light (daylight with room temperature excursion and accelerated light exposure). Conclusions: Thus, we suggest that Erbitux® (5 mg/mL) should be shielded from these environmental conditions, as they compromise both the safety and efficacy of the drug product. Full article
(This article belongs to the Special Issue Physical and Chemical Stability of Drug Formulation)
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