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Pharmaceutics
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Applications of Stable Nuclide and Radionuclides in the Area of...
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Applications of Stable Nuclide and Radionuclides in the Area of Pharmacokinetic Process Control and Targeted Drug Therapy

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Drug Targeting and Design".

Deadline for manuscript submissions: 30 June 2025 | Viewed by 2533

Special Issue Editors

Prof. Dr. Roman Zubarev

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Guest Editor
Division of Chemistry I, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, SE-17 177 Stockholm, Sweden
Interests: immunology
Prof. Dr. Anton V. Syroeshkin

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Guest Editor
Department of Pharmaceutical and Toxicological Chemistry, Medical Institute, RUDN University, 6 Miklukho-Maklaya Street, 117198 Moscow, Russia
Interests: biokinetics; dispersed systems; analytical chemistry; environmental pollution
Special Issues, Collections and Topics in MDPI journals
Dr. Elena V. Uspenskaya

E-Mail Website
Guest Editor
Department of Pharmaceutical and Toxicological Chemistry, Medical Institute, RUDN University, 6 Miklukho-Maklaya Street, 117198 Moscow, Russia
Interests: kinetic isotope effect; nanoparticle drugs; supramolecular complexes; laser diffraction spectroscopy; dissolution rate; validation studies
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Technologies related to the use of stable and radioactive isotopes are becoming increasingly important for elucidating the mechanism of pathogenesis, diagnosis of disease, management of pharmacokinetic processes, therapy of diseases with aggressive clinical courses, properties of drug molecules, and the search for novel drugs. Innovative isotope technologies have been developed by nuclear chemists, microbiologists, engineers, and a wide range of scientists and medical professionals; they have since been approved by the FDA and the Center for Drug Evaluation and Research (CDER). Herein, a current list of FDA-approved radiopharmaceuticals is provided.

We are pleased to invite submissions to a new Special Issue of Pharmaceutics dedicated to the application of isotopes in pharmacy. This Special Issue aims to cover current research on isotope technologies in pharmaceutical use.

We encourage the submission of original research articles and reviews to this Special Issue. Research areas may include (but are not limited to) the following: isotope-modified drug substances and dissolution media; isotope control of pharmacokinetics; isotope diagnostics with radiopharmaceuticals; isotopologues for pharmacy; methods for the study of media containing isotopes; and isotope-containing adjuvants.

We are looking forward to receiving your contributions

Prof. Dr. Roman Zubarev
Prof. Dr. Anton V. Syroeshkin
Dr. Elena Uspenskaya
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

  • • stable nuclide
    • radionuclides
    • isotopologues
    • deuterated drugs
    • pharmacokinetics
    • radiopharmaceuticals
    • deuterium depleted water
    • heavy water
    • isotope analysis
    • isotope ratio

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Published Papers (2 papers)

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Research

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14 pages, 1409 KiB  
Article
Production, Validation, and Exposure Dose Measurement of [13N]Ammonia Under Academic Good Manufacturing Practice Environments
by Katsumi Tomiyoshi, Yuta Namiki, David J. Yang and Tomio Inoue
Pharmaceutics 2025, 17(5), 667; https://doi.org/10.3390/pharmaceutics17050667 - 19 May 2025
Viewed by 61
Abstract
Objective: Current good manufacturing practice (cGMP) guidance for positron emission tomography (PET) drugs has been established in Europe and the United States. In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) approved the use of radiosynthesizers as medical devices for the in-house manufacturing [...] Read more.
Objective: Current good manufacturing practice (cGMP) guidance for positron emission tomography (PET) drugs has been established in Europe and the United States. In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) approved the use of radiosynthesizers as medical devices for the in-house manufacturing of PET drugs in hospitals and clinics, regardless of the cGMP environment. Without adequate facilities, equipment, and personnel required by cGMP regulations, the quality assurance (QA) and clinical effectiveness of PET drugs largely depend on the radiosynthesizers themselves. To bridge the gap between radiochemistry standardization and site qualification, the Japanese Society of Nuclear Medicine (JSNM) has issued guidance for the in-house manufacturing of small-scale PET drugs under academic GMP (a-GMP) environments. The goals of cGMP and a-GMP are different: cGMP focuses on process optimization, certification, and commercialization, while a-GMP facilitates the small-scale, in-house production of PET drugs for clinical trials and patient-specific standard of care. Among PET isotopes, N-13 has a short half-life (10 min) and must be synthesized on site. [13N]Ammonia ([13N]NH3) is used for myocardial perfusion imaging under the Japan Health Insurance System (JHIS) and was thus selected as a working example for the manufacturing of PET drugs in an a-GMP environment. Methods: A [13N]NH3-radiosynthesizer was installed in a hot cell within an a-GMP-compliant radiopharmacy unit. To comply with a-GMP regulations, the air flow was adjusted through HEPA filters. All cabinets and cells were disinfected to ensure sterility once a month. Standard operating procedures (SOPs) were applied, including analytical methods. Batch records, QA data, and radiation exposure to staff in the synthesis of [13N]NH3 were measured and documented. Results: 2.52 GBq of [13N]NH3 end-of-synthesis (EOS) was obtained in an average of 13.5 min in 15 production runs. The radiochemical purity was more than 99%. Exposure doses were 11 µSv for one production run and 22 µSv for two production runs. The pre-irradiation background dose rate was 0.12 µSv/h. After irradiation, the exposed dosage in the front of the hot cell was 0.15 µSv/h. The leakage dosage measured at the bench was 0.16 µSv/h. The exposure and leakage dosages in the manufacturing of [13N]NH3 were similar to the background level as measured by radiation monitoring systems in an a-GMP environments. All QAs, environmental data, bacteria assays, and particulates met a-GMP compliance standards. Conclusions: In-house a-GMP environments require dedicated radiosynthesizers, documentation for batch records, validation schedules, radiation protection monitoring, air and particulate systems, and accountable personnel. In this study, the in-house manufacturing of [13N]NH3 under a-GMP conditions was successfully demonstrated. These findings support the international harmonization of small-scale PET drug manufacturing in hospitals and clinics for future multi-center clinical trials and the development of a standard of care. Full article
(This article belongs to the Special Issue Applications of Stable Nuclide and Radionuclides in the Area of Pharmacokinetic Process Control and Targeted Drug Therapy)
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Review

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18 pages, 1230 KiB  
Review
Optimization Processes of Clinical Chelation-Based Radiopharmaceuticals for Pathway-Directed Targeted Radionuclide Therapy in Oncology
by Katsumi Tomiyoshi, Lydia J. Wilson, Firas Mourtada, Jennifer Sims Mourtada, Yuta Namiki, Wataru Kamata, David J. Yang and Tomio Inoue
Pharmaceutics 2024, 16(11), 1458; https://doi.org/10.3390/pharmaceutics16111458 - 15 Nov 2024
Viewed by 1463
Abstract
Targeted radionuclide therapy (TRT) for internal pathway-directed treatment is a game changer for precision medicine. TRT improves tumor control while minimizing damage to healthy tissue and extends the survival for patients with cancer. The application of theranostic-paired TRT along with cellular phenotype and [...] Read more.
Targeted radionuclide therapy (TRT) for internal pathway-directed treatment is a game changer for precision medicine. TRT improves tumor control while minimizing damage to healthy tissue and extends the survival for patients with cancer. The application of theranostic-paired TRT along with cellular phenotype and genotype correlative analysis has the potential for malignant disease management. Chelation chemistry is essential for the development of theranostic-paired radiopharmaceuticals for TRT. Among image-guided TRT, 68Ga and 99mTc are the current standards for diagnostic radionuclides, while 177Lu and 225Ac have shown great promise for β- and α-TRT, respectively. Their long half-lives, potent radiobiology, favorable decay schemes, and ability to form stable chelation conjugates make them ideal for both manufacturing and clinical use. The current challenges include optimizing radionuclide production processes, coordinating chelation chemistry stability of theranostic-paired isotopes to reduce free daughters [this pertains to 225Ac daughters 221Fr and 213Bi]-induced tissue toxicity, and improving the modeling of micro dosimetry to refine dose–response evaluation. The empirical approach to TRT delivery is based on standard radionuclide administered activity levels, although clinical trials have revealed inconsistent outcomes and normal-tissue toxicities despite equivalent administered activities. This review presents the latest optimization methods for chelation-based theranostic radiopharmaceuticals, advancements in micro-dosimetry, and SPECT/CT technologies for quantifying whole-body uptake and monitoring therapeutic response as well as cytogenetic correlative analyses. Full article
(This article belongs to the Special Issue Applications of Stable Nuclide and Radionuclides in the Area of Pharmacokinetic Process Control and Targeted Drug Therapy)
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