China
Africa
Explore chapters and articles related to this topic
Environmental Compliance and Control for Radiopharmaceutical Production
Published in Michael Ljungberg, Handbook of Nuclear Medicine and Molecular Imaging for Physicists, 2022
Ching-Hung Chiu, Ya-Yao Huang, Wen-Yi Chang, Jacek Koziorowski
Fourth, in addition to aseptically performed operations, membrane filtration is a commonly used approach for radiopharmaceutical preparation using a bacterial retention filter to abate the microbiological risk derived from the above compromised solutions. Accordingly, an integrity test usually has to be performed immediately after the preparation. However, it adds an additional risk for radiation exposure, even if rinsing the filter before the integrity test is performed. Thus, an alternative filter-based sterilization method of radiopharmaceuticals has been suggested, with the use of two filters in series and waiving the integrity testing before release [26].
Respiratory, endocrine, cardiac, and renal topics
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
Treatment must be based on the cause if known or suspected. In renal disease intravascular fluid (“saline”) overload is often under-estimated, and tissue oedema is not well correlated with intravascular volume. Thus the drug of choice may be a diuretic in the infant or child whose main problem is systemic fluid overload, with hypertension as part of the clinical picture. Renal function will profoundly influence management, particularly use of drugs. Urine output should be monitored and, if serum creatinine is outside the normal range, caution given in the use of drugs excreted though the renal route. Renal dialysis or filtration may be required. Renin-dependent causes will influence the use of ACE-inhibitors, particularly if renovascular. Catecholamine-driven hypertension needs specialist advice regarding both oc-adrenergic and β-blockade, with particular attention to problems around surgery for phaeochromocytoma.
The Animal Radiopharmacology Laboratory
Published in Howard J. Glenn, Lelio G. Colombetti, Biologic Applications of Radiotracers, 2019
Y. I. Cohen, Madeleine R. Besnard
The binding of such cations as calcium has been sudied with 45Ca, that of mercury with 197Hg and 203Hg, of chromium with 51Cr. Ultrafiltration, dialysis, gel filtration, and electrophoresis have been used. Numerous drugs were investigated, labeled with 125I (insulin, contrast media, thyroid hormones); with 14C (barbiturates, anti-inflammatory drugs, steroids, cardiac glycosides); with tritium (sympathomimetic amines, antiepileptics, anticoagulants).
Preparation and cytotoxicity evaluation of folic acid-modified YF8-OA self-assembled lipid prodrug nanoparticles
Published in Pharmaceutical Development and Technology, 2023
Fu Li, Fangfang Yang, Chenxi Guan, Pengcheng Wei, Dongqiong He, Qingwen Li, Lisheng Wang, Mingqing Yuan
The results showed that the parent drug YF8 had an IC50 below 20 μg/mL for all three cell lines (A549, HeLa, and HepG2). However, after application with LPs strategy, the cytotoxicity of LPs decreased to 15–36 times lower than that of YF8. This decrease in cytotoxicity could be due to several reasons. First, the increased hydrophobicity of the LPs could result in insufficient prodrug entering into the cells, as evidenced by the strong cell proliferation inhibition observed in the HeLa cell line treated with the FA-modified group. Second, the filtration process through 220 nm microporous filter membranes before administration to cells could lead to drug loss, reducing its effectiveness. Finally, the rate of drug release may also play a role, as in vitro release experiments showed that in the presence of esterase, only 60%–86% of the drug was released in 24 h, while in the absence of esterase, the release was limited to less than 20% in 96 h, which may not provide sufficient time for the drugs to reach the required concentration to kill cells.
Solid lipid nanoparticles and nanostructured lipid carriers: a review of the methods of manufacture and routes of administration
Published in Pharmaceutical Development and Technology, 2022
Jafar Akbari, Majid Saeedi, Fatemeh Ahmadi, Seyyed Mohammad Hassan Hashemi, Amirhossein Babaei, Sadra Yaddollahi, Seyyed Sohrab Rostamkalaei, Kofi Asare-Addo, Ali Nokhodchi
Nanomaterials have gained several advantages which make them suitable candidates for a wide range of clinical applications. Though there has been much hype around the emerging field of nanomedicine, there are currently very little official regulations in this field. Many nanomedicines study through direct interaction with biomolecules (e.g. protein, gene, compound, and chemical) are vital for cell division and normal genome function (Zhang et al. 2012), all of which can lead to mutagenicity and genotoxicity. Currently, the specific interactions of biological systems with several nanolipidic are not completely realized thus making the deduction about the toxicological and physicochemical properties of nanomedicines are challenging. The absence therefore of official regulation of nanolipidic production and nanomedicines for health-related applications is a global problem. Some concern is thus imperative in the regulatory plan and is as such presented in Figure 2(a). The main issues faced in the regulation of SLN are described in Figure 2(b). Nevertheless, this over-cautious approach seems to be demonstrating great inertia within the field. However, the standard checks needed for approval are still vague and align with the regulation for small drug molecules (Figure 2(c)) which do not correctly reflect the nanomaterials potential. If the regulation was therefore appropriate and bespoke, it would enable better filtration at preclinical studies, decreasing failure rate either later in the clinical trials or indeed after clinical use and marketing.
Current challenges in biotherapeutic particles manufacturing
Published in Expert Opinion on Biological Therapy, 2020
Mafalda G. Moleirinho, Ricardo J.S. Silva, Paula M. Alves, Manuel J. T. Carrondo, Cristina Peixoto
Following a biopharmaceutical process structure, sterile filtration is usually the latest process before vialing. This step is extremely desirable from a safety and regulatory perspective and is highly dependent on the particle size, where particles larger than 200 nm cannot be filtered, such as the case of poxvirus and vaccinia virus. The membrane material is a key parameter in sterile filtration that should be optimized to minimize the particles’ losses due to nonspecific binding and membrane fouling [33,132]. Shoaebargh et al recently evaluated several sterile filters (0.2 and 0.22 µm) for oncolytic adenovirus filtration where the two-layered sterile filters, Fluorodyne EX EDF, and MiniSart Plus, demonstrated slower transmembrane pressure (TMP) increase along with a higher filtered viral volume [132]. Among the filters tested, the total virus recovery did not exceed 25%. This value is quite low and represents a particular concern that affects the large-scale manufacturing of several therapeutic particles. Furthermore, and as described by Shoaebargh et al, the presence of aggregated virus particles may cause partial blockage of the pore of the membranes [132]. Due to the challenges and difficulties observed with sterile filtration, there are some manufacturing processes that instead of performing this step take every precaution to ensure product sterility at all steps of the downstream.