China
Africa
Explore chapters and articles related to this topic
Indications for and preparing and administering subcutaneous allergen vaccines
Published in Richard F. Lockey, Dennis K. Ledford, Allergens and Allergen Immunotherapy, 2020
A number of other approaches to preserve extract potency have been suggested but have not found wide acceptance. Siliconization of vials has been suggested to decrease adsorption of proteins to their surface. Testing this method revealed it to be without effect [74]. Polysorbate 80 in concentrations of 0.002%–0.2% had a slight effect in preserving potency, but it was less effective than human serum albumin [74].
Manufacture and Applications of Gelatin Nanoparticles: A Practical Approach
Published in Andreia Ascenso, Sandra Simões, Helena Ribeiro, Carrier-Mediated Dermal Delivery, 2017
Diogo Pineda Rivelli, Silvia Berlanga de Moraes Barros
Khan et al. [28] optimized the nanoprecipitation technique for gelatin nanoparticle preparation varying several parameters of this process. They verified that polysorbate 20 and 80 were unsuitable stabilizers, whereas poloxamer 188 and 407 could be used at a minimum concentration of 7%. Regarding the nanoparticle formation, methanol and ethanol could be successfully used as non-solvents, while isopropyl alcohol, acetone, and acetonitrile caused a great aggregation. The average size at optimal conditions was 250 nm.
Preparing Subcutaneous Allergen Vaccines
Published in Richard F. Lockey, Dennis K. Ledford, Allergens and Allergen Immunotherapy, 2014
A number of other approaches to preserve extract potency have been suggested but have not found wide acceptance. Siliconization of vials has been suggested to decrease adsorption of proteins to their surface. Testing this method revealed it to be without effect [48]. Polysorbate 80 in concentrations of 0.002%–0.2% had a slight effect in preserving potency, but it was less effective than human serum albumin [48].
Success of nano-vaccines against COVID-19: a transformation in nanomedicine
Published in Expert Review of Vaccines, 2022
Manoj Kumar Sarangi, Sasmita Padhi, Gautam Rath, Sitansu Sekhar Nanda, Dong Kee Yi
Micelles are self-assembled amphiphilic structures that can deliver SARS-CoV-2 proteins, such as the vaccine developed by Novavax (NVX-CoV2373) currently in a phase III clinical trial. The vaccine incorporates polysorbate 80 (Tween 80), an amphiphilic detergent, and saponin-based Matrix-M1, thereby driving micellular self-assembly with pre-fusion S protein expression [94,95]. During mixing, the hydrophobic transmembrane domain of S protein interacts with the hydrophobic micellular core to form a detergent-encapsulated protein structure. A UK clinical trial on NVX-CoV2373 showed 86% efficacy against alpha VOC and 96% efficacy against wild-type SARS-CoV-2, protecting recipients with mild to severe disease [96]. The Matrix-M1 plus S-micelle vaccine (as reported in a phase I/II clinical trial) sparing a double dose (5 mg/dose) regimen provoked increased nAb titers and serum IgG compared to recuperating individuals [97]. However, in South Africa, the vaccine revealed a lesser efficacy of 49.4% in the phase IIb trial (NCT04533399) against the beta VOC [98].
Differences between the quality aspects of various generic and branded docetaxel formulations
Published in Current Medical Research and Opinion, 2021
Docetaxel is available as a 20- or 80-mg/mL solution formulated in a non-ionic surfactant polysorbate 80 and dehydrated ethanol in 1:1 ratio to enhance its solubility and further bioavailability40. Polysorbate 80 is used an auxiliary material to increase the solubility of docetaxel, thus forming a micelle system. The micelle system can increase the stability of docetaxel delivery and release. The stability of micelles in this type of pharmaceutical preparation has a crucial impact on the quality of the drug17. However, the excipient, polysorbate 80 is not pharmacologically inert and has been reported to cause acute hypersensitivity reactions (HSR) and peripheral neuropathy41,42. Significant hemolytic activity has also been reported from polysorbate 80, and these formulations are insufficiently stable in clinical use over prolonged storage periods43. Furthermore, since the effects of antineoplastic agents cannot be investigated in healthy individuals as required by the Phase I, bioequivalence tests, quality control of docetaxel is complicated. Owing to these limitations, content of docetaxel along with the amount of impurities, excipients and solvents need to be precisely monitored to ensure the safe drug delivery to patients.
Association between in-line filtration and Type I hypersensitivity reactions in pediatric oncology patients receiving intravenous etoposide
Published in Pediatric Hematology and Oncology, 2021
Rebecca Ronsley, Lisa Jacques, James E. Potts, Kerri Clement, David B. Dix, Paula Mahon
The mechanism of hypersensitivity reactions with most chemotherapy medications is not well understood and there is little data describing hypersensitivity related to inline filters. Although hypersensitivity is reported in other chemotherapy medications where inline filters are used,20 the pathophysiology of these reactions is not described. Previously, it was hypothesized that higher concentrations of etoposide resulted in an increased risk for hypersensitivity reactions.21 Despite these data, other studies have demonstrated hypersensitivity reactions with a wide range of etoposide concentrations.19, 22,23 The diluent used during the etoposide infusion may play a role in hypersensitivity reactions. Weiss et al published data suggesting that polysorbate conferred risk for a hypersensitivity reaction when compared to etoposide dissolved in benzyl alcohol.18 Our data did not demonstrate an association between diluent used (dextrose versus normal saline) and risk of hypersensitivity reaction. Furthermore, in our model, diluent was not associated with the presence or absence of a hypersensitivity reaction.