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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].
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].
Published in Ronald M. Atlas, James W. Snyder, Handbook Of Media for Clinical Microbiology, 2006
Ronald M. Atlas, James W. Snyder
Preparation of Medium: Add components, except polysorbate 80, to distilled/deionized water and bring volume to 990.0mL. Mix thoroughly. Gently heat and bring to boiling. Add polysorbate 80. Mix thoroughly. Distribute into tubes or flasks. Autoclave for 15 min at 15 psi pressure-121°C. Pour into sterile Petri dishes.
Intraocular delivery considerations of ocular biologic products and key preclinical determinations
Published in Expert Opinion on Drug Delivery, 2023
Patrick Hughes, Hongwen M. Rivers, Vladimir Bantseev, Chun-Wan Yen, Hanns-Christian Mahler, Swati Gupta
Aguirre et al. (2018) [151] assessed tolerability and safety of 21 formulations, commonly used in the parenteral formulations containing single or multiple excipients, in Dutch Belted rabbits following intravitreal injection. Polylactic-co-glycolic acid (Medisorb®) induced inflammation and retinal toxicity when administered alone or with other excipients. Solutol® HS 15, a nonionic solubilizer and emulsifying agent, resulted in similar effects. By contrast, polysorbate 80 was generally tolerable in the rabbit eye [151]. Younis et al. (2008) [152] characterized the safety and tolerability profiles of inactive excipients following sub-Tenon administration in Dutch Belted rabbits. All excipients assessed in this study were commonly used in the parenteral formulations; however, 2% w/v poloxamer 182 and carboxymethylcellulose (0.5 w/v, 700 kDa) both demonstrated microscopic findings and edema in episcleral tissues [152].
Allergic reactions to COVID-19 vaccines: statement of the Belgian Society for Allergy and Clinical Immunology (BelSACI)
Published in Acta Clinica Belgica, 2022
Sebastiaan Tuyls, Xavier Van Der Brempt, Margaretha Faber, Romy Gadisseur, Bita Dezfoulian, Rik Schrijvers, Antoine Froidure
The vaccines from Pfizer-BioNTech and Moderna do not contain any food or drug or latex allergen, or any component that may interact with hymenoptera venoms, but both contain polyethylene glycol (PEG), a potential allergen [27]. To date, PEG is suspected to be the culprit in some anaphylactic reactions occurring after vaccination with mRNA vaccines, although this remains to be proven. The AstraZeneca vaccine does not contain PEG but does contain polysorbate 80, which may cross-react with PEG. Allergies to PEG or polysorbate-80 are extremely rare [28] but currently constitute a formal contra-indication for the administration of the Pfizer-BioNTech, Moderna, and AstraZeneca vaccines. Similarly, patients who have suffered from an allergic reaction after administration of the first dose of a COVID-19 vaccine should not be administered the second dose without a complete allergic workup. Given the restricted window of administering the booster within 3–4 weeks, ruling-out allergies and a possible new reaction might be very difficult, with a formal contra-indication for a second dose ensuing this uncertainty. If necessary, the complete list of excipients contained in the vaccines is available on manufacturers’ notices.
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.