Use of subcutaneous tocilizumab to prepare intravenous solutions for COVID-19 emergency shortage: Comparative analytical study of physicochemical quality attributes
| Autor: | Antonio Salmerón-García, José Hernández-Jiménez, Natalia Navas, Anabel Torrente-López, Jesús Hermosilla, José Cabeza, Raquel Pérez-Robles |
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| Přispěvatelé: | [Navas,N, Hermosilla,J, Torrente-López,A, Hernández-Jiménez,J, Pérez-Robles,R] Department of Analytical Chemistry, Science Faculty / Biomedical Research Institute ibs.Granada, University of Granada, Granada, Spain. [Cabeza, J, Salmerón-García,A] UGC Farmacia Hospitalaria, Biomedical Research Institute ibs.Granada. Hospital Universitario San Cecilio de Granada, Granada, Spain. |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Drug
medicine.medical_specialty Coronavirus disease 2019 (COVID-19) media_common.quotation_subject Pharmaceutical Science Economic shortage 02 engineering and technology Pharmacy 01 natural sciences Article Analytical Chemistry Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings] chemistry.chemical_compound Tocilizumab Cytokine release syndrome Chemicals and Drugs::Amino Acids Peptides and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies Monoclonal::Antibodies Monoclonal Humanized [Medical Subject Headings] Health Care::Environment and Public Health::Public Health [Medical Subject Headings] Drug Discovery Electrochemistry medicine Critical quality attributes Analytical Diagnostic and Therapeutic Techniques and Equipment::Equipment and Supplies::Syringes [Medical Subject Headings] Chemicals and Drugs::Amino Acids Peptides and Proteins::Proteins::Intercellular Signaling Peptides and Proteins::Cytokines::Interleukins::Interleukin-6 [Medical Subject Headings] Intensive care medicine Síndrome de liberación de citoquinas Spectroscopy Syringe media_common Health Care::Health Care Facilities Manpower and Services::Health Facilities::Hospitals [Medical Subject Headings] Analytical Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Prescriptions::Off-Label Use [Medical Subject Headings] IV and SC medicines SARS-CoV-2 Mortality rate lcsh:RM1-950 010401 analytical chemistry COVID-19 Health Care::Environment and Public Health::Public Health::Disease Outbreaks::Epidemics::Pandemics [Medical Subject Headings] Chemicals and Drugs::Pharmaceutical Preparations [Medical Subject Headings] 021001 nanoscience & nanotechnology medicine.disease 0104 chemical sciences Clinical trial lcsh:Therapeutics. Pharmacology chemistry Preparaciones farmacéuticas 0210 nano-technology |
| Zdroj: | Digibug: Repositorio Institucional de la Universidad de Granada Universidad de Granada (UGR) Digibug. Repositorio Institucional de la Universidad de Granada instname Journal of Pharmaceutical Analysis, Vol 10, Iss 6, Pp 532-545 (2020) Journal of Pharmaceutical Analysis |
| Popis: | COVID-19, a disease caused by the novel coronavirus SARS-CoV-2, has produced a serious emergency for global public health, placing enormous stress on national health systems in many countries. Several studies suggest that cytokine storms (interleukins) may play an important role in severe cases of COVID19. Neutralizing key inflammatory factors in cytokine release syndrome (CRS) could therefore be of great value in reducing the mortality rate. Tocilizumab (TCZ) in its intravenous (IV) form of administration -RoActemra® 20 mg/mL (Roche)-is indicated for treatment of severe CRS patients. Preliminary investigations have concluded that inhibition of IL-6 with TCZ appears to be efficacious and safe, with several ongoing clinical trials. This has led to a huge increase in demand for IV TCZ for treating severe COVID-19 patients in hospitals, which has resulted in drug shortages. Here, we present a comparability study assessing the main critical physicochemical attributes of TCZ solutions used for infusion, at 6 mg/ mL and 4 mg/mL, prepared from RoActemra® 20 mg/mL (IV form) and from RoActemra® 162 mg (0.9 mL solution pre-filled syringe, subcutaneous(SC) form), to evaluate the use of the latter for preparing clinical solutions required for IV administration, so that in a situation of shortage of the IV medicine, the SC form could be used to prepare the solutions for IV delivery of TCZ. It is important to remember that during the current pandemic all the medicines are used off-label, since none of them has yet been approved for the treatment of COVID-19. Instituto Carlos III, Ministerio de Economia y Competitividad, Spain FIS: PI-17/00547 European Union (EU) Ministry of Universities, Spain FPU18/03131 University of Granada (Spain) |
| Databáze: | OpenAIRE |
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