Preparation and physicochemical stability of 50 mg/mL hydroxychloroquine oral suspension in SyrSpendⓇ SF PH4 (dry).
Identifieur interne : 000998 ( Main/Corpus ); précédent : 000997; suivant : 000999Preparation and physicochemical stability of 50 mg/mL hydroxychloroquine oral suspension in SyrSpendⓇ SF PH4 (dry).
Auteurs : Guillaume Binson ; Nicolas Venisse ; Alexis Sauvaget ; Astrid Bacle ; Pauline Lazaro ; Antoine DupuisSource :
- International journal of antimicrobial agents [ 1872-7913 ] ; 2020.
English descriptors
- KwdEn :
- MESH :
- chemical , chemistry : Hydroxychloroquine.
- drug therapy : COVID-19.
- chemical , therapeutic use : Hydroxychloroquine.
- Administration, Oral, Drug Stability, Humans, SARS-CoV-2, Suspensions.
Abstract
In the context of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, hydroxychloroquine has been proposed as a potential agent to treat patients with COVID-19 (coronavirus disease 2019) caused by SARS-CoV-2 infection. Older adults are more susceptible to COVID-19 and some patients may require admission to the intensive care unit, where oral drug administration of solid forms may be compromised in many COVID-19 patients. However, a liquid formulation of hydroxychloroquine is not commercially available. This study describes how to prepare a 50 mg/mL hydroxychloroquine oral suspension using hydroxychloroquine sulfate powder and SyrSpendⓇ SF PH4 (dry) suspending vehicle. Moreover, a fully validated stability-indicating method has been developed to demonstrate the physicochemical stability of the compounded hydroxychloroquine oral suspension over 60 days under refrigeration (5 ± 3 °C). Finally, use of the proposed oral suspension provides a reliable solution to perform safe and accurate administration of hydroxychloroquine to patients with SARS-CoV-2 infection.
DOI: 10.1016/j.ijantimicag.2020.106201
PubMed: 33075513
PubMed Central: PMC7566679
Links to Exploration step
pubmed:33075513Le document en format XML
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SF PH4 (dry).</title>
<author><name sortKey="Binson, Guillaume" sort="Binson, Guillaume" uniqKey="Binson G" first="Guillaume" last="Binson">Guillaume Binson</name>
<affiliation><nlm:affiliation>University Hospital of Poitiers, Pharmacy Department, 2 rue de la milétrie, 86021 Poitiers, France; CIC Inserm 1402, HEDEX Group, 2 rue de la milétrie, 86021 Poitiers, France, and School of Medicine and Pharmacy, University of Poitiers, Poitiers, France.</nlm:affiliation>
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<author><name sortKey="Bacle, Astrid" sort="Bacle, Astrid" uniqKey="Bacle A" first="Astrid" last="Bacle">Astrid Bacle</name>
<affiliation><nlm:affiliation>Université de Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail) - UMR_S 1085, 2 Avenue du Pr Léon Bernard, 35043 Rennes, France, and Pôle Pharmacie, Centre Hospitalier Universitaire, 2 rue Henri Le Guilloux, 35033 Rennes, France.</nlm:affiliation>
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<series><title level="j">International journal of antimicrobial agents</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral (MeSH)</term>
<term>COVID-19 (drug therapy)</term>
<term>Drug Stability (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Hydroxychloroquine (chemistry)</term>
<term>Hydroxychloroquine (therapeutic use)</term>
<term>SARS-CoV-2 (MeSH)</term>
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<front><div type="abstract" xml:lang="en">In the context of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, hydroxychloroquine has been proposed as a potential agent to treat patients with COVID-19 (coronavirus disease 2019) caused by SARS-CoV-2 infection. Older adults are more susceptible to COVID-19 and some patients may require admission to the intensive care unit, where oral drug administration of solid forms may be compromised in many COVID-19 patients. However, a liquid formulation of hydroxychloroquine is not commercially available. This study describes how to prepare a 50 mg/mL hydroxychloroquine oral suspension using hydroxychloroquine sulfate powder and SyrSpend<sup>Ⓡ</sup>
SF PH4 (dry) suspending vehicle. Moreover, a fully validated stability-indicating method has been developed to demonstrate the physicochemical stability of the compounded hydroxychloroquine oral suspension over 60 days under refrigeration (5 ± 3 °C). Finally, use of the proposed oral suspension provides a reliable solution to perform safe and accurate administration of hydroxychloroquine to patients with SARS-CoV-2 infection.</div>
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SF PH4 (dry).</ArticleTitle>
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<Abstract><AbstractText>In the context of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, hydroxychloroquine has been proposed as a potential agent to treat patients with COVID-19 (coronavirus disease 2019) caused by SARS-CoV-2 infection. Older adults are more susceptible to COVID-19 and some patients may require admission to the intensive care unit, where oral drug administration of solid forms may be compromised in many COVID-19 patients. However, a liquid formulation of hydroxychloroquine is not commercially available. This study describes how to prepare a 50 mg/mL hydroxychloroquine oral suspension using hydroxychloroquine sulfate powder and SyrSpend<sup>Ⓡ</sup>
SF PH4 (dry) suspending vehicle. Moreover, a fully validated stability-indicating method has been developed to demonstrate the physicochemical stability of the compounded hydroxychloroquine oral suspension over 60 days under refrigeration (5 ± 3 °C). Finally, use of the proposed oral suspension provides a reliable solution to perform safe and accurate administration of hydroxychloroquine to patients with SARS-CoV-2 infection.</AbstractText>
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