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
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Preparation and physicochemical stability of 50 mg/mL hydroxychloroquine oral suspension in SyrSpend<sup>Ⓡ</sup> 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></affiliation></author><author><name sortKey="Venisse, Nicolas" sort="Venisse, Nicolas" uniqKey="Venisse N" first="Nicolas" last="Venisse">Nicolas Venisse</name><affiliation><nlm:affiliation>CIC Inserm 1402, HEDEX Group, 2 rue de la milétrie, 86021 Poitiers, France, and School of Medicine and Pharmacy, University of Poitiers, Poitiers, France; University Hospital of Poitiers, Pharmacokinetics Department, 2 rue de la milétrie, 86021 Poitiers, France.</nlm:affiliation></affiliation></author><author><name sortKey="Sauvaget, Alexis" sort="Sauvaget, Alexis" uniqKey="Sauvaget A" first="Alexis" last="Sauvaget">Alexis Sauvaget</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></affiliation></author><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></affiliation></author><author><name sortKey="Lazaro, Pauline" sort="Lazaro, Pauline" uniqKey="Lazaro P" first="Pauline" last="Lazaro">Pauline Lazaro</name><affiliation><nlm:affiliation>University Hospital of Poitiers, Pharmacy Department, 2 rue de la milétrie, 86021 Poitiers, France.</nlm:affiliation></affiliation></author><author><name sortKey="Dupuis, Antoine" sort="Dupuis, Antoine" uniqKey="Dupuis A" first="Antoine" last="Dupuis">Antoine Dupuis</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. Electronic address: a.dupuis@chu-poitiers.fr.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:33075513</idno><idno type="pmid">33075513</idno><idno type="doi">10.1016/j.ijantimicag.2020.106201</idno><idno type="pmc">PMC7566679</idno><idno type="wicri:Area/Main/Corpus">000998</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000998</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Preparation and physicochemical stability of 50 mg/mL hydroxychloroquine oral suspension in SyrSpend<sup>Ⓡ</sup> 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></affiliation></author><author><name sortKey="Venisse, Nicolas" sort="Venisse, Nicolas" uniqKey="Venisse N" first="Nicolas" last="Venisse">Nicolas Venisse</name><affiliation><nlm:affiliation>CIC Inserm 1402, HEDEX Group, 2 rue de la milétrie, 86021 Poitiers, France, and School of Medicine and Pharmacy, University of Poitiers, Poitiers, France; University Hospital of Poitiers, Pharmacokinetics Department, 2 rue de la milétrie, 86021 Poitiers, France.</nlm:affiliation></affiliation></author><author><name sortKey="Sauvaget, Alexis" sort="Sauvaget, Alexis" uniqKey="Sauvaget A" first="Alexis" last="Sauvaget">Alexis Sauvaget</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></affiliation></author><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></affiliation></author><author><name sortKey="Lazaro, Pauline" sort="Lazaro, Pauline" uniqKey="Lazaro P" first="Pauline" last="Lazaro">Pauline Lazaro</name><affiliation><nlm:affiliation>University Hospital of Poitiers, Pharmacy Department, 2 rue de la milétrie, 86021 Poitiers, France.</nlm:affiliation></affiliation></author><author><name sortKey="Dupuis, Antoine" sort="Dupuis, Antoine" uniqKey="Dupuis A" first="Antoine" last="Dupuis">Antoine Dupuis</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. Electronic address: a.dupuis@chu-poitiers.fr.</nlm:affiliation></affiliation></author></analytic><series><title level="j">International journal of antimicrobial agents</title><idno type="eISSN">1872-7913</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><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><term>Suspensions (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="chemistry" xml:lang="en"><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term><term>Drug Stability</term><term>Humans</term><term>SARS-CoV-2</term><term>Suspensions</term></keywords></textClass></profileDesc></teiHeader><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></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">33075513</PMID><DateCompleted><Year>2020</Year><Month>12</Month><Day>08</Day></DateCompleted><DateRevised><Year>2021</Year><Month>02</Month><Day>01</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1872-7913</ISSN><JournalIssue CitedMedium="Internet"><Volume>56</Volume><Issue>6</Issue><PubDate><Year>2020</Year><Month>Dec</Month></PubDate></JournalIssue><Title>International journal of antimicrobial agents</Title><ISOAbbreviation>Int J Antimicrob Agents</ISOAbbreviation></Journal><ArticleTitle>Preparation and physicochemical stability of 50 mg/mL hydroxychloroquine oral suspension in SyrSpend<sup>Ⓡ</sup> SF PH4 (dry).</ArticleTitle><Pagination><MedlinePgn>106201</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0924-8579(20)30407-6</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ijantimicag.2020.106201</ELocationID><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><CopyrightInformation>Copyright © 2020 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Binson</LastName><ForeName>Guillaume</ForeName><Initials>G</Initials><AffiliationInfo><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.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Venisse</LastName><ForeName>Nicolas</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>CIC Inserm 1402, HEDEX Group, 2 rue de la milétrie, 86021 Poitiers, France, and School of Medicine and Pharmacy, University of Poitiers, Poitiers, France; University Hospital of Poitiers, Pharmacokinetics Department, 2 rue de la milétrie, 86021 Poitiers, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sauvaget</LastName><ForeName>Alexis</ForeName><Initials>A</Initials><AffiliationInfo><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.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bacle</LastName><ForeName>Astrid</ForeName><Initials>A</Initials><AffiliationInfo><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.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lazaro</LastName><ForeName>Pauline</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>University Hospital of Poitiers, Pharmacy Department, 2 rue de la milétrie, 86021 Poitiers, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dupuis</LastName><ForeName>Antoine</ForeName><Initials>A</Initials><AffiliationInfo><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. Electronic address: a.dupuis@chu-poitiers.fr.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>10</Month><Day>16</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Int J Antimicrob Agents</MedlineTA><NlmUniqueID>9111860</NlmUniqueID><ISSNLinking>0924-8579</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013535">Suspensions</NameOfSubstance></Chemical><Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber><NameOfSubstance UI="D006886">Hydroxychloroquine</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000284" MajorTopicYN="N">Administration, Oral</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004355" MajorTopicYN="N">Drug Stability</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName><QualifierName UI="Q000737" MajorTopicYN="Y">chemistry</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000086402" MajorTopicYN="Y">SARS-CoV-2</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013535" MajorTopicYN="N">Suspensions</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Hydroxychloroquine</Keyword><Keyword MajorTopicYN="N">Oral suspension</Keyword><Keyword MajorTopicYN="N">SARS-CoV-2</Keyword><Keyword MajorTopicYN="N">Stability-indicating assay</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>04</Month><Day>17</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2020</Year><Month>10</Month><Day>07</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>10</Month><Day>11</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>10</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>12</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>10</Month><Day>19</Day><Hour>20</Hour><Minute>9</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33075513</ArticleId><ArticleId IdType="pii">S0924-8579(20)30407-6</ArticleId><ArticleId IdType="doi">10.1016/j.ijantimicag.2020.106201</ArticleId><ArticleId IdType="pmc">PMC7566679</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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