Formulation and stability study of hydroxychloroquine sulfate oral suspensions.
Identifieur interne : 000507 ( Main/Corpus ); précédent : 000506; suivant : 000508Formulation and stability study of hydroxychloroquine sulfate oral suspensions.
Auteurs : Sarah El Mershati ; Agathe Thouvenin ; Philippe-Henri Secretan ; Pascale De Lonlay ; Caroline Tuchmann-Durand ; Salvatore Cisternino ; Joël SchlatterSource :
- Pharmaceutical development and technology [ 1097-9867 ] ; 2021.
English descriptors
- KwdEn :
- MESH :
- chemical , chemistry : Antimalarials, Hydroxychloroquine.
- drug therapy : COVID-19.
- prevention & control : Drug Contamination.
- Chromatography, High Pressure Liquid, Drug Compounding, Drug Stability, Humans, Quality Control, Suspensions, Taste.
Abstract
Hydroxychloroquine is an antimalarial drug indicated in the treatment of acute attacks of malaria due to Plasmodium vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. It is also used for the treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and more recently proposed in COVID-19 therapy. Hydroxychloroquine is only available in tablets which are not easy to administer for pediatric and geriatric patients, and patients unable to swallow such as patients found in intensive care units. The aim of this work was to develop and optimize a ready to use liquid hydroxychloroquine formulation and to carry out the corresponding chemical and microbiological stability studies. The formulation was evaluated for ease of preparation, physical properties, and palatability. Its stability was performed at ambient temperature and under refrigeration. After 6 months of stability testing, the results showed no pH change, no drug loss, no microbial development, and no visual change. The formulation, employing excipients in a range that EMA has recommended, showed chemical and microbiological stability for at least 6 months even in the worst storage conditions.
DOI: 10.1080/10837450.2021.1871918
PubMed: 33428504
Links to Exploration step
pubmed:33428504Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Formulation and stability study of hydroxychloroquine sulfate oral suspensions.</title><author><name sortKey="El Mershati, Sarah" sort="El Mershati, Sarah" uniqKey="El Mershati S" first="Sarah" last="El Mershati">Sarah El Mershati</name><affiliation><nlm:affiliation>Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Thouvenin, Agathe" sort="Thouvenin, Agathe" uniqKey="Thouvenin A" first="Agathe" last="Thouvenin">Agathe Thouvenin</name><affiliation><nlm:affiliation>Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Secretan, Philippe Henri" sort="Secretan, Philippe Henri" uniqKey="Secretan P" first="Philippe-Henri" last="Secretan">Philippe-Henri Secretan</name><affiliation><nlm:affiliation>Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="De Lonlay, Pascale" sort="De Lonlay, Pascale" uniqKey="De Lonlay P" first="Pascale" last="De Lonlay">Pascale De Lonlay</name><affiliation><nlm:affiliation>Reference Center for Inherited Metabolic Diseases, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>INSERM, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Tuchmann Durand, Caroline" sort="Tuchmann Durand, Caroline" uniqKey="Tuchmann Durand C" first="Caroline" last="Tuchmann-Durand">Caroline Tuchmann-Durand</name><affiliation><nlm:affiliation>Imagine Institut des Maladies Génétiques, Paris, France and Department of Biotherapy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Cisternino, Salvatore" sort="Cisternino, Salvatore" uniqKey="Cisternino S" first="Salvatore" last="Cisternino">Salvatore Cisternino</name><affiliation><nlm:affiliation>Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Faculté de Pharmacie, Université de Paris, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Schlatter, Joel" sort="Schlatter, Joel" uniqKey="Schlatter J" first="Joël" last="Schlatter">Joël Schlatter</name><affiliation><nlm:affiliation>Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2021">2021</date><idno type="RBID">pubmed:33428504</idno><idno type="pmid">33428504</idno><idno type="doi">10.1080/10837450.2021.1871918</idno><idno type="wicri:Area/Main/Corpus">000507</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000507</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Formulation and stability study of hydroxychloroquine sulfate oral suspensions.</title><author><name sortKey="El Mershati, Sarah" sort="El Mershati, Sarah" uniqKey="El Mershati S" first="Sarah" last="El Mershati">Sarah El Mershati</name><affiliation><nlm:affiliation>Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Thouvenin, Agathe" sort="Thouvenin, Agathe" uniqKey="Thouvenin A" first="Agathe" last="Thouvenin">Agathe Thouvenin</name><affiliation><nlm:affiliation>Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Secretan, Philippe Henri" sort="Secretan, Philippe Henri" uniqKey="Secretan P" first="Philippe-Henri" last="Secretan">Philippe-Henri Secretan</name><affiliation><nlm:affiliation>Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="De Lonlay, Pascale" sort="De Lonlay, Pascale" uniqKey="De Lonlay P" first="Pascale" last="De Lonlay">Pascale De Lonlay</name><affiliation><nlm:affiliation>Reference Center for Inherited Metabolic Diseases, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>INSERM, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Tuchmann Durand, Caroline" sort="Tuchmann Durand, Caroline" uniqKey="Tuchmann Durand C" first="Caroline" last="Tuchmann-Durand">Caroline Tuchmann-Durand</name><affiliation><nlm:affiliation>Imagine Institut des Maladies Génétiques, Paris, France and Department of Biotherapy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Cisternino, Salvatore" sort="Cisternino, Salvatore" uniqKey="Cisternino S" first="Salvatore" last="Cisternino">Salvatore Cisternino</name><affiliation><nlm:affiliation>Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Faculté de Pharmacie, Université de Paris, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Schlatter, Joel" sort="Schlatter, Joel" uniqKey="Schlatter J" first="Joël" last="Schlatter">Joël Schlatter</name><affiliation><nlm:affiliation>Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Pharmaceutical development and technology</title><idno type="eISSN">1097-9867</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antimalarials (chemistry)</term><term>COVID-19 (drug therapy)</term><term>Chromatography, High Pressure Liquid (MeSH)</term><term>Drug Compounding (MeSH)</term><term>Drug Contamination (prevention & control)</term><term>Drug Stability (MeSH)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (chemistry)</term><term>Quality Control (MeSH)</term><term>Suspensions (MeSH)</term><term>Taste (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="chemistry" xml:lang="en"><term>Antimalarials</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Drug Contamination</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Chromatography, High Pressure Liquid</term><term>Drug Compounding</term><term>Drug Stability</term><term>Humans</term><term>Quality Control</term><term>Suspensions</term><term>Taste</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Hydroxychloroquine is an antimalarial drug indicated in the treatment of acute attacks of malaria due to <i>Plasmodium vivax</i>, <i>P. malariae</i>, <i>P. ovale</i>, and susceptible strains of <i>P. falciparum</i>. It is also used for the treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and more recently proposed in COVID-19 therapy. Hydroxychloroquine is only available in tablets which are not easy to administer for pediatric and geriatric patients, and patients unable to swallow such as patients found in intensive care units. The aim of this work was to develop and optimize a ready to use liquid hydroxychloroquine formulation and to carry out the corresponding chemical and microbiological stability studies. The formulation was evaluated for ease of preparation, physical properties, and palatability. Its stability was performed at ambient temperature and under refrigeration. After 6 months of stability testing, the results showed no pH change, no drug loss, no microbial development, and no visual change. The formulation, employing excipients in a range that EMA has recommended, showed chemical and microbiological stability for at least 6 months even in the worst storage conditions.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">33428504</PMID><DateCompleted><Year>2021</Year><Month>02</Month><Day>25</Day></DateCompleted><DateRevised><Year>2021</Year><Month>02</Month><Day>25</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1097-9867</ISSN><JournalIssue CitedMedium="Internet"><Volume>26</Volume><Issue>3</Issue><PubDate><Year>2021</Year><Month>Mar</Month></PubDate></JournalIssue><Title>Pharmaceutical development and technology</Title><ISOAbbreviation>Pharm Dev Technol</ISOAbbreviation></Journal><ArticleTitle>Formulation and stability study of hydroxychloroquine sulfate oral suspensions.</ArticleTitle><Pagination><MedlinePgn>328-334</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1080/10837450.2021.1871918</ELocationID><Abstract><AbstractText>Hydroxychloroquine is an antimalarial drug indicated in the treatment of acute attacks of malaria due to <i>Plasmodium vivax</i>, <i>P. malariae</i>, <i>P. ovale</i>, and susceptible strains of <i>P. falciparum</i>. It is also used for the treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and more recently proposed in COVID-19 therapy. Hydroxychloroquine is only available in tablets which are not easy to administer for pediatric and geriatric patients, and patients unable to swallow such as patients found in intensive care units. The aim of this work was to develop and optimize a ready to use liquid hydroxychloroquine formulation and to carry out the corresponding chemical and microbiological stability studies. The formulation was evaluated for ease of preparation, physical properties, and palatability. Its stability was performed at ambient temperature and under refrigeration. After 6 months of stability testing, the results showed no pH change, no drug loss, no microbial development, and no visual change. The formulation, employing excipients in a range that EMA has recommended, showed chemical and microbiological stability for at least 6 months even in the worst storage conditions.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>El Mershati</LastName><ForeName>Sarah</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thouvenin</LastName><ForeName>Agathe</ForeName><Initials>A</Initials><Identifier Source="ORCID">https://orcid.org/0000-0002-7687-0999</Identifier><AffiliationInfo><Affiliation>Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Secretan</LastName><ForeName>Philippe-Henri</ForeName><Initials>PH</Initials><AffiliationInfo><Affiliation>Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>De Lonlay</LastName><ForeName>Pascale</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Reference Center for Inherited Metabolic Diseases, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>INSERM, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tuchmann-Durand</LastName><ForeName>Caroline</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Imagine Institut des Maladies Génétiques, Paris, France and Department of Biotherapy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cisternino</LastName><ForeName>Salvatore</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Faculté de Pharmacie, Université de Paris, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schlatter</LastName><ForeName>Joël</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2021</Year><Month>01</Month><Day>17</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Pharm Dev Technol</MedlineTA><NlmUniqueID>9610932</NlmUniqueID><ISSNLinking>1083-7450</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000962">Antimalarials</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013535">Suspensions</NameOfSubstance></Chemical><Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber><NameOfSubstance UI="D006886">Hydroxychloroquine</NameOfSubstance></Chemical></ChemicalList><SupplMeshList><SupplMeshName Type="Protocol" UI="C000705127">COVID-19 drug treatment</SupplMeshName></SupplMeshList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000962" MajorTopicYN="N">Antimalarials</DescriptorName><QualifierName UI="Q000737" MajorTopicYN="Y">chemistry</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002851" MajorTopicYN="N">Chromatography, High Pressure Liquid</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004339" MajorTopicYN="N">Drug Compounding</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004340" MajorTopicYN="N">Drug Contamination</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</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></MeshHeading><MeshHeading><DescriptorName UI="D011786" MajorTopicYN="N">Quality Control</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013535" MajorTopicYN="N">Suspensions</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013649" MajorTopicYN="N">Taste</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Hydroxychloroquine sulfate</Keyword><Keyword MajorTopicYN="N">formulation</Keyword><Keyword MajorTopicYN="N">palatability</Keyword><Keyword MajorTopicYN="N">stability</Keyword><Keyword MajorTopicYN="N">suspension</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2021</Year><Month>1</Month><Day>12</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2021</Year><Month>2</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2021</Year><Month>1</Month><Day>11</Day><Hour>17</Hour><Minute>10</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33428504</ArticleId><ArticleId IdType="doi">10.1080/10837450.2021.1871918</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Sante/explor/CovidChloroV1/Data/Main/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000507 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Corpus/biblio.hfd -nk 000507 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Sante
|area= CovidChloroV1
|flux= Main
|étape= Corpus
|type= RBID
|clé= pubmed:33428504
|texte= Formulation and stability study of hydroxychloroquine sulfate oral suspensions.
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Corpus/RBID.i -Sk "pubmed:33428504" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Main/Corpus/biblio.hfd \
| NlmPubMed2Wicri -a CovidChloroV1
| This area was generated with Dilib version V0.6.38. |  |