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Article: Poor preservation efficacy versus quality and safety of pediatric extemporaneous liquids

TitlePoor preservation efficacy versus quality and safety of pediatric extemporaneous liquids
Authors
KeywordsCompounding
Extemporaneous
Pediatrics
Preservatives
Stability
Vehicles
Issue Date2007
PublisherHarvey Whitney Books Company. The Journal's web site is located at http://www.theannals.com
Citation
Annals Of Pharmacotherapy, 2007, v. 41 n. 5, p. 857-860 How to Cite?
AbstractBACKGROUND: Most medicines are available only as solid, adult-strength dosage forms from which oral extemporaneous liquids are often prepared for children. There are few comprehensive reference lists for the preparation of pediatric extemporaneous formulations. Some pediatric reformulations are made by diluting the suspending vehicle, and a shelf life of up to 3 months can be used without documented microbial stability. Although most commercially available ready-to-use vehicles are supplied as preserved formulations, it is still common practice in many European dispensaries to prepare and dilute these vehicles as required for specific prescriptions. OBJECTIVE: To determine what influence dilution of vehicles has on the preservation efficiency of extenporaneous formulations. METHODS: Suspending vehicles were made by diluting methylcellulose 1% and simple syrup, BP (British Pharmacopoeia) in ratios of 1:1 and 1:4. The efficacy of antimicrobial preservation was tested according to the 2007 standards required by the BP. RESULTS: Dilution in ratios greater than 1:1 failed the BP 2007 criteria. Such dilution represents a potential biohazard, especially to premature, newborn, or immunocompromised children, exposing them not only to possible organoleptic changes of the preparation, but also to ingestion of either dangerous numbers of microorganisms or medicines that may have undergone biotransformation, rendering them inactive or toxic. CONCLUSIONS: Significant concerns have been raised regarding the quality of extemporaneous preparations. We call for further research in this neglected area to address issues of antimicrobial preservation, including revision of existing quality assurance monographs. Moreover, these monographs should take into account testing that simulates multiple dosing from a single storage container during the intended in-use shelf life of multidose extemporaneous preparations.
Persistent Identifierhttp://hdl.handle.net/10722/132866
ISSN
2015 Impact Factor: 2.119
2015 SCImago Journal Rankings: 0.863
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorGhulam, Aen_HK
dc.contributor.authorKeen, Ken_HK
dc.contributor.authorTuleu, Cen_HK
dc.contributor.authorWong, ICKen_HK
dc.contributor.authorLong, PFen_HK
dc.date.accessioned2011-04-04T07:57:40Z-
dc.date.available2011-04-04T07:57:40Z-
dc.date.issued2007en_HK
dc.identifier.citationAnnals Of Pharmacotherapy, 2007, v. 41 n. 5, p. 857-860en_HK
dc.identifier.issn1060-0280en_HK
dc.identifier.urihttp://hdl.handle.net/10722/132866-
dc.description.abstractBACKGROUND: Most medicines are available only as solid, adult-strength dosage forms from which oral extemporaneous liquids are often prepared for children. There are few comprehensive reference lists for the preparation of pediatric extemporaneous formulations. Some pediatric reformulations are made by diluting the suspending vehicle, and a shelf life of up to 3 months can be used without documented microbial stability. Although most commercially available ready-to-use vehicles are supplied as preserved formulations, it is still common practice in many European dispensaries to prepare and dilute these vehicles as required for specific prescriptions. OBJECTIVE: To determine what influence dilution of vehicles has on the preservation efficiency of extenporaneous formulations. METHODS: Suspending vehicles were made by diluting methylcellulose 1% and simple syrup, BP (British Pharmacopoeia) in ratios of 1:1 and 1:4. The efficacy of antimicrobial preservation was tested according to the 2007 standards required by the BP. RESULTS: Dilution in ratios greater than 1:1 failed the BP 2007 criteria. Such dilution represents a potential biohazard, especially to premature, newborn, or immunocompromised children, exposing them not only to possible organoleptic changes of the preparation, but also to ingestion of either dangerous numbers of microorganisms or medicines that may have undergone biotransformation, rendering them inactive or toxic. CONCLUSIONS: Significant concerns have been raised regarding the quality of extemporaneous preparations. We call for further research in this neglected area to address issues of antimicrobial preservation, including revision of existing quality assurance monographs. Moreover, these monographs should take into account testing that simulates multiple dosing from a single storage container during the intended in-use shelf life of multidose extemporaneous preparations.en_HK
dc.languageengen_US
dc.publisherHarvey Whitney Books Company. The Journal's web site is located at http://www.theannals.comen_HK
dc.relation.ispartofAnnals of Pharmacotherapyen_HK
dc.subjectCompoundingen_HK
dc.subjectExtemporaneousen_HK
dc.subjectPediatricsen_HK
dc.subjectPreservativesen_HK
dc.subjectStabilityen_HK
dc.subjectVehiclesen_HK
dc.titlePoor preservation efficacy versus quality and safety of pediatric extemporaneous liquidsen_HK
dc.typeArticleen_HK
dc.identifier.emailWong, ICK: wongick@hku.hken_HK
dc.identifier.authorityWong, ICK=rp01480en_HK
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1345/aph.1H611en_HK
dc.identifier.pmid17440007-
dc.identifier.scopuseid_2-s2.0-34248588479en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-34248588479&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume41en_HK
dc.identifier.issue5en_HK
dc.identifier.spage857en_HK
dc.identifier.epage860en_HK
dc.identifier.isiWOS:000246280800015-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridGhulam, A=53874872100en_HK
dc.identifier.scopusauthoridKeen, K=53874879300en_HK
dc.identifier.scopusauthoridTuleu, C=8446290500en_HK
dc.identifier.scopusauthoridWong, ICK=7102513915en_HK
dc.identifier.scopusauthoridLong, PF=7201512275en_HK

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