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Article: Physical and microbiological stability of an extemporaneous tacrolimus suspension for paediatric use

TitlePhysical and microbiological stability of an extemporaneous tacrolimus suspension for paediatric use
Authors
KeywordsExtemporaneous
Formulation
Paediatric
Stability
Suspension
Tacrolimus
Issue Date2006
PublisherBlackwell Publishing Ltd
Citation
Journal Of Clinical Pharmacy And Therapeutics, 2006, v. 31 n. 2, p. 167-172 How to Cite?
AbstractObjective: An extemporaneous suspension of tacrolimus for paediatric use has recently been developed but poor bioavailability and erratic plasma concentrations were observed during clinical use. It was not clear whether this was due to changes in the physical properties of the suspension during storage. The aim of this work was to investigate the physical and microbiological stability over the recommended 8-week shelf-life of this extemporaneous tacrolimus suspension. Methods: Suspensions (0·5 mg/mL) were custom made by a special manufacturer under Good Manufacturing Practice conditions. The procedure involved mixing tacrolimus capsule contents into Ora Plus ® and Simple Syrup (1: 1) using a mortar and pestle followed by an homogenization step. The particle sizes of the suspensions were measured using a MasterSizer. A light microscope equipped with polarizers was used to visualize any particle size changes or crystal growth. Viable bacterial and fungal contamination was assessed using standard colony count techniques on solid media. The suspensions were kept at 22-26 °C and evaluated weekly. Results: The volume mean diameter d (4,3) from laser diffraction did not change significantly. Light microscopy did not reveal any significant change in particle size or crystal growth. Contamination by viable and culturable micro-organisms could not be detected. Conclusion: The suspension was physically (particle size) and microbiologically stable during the 8-week study period suggesting other factors including poor dosing could be responsible for the pharmacokinetic variation observed during clinical use which warrants further investigation. © 2006 Blackwell Publishing Ltd.
Persistent Identifierhttp://hdl.handle.net/10722/132876
ISSN
2015 Impact Factor: 1.833
2015 SCImago Journal Rankings: 0.638
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorHan, Jen_HK
dc.contributor.authorBeeton, Aen_HK
dc.contributor.authorLong, PFen_HK
dc.contributor.authorWong, Ien_HK
dc.contributor.authorTuleu, Cen_HK
dc.date.accessioned2011-04-04T07:57:44Z-
dc.date.available2011-04-04T07:57:44Z-
dc.date.issued2006en_HK
dc.identifier.citationJournal Of Clinical Pharmacy And Therapeutics, 2006, v. 31 n. 2, p. 167-172en_HK
dc.identifier.issn0269-4727en_HK
dc.identifier.urihttp://hdl.handle.net/10722/132876-
dc.description.abstractObjective: An extemporaneous suspension of tacrolimus for paediatric use has recently been developed but poor bioavailability and erratic plasma concentrations were observed during clinical use. It was not clear whether this was due to changes in the physical properties of the suspension during storage. The aim of this work was to investigate the physical and microbiological stability over the recommended 8-week shelf-life of this extemporaneous tacrolimus suspension. Methods: Suspensions (0·5 mg/mL) were custom made by a special manufacturer under Good Manufacturing Practice conditions. The procedure involved mixing tacrolimus capsule contents into Ora Plus ® and Simple Syrup (1: 1) using a mortar and pestle followed by an homogenization step. The particle sizes of the suspensions were measured using a MasterSizer. A light microscope equipped with polarizers was used to visualize any particle size changes or crystal growth. Viable bacterial and fungal contamination was assessed using standard colony count techniques on solid media. The suspensions were kept at 22-26 °C and evaluated weekly. Results: The volume mean diameter d (4,3) from laser diffraction did not change significantly. Light microscopy did not reveal any significant change in particle size or crystal growth. Contamination by viable and culturable micro-organisms could not be detected. Conclusion: The suspension was physically (particle size) and microbiologically stable during the 8-week study period suggesting other factors including poor dosing could be responsible for the pharmacokinetic variation observed during clinical use which warrants further investigation. © 2006 Blackwell Publishing Ltd.en_HK
dc.languageengen_US
dc.publisherBlackwell Publishing Ltden_US
dc.relation.ispartofJournal of Clinical Pharmacy and Therapeuticsen_HK
dc.subjectExtemporaneousen_HK
dc.subjectFormulationen_HK
dc.subjectPaediatricen_HK
dc.subjectStabilityen_HK
dc.subjectSuspensionen_HK
dc.subjectTacrolimusen_HK
dc.titlePhysical and microbiological stability of an extemporaneous tacrolimus suspension for paediatric useen_HK
dc.typeArticleen_HK
dc.identifier.emailWong, I: wongick@hku.hken_HK
dc.identifier.authorityWong, I=rp01480en_HK
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1111/j.1365-2710.2006.00720.xen_HK
dc.identifier.pmid16635051-
dc.identifier.scopuseid_2-s2.0-33645472113en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-33645472113&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume31en_HK
dc.identifier.issue2en_HK
dc.identifier.spage167en_HK
dc.identifier.epage172en_HK
dc.identifier.eissn1365-2710-
dc.identifier.isiWOS:000237472300008-
dc.publisher.placeUnited Kingdomen_HK
dc.identifier.scopusauthoridHan, J=7406442168en_HK
dc.identifier.scopusauthoridBeeton, A=8305040700en_HK
dc.identifier.scopusauthoridLong, PF=7201512275en_HK
dc.identifier.scopusauthoridWong, I=7102513915en_HK
dc.identifier.scopusauthoridTuleu, C=8446290500en_HK
dc.identifier.citeulike575581-

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