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dc.contributor.authorLiu, F.
dc.contributor.authorMerchant, H.A.
dc.contributor.authorKulkarni, R.P.
dc.contributor.authorAlkademi, M.
dc.contributor.authorBasit, A.W.
dc.date.accessioned2011-06-08T07:26:44Z
dc.date.available2011-06-08T07:26:44Z
dc.date.issued2011-05
dc.identifier.citationLiu , F , Merchant , H A , Kulkarni , R P , Alkademi , M & Basit , A W 2011 , ' Evolution of a physiological pH 6.8 bicarbonate buffer system : application to the dissolution testing of enteric coated products ' , European Journal of Pharmaceutics and Biopharmaceutics , vol. 78 , no. 1 , pp. 151-157 . https://doi.org/10.1016/j.ejpb.2011.01.001
dc.identifier.issn0939-6411
dc.identifier.otherPURE: 184248
dc.identifier.otherPURE UUID: 38e034b3-28c6-4dbd-a4fb-993b0c27f758
dc.identifier.otherdspace: 2299/5921
dc.identifier.otherScopus: 79953163697
dc.identifier.urihttp://hdl.handle.net/2299/5921
dc.descriptionOriginal article can be found at : http://www.sciencedirect.com Copyright Elsevier
dc.description.abstractThe use of compendial pH 6.8 phosphate buffer to assess dissolution of enteric coated products gives rise to poor in vitro-in vivo correlations because of the inadequacy of the buffer to resemble small intestinal fluids. A more representative and physiological medium, pH 6.8 bicarbonate buffer, was developed to evaluate the dissolution behaviour of enteric coatings. The bicarbonate system was evolved from pH 7.4 Hanks balanced salt solution to produce a pH 6.8 bicarbonate buffer (modified Hanks buffer, mHanks), which resembles the ionic composition and buffer capacity of intestinal milieu. Prednisolone tablets were coated with a range of enteric polymers: hypromellose phthalate (HP-50 and HP-55), cellulose acetate phthalate (CAP), hypromellose acetate succinate (HPMCAS-LF and HPMCAS-MF), methacrylic acid copolymers (EUDRAGIT® L100-55, EUDRAGIT® L30D-55 and EUDRAGIT® L100) and polyvinyl acetate phthalate (PVAP). Dissolution of coated tablets was carried out using USP-II apparatus in 0.1 M HCl for 2 h followed by pH 6.8 phosphate buffer or pH 6.8 mHanks bicarbonate buffer. In pH 6.8 phosphate buffer, the various enteric polymer coated products displayed rapid and comparable dissolution profiles. In pH 6.8 mHanks buffer, drug release was delayed and marked differences were observed between the various coated tablets, which is comparable to the delayed disintegration times reported in the literature for enteric coated products in the human small intestine. In summary, the use of pH 6.8 physiological bicarbonate buffer (mHanks) provides more realistic and discriminative in vitro release assessment of enteric coated formulations compared to compendial phosphate buffer.en
dc.language.isoeng
dc.relation.ispartofEuropean Journal of Pharmaceutics and Biopharmaceutics
dc.rightsOpen
dc.subjectpH-sensitive polymers
dc.subjectenteric polymers
dc.subjectenteric coatings
dc.subjectmodified release
dc.subjectphysiological buffers
dc.subjectbicarbonate media
dc.subjectbiorelevant dissolution
dc.titleEvolution of a physiological pH 6.8 bicarbonate buffer system : application to the dissolution testing of enteric coated productsen
dc.contributor.institutionDepartment of Pharmacy
dc.contributor.institutionSchool of Life and Medical Sciences
dc.contributor.institutionHealth & Human Sciences Research Institute
dc.contributor.institutionCentre for Research into Topical Drug Delivery and Toxicology
dc.contributor.institutionPharmaceutics
dc.contributor.institutionPharmaceutical Analysis and Product Characterisation
dc.contributor.institutionBioadhesive Drug Delivery Group
dc.contributor.institutionModified Release Dosage Forms
dc.description.statusPeer reviewed
dc.relation.schoolSchool of Life and Medical Sciences
dcterms.dateAccepted2011-05
rioxxterms.versionofrecordhttps://doi.org/10.1016/j.ejpb.2011.01.001
rioxxterms.typeJournal Article/Review
herts.preservation.rarelyaccessedtrue
herts.rights.accesstypeOpen


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