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dc.contributor.authorShojaee, Saeed
dc.contributor.authorCumming, Iain
dc.contributor.authorKaialy, Waseem
dc.contributor.authorNokhodchi, Ali
dc.date.accessioned2015-08-25T14:00:52Zen
dc.date.available2015-08-25T14:00:52Zen
dc.date.issued2013-11-01
dc.identifier.citationThe influence of vitamin E succinate on the stability of polyethylene oxide PEO controlled release matrix tablets. 2013, 111:486-92 Colloids Surf B Biointerfaces
dc.identifier.issn1873-4367
dc.identifier.pmid23880087
dc.identifier.doi10.1016/j.colsurfb.2013.06.038
dc.identifier.urihttp://hdl.handle.net/2436/575938
dc.description.abstractHydrophilic matrices are a principal technology used for extended release (ER) oral dosage forms and a recent review concluded that their development is currently one of the most important challenges in pharmaceutical research. High molecular weight polyethylene oxides (PEOs) have been proposed as an alternative to hydroxypropylmethylcellulose (HPMC) for the manufacture of controlled release matrix tablets. It is known that PEO's are prone to oxidative degradation which can occur by chain scission and can be catalyzed by metal ions. In this study, we investigated the stability of PEO matrix tablets, of different molecular weight, containing diltiazem hydrochloride, when stored at 40 °C. The results show that there were dramatic increases in the release rate of the diltiazem following storage over only a few weeks, resulting in immediate release profiles after eight weeks, even for the highest molecular weight grade. We employed Gel permeation chromatography (GPC), viscosity and differential scanning calorimetry (DSC) techniques to try and determine the underlying causes of these dramatic shifts in dissolution profiles on storage. The results showed that there were significant decreases in the molecular weight of the PEO's during storage. The second part of the study looked at the addition of three different levels of vitamin E succinate to the tablets. The results clearly demonstrate the ability of the added antioxidant to reverse the significant reductions in molecular weight seen using GPC, viscosity and DSC. Importantly the addition of the antioxidant was able to stabilize the release profile of the diltiazem especially when present at a 1% level. Researchers and those working in pharmaceutical development should be aware of the potential stability risks when making matrix tablets containing PEO's and may wish to consider the addition of an antioxidant to the tablet formulation.
dc.language.isoen
dc.publisherElsevier
dc.subjectAnti-oxidant
dc.subjectControlled release
dc.subjectMatrix tablets
dc.subjectPolyethylene oxide PEO
dc.subjectStability
dc.subject.meshAntioxidants
dc.subject.meshCalorimetry, Differential Scanning
dc.subject.meshChromatography, Gel
dc.subject.meshDelayed-Action Preparations
dc.subject.meshDiltiazem
dc.subject.meshDrug Stability
dc.subject.meshMolecular Weight
dc.subject.meshPolyethylene Glycols
dc.subject.meshTablets
dc.subject.meshalpha-Tocopherol
dc.titleThe influence of vitamin E succinate on the stability of polyethylene oxide PEO controlled release matrix tablets.
dc.typeJournal article
dc.identifier.journalColloids and surfaces. B, Biointerfaces
html.description.abstractHydrophilic matrices are a principal technology used for extended release (ER) oral dosage forms and a recent review concluded that their development is currently one of the most important challenges in pharmaceutical research. High molecular weight polyethylene oxides (PEOs) have been proposed as an alternative to hydroxypropylmethylcellulose (HPMC) for the manufacture of controlled release matrix tablets. It is known that PEO's are prone to oxidative degradation which can occur by chain scission and can be catalyzed by metal ions. In this study, we investigated the stability of PEO matrix tablets, of different molecular weight, containing diltiazem hydrochloride, when stored at 40 °C. The results show that there were dramatic increases in the release rate of the diltiazem following storage over only a few weeks, resulting in immediate release profiles after eight weeks, even for the highest molecular weight grade. We employed Gel permeation chromatography (GPC), viscosity and differential scanning calorimetry (DSC) techniques to try and determine the underlying causes of these dramatic shifts in dissolution profiles on storage. The results showed that there were significant decreases in the molecular weight of the PEO's during storage. The second part of the study looked at the addition of three different levels of vitamin E succinate to the tablets. The results clearly demonstrate the ability of the added antioxidant to reverse the significant reductions in molecular weight seen using GPC, viscosity and DSC. Importantly the addition of the antioxidant was able to stabilize the release profile of the diltiazem especially when present at a 1% level. Researchers and those working in pharmaceutical development should be aware of the potential stability risks when making matrix tablets containing PEO's and may wish to consider the addition of an antioxidant to the tablet formulation.


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