11/22/2016 ScopusPrintDocument

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MazurekWadokowska,E.a ,Winnicka,K.a ,Czyzewska,U.b ,Miltyk,W.b

Effectofsimultaneouslysilicifiedmicrocrystallinecelluloseandpregelatinizedstarchonthetheophyllinetablets
stability
(2016)ActaPoloniaePharmaceuticaDrugResearch,73(4),pp.10291036.

a DepartmentofPharmaceuticalTechnology,MedicalUniversityofBiaystok,Mickiewicza2c,Biaystok,Poland
b DepartmentofPharmaceuticalAnalysis,MedicalUniversityofBiaystok,Mickiewicza2d,Biaystok,Poland

Abstract
Highprofitabilityandsimplicityofdirectcompression,encouragespharmaceuticalindustrytocreateuniversalexcipients
toimprovetechnologyprocess.ProsolvSMCCsilicifiedmicrocrystallinecelluloseandStarch1500pregelatinized
starch,aretheexampleofmultifunctionalexcipients.Theaimofthepresentstudywastoevaluatethestabilityof
theophylline(API)inthemixtureswithexcipientswithvariousphysicochemicalproperties(ProsolvSMCC90,Prosolv
SMCCHD90,ProsolvSMCC50,Starch1500andmagnesiumstearate).Thestudypresentsresultsofthermal
analysisofthemixtureswiththeophyllinebeforeandafter6monthsstorageofthetabletsatvarioustemperaturesand
relativehumidityconditions(252C/405%RH,402C/755%RH).ItwasshownthathighconcentrationofStarch
1500(49%)affectsthestabilityofthetheophyllinetabletswithProsolvSMCC.ProsolvSMCChadnoeffectonAPI
stabilityasconfirmedbythedifferentialscanningcalorimetry(DSC).Changesinpeakplacementswereobservedjust
aftertablettingprocess,whichmightindicatethatcompressionacceleratedtheincompatibilitiesbetweentheophyllineand
Starch1500.TGAanalysisshowedlossintabletsmassequaltowatercontentinstarch.GCMSstudyestablishedno
chemicaldecompositionoftheophylline.WedemonstratedthathighcontentofStarch1500(49%)inthetabletmass,
affectsstabilityontabletscontainingtheophyllineandProsolvSMCC.2016,PolishPharmaceuticalSociety.Allrights
reserved.

AuthorKeywords
DrugexcipientcompatibilitystudiesDSCProsolvSMCCStarch1500TabletsTheophylline

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CorrespondenceAddress
MazurekWadolkowskaE.DepartmentofPharmaceuticalTechnology,MedicalUniversityofBiaystok,Mickiewicza2c,
Polandemail:edyta.wadolkowska@umb.edu.pl

Publisher:PolishPharmaceuticalSociety

ISSN:00016837
CODEN:APPHA
LanguageofOriginalDocument:English
AbbreviatedSourceTitle:ActaPol.Pharm.DrugRes.
DocumentType:Article
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DocumentType:Article
Source:Scopus

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