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无味盐酸苯环壬酯树脂复合物口腔崩解片的研究.docx

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无味盐酸苯环壬酯树脂复合物口腔崩解片的研究 Abstract Theaimofthisstudyistodevelopanorallydisintegratingtablet(ODT)formulationoftastelessbenzydaminehydrochlorideandcyclohexylresincomposite.TheODTwaspreparedbydirectcompressionmethodusingsuperdisintegrants,lactosemonohydrate,microcrystallinecelluloseandacombinationofhydroxypropylmethylcelluloseandcroscarmellosesodium.ThepreparedODTwasevaluatedforitsphysicochemicalproperties,invitrodisintegrationtime,andinvitrodrugreleaseprofile.TheoptimizedbatchofODTwassubjectedtoacceleratedstabilitystudies.ThedevelopedODTshowedgoodphysicochemicalpropertiesandmetthepharmacopoeialrequirements.Theoptimizedformulationcontaining5mgofbenzydaminehydrochlorideand20mgofcyclohexylresinshowedacceptableinvitrodisintegrationtime(<30sec)anddrugreleaseprofile(>90%in10min).Thedevelopedformulationretaineditsstabilityforaperiodof3monthsat40°C/75%RH. Introduction Orallydisintegratingtablets(ODTs)aresoliddosageformsthatdisintegraterapidlyintheoralcavitytoreleasedrugsthataredesignedtobeswallowedwithoutwater.ODTsareintendedforpopulationswithswallowingdifficultiessuchaspediatric,geriatric,andmentallychallengedindividuals.Inaddition,thesearealsosuitableforpatientswithnauseaandvomiting,andthosewhohavedifficultyinswallowingconventionaltabletsandcapsules. Thetasteofdrugscanbeunpleasantandcaninterferewithpatientcompliance,especiallyinchildren.Tastemaskingofdrugscanbeachievedbycomplexation,ionexchange,adsorption,orencapsulation.Tastelessresinssuchascyclohexylresinhavebeenusedastastemaskingagentsforvariousdrugs.Benzydaminehydrochlorideisanon-steroidalanti-inflammatorydrugusedforthetreatmentofpain,inflammation,andirritationofthemouthandthroat.Ithasabittertaste,whichlimitsitsuseinpediatricandgeriatricpopulations.Therefore,atastelessbenzydaminehydrochlorideformulationisdesirable. Inthisstudy,wereportsthedevelopmentofanODTformulationcontainingtastelessbenzydaminehydrochlorideandcyclohexylresin.Thestudyinvolvestheformulationandevaluationofphysicochemicalproperties,invitrodisintegrationtime,