DESIGN AND DEVELOPMENT OF AMBROXOL HYDROCHLORIDE SUSTAINED RELEASE MATRIX TABLETS

摘要

In. the. present. investigation,. an. attempt. was. made. to. formulate. the. oral. sustained. release.matrix. tablets. of.Ambroxol. HCl. in. order. to. improve.efficacy,. reduce. the. frequency.of. administration,. and.better. patient. compliance..Ambroxol.Hydrochloride. is. a. potent. mucolytic. agent. capable. of.inducing.bronchial. secretions. used.in. the.treatment.of.respiratory.disorders..Differential.scanning.calorimetric.analysis. confirmed.the. absence. of.any.drug.polymer.interaction..Matrix.tablets.of.Ambroxol.Hydrochloride.were.formulated.employing.hydrophilic.polymers.HPMC.K100M,.Carbopol.934P.and.hydrophobic.polymer.Ethyl.cellulose. as.release.retardant.polymers...The.powder.blend.was.evaluated.for.micromeritic.properties..The.sustained.release.matrix.tablets.were.prepared.by.direct.compression. technique.. The. tablets. were. evaluated. for. thickness,. diameter,. weight.variation.test,.hardness,.friability,.and.drug. content..The.in. vitro.drug.release.characteristics.were.studied.in.simulated.gastric. fluid.(2.hours).and.intestinal.fluid.for. a.period. of.10.hours.using. USP.type.II.dissolution. apparatus.(total.12hours)..The.results.of. dissolution. studies.indicated.that.formulation.F7.(drug.to.polymer.1:0.26),.the.most.successful.of.the.study.and.exhibited.satisfactory.drug.release.in.the.initi al.hours.and.the.total.release.was.very.close.to.the.theoretical.release.profile..Matrix.tablet.containing.Ethyl.cellulose.(F7). formulation.were. found.to.show.good.initial.release.24.24%.at.2.hrs.and.at.the.end.of.12.hrs.the.drug.release.was.found.to.be.96.86%...The.n.value.for.F7.obtained.from.Korsmeyer.–.peppas.model.confirmed.that.the.drug.release.was.anomalous.diffusion.mechanism..