FORMULATION OPTIMIZATION OF HYDRODYNAMICALLY BALANCED ORAL CONTROLLED RELEASE BIOADHESIVE TABLETS OF TRAMADOL HYDROCHLORIDE

摘要

The. directly. compressible. floating‐bioadhesive. tablets. of. tramadol. were. formulated. using. varying. amounts. Carbopol. 971P. (CP). an d.hydroxypropylmethylcellulose.(HPMC),.along.with.other.requisite.excipients..In. vitro.drug. release.profile,.floatational. characteristics.and. ex. vivo.bioadhesive.strength.using.texture.analyzer.were.determined,.and.systematically.optimized.using.a.32.central.composite.design.(CCD)..The.studies.indicated. successful. formulation. of. gastroretentive. compressed. matrices. with. excellent. controlled. release,. mucoadhesion. and. hydrodynamic.balance.. Comparison.of. the.dissolution.profiles.of.the.optimized. formulation,.with.optimal.composition.of.CP:HPMC.::.80.0:125.0,.with.that.of.the.marketed. controlled.release.formulation. other. indicated. analogy. of. drug. release.performance. with.each. other.. Validation.of. optimization.study.using.eight.confirmatory.experimental.runs.indicated.very.high.degree.of.prognostic.ability.of.CCD.with.mean.±.SEM.of..0.06%.±.0.37.Further,.the.study.successfully.unravels.the.effect.of.the.polymers.on.the.selected.response.variables..