The present study involves formulation development and optimization of oral taste masked Mouth Dissolving Films (MDFs) of Bisoprolol Hemifumarate(BH). MDF is novel dosage forms that improve disintegration and dissolve within the oral cavity in seconds. BH (Ã?Ÿ-blocker) belongs to BCS class-I, a drug of choice for hypertensive patients.\r\nBH is bitter tasting drug. Various taste masking techniques were utilized to formulate MDF with acceptable taste. For this purpose, various sweetening agents like sucralose, mannitol, sucrose, sorbitol, aspartame and menthol were tried but, taste masking was not successfully achieved. Thus Ã?Ÿââ?¬â??cyclodextrin (Ã?Ÿ-CD) was used to mask bitter taste by complexation with drug. Various molar ratio of BH to Ã?Ÿ-CD was tried, complete taste masking of BH were achieved using 1:0.25 molar ratio of BH:Ã?Ÿââ?¬â??CD.\r\nPolymers like Hydroxypropyl methylcellulose (HPMC) and Polyethylene oxide were used in developing MDF of BH using solvent casting method. The effect of amount of polymer and amount of plasticizer (propylene glycol) was studied. MDFs were evaluated for organoleptic properties, thickness, mechanical properties like tensile strength and folding endurance, in vitro disintegration and in vitro dissolution studies. \r\nBatch F-19 containing HPMC (5cps) at 4%w/v concentration and PG at ratio (0.4:1) as plasticizer showed acceptable thickness (600Ã?µm), tensile strength (46.386 N/cm2), folding endurance was 30 and in vitro disintegration time (32 sec). Complete drug was released within 20 minutes using simulated saliva as a medium. The study indicated that developed film formulation will be highly effective in improving onset of action thus, useful to hypertensive patient.
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