FORMULATION AND CHARACTERIZATION OF MOUTH DISSOLVING TABLETS CONTAINING BENZODIAZEPINE

Article history Clonazepam is a benzodiazepine indicated for seizure disorder, panic disorder and epilepsy. Patients suffering from seizures will have difficulty in swallowing the tablets or will be reluctant to take the tablets or will spit the administered tablet. In such cases, mouth dissolving dosage forms will be an effective solution for patient compliance and efficient medicine regimen. Clonazepam tablets are available in different strengths namely 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 2 mg. In the present research, mouth dissolving tablet of Clonazepam was made by aqueous wet granulation process. Pearlitol Flash and Microcrystalline Cellulose were used as diluent. Crospovidone was used as disintegrant. Strawberry Flavor and Aspartame were used as flavoring and sweetening agents. Sodium Lauryl Sulphate was used as a wetting agent. Colloidal Silicon Dioxide was used as glidant. Talc and Magnesium Stearate were used as lubricants. The prepared tablets were evaluated for weight, thickness, hardness, friability, disintegration time and dissolution. Prepared tablets showed disintegration time of less than 30 seconds and drug dissolution of about 75% achieved within 30 minutes. After finalizing the composition with 2 mg strength, using the same composition 0.125 mg, 0.25 mg, 0.5 mg and 1 mg strengths were made. The prepared tablets were stability tested at 40°C / 75% RH for 3 months and were found to be stable. Prepared mouth dissolving tablets of Clonazepam 1 mg was found to be bioequivalent under fasting and fed conditions with the marketed product.