Abstract

FORMULATION AND EVALUATION OF CLONAZEPAM ORALLY DISINTEGRATING TABLETS, 1 MG

Venkateswaran Chidambaram Seshadri*, Packiaraj Jeyachandran Manohari,
Janakiraman Kunchithapatham and Jayanarayan Kulathingal

Abstract

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, orally disintegrating tablets will be an effective solution for patient compliance and efficient medicine regimen. In the present research, orally disintegrating 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. The prepared tablets were stability tested at 40°C / 75% RH for 3 months and were found to be stable. Prepared orally disintegrating tablets of Clonazepam 1 mg was found to be bioequivalent under fasting and fed conditions with the internationally marketed product.

Keywords: Wet granulation and bioequivalence under Fasting and Fed.