Abstract

FORMULATION & EVALUATION OF DARIFENACIN HBR EXTENDED RELEASE FILM COATED TABLETS AND COMPARED WITH THE INNOVATOR PRODUCT ENABLEX

Praveen Kumar Uppala*, Murali Krishna. B, K. Atchuta Kumar, R. Sailaja Kumari

Abstract

Darifenacin Hydrobromide is a muscarinic M3 selective receptor antagonist. It is used in the treatment of urge incontinence or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. The present work focused on developing an extended release dosage form to offer benefits such as less inter and intra-subject variability in gastrointestinal transit time and show better reproducible pharmacokinetic behavior than conventional formulations which is equivalent to the marketed product Enablex. Formulation F3 gave a release profile similar to that of innovator product (Enablex). Formulation-F3 containing 7.5 mg of Darifenacin per tablet and developed employing Anhydrous Lactose (49.02 mg), Dibasic Calcium Phosphate (40 mg), Methocel K4M CR (90 mg), Methocel K100M CR (10 mg) in the core and by film coating with Opadry White, is similar and equal to the innovator product in respect of all tablets properties and dissolution rate. Stability studies have been conducted as per ICH guidelines and the product was found stable till 3 months.

Keywords: Darifenacin Hydrobromide, Extended release, Dissolution, Overactive bladder syndrome.