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 using multiparticulate drug delivery system to offer benefits such as less inter and intra-subject variability in gastrointestinal transit time and show better reproducible pharmacokinetic behavior than

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... conventional (monolithic) formulations which is equivalent to the marketed product Enablex. To design the dosage form, suitable cell spheres were selected for drug layering, followed by coating with ethyl cellulose polymer to obtain a drug reservoir system. Compatibility of Darifenacin Hydrobromide has been established with the proposed ingredients and preceded with the formulation optimization. F1 formulation has 5% ethyl cellulose coating, which was optimized to 14% in F8 formulation to obtain the required release pattern and complete release at 24 hr time point with similar profile as of Reference product with satisfactory similarity values (F2). Stability studies have been conducted as per ICH guidelines and the product was found stable till 3 months.