Formulation, development and optimization of fast dissolving oral film of racecadotril

Ankit Kumar Vishwakarma Ankit Kumar Vishwakarma; Isha Pant Isha Pant; Mukesh Kumar Patel Mukesh Kumar Patel; Arun Pandey Arun Pandey

Ankit Kumar Vishwakarma Mittal Institute of Pharmacy, Bhopal-462038, MP (India)
Isha Pant Mittal Institute of Pharmacy, Bhopal-462038, MP (India)
Mukesh Kumar Patel Mittal Institute of Pharmacy, Bhopal-462038, MP (India)
Arun Pandey Mittal Group of Institutions, Bhopal-462038, MP (India)

Abstract

Objective: The present research work deals with formulation development and optimization of oral fast dissolving films of racecadotril to improve bioavailability and patient compliance.

Methods: Fast dispersible films of racecadotril were prepared by solvent casting method. Hydroxyl propyl methyl cellulose (HPMC) and Poly vinyl alcohol (PVA) was used as film forming polymers, Poly ethylene glycol-400 (PEG-400) was used as plasticizer, ethanol water was used as solvents, citric acid was used as saliva stimulating agent and aspartame was used as sweetening and flavouring agents. The prepared films were evaluated for thickness, folding endurance, tensile strength, disintegration time, in vitro drug release and drug content uniformity.

Results: Films prepared were found to be of good quality fulfilling all the requirements. It was observed that concentration of polymer effects the formation of film and dissolution time of the formulations. F3 formulation was considered as the best according to the obtained results with disintegrating time of 35 sec. The disintegration and release rates were found to be faster for films prepared with lowest concentration of HPMC along with maximum concentration of superdisintegrants.

Conclusion: Fast dispersible films of racecadotril were successfully formulated by solvent casting technique with immediate onset of action & improved patient compliance.

Keywords: Racecadotril, Fast oral dissolving films, Immediate release, Solvent casting method

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