FORMULATION AND EVALUATION OF ORAL DISPERSIBLE FILM OF DAPAGLIFLOZIN

Jinal Patel*, Bhavana A. Patel, Dr. Shailesh T. Prajapati

ABSTRACT

Objective: The objective of this research work was to formulate and evaluate oral dispersible film of Dapagliflozin by enhancement of Permeability by preparing inclusion complex of Dapagliflozin with β-CD and to increase patient compliance which is useful in the treatment of Diabetes. Materials and Methods: In this research, the method used to prepare oral dispersible films was solvent casting to decrease time and cost. Preliminary batches were evaluated for Physico-chemical parameters.β-CD inclusion complex with Dapadliflozin in 1:1 ratio to increase permeability of drug. 32 Full Factorial design was used for optimization by selecting two independent factors –concentration of film forming agent (HPMC E5)-XI and concentration of plasticizer (Propylene glycol)-XII and their effect on Disintegration time- (R I), and % drug release- (R II). Optimization of factorial batches was done using Design Expert 13 software. Result: Best results were obtained in Batch F1 in which HPMC E5 was 150mg and Propylene glycol was 1ml with 31.8 seconds of disintegration time and 98.45 % cumulative drug release at 15 minutes. Check point batch shows 34.72 seconds of disintegration time 97.96% cumulative drug release. A 1 month accelerated Short term stability study was done on prepared films and it is stable for 1 month. Conclusion: Oral dispersible film containing Dapagliflozin were formulated using HPMC E5 as a film forming agent and Propylene glycol as a plasticizer by solvent casting method. Hence, from the results it was concluded that faster disintegration and faster drug release can be achieved by the ODF.

Keywords: Oral dispersible films, Dapagliflozin, HPMC E5, Propylene glycol, Solvent casting, design expert.