Formulation and Evaluation of Silodosin Buccal Film

Objective: The objective of this research work was to formulate and evaluate buccal film containing Silodosin by enhancement of Permeability by preparing inclusion complex of Silodosin with ꞵ-CD and to increase patient compliance which is useful in the treatment of Hyperplasia. Materials and Methods: In this research, the method used to prepare buccal films was solvent casting. ꞵ-CD inclusion complex with silodosin 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)-X I and concentration of plasticizer (Propylene glycol)-X II 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 31.4 seconds of disintegration time and 99.1 % cumulative drug release at 15 minutes. Check point batch shows 34.74 seconds of disintegration time 97.09 % cumulative drug release. A 1 month accelerated Short term stability study was done on prepared films and it is stable for 1 month. Conclusion: Buccal film containing Silodosin were formulated using HPMC E5 as a film forming 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 buccal film of Silodosin.