Abstract

FORMULATION AND EVALUATION OF FAST DISSOLVING ORAL FILMS CONTAINING RIZATRIPTAN BENZOATE BY USING NOVEL FILM FORMER: HAMS-HIGH AMYLOSE MAIZE STARCH

Patel Khushil Ashok Kumar*, Dr. Kalgi Ashokbhai Patel, Ms. Jinal A Patel, Ms. Bansi Zalava Dia, Mr. Jay A Patel

ABSTRACT

Objective: The objective of this research work was to formulate, develop and evaluate Rizatriptan Benzoate fast dissolving oral films to bypass the hepatic metabolism, increase bioavailability and to increase patient compliance which is useful in the treatment of migraine. Materials and Methods: In this research, the method used to prepare fast dissolving oral films was solvent casting to decrease time and cost. A preliminary study was done for the selection of excipients such as, film-forming agent and plasticizers. Preliminary batches were evaluated for Physico-chemical parameters. 32 Full Factorial design was used for optimization by selecting two independent factors –concentration of film forming agent (HAMS)-X1 and concentration of plasticizer (PEG 400)-X2 and their effect on Disintegration time-(R1), folding endurance-(R2) and % drug release-(R3). Optimization of factorial batches was done using Design Expert Software. Result: Best results were obtained in Batch F5 in which HAMS was 30 mg and PEG 400 was 3.5 mg with 29 seconds of disintegration time, folding endurance of 275and 99.68 % cumulative drug release at 10 minutes. Check point batch shows 26 seconds of disintegration time, folding endurance of 251, 99.69 % cumulative drug release. A 1 month accelerated stability study was done on prepared films and it is stable for 1 month. Conclusion: Hence, from the results it was concluded that faster disintegration and faster drug release can be achieved by the fast-dissolving oral film of Rizatriptan Benzoate hepatic metabolism can be bypassed and bioavailability of drug is increased.

Keywords: Rizatriptan Benzoate, HAMS- High Amylose Maize Starch, FDOFs- Fast Dissolving Oral Films.