Abstract

DESIGN, FORMULATION AND EVALUATION OF MOUTH DISSOLVING FILMS OF RIZATRIPTAN BY SOLVENT CASTING METHOD

Rahul K. Mahajan*, Harshal Sonje, Amit Birari, Ghanashyam Yadav, Avish Maru.

Abstract

Rizatriptan Benzoate, a serotonin 5-HT1 receptor agonist is a new generation antimigraine drug which has oral bioavailability of 47% due to hepatic first pass metabolism. The present study investigated the possibility of developing Rizatriptan benzoate fast dissolving sublingual films allowing fast, reproducible drug dissolution in the oral cavity, thus bypassing first pass metabolism to provide rapid onset of action of the drug. The fast dissolving films were prepared by solvent casting method. Hydroxylpropyl methylcellulose (HPMC K 15) and maltodextrin were used in combination as film forming polymer, due to their hydrophilic nature and palatable taste. To decrease the disintegration time of formulations sodium starch glycolate was used as disintegrating agent. Glycerol is used as a cooling agent and mannitol, aspartame is used as sweetening agent. All the films formulations (F1-F9) was evaluated for their thickness, weight variations, tensile strength, percentage elongation, folding endurance, surface pH, in-vitro disintegration, drug content, in-vitro drug release and ex-vivo permeation. Disintegration time showed by the formulations was found to be in range of 20-40 sec. Formulations F1 and F2 showed 90% drug release within 15 min. The film showed an excellent stability at least for 4 weeks when stored at 400 C and 75% in humidity.

Keywords: Rizatriptan Films, Mouth Dissolving Films, Fast Dissolving Film.