FORMULATION AND CHARACTERIZATION OF RIZATRIPTAN LOADED MOUTH DISSOLVING FILMS

The most common type of headache is a migraine, which can range in severity from mild to severe and is exacerbated by any regular physical activity. Patients have trouble swallowing solid dosage forms like tablets and hard gelatin capsules, particularly those who are younger or older. Oral thin films that dissolve in the mouth are one such newly created dosage form. When in contact with saliva, the thin oral strip made of hydrophilic polymer dissolves quickly. Thus, aim of this study is formulation and evaluation of mouth dissolving film of rizatriptan. The formulation and evaluation of tablet was performed according to standard methods. In total 16 formulations were prepared. All were observed to be Homogenous, transparent, colorless, both sides smooth.  The thickness of formulation ranged from 68.22 ± 4.08 to 108.27 ± 4.08mm. The variation in mg ranged from 3.85 ± 0.204mg to 4.45 ± 0.108mg. The tensile strength extends from 3.12 ± 0.07 to 14.82 ± 0.26. The % elongation varied from 40.19 ± 0.96 to 97.64 ± 1.40. The folding endurance ranged from 31±35 to 115±29.63. The least disintegration time was observed for formulation F11 which is 7.65 ± 0.58 seconds while maximum disintegration time of 65.32 ±1.50 seconds was noted for 65.32 ± 1.50The formulation F11 was proved to be ideal among all. The drug release data of RIZ F11 (n=3) was then noted. The drug percent release in 5 seconds was estimated to be 13.84 ± 1.57. The regression value for first order spot was calculated to be 0.969. The Mean ‘k’ (sec^-1)  (0-40 sec). The formulation F11 (1% w/w RIZ with HPMC E3 and PVP K 30), were subjected to stability tests."  The MDFs were sealed in aluminum pouches and kept for 6 months at 40 degrees Celsius and 75 percent relative humidity. No crystallization was seen in the MDFs, and their appearance did not alter during the course of the research. The weight variation at sixth month was noted to be 98-100%. The RIZ content at sixth month was determined to be 96-103%.

Keywords: Migraine, Rizatriptan, Mouth dissolving film (MDF), Fast dissolving drug delivery systems (FDDDS)