FORMULATION DESIGN, DEVELOPMENT AND INVITRO EVALUATION OF MOUTH DISSOLVING TABLETS OF ZOLMITRIPTAN
M. Sai Lakshmi*, A. Priyanka Reddy, R. Swathi, M. Sachitha, MD and Masuque Ahemed
ABSTRACT
The basic approach used in the development of the ODTs is the use of superdisintegrants. Many approaches have been developed to manufacture ODTs. Zolmitriptan are the new serotogenic agonist with excellent oral bioavailability exhibiting a potent symptomatic antimigraine effect. Zolmitriptan fast dissolving tablets were prepared by direct compression method using superdisintegrants is Pharmaburst ODT, in varying concentrations.Angle of repose: is 28° shows good flow.Bulk density and tapped density: is 0.410(g/ml) and 0.500 (g/ml), respectively. The values for compressibility index and Hausner ratio is 19.05 and 1.24, respectively.Weight variation test is found 121.4 mg to 126.1 mg as per IP specification. Friability: Less than 0.31%, the results indicate that the percentage losses were not more than 1.0% (complies IP specifications). Thickness: Range from 2.90 mm to 2.99 mm; the results indicate that the tablets are suitable for packing. Content uniformity was found in between 98.62% and 100.3%. Hardness of the tablet was found to be between 4 to 4.6 kg/cm2. The results indicate that the tablets are mechanically strong and are in limit. Disintegration time which was in-between 0‟11 sec to 0‟16 sec, the results indicate that disintegration time of tablets is within 30 seconds. Dissolution study was carried out in 6.8 pH phosphate buffer for formulations FZ1, FZ2, FZ3, ZF4, FZ5, ZF6, FZ7, FZ8, and FZ9 from time 0 to 15 min. And % assay for optimized batch was found to be 99.2 %.
Keywords: Mouth dissolving tablets, Zolmitriptan, direct compression, Preformulation, Kinetic study.
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