Formulation and Evaluation of Mouth Dissolving Tablet Rivaroxaban and its Validation.

Laxmikant B. Borse^1*, Atul R. Bendale¹, Sandhya L. Borse² , Vaishali D. Naphade² and Anil G. Jadhav¹

¹Sandip Institute of Pharmaceutical Sciences, Nasik, Maharashtra, 422213, India.

²School of Pharmaceutical Sciences, Sandip University, Nasik, Maharashtra, 422213, India.

Corresponding Author E-mail: laxmikant.borse@gmail.com

DOI : http://dx.doi.org/10.13005/bbra/3043

ABSTRACT: The foremost intention of present research was the preparation and assessment of mouth dissolving formulation Rivaroxaban and its validation. During present work, this tablet was formulated by straight compression technique by means of Cros-carmellose sodium and Sodium starch glycolate as super-disintegrants (concentration of 2, 4, 6%) and Avicel 102 as a binder. The formulated preparations were exposed to different consideration parameters like hardness test, friability test, disintegration test, release of drug and content of drug. The calibration curve of API using solvent phosphate buffer pH 6.8 was carried out. All prepared formulations exposed to different assessment parameters have shown the findings within prescribed limit. Due to the large concentration of super disintegrants in F8, disintegration time can reach 29±0.06 seconds. In used buffer, drug release was calculated at intervals of 0, 2, 4, 6, 8, 10, and 12 minutes. The F8 demonstrates 96.5±0.567 percent medication release. UV spectrophotometric validation was performed for the quantification of Rivaroxaban in bulk. Rivaroxaban was estimated at 247nm in phosphate buffer 6.8. The linearity range was observed 2–12µg/ml.

KEYWORDS: Croscarmellose Sodium; Mouth Dissolving Tablet; Rivaroxaban; Sodium Starch Glycolate; Validation

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