Abstract

SCREENING OF NATURAL AND SYNTHETIC SUPERDISINTEGRANT IN FORMULATION AND EVALUATION OF GINGEROL ORODISPERSIBLE TABLETS

Samyuktha Metta*, M. Venkata Swamy, Sundaragiri Maneesha, Nomula Ambica Bala, Nandanam Manasa and Nabeela Fatima

ABSTRACT

Orodispersable tablets (ODTs) have received rapid-increasing demand during the last decade and the field has become a ever growing area in the pharmaceutical industry. Orodispersable tablets (ODTs) are those solid dosage forms when put on tongue, disintegrate or dissolve instantaneously, releasing the drug, within a few seconds without the need of water, offering immediate release and enhanced bioavailability, to achieve better patient compliance. Gingerol has been traditionally used to treat gastrointestinal symptoms, nausea and emesis. Moreover, nausea and emesis are common side effects of chemotherapy. The activation of vagal afferent mediated by serotonin (5-HT) is crucial in the mechanism of emesis. Gingerol inhibited emetic signal transmission in vagal afferent neurons by suppressing the
5-HT receptor, and similarly 6-shogaol had the strongest inhibitory efficacy. Furthermore, ginger extract alleviated chemotherapy-induced nausea and emesis by suppressing the activation of 5-HT receptors in enteric neuronsThe tablets were prepared by using extracted natural superdisintegrants such as Musa paradisiaca starch, modified Musa paradisiaca starch(starch glutamate) and synthetic superdisintegrant sodium starch glycolate in different ratios by using direct compression method. Micro crystalline cellulose as direct compressible material and aspartame as sweetener were also included. The IR spectral studies showed no interaction between drug and superdisintegrants. Satisfactory results were obtained when prepared tablets subjected to post compression evaluation tests such as uniformity of weight, thickness, drug content, Invitro dispersion time, wetting time, water absorption ratio and Invitro disintegration studies. Tablets were also subjected to in vitro drug release studies by using USP dissolution apparatus. Of all the formulations, the tablets formulated with 6% Modified Musa paradisiacastarch (GIODT3) showed the least wetting time of 17.66 seconds, which had a direct impact on high water absorption ratio 96.63±0.41%. It was observed that the increased concentration of superdisintegrants decreased the disintegration time and optimized the drug release. Modified Musa paradisiaca starch(starch glutamate) in the concentration of 6 % acts as an eminent superdisintegrant and disintegrates the tablet within 17.66 seconds fulfilling the criteria of ODT. Further the higher dissolution rate of the GIODT3 formulation 99.89% at the end of 16 min indicated that modified Musa paradisiaca starch(starch glutamate) is a better choice among the renowned synthetic super disintegrant like sodium starch glycolate.From the results it is concluded, that in comparison with modified Musa paradisiaca starch (starch glutamate), Musa paradisiaca starch and sodium starch glycolate, the modified natural super disintegrant i.e., starch glutamate act as a good superdisintegrating agent and showed it acts as a promising additive in formulation of Orodispersible tablets of anti-emetic drug, Gingerol.

Keywords: Orodispersable tablets (ODTs), Gingerol, Natural and synthetic Superdisintegrants, Enhanced bioavailability, Patient’s compliance, Evaluation.