Volume 15, Issue 35, January - June, 2021

Development and Characterization of Tolvaptan HCl Fast Dissolving Tablets

Raghavendra Kumar Gunda^1♦, Prasada Rao Manchineni², Rajini Sudireddy³

¹Assistant Professor, Department of Pharmaceutics, M.A.M college of Pharmacy, Kesanupalli (V), Narasaraopet, Guntur (Dt), Andhra Pradesh, India-522601.
²Professor cum Principal, Department of Pharmaceutical Analysis, M.A.M college of Pharmacy, Kesanupalli (V), Narasaraopet, Guntur (Dt), Andhra Pradesh, India-522601.
³Assistant Professor, Department of Pharmacy Practice, M.A.M college of Pharmacy, Kesanupalli (V), Narasaraopet, Guntur (Dt), Andhra Pradesh, India-522601.

^♦Corresponding author
Mr. Raghavendra Kumar Gunda, M.Pharm.,(Ph.D) Assistant Professor, Department of Pharmaceutics, MA.M college of Pharmacy, Kesanupalli (V) Narasaraopet, Guntur(D.t), A.P. India-522601. E-mail: raghav.gunda@gmail.com, Researcher id: G-5095-2015, Orcid id : 0000-0002-4271-8614, Mob: +91-9666705894.

ABSTRACT

Objective: The purpose of present investigation to formulate, characterize the oral dissolving tablets (ODT) for Tolvaptan HCl. Tolvaptan HCl, a newer aquaretic sorvaptan. It mainly used for the effective management of Hyponatremia associated with Syndrome of inappropriate anti diuretic hormone (SIDAH), cardiac cirrhosis and congestive cardiac failure. Methods: ODT formulations of Tolvaptan HCl were prepared using different quantities of Ac-di-sol & Polyplasdone employed as Superdisintegrants by Direct Compression technique. Nine trials were formulated and evaluated for Pharmaceutical Product Performance. Results: Results shows that all the formulations were lie within the acceptance criterion and the In-vitro dissolution profiles were subjected to kinetic modeling. Conclusion: Formulation (TF1) containing 50 mg of Ac-di-sol & 50 mg of Polyplasdone was found to be best one among all and also similar to the Marketed product (HYPONAT-O-30) (f2= 70.613, f1= 4.038 & No significant difference, t= 0.04738) to marketed product. Formulation (TF1) follow first order, whereas release mechanism found to be nonfickian type (n= 0.863)

Keywords: Tolvaptan HCl, super-disintegrants, Polyplasdone, Ac-di-sol, Non-Fickian Diffusion.

Drug Discovery, 2021, 15(35), 6-15

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