Ashok Thulluru, Narahari N Palei, M. Vimala, M. Vidyasagar, K. Vishnupriya
Ashok Thulluru*, Narahari N Palei, M. Vimala, M. Vidyasagar, K. Vishnupriya
Sree Vidyanikethan College of Pharmacy, A. Rangampet, Tirupati-517102, A. P.
Volume - 10,
Issue - 3,
Year - 2018
Optimized taste masked orally disintegrating tablets (ODTs) containing Zolpidem Tartrate (ZT) were prepared by direct compression method. Three factors, two levels (23) full factorial design was used to optimize the effect of taste masking agent (EudragitE100; X1); superdisintegrant: Crospovidone (CPV; X2) and solid binder: Hydroxy propyl cellulose (HPC; X3) on tablet properties: Disintegration time (DT; Y1) and % of ZT dissolved within 15 min (D15; Y2). A composite was prepared by mixing ethanolic solution of ZT and Eudragit E100 with mannitol prior to mixing with other tablet ingredients. The prepared ODTs were characterized for pre- and post- compression studies (wt. variation, hardness, friability, wetting time and assay). The prepared ODTs were complying with the pharmacopoeial guidelines regarding the pre- and post- compression parameters. EudragitE100 (X1) had no significant effect on tablet DT (Y1) and D15(Y2). However, the effects of both CPV(X2) and HPC (X3) on ODTs DT (Y1) and D15 (Y2) were significant (p<0.05). The formulation F3 (3% Eudragit E100, 5% CPV and 1%HPC) showing lesser DT (13.38 sec) and higher D15 (84.18%) is an optimized taste masked ZT ODT, which passed the stability test as per ICH guidelines.
Cite this article:
Ashok Thulluru, Narahari N Palei, M. Vimala, M. Vidyasagar, K. Vishnupriya. Quality By Design approach to optimize the taste masked Zolpidem tartrate Oral Disintegrating Tablets. Res. J. Pharma. Dosage Forms and Tech.2018; 10(3):139-148. doi: 10.5958/0975-4377.2018.00022.8