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Research Journal of Pharmaceutical Dosage Forms and Technology
Year : 2018, Volume : 10, Issue : 3
First page : ( 139) Last page : ( 148)
Print ISSN : 0975-234X. Online ISSN : 0975-4377.
Article DOI : 10.5958/0975-4377.2018.00022.8

Quality By Design approach to optimize the taste masked Zolpidem tartrate Oral Disintegrating Tablets

Thulluru Ashok*, Palei Narahari N, Vimala M., Vidyasagar M., Vishnupriya K.

Sree Vidyanikethan College of Pharmacy, A. Rangampet, Tirupati-517102, A. P.

*Corresponding Author E-mail: ashokthulluru@gmail.com

Online published on 31 October, 2018.

Abstract

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 postcompression 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.

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Keywords

Zolpidem Tartrate (ZT), orally disintegrating tablets (ODTs), factorial design, EudragitE100, crospovidone, hydroxypropyl cellulose.

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