Application of Design of Experiment for Floating Drug Delivery of Tapentadol Hydrochloride

Swati C. Jagdale,^1,2 Somnath Patil,¹ and Bhanudas S. Kuchekar¹

¹MAEER's Maharashtra Institute of Pharmacy, MIT Campus, Paud Road, Kothrud, Pune, Maharashtra 411038, India

²Department of Pharmaceutics, MAEER's Maharashtra Institute of Pharmacy, MIT Campus, S.No. 124, Kothrud, Pune, Maharashtra 411038, India

Received 16 May 2013; Accepted 11 June 2013

Academic Editor: Sophia Kossida

Copyright © 2013 Swati C. Jagdale et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

(DOE04)

Abstract

The aim of the present study was to apply design of experiment (DOE) to optimize floating drug delivery of tapentadol hydrochloride.

Tapentadol hydrochloride is a synthetic opioid used as a centrally acting analgesic and effective in both experimental and clinical pain.

The half-life of the drug is about 4 hours and oral dose is 50 to 250 mg twice a day. For optimization 32 full factorial design was employed for formulation of tapentadol hydrochloride tablets.

Sodium bicarbonate was incorporated as a gas-generating agent. Combination of polymers Xanthan gum and Locust bean gum was used to achieve controlled release effect.

The concentration of polymers was considered as the independent variables and dependent variables were floating lag time and swelling index of the tablets.

From the factorial batches, it was observed that formulation containing combination of 20% sodium bicarbonate and 10% citric acid shows optimum floating ability whereas the formulation containing 20% Xanthan gum and 28% Locust bean gum shows optimum sustained drug release pattern with adequate floating.