Design and Evaluation of a
Novel Gas Formation-Based Multiple-Unit Gastro-Retentive
Floating Drug Delivery System for Quetiapine Fumarate
Vinay Kumar Katakam*,
Sunil Reddy, Pavan Kumar Panakanti and Madhusudan Rao
Yamsani
University College of
Pharmaceutical Sciences, Kakatiya University, Warangal,
-506009 (A.P), India
*For correspondence:
Email:
yamsani123@gmail.com,
vinaykatakam@yahoo.co.in;
Tel: +91-870-2570543
Received: 6 March 2013
Revised accepted: 4
February 2014
Tropical
Journal of Pharmaceutical Research, April 2014;
13(4):
489-496
http://dx.doi.org/10.4314/tjpr.v13i4.1
Abstract
Purpose: To develop a
gastro-retentive formulation of quetiapine fumarate in
the form of floating mini-tablets.
Methods: The system consisted of
core units prepared by direct compression process, which
were coated with three successive layers, namely, an
inner seal coat, effervescent layer and an outer
polymeric layer of polymethacrylates.
Results: Mini-tablets coated with
Eudragit RS 30D (5, 7.5 and 10%) released ≤ 85% of the
drug after 12 h, while those coated with Eudragit RL 30D
(5, 7.5 and 10%) released ≥ 85% drug within the same
period. Drug release kinetic studies showed that drug
diffusion fitted best to zero order and Higuchi models,
indicating that drug release was anomalous non-Fickian
transport. In vivo gastric residence time results
indicate that the units remained in the stomach for
about 6 h (n = 3). There was no significant change in
dissolution profiles before and after storage at 40°C
and 75% RH for 6 months.
Conclusion: The developed floating
mini-tablets of quetiapine fumarate exhibit prolonged
release for ≥12 h, and thus may improve bioavailability
and minimize fluctuations in plasma drug concentrations.
Keywords: Mini-tablets;
Floating delivery system; Effervescence, Polymeric
membrane, Controlled release, Quetiapine fumarate
