Abstract
The main aim present work was to optimize fast dissolving tablet (FDT) formulation using response surface approach. The variables studied were sodium bicarbonate (X1), citric acid (X2), and superdisintegrant, Ac-Di-Sol (X3). The main aspect of present work was to develop FDT of Domperidone which possesses fast disintegration and high mechanical strength. It was found that the response was affected by all the three factors studied. The statistical models were successfully used to prepare FDT of Domperidone with fast disintegration (31.08 seconds) and adequate hardness (4.1 kg/cm2). Pharmacokinetic studies in rats showed statistically insignificant difference (p>0.05) between Domperidone fast dissolving tablet (DFDT) and market product. This concluded that optimized FDT is bioequivalent with the marketed formulation. The values of Tmax were found to be 0.5 h and 0.75 h for DFDT and reference product, respectively. Conditioned place aversion study was performed on Swiss Albino mice and the study showed the better anti emetic potency of optimized FDT in nauseated condition over market product (p<0.05). Thus, the present investigation conclusively demonstrates the potential role in terms of rapid disintegration and high mechanical strength.
Keywords: Ac-Di-Sol, central composite design, effervescent material, fast dissolving tablet.
Graphical Abstract
Current Drug Delivery
Title:Design and Optimization of Domperidone Fast Dissolving Tablet Using Central Composite Design
Volume: 12 Issue: 6
Author(s): Bhatt Shailendra, Mandge Shailendra, Jaimini Manish, Tanwar Yuveraj Singh and Trivedi Priti
Affiliation:
Keywords: Ac-Di-Sol, central composite design, effervescent material, fast dissolving tablet.
Abstract: The main aim present work was to optimize fast dissolving tablet (FDT) formulation using response surface approach. The variables studied were sodium bicarbonate (X1), citric acid (X2), and superdisintegrant, Ac-Di-Sol (X3). The main aspect of present work was to develop FDT of Domperidone which possesses fast disintegration and high mechanical strength. It was found that the response was affected by all the three factors studied. The statistical models were successfully used to prepare FDT of Domperidone with fast disintegration (31.08 seconds) and adequate hardness (4.1 kg/cm2). Pharmacokinetic studies in rats showed statistically insignificant difference (p>0.05) between Domperidone fast dissolving tablet (DFDT) and market product. This concluded that optimized FDT is bioequivalent with the marketed formulation. The values of Tmax were found to be 0.5 h and 0.75 h for DFDT and reference product, respectively. Conditioned place aversion study was performed on Swiss Albino mice and the study showed the better anti emetic potency of optimized FDT in nauseated condition over market product (p<0.05). Thus, the present investigation conclusively demonstrates the potential role in terms of rapid disintegration and high mechanical strength.
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Shailendra Bhatt, Shailendra Mandge, Manish Jaimini, Singh Yuveraj Tanwar and Priti Trivedi, Design and Optimization of Domperidone Fast Dissolving Tablet Using Central Composite Design, Current Drug Delivery 2015; 12 (6) . https://dx.doi.org/10.2174/1567201811666141022101415
DOI https://dx.doi.org/10.2174/1567201811666141022101415 |
Print ISSN 1567-2018 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-5704 |
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