Formulation and evaluation of a bilayer floating drug delivery system of nizatidine for nocturnal acid breakthrough.
Keywords:
Bilayer floating tablets, Gastroretentive drug delivery system, Nizatidine, Nocturnal acid breakthroughAbstract
Aim: The present work aims to develop a bilayer floating drug delivery system intended for release of drug to provide relief from acid secretion in response to fatty meals as well as to attenuate the ’’nocturnal acid breakthrough” seen to occur in patients in response to circadian rhythm to gastric acid secretion.
Materials and Methods: The formulation comprises of a bilayer tablet with an immediate release layer and a floating matrix layer. Bilayer floating tablets of nizatidine were prepared employing different types of polymers by effervescent technique; these polymers were evaluated for their gel forming properties. Sodium bicarbonate was incorporated as a gas-generating agent.
Results: The floating tablets were evaluated for uniformity of weight, hardness, friability, drug content, in-vitro buoyancy and dissolution studies. The prepared tablets exhibited satisfactory physico-chemical characteristics. All the prepared batches showed good in vitro buoyancy. The tablets swelled radially and axially during in vitro buoyancy studies. Optimized formulation released more than 98% drug in 8 h in vitro, while the floating lag time was 25 s and the tablet remained floatable throughout the studies.
Conclusions: Thus the bimodal drug release comprising of immediate release for quick onset of action followed by controlled release to attenuate the nocturnal acid breakthrough was achieved.
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