Abstract
The purpose of this study was to develop a bilayer floating drug delivery system of Diltiazem Hydrochloride (DTZ). Floating drug delivery systems can remain in the gastric region for several hours and therefore prolong the astric residence time of drugs and improve drug bioavailability. In this study novel bilayer formulation of floating tablet comprising drug contained core and floated outer layer was prepared. The tablets were prepared by direct compression technique, using polymers such as Hydroxypropyl ethylcellulose (HPMC), Ethyl cellulose and Tragacanth alone or in combination, and other standard excipients. Sodium bicarbonate was incorporated as a gas-generating agent. Floating properties, drug release and release kinetic were assessed. The results of buoyancy and release studies showed that a combination of HPMC, tragacanth and sodium bicarbonate favors the preparation of the outer layer of bilayer floating controlled release DTZ tablets. The linear regression analysis and model fitting demonstrated that the optimized formulation followed linear probability model. Overall it was possible to control the release of highly soluble DTZ by combining the floating and bilayered tablet tools.
Highlights
Diltiazem Hydrochloride (DTZ) is a calcium channel blocker
Ethyl cellulose is practically insoluble in water [9], so it was added to Hydroxypropyl Methylcellulose (HPMC) to prolong the floating time of the tablets (F3 and F4), but these two formulations didn’t float either
Sodium bicarbonate was used as a gasgenerating agent in order to obtain floating property of the tablet (F5)
Summary
Diltiazem Hydrochloride (DTZ) is a calcium channel blocker. It is generally used for the treatment of hypertension and angina. Extended gastric retention may be suitable for drugs that act locally like antibiotics used in the treatment of peptic ulcer. It can be beneficial for drugs that have an absorption window in the stomach or in the upper intestine, drugs with low solubility in the intestinal tract, and for drugs that are unstable at higher pH [4,5,6]. DTZ needs multiple daily drug dosage so that it upholds adequate plasma concentrations. It is a proper model candidate for gastroretentive formulation [1]. The objective of this study was to formulate a bilayer gastro-retentive floating system and control the release rate of DTZ which has a high solubility
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