Development of a Sustained Release Solid Dosage Formulation for Delivery of a Poorly Water Soluble Hypoglycemic Agent Using Novel Ceramic Vehicle

Gliclazide is a second-generation sulfonylurea compound used as a prescription medicine in the treatment of non insulin dependent diabetes mellitus (NIDDM) or type II diabetes. As a consequence of the poor aqueous solubility, the therapeutic efficacy of the drug in oral dosage form suffers from major drawbacks, e.g., inter-individual variable bioavailability. To overcome the same, various extended/sustained release (SR, matrix mediated) oral dosage formulations have been attempted and in the present communication, we report the use of a biocompatible and biodegradable anionic clay, known as Mg–Al layered double hydroxides (LDHs) to encapsulate the gliclazide drug by ex situ anion exchange process, to form LDH-GLZSR sustained release tablet, known as LDH-GLZSR. It was characterized structurally and compositionally by various analytical techniques. The LDH-GLZSR tablet was manufactured by direct compression method, followed by using microcrystalline cellulose as binder, crospovidone as disintegrator and magnesium stearate as lubricant. Different post formulation parameters of LDH-GLZSR tablets were evaluated and in vitro dissolution study was carried out in two pH conditions (1.2 for stomach and 6.8 for colon), comparing the same to a market available polymer based SR formulation (tablet) of the same drug, named as GLZ-SR to estimate the suitability of the former for a similar use