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

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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.
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Keywords: EX SITU ANION EXCHANGE; GLZ-SR TABLET; LDH-GLZSR; POOR AQUEOUS SOLUBILITY; SR TABLET; VARIABLE BIOAVAILABILITY

Document Type: Research Article

Publication date: June 1, 2017

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  • Advanced Science, Engineering and Medicine (ASEM) is a science, engineering, technical and medical journal focused on the publishing of peer-reviewed multi-disciplinary research articles dealing with all fundamental and applied research aspects in the areas of (1) Physical Sciences, (2) Engineering, (3) Biological Sciences/Health Sciences, (4) Medicine, (5) Computer and Information Sciences, (6) Mathematical Sciences, (7) Agriculture Science and Engineering, (8) Geosciences, and (9) Energy/Fuels/Environmental/Green Science and Engineering.
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