DESIGN AND DEVELOPMENT OF FAST DISSOLVING TABLETS OF GLICLAZIDE BY SOLID DISPERSIONS TECHNIQUE
Syed Shariff Miyan, Mohammed Khaleel, Vazir Ashfaq Ahamed, H. Mohammed Yakhoob
Abstract
Syed Shariff Miyan, Mohammed Khaleel, Vazir Ashfaq Ahamed, H. Mohammed Yakhoob
Abstract
The aim of present investigation was to prepare fast dissolving tablets of a hypoglycemic drug Gliclazide. The solubility of poorly soluble drug was enhanced by preparing solid dispersions of the drug with PEG 6000 in various concentrations. The optimized solid dispersions (Drug: PEG-6000, 1:2 ratio) were further kneaded with suitable proportions of superdisintegrants such as; Crosscarmellose, Sodium starch glycolate and Crosspovidone. Fast dissolving tablets of Gliclazide was prepared by direct compression method. The pre-compressive parameters for the blends and post-compressive parameters for the prepared tablets were evaluated. All formulations showed desired pre and post-compressive characteristics. Short term accelerated stability study was performed for optimized formulation and found no evidence of physical and chemical changes. FT IR study showed no evidence of drugexcipient interaction. The optimized formulation was found to be FDT6. It was concluded that fast dissolving tablets of Gliclazide can be prepared by solid dispersions of drug with PEG-6000 and combination of two superdisintegrants provide complete and better dissolution within in shorter period of time. Hence effective diabetic treatment anywhere, and anytime particularly for geriatric, pediatric, mentally ill, bedridden and patients who do not have easy access to water.
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The aim of present investigation was to prepare fast dissolving tablets of a hypoglycemic drug Gliclazide. The solubility of poorly soluble drug was enhanced by preparing solid dispersions of the drug with PEG 6000 in various concentrations. The optimized solid dispersions (Drug: PEG-6000, 1:2 ratio) were further kneaded with suitable proportions of superdisintegrants such as; Crosscarmellose, Sodium starch glycolate and Crosspovidone. Fast dissolving tablets of Gliclazide was prepared by direct compression method. The pre-compressive parameters for the blends and post-compressive parameters for the prepared tablets were evaluated. All formulations showed desired pre and post-compressive characteristics. Short term accelerated stability study was performed for optimized formulation and found no evidence of physical and chemical changes. FT IR study showed no evidence of drugexcipient interaction. The optimized formulation was found to be FDT6. It was concluded that fast dissolving tablets of Gliclazide can be prepared by solid dispersions of drug with PEG-6000 and combination of two superdisintegrants provide complete and better dissolution within in shorter period of time. Hence effective diabetic treatment anywhere, and anytime particularly for geriatric, pediatric, mentally ill, bedridden and patients who do not have easy access to water.
Key concepts: Gliclazide, Dissolution, Solubility, Materials science, Chromatography, Drug, Dosage form, PEG ratio