Formulation, characterization and in-vitro evaluation of fast dissolving tablets containing gliclazide hydrotropic solid dispersions

Madan, JR; Kamate, VJ; Awasthi, R; Dua, K

Formulation, characterization and in-vitro evaluation of fast dissolving tablets containing gliclazide hydrotropic solid dispersions

Madan, JR Kamate, VJ Awasthi, R Dua, K

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Publication Type:: Journal Article
Citation:: Recent Patents on Drug Delivery and Formulation, 2017, 11 (2), pp. 147 - 154
Issue Date:: 2017-08-01

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Field	Value	Language
dc.contributor.author	Madan, JR	en_US
dc.contributor.author	Kamate, VJ	en_US
dc.contributor.author	Awasthi, R	en_US
dc.contributor.author	Dua, K https://orcid.org/0000-0002-7507-1159	en_US
dc.date.available	2017-04-16	en_US
dc.date.issued	2017-08-01	en_US
dc.identifier.citation	Recent Patents on Drug Delivery and Formulation, 2017, 11 (2), pp. 147 - 154	en_US
dc.identifier.issn	1872-2113	en_US
dc.identifier.uri	http://hdl.handle.net/10453/126172
dc.description.abstract	© 2017 Bentham Science Publishers. Background: Low aqueous solubility is a major problem faced with new drug molecules. The purpose of this research was to provide a fast dissolving oral dosage form of Gliclazide (GLZ) using the concept of mixed hydrotropy. The recent patents on Adenosine (US20140107059A1), Growth hormone releasing factor peptide (EP0984788A1) and Paclitaxel (WO2002030466A2) helped in selecting the hydrotropes. Methods: Solubility of GLZ was determined individually in sodium salicylate, nicotinamide, lactose, sodium acetate, urea, trisodium citrate and sodium benzoate. Highest solubility was obtained in 40% sodium benzoate solution. In order to decrease the individual hydrotrope amount, mixed hydrotropic agents were used. Results: Highest solubility was obtained in 25:15 ratio of sodium salicylate and sodium benzoate. This optimized combination was utilized in the preparation of solid dispersions which were evaluated for X-ray diffractometry, Differential Scanning Calorimetry (DSC) and Fourier-transform infrared to show no drug-hydrotropes interaction. This solid dispersion was compressed to form fast dissolving tablets. Dissolution studies of prepared tablets were done using USP Type II apparatus. Conclusion: The batch G3 tablets showed 86% cumulative drug release within 14min with in vitro dispersion time of 33sec. It was concluded that the enhancement in solubility of GLZ is a clear indication of the potential of mixed hydrotropy which is a novel, safe and cost-effective technique to be employed for other poorly water-soluble drugs having low bioavailability.	en_US
dc.relation.ispartof	Recent Patents on Drug Delivery and Formulation	en_US
dc.relation.isbasedon	10.2174/1872211311666170427100213	en_US
dc.subject.classification	Pharmacology & Pharmacy	en_US
dc.subject.mesh	Gliclazide	en_US
dc.subject.mesh	Tablets	en_US
dc.subject.mesh	Administration, Oral	en_US
dc.subject.mesh	Solubility	en_US
dc.subject.mesh	Patents as Topic	en_US
dc.subject.mesh	In Vitro Techniques	en_US
dc.subject.mesh	Drug Liberation	en_US
dc.title	Formulation, characterization and in-vitro evaluation of fast dissolving tablets containing gliclazide hydrotropic solid dispersions	en_US
dc.type	Journal Article
utslib.citation.volume	2	en_US
utslib.citation.volume	11	en_US
utslib.for	1115 Pharmacology and Pharmaceutical Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Graduate School of Health
utslib.copyright.status	closed_access
pubs.issue	2	en_US
pubs.publication-status	Published	en_US
pubs.volume	11	en_US

Abstract:

© 2017 Bentham Science Publishers. Background: Low aqueous solubility is a major problem faced with new drug molecules. The purpose of this research was to provide a fast dissolving oral dosage form of Gliclazide (GLZ) using the concept of mixed hydrotropy. The recent patents on Adenosine (US20140107059A1), Growth hormone releasing factor peptide (EP0984788A1) and Paclitaxel (WO2002030466A2) helped in selecting the hydrotropes. Methods: Solubility of GLZ was determined individually in sodium salicylate, nicotinamide, lactose, sodium acetate, urea, trisodium citrate and sodium benzoate. Highest solubility was obtained in 40% sodium benzoate solution. In order to decrease the individual hydrotrope amount, mixed hydrotropic agents were used. Results: Highest solubility was obtained in 25:15 ratio of sodium salicylate and sodium benzoate. This optimized combination was utilized in the preparation of solid dispersions which were evaluated for X-ray diffractometry, Differential Scanning Calorimetry (DSC) and Fourier-transform infrared to show no drug-hydrotropes interaction. This solid dispersion was compressed to form fast dissolving tablets. Dissolution studies of prepared tablets were done using USP Type II apparatus. Conclusion: The batch G3 tablets showed 86% cumulative drug release within 14min with in vitro dispersion time of 33sec. It was concluded that the enhancement in solubility of GLZ is a clear indication of the potential of mixed hydrotropy which is a novel, safe and cost-effective technique to be employed for other poorly water-soluble drugs having low bioavailability.

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http://hdl.handle.net/10453/126172