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KMID : 0369820130430050417
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Jorunal of Korean Pharmaceutical Sciences
2013 Volume.43 No. 5 p.417 ~ p.429
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Synthesis and evaluation of octenyl succinate anhydride derivative of fenugreek gum as extended release polymer
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Sav Ajay Kumar
Fule Ritesh Amol
Ali Meer Tarique
Amin Purnima
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Abstract
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In current study, fenugreek gum (FG) plant derived product was investigated as a release retarding polymer. The octenyl succincate anhydride derivative of fenugreek gum (OSFG) was synthesized to introduce hydrophobic property and investigated for its drug release retarding property with reference to FG. The reaction was carried out in anhydrous conditions at different temperature (40?98 °C) using NaHCO3 as a mild base catalyst and the influences of three factors such as reagent/substrate concentration, reaction temperature and time on the degree of substitution of OSFG were studied. Highly water-soluble metoprolol succinate (MPS) and poorly water-soluble carbamazepine (CBZ) were selected as model drug as for release studies. It was observed that increase in reaction temperature and reagent concentration resulted in high degree of substitution with significant decrease in viscosity. Reaction carried out at 98 °C for 2 h showed high degree of substitution (0.133) with moderate retention of viscosity compared to plain FG. FTIR, DSC, XRD, solid state CPMAS 13C-NMR, and SEM studies provide structural information of synthesized OSFG. MPS ER tablet prepared with drug:OSFG:FG at the weight of 1:4:2 and CBZ ER tablet with drug:OSFG at the weight ratio of 1:3, respectively. Both formulations showed similar drug release profile compared to marketed formulations. Optimized tablet formulations were found to be stable under stability condition according to ICH guidelines. It was concluded that the developed formulations with OSFG have a release retarding property and can be used alone or in combination with other polymers for a controlled release.
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KEYWORD
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Fenugreek gum, Octenyl succinic anhydride, Degree of substitution, Swelling, Viscosity
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