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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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PRODUCTION AND CHARACTERIZATION OF SELF EMULSIFYING TABLET OF DEXAMETHASONE

Author: DEBABRATA DASTIDAR, SOUVIK GHOSH, ABHIJIT SENGUPTA, DIPANJAN GHOSH, DIBYA DAS, GOURANGA DUTTA, NILAYAN GUHA
Abstract: Dexamethasone is clinically very important adrenocortical steroid. But erratic oral absorption leading to irregular bioavailability, is the main problems to its clinical use. In this study a self emulsifying tablet of dexamethasone has been developed. Castor oil, Tween® 80 and Propylene glycol were used as oil vehicle, surfactant and cosurfactant. Formulation optimization was done using 9 run Randomized Quadratic D-Optimal Mixture Design. The optimum composition of liquid SEDDS was found out to be 14% (w/w) castor oil, 43% (w/w) Tween® 80 and 43% (w/w) propylene glycol. 1mg dexamethasone was dissolved in 37mg of this mixture. Upon addition in water it produced Grade I type microemulsion with 107.4nm droplet diameter and -18.97mV ?-potential. The granules prepared with this liquid SEDDS had excellent flow properties. Upon compression it formed tablet with good hardness (3.3 kg/cm2) and low friability (0.48%). Upon addition in water, it disintegrated within 10min and formed colloidal dispersion of 144nm diameter and -15.1mV ?-potential. DSC results confirmed that dexamethasone was in amorphous state in tablet. This may have increased the aqueous solubility of dexamethasone leading to ~46% burst release of drug in dissolution medium within 5min. Thereafter ~21% drug was released during 90minute at a constant rate of 0.239±0.012% per minute (K0) till the equilibrium was attained. Thus ~33% dexamethasone was loaded into the dispersed microemulsion droplets of castor oil. The released drug is subjected to abortion into portal circulation whereas the rest of the drug (loaded within microemulsion droplets) will be absorbed through lymphatic channel.
Keyword: Dexamethasone; Self emulsifying tablet; microemulsion; D-optimal Optimization; Lymphatic channel
DOI: https://doi.org/10.31838/ijpr/2019.11.04.033
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