Modified Polysaccharides as Fast Disintegrating Excipients for Orodispersible Tablets of Roxithromycin |
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Authors: | Vijay Sharma Anil K Philip Kamla Pathak |
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Institution: | (1) Department of Pharmaceutics, Rajiv Academy For Pharmacy, NH#2, Delhi–Mathura bypass, P. O. Chattikkara, Mathura, 281001, Uttar Pradesh, India |
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Abstract: | The purpose of this study was to develop a dosage form that was easy to administer and provides rapid release of the drug
roxithromycin, using modified polysaccharides as rapidly disintegrating excipients. Modified polysaccharides co grinded treated
agar (C-TAG) and co grinded treated guar gum (C-TGG) were prepared by subjecting pure polysaccharides namely agar and guar
gum respectively to sequential processes of wetting, drying and co grinding with mannitol (1:1). The modified polysaccharides
were characterized by Scanning Electron Microscopy and Diffuse Reflectance Spectroscopy and evaluated for particle size distribution,
derived properties, swelling index and biodegradability. Optimization studies based on 22 factorial designs, with friability and disintegration time as response parameters were used to formulate orodispersible tablets
of roxithromycin and evaluated for wetting time, water absorption ratio and in vitro drug release at salivary pH 6.4 and physiological pH 7.4. Results indicated that lower levels of modified polysaccharides
namely C-TAG in F3 and C-TGG in F7 and higher levels of microcrystalline cellulose, exhibited least disintegration times without friability concerns. In vitro release of optimized formulations F3 and F7, both at salivary pH and physiological pH was found to be more than 90% within 30 min as compared to 27.82% at the same time
point of conventional formulation. Stability studies carried out as per ICH Q1A guidelines suggested the formulations to be
stable for a period of 6 months. Thus the approach of using modified polysaccharides as fast disintegrating excipient can
be used to formulate a stable orodispersible formulation. |
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Keywords: | modified polysaccharides orodispersible roxithromycin swelling index 22 factorial design |
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