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KMID : 0369820140440020079
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Jorunal of Korean Pharmaceutical Sciences
2014 Volume.44 No. 2 p.79 ~ p.102
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Development and characterization of mouth dissolving tablets of prednisolone
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Basu Biswajit
Aviya Ketan R.
Bhattacharya Amitava
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Abstract
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Prednisolone is a glucocorticoid with the general properties of the corticosteroids. It is used as anti-inflammatory or immunosuppressive agent in asthmatic condition mostly in pediatric and geriatric population. So the present investigation was conducted with an aim of to formulate a taste masked patient friendly dosage form i.e. mouth dissolving tablets of prednisolone. In this study, taste masking of drug was critical parameter for this study. Masking of bitter taste of prednisolone was carried out using techniques like preparation of solid dispersion with PEG 6000, complex formation with Indion-204 resin and β-cyclodextrin. Among them complex prepared from β-cyclodextrin in weight ratio 1:4 was optimized basis on taste panel evaluation and drug release from complex. A successful taste masking of complex was confirmed by time intensity method and also by taking drug release in simulated gastric fluid and in simulated salivary fluid. The values of pre-compression parameters evaluated, were within prescribed limits and indicated good free flowing properties. Tablets optimization was carried out through 32 full factorial designs, concentration of superdisintegrants like croscarmellose sodium and sodium starch glycolate as independent variable. Whereas wetting time, disintegrating time and cumulative percentage of drug release as dependent variable. The data obtained of post-compression parameters such as weight variation, hardness, friability, wetting time, water absorption ratio, content uniformity, disintegration time and dissolution was found within specified limit. Prepared check point batch having disintegrating time 16.12 s and drug release 98.34 after 30 min was selected as optimized formula. This formula was compared with marketed formulation and was found better disintegration and drug release property. Optimized formulation was subjected for accelerated stability study as per ICH guideline.
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KEYWORD
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Prednisolone, Mouth dissolving tablet, Taste masking, 32 full factorial designs
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