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Development and characterization of mouth dissolving tablets of prednisolone

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Abstract

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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Acknowledgments

This article dose not contain any studies with human and animal subjects performed by any of the authors. All authors (B. Basu, K.R. Aviya, A.B. Bhattchaarya) declare that they have no conflict of interest. We would like to thank the company Tianjin Tianyao Pharmaceuticals Co., Ltd. for giving us the free gift samples of prednisolone. We are thankful to Mr. Amitava Bhattacharya, Sr. Executive of Macleods Pharmaceuticals Ltd. for his genuine interest and timely suggestion and infinite help and sturdy motivation during this research work. We are also thankful to Maruti Chemicals, Gandhinagar for a gift sample of SSG and sincerely thankful to Mr. Krunal Desai, for providing necessary facilities to carry out this research work and providing a congenial environment and all the members of Macleods Pharmaceuticals Ltd. for their precious guidance and kind help throughout the course.

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Authors and Affiliations

  1. Department of Pharmaceutics, Atmiya Institute of Pharmacy, Yogidham Gurukul, Kalawad Road, Rajkot, 360005, Gujarat, India

    Biswajit Basu & Ketan R. Aviya

  2. Macleods Pharmaceuticals Ltd., Vapi, India

    Amitava Bhattacharya

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  1. Biswajit Basu
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  2. Ketan R. Aviya
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  3. Amitava Bhattacharya
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Correspondence to Biswajit Basu.

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Basu, B., Aviya, K.R. & Bhattacharya, A. Development and characterization of mouth dissolving tablets of prednisolone. Journal of Pharmaceutical Investigation 44, 79–102 (2014). https://doi.org/10.1007/s40005-013-0107-y

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  • DOI: https://doi.org/10.1007/s40005-013-0107-y

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