Preparation and evaluation of taste-masked orally disintegrating tablets of prednisolone
V. Anand1*, R. Kandarapu2, S. Garg3
1Department of Pharmaceutics, Seth G. L. Bihani S. D. College of Technical Education, Sri Ganganagar, Rajasthan, India2Research and Development, Dr. Reddy's Laboratories Ltd. (Generics), Bachupally, Hyderabad, India3School of Pharmacy, University of Aukland, New Zealand
Abstract Purpose: To prepare taste-masked orally disintegrating tablets (ODTs) of prednisolone (PDL) by incorporation of microspheres in the tablets for use in specific populations viz. pediatrics, geriatrics and patients experiencing difficulty in swallowing. Methods: Microspheres containing PDL were prepared by the solvent evaporation method using acetone as solvent for pH-sensitive polymer and light liquid paraffin as the encapsulating medium. Prepared microspheres were characterized with regard to the yield, drug content, particle size and size distribution, surface features, in vitro drug release and taste. Tablets, prepared by direct compression containing microspheres, were evaluated with regard to crushing strength, friability, disintegration time, drug content and in vitro drug release and taste. Results: The results obtained showed that the average size of microspheres is influenced greatly by the speed of stirring. Microspheres prepared by the solvent evaporation method in acetone were of a regular spherical shape with satisfactory results in terms of the size and size distribution. The comparison of the dissolution profiles of microspheres in different media shows that microspheres produce a retarding effect in pH 6.8 buffer. Taste evaluation studies confirmed that microspheres of PDL having a drug to polymer ratio of 1:10 are tasteless and these were further used for formulation into ODTs. Compression of microspheres resulted in breaking of a fraction of the microspheres but this did not adversely affect the taste. Conclusion: Effective taste-masking was achieved for PDL using the technique of microencapsulation and ODTs of acceptable characteristics were obtained by disintegrant addition and direct compression.
2007, Vol. 2 