FORMULATION AND IN-VITRO EVALUATION OF DEFERASIROX ORO-DISPERSIBLE TABLETS
Keywords:Oro-dispersible tablets, Superdisintegrants, Deferasirox
Objective: Deferasirox is a once daily, oral iron chelator approved for treatment of transfusional iron overload in adult and paediatric patients. In case of iron overdose or poisoning, immediate attention deferasirox is required in the systemic circulation to counter act the iron. Hence we feel that formulation of Oro-dispersible tablets of deferasirox is an ideal approach.
Methods: FTIR showed that there is no interaction between drug and excipients. Mouth dissolving tablets of Deferasirox were prepared using crospovidone, croscarmellose and sodium starch glycolate as superdisintegrants by direct compression method. Dissolution of prepared Oro-dispersible tablets of Deferasirox was performed using USP type II apparatus in 6.8 pH phosphate buffer at 50 rpm with temperature being maintained at 37Â±0.5oC. Samples were withdrawn at 10, 15, 20, 30 and 45min time points and were analysed using UV- visible spectrophotometer at 245 nm.
Results: The tablets prepared were evaluated for various parameters like weight variation, hardness, friability, in-vitro dispersion time, drug polymer interaction, drug content, water absorption ratio and wetting time and in-vitro release and were found to be within the limits.
Conclusion: Formulation with crospovidone containing superdisintegrants has shown better in-vitro dissolution profile compared with other formulations. In conclusion, development of fast dissolving tablets using superdisintegrants gives rapid drug delivery and rapid onset of action.
Hisakadzu.S. and Bi.Y. Preparation, evaluation and optimization of rapidly disintegrating tablets. Powders Technol.2002;122:188-98.
Schiermeier, and Schmidt P.C. Fast dispersible ibuprofen tablets. Eur. J. Pharm.Sci.2002;15:295-305.
Honda, Y. and Nakano, M., 1998. Evaluation of preference for swallowing orally disintegrating famotidine tablet in outpatients. Jpn. J.Hosp. Pharm.1998;24:533-40.
Ghosh T, Ghosh A and Prasad D. A review on new generation oro-dispersible tablets and its future prospective. International Journal of Pharmacy and Pharmaceutical Sciences.2011;3(1):1-7.
Kulkarni MS. Formulation and Evaluation of Oro-dispersible tablet of Ornidazole. IJPSR.2010;1 (2):39-47.
Shid SL, Hiremath SP, Borkar SN, Sawant VA. Effect of superdisintegrants in rapidly disintegrating Flurbiprofen sodium Oro-dispersible tablets via direct compression. JGPT. 2010;2(1):107-17.
Khalid K.Abed, Ahmed A.Hussein, Mowafaq M.Ghareeb. Formulation and Optimization of Oro-dispersible tablets of Diazepam. AAPS PharmSciTech. 2010;11(1):356â€“61.
Swamy PV, Gada SN, Shirsand SB, Kinagi MB and Shilpa H. Design and evaluation of cost effective oro-dispersible tablets. IJPSR. 2010;1 (6):258-64.
Abdelbary G, Eouani C, Prinderre P, Joachim J, Reynier JP. Determination of the in-vitro disintegration profile of rapidly disintegrating tablets and correlation with oral disintegration. Int J Pharm. 2005;292(1-2):29-41.
Mizumoto T, Masuda Y, Yamamoto T. Formulation design of a novel fast-disintegrating tablet. Int J Pharm. 2005;306:83-90.
Indhumathi D, Rathnam G. Design and optimization of orodissolving tablet of antidepressant drug by superdisintegrant addition method. Int. J. of Pharm. Sci. Review and Res. 2010;2(2):1-9