Abstract
Objective: To evaluate starch xanthate as a super disintegrant in the formulation of fast dissolving tablets of poorly soluble drugs employing 23 factorial design.Methods: Starch xanthate was synthesized by gelatinization process. The synthesized starch xanthate was subjected to physical and micromeritic evaluation. To establish as starch xanthate as a super disintegrant, fast dissolving tablet of ibuprofen was prepared employing starch xanthate in different proportions in each case by direct compression method employing 23 factorial design. All fast dissolving tablets prepared were evaluated for drug content, hardness, friability, disintegration time and other dissolution characteristics like percent dissolved in 5 min (PD5), Dissolution efficiency in 5 Min (DE5%) and first order rate constant(K1).Results: The starch xanthate prepared was found to be fine, free flowing slightly crystalline powder. Starch xanthate exhibited good swelling in water. Fourier transform infrared spectra (FTIR) and Differential scanning calorimetry (DSC) study indicated the absence of interaction between Ibuprofen and starch xanthate. All the fast dissolving tablets formulated employing starch xanthate were of good quality with regard to drug content(100±5%), hardness (3.6–4 kg/sq. cm), and friability (0.12-0.15%). The disintegration time of all the formulated tablets was found to be in the range of 13±0. 02 to 108±0.02s. The optimised formulation FL7 has the least disintegration time i.e., 13±0. 02s. The In vitro wetting time of the formulated tablets was found to be in the range of 90±0.15 to 369±0.17s. The In–Vitro wetting time was less (i.e., 90s) in optimized formulation FL7. The water absorption ratio of the formulated tablets was found to be in the range of 94±0.16 to 192±0.15%. The cumulative drug dissolved in the optimized formulation FL7 was found to be 99.63±0.24% in 5 min.Conclusion: Starch xanthate was found to be a super disintegrant which enhanced the dissolution efficiency when combined with sodium starch glycolate, croscarmellose sodium, with the ibuprofen and hence it could be used in the formulation of fast dissolving tablets to provide immediate release of the contained drug within 5 min.
Highlights
Oral routes of drug administration have wide acceptance up to 5060% of the total dosage form
It was insoluble in aqueous solvents and insoluble in organic solvents tested and the pH of 0.1% aqueous dispersion was 6.196 which is suitable in the formulation of fast dissolving tablets
*SD Standard Deviation from mean, n=3, percent dissolved in 5 min (PD5)-Percent dissolved in 5 min., DE5%-Dissolution efficiency in 5 min., K1 =First Order Rate Constant
Summary
Oral routes of drug administration have wide acceptance up to 5060% of the total dosage form. Fast dissolving tablets (FDT) are solid dosage form containing indicated substances which disintegrate rapidly, usually within few seconds when placed upon tongue requiring additional water to facilitate swallowing [1]. Fast dissolving tablets offer great advantages for the patients having difficulty in swallowing [2]. Fast dissolving tablet formulation provides sufficient strength, quick disintegration/dissolution in the mouth without water [6], rapid dissolution and absorption of the drug, which will produce the quick onset of action. Direct compression one of the techniques which require the incorporation of super disintegrant or highly water-soluble excipients into the formulation to achieve fast tablet disintegration. The aim of the work was to formulate and characterize fast-dissolving tablets of ibuprofen by utilizing optimization techniques for rapid dissolution of drug and absorption employing a new super disintegrant i.e., starch xanthate
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