Optimisation of Ibuprofen Fast Dissolving Tablets Employing Starch Xanthate Using 23 Factorial Design

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.

Design, Optimization and Evaluation of Cetrizine Dihydrochloride Fast Dissolving Films Employing Starch Tartrate–a Novel Superdisintegrant

“…Starch tartrate was checked for its solubility in distilled water and in prepared buffers of pH 1.2, 4.5 and 7.4 (aqueous solvents) and in acetone, petroleum ether, alcohol, chloroform and dichloromethane (organic solvents) [10].…”

“…Starch tartrate 1% slurry was prepared by dissolving 1 part in 100 ml of distilled water and then checked for its pH using pH meter [10].…”

“…The melting point apparatus was used to determine the melting point of prepared starch tartrate [10].…”

“…Viscosity was measured by preparing 1% dispersion of starch tartrate in distilled water then dispersion was checked for its viscosity by Ostwald viscometer [10].…”

“…Accurately weighed 200 mg of the starch tartrate was added in both the test tubes containing distilled water and liquid paraffin and mixed well. Then, the test tubes were kept aside for 12 h and after 12 h volume of sediment was recorded [10]. The formula used for the calculation of swelling index is as given below.…”