SYNTHESIS, CHARACTERIZATION AND EVALUATION OF STARCH XANTHATE AS A SUPERDISINTEGRANT IN THE FORMULATION OF FAST DISSOLVING TABLETS
Keywords:Fast dissolving, Superdisintegrant, Starch xanthate, Dissolution efficiency
Objective: To synthesize, characterize and evaluate starch xanthate as a superdisintegrant in the formulation of fast dissolving tablets by employing 23 factorial design.
Methods: Starch xanthate was synthesized by gelatinization process. The physical and micromeritic properties were performed to evaluate the synthesized starch xanthate. The fast dissolving tablet of ibuprofen was prepared by employing starch xanthate as a superdisintegrant in different proportions in each case by direct compression method using 23 factorial design. The 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) were used in the evaluation of prepared fast dissolving tablets.
Results: The starch xanthate prepared was found to be fine, free flowing slightly crystalline powder. Starch xanthate exhibited good swelling in water. The study between ibuprofen and starch xanthate was shown the absence of interaction by fourier transform infrared spectra (FTIR) and differential scanning calorimetry (DSC). The drug content (100Â±5%), hardness (3.6â€“4 kg/sq. cm), and friability (0.12-0.15%) has been effective with regard to all the formulated fast dissolving tablets employing starch xanthate. The disintegration time of all the formulated tablets was found to be in the range of 12Â±0.01 to 312Â±0.02s. The optimized formulation F5 has the least disintegration time i.e., 12Â±0.01s. The In vitro wetting time of the formulated tablets was found to be in the range of 76Â±0.21 to 217Â±0.17s. The In vitro wetting time was less (i.e., 90s) in optimized formulation F5. The water absorption ratio of the formulated tablets was found to be in the range of 16Â±0.16 to 174Â±0.21%. The cumulative drug dissolved in the optimized formulation F5 was found to be 99.83Â±0.56% in 5 min.
Conclusion: The dissolution efficiency of ibuprofen was enhanced when starch xanthate was found to be a superdisintegrant when combined with sodium starch glycolate, croscarmellose sodium and, hence it could be used in the formulation of fast dissolving tablets to provide immediate release of the contained drug within 5 min.
Sanket Kumar, Shiv Kr Garg. Fast dissolving tablets (fdts): current status, new market opportunities, recent advances in manufacturing technologies and future prospects. Int J Pharm Pharm Sci 2014;3:22-35.
Anupam Roy. Orodispersible tablets: a review. Asain J Pharm Clin Res 2016;9:19-26.
Ashish Masih, Amar Kumar, Shivam Singh, Ajay Kumar Tiwari. Fast dissolving tablets: a review. Int J Curr Pharm Res 2017;9:8-18.
Pratik Swarup Das, Sushma Verma, Puja Saha. Fast dissolving tablet using solid dispersion technique: a review. Int J Curr Pharm Res 2017;9:1-4.
Lachman L, Libermann HA, Kanig JL. The theory and practice of industrial pharmacy. 3rdedition; 1991. p. 233-5.
Biradar S, Bhagavati S, Kuppasad I. Fast dissolving drug delivery system: a brief overview. Int J Pharmacol 2005;4:2.
Rubendra Kurmi, Dinesh Kumar Mishra, Dinesh Kumar Jain. Solid dispersion: a novel means of solubility enhancement. J Crit Rev 2016;3:1-8.
The United States Pharmacopoeia 29, National Formulary 24, Asian Edition. Rockville, MD: United States Pharmacopoeia Convention, Inc; 2006. p. 1890.
GB Preethi, Sayan Banerjee, HN Shivakumar, M Ravi Kumar. Formulation of fast-dissolving tablets of doxazosin mesylate drug by direct compression method. Int J Appl Pharm 2017;9:22-8.
Hiremath JG, Shastry CS, Srinath MS. Pharmaceutical approaches of taste masking in oral dosage forms. Indian Drugs 2004;41:253-7.
Abdelbary A, Elshafeey AH, Zidan G. Comparative effects of different cellulosic-based directly compressed orodispersible tablets on oral bioavailability of famotidine. Carbohydrate Polymers 2009;77:799-806.
Amrita Soni, Vaibhav Rajoriya, Varsha Kashaw. Formulation development and evaluation of fast dissolving tablet of ramipril. Int J Pharm Pharm Sci 2015;7:127-31.
Goel H, Vora N, Rana V. A novel approach to optimize and formulate fast disintegrating tablets for nausea and vomiting. AAPS PharmSciTech 2008;9:774â€“8.
Ministry of Health and Family Welfare, Government of India. Indian Pharmacopoeia. Volume I, 2010 edition. Ghaziabad: The Indian Pharmacopoeia Commission; 2010. p. 218-20.
Hrishav Das Purkayastha, Bipul Nath. Formulation and evaluation of oral fast disintegrating tablet of ibuprofen using two super disintegrants. Int J Curr Pharm Res 2017;9:92-5.