OPTIMIZATION OF STARCH CROTONATE AS A NOVEL SUPERDISINTEGRANT IN THE FORMULATION OF FAST DISSOLVING TABLETS THROUGH 23 FACTORIAL DESIGN
Keywords:Superdisintegrant, Fast dissolving, Optimization, Starch crotonate
Objective: To synthesize, characterize and evaluate starch crotonate as a superdisintegrant in the formulation of Piroxicam fast dissolving tablets by employing 23 factorial design.
Methods: Starch crotonate was synthesized and its physical and micromeritic properties were performed to evaluate it. The fast dissolving tablet of Piroxicam were prepared by employing starch crotonate as a superdisintegrant in different proportions in each case by direct compression method using 23 factorial design.
Results: The starch chrotonate prepared was found to be fine, free flowing and amorphous. Starch crotonate exhibited good swelling in water with swelling index (50%). The study of starch crotonate was shown by fourier transform infrared spectra (FTIR). The drug content (100±5%), hardness (3.6–4 kg/sq. cm), and friability (<0.15%) have been effective with regard to all the formulated fast dissolving tablets employing starch crotonate. The disintegration time of all the formulated tablets was found to be in the range of 18±03 to 66±03 sec. The optimized formulation F8 had the least disintegration time i.e., 18±03 sec. The wetting time of the tablets was found to be in the range of 49.92±0.11 to 140±0.18s. The In vitro wetting time was less (i.e., 74±0.37s) in optimized formulation F8. The water absorption ratio of the formulated tablets was found to be in the range of 27.58±0.01 to 123.07±0.33%. The percent drug dissolved in the optimized formulation F8 was found to be 99.83% in 10 min.
Conclusion: Starch crotonate, when combined with sodium starch glycolate, croscarmellose sodium, with Piroxicam was found to be an effective super disintegrant which improved the dissolution efficiency and could therefore be used in the formulation of quick dissolving tablets to provide immediate release of the contained drug within 10 min.
Panigrahi R, Behera S, Panda C. A review on fast dissolving tablets. Web Med Central Pharm Sci 2010;1:1107.
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;6:22-35.
Alok Kumar Gupta, Anuj Mittal, Prof KK Jha. Fast dissolving tablet-a review. Pharma Innovation 2012;1:1-8.
Masih A, A Kumar, S Singh, AK Tiwari. Fast dissolving tablets: a review. Int J Curr Pharm Res 2017;9:8-18.
Sehgal Prateek, Gupta Ramdayal, Singh Umesh Kumar, Chaturvedi Ashwani, Gulati Ashwini, Sharma Mansi. Fast dissolving tablets: a new venture in drug delivery. Am J PharmTech Res 2012;2:2249-3387.
Garima Yadav, Anupriya Kapoor, Shilpi Bhargava. Fast dissolving tablets recent advantages: a review. Int J Pharm Sci Res 2012;3:728-36.
Dobetti L. Fast melting tablets: development and technologies. Pharmtech 2001;37:44-8.
Virely P, Yarhood R. Zydis–a novel fast dissolving dosage form. Manufact Chem 1989;2:37-8.
Reddy LH, Ghosh B, Rajnees. Fast dissolving drug delivery systems: a review of the literature. Indian J Pharm Sci 2002;64:331-6.
Habib W, Khankari R, Hontz J. Fast dissolving drug delivery system: critical review in therapeutics. Drug Carrier Systems 2000;17:61-72.
Lorenzp Lamosa ML, Cuna M, Vila Jato JL, Torre SD. Fast dissolving drug delivery system: an update. J Microencapsul 1997;14:607.
Tackgi H, Kajiyama A, Yanagisawa M. Rapidly disintegrable pharmaceutical composition. USP Patent 2005;6:899.
Priyanka P Pande, NT Rangari. Formulation and stability indicating analysis of orodispersible tablet of piroxicam. Asian J Pharm Clin Res 2015;8:115-9.
R Santosh Kumar, T Naga Satya Yagnesh, V Goutham Kumar. Optimisation of ibuprofen fast dissolving tablets employing starch xanthate using 23factorial design. Int J Appl Pharm 2017;9:51-9.
R Santosh Kumar, T Naga Satya Yagnesh. Synthesis, characterization and evaluation of starch xanthate as a superdisintegrant in the formulation of fast dissolving tablets. Int J Appl Pharm 2018;10:249-58.
R Santosh Kumar, Ankita Gosh. Design, optimisation and evaluation of piroxicam fast dissolving tablets employing starch tartrate-a new superdisintegrant. Int J Appl Pharm 2019;11:89-9.
R Santosh Kumar, Sahithi Mulidi. Optimization of statistically designed aceclofenac fast dissolving tablets employing starch glutamate as a novel superdisintegrant. Int J Appl Pharm 2020;12:77-88.
S Jaya, V Amala. Formulation and in vitro evaluation of oral disintegrating tablets of amlodipine besylate. Int J Appl Pharm 2019;11:49.
Rasha Khalid Dhahir, Myasar Al-Kotaji. Formulation of orally disintegrating tablets of cinnarizine by using direct compression method. Int J Appl Pharm 2019;11:117-23.
Prashant Bhide, Reeshwa Nachinolkar. Formulation development and characterisation of meclizine hydrochloride fast dissolving tablets using solid dispersion technique. Int J Appl Pharm 2018;10:141-6.
S Panwar, V Nagori, J Chauhan, GN Darwhekar, DK Jain. Formulation and evaluation of fast dissolving tablet of piroxicam. Am J PharmTech Res 2011;1:255-73.
Nani Parfati, Karina Citra Rani, Nathanael Charles, Valencia Geovanny. Preparation and evaluation of atenolol-β-cyclodextrin orally disintegrating tablets using co-process crospovidone-sodium starch glycolate. Int J Appl Pharm 2018;10:190-4.
GB Preethi, Sayan Banerjee H, N 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.