ABSTRACT:
In solid dosage forms, fast dissolving tablets has shows the superior way for ease of administration for the patients. The present senario involves in the optimization andevaluation of starch glutarate as a novel superdintegrant in the formulation of fast dissolving tablets of Ibesartan employing 23 factorial design. Starch glutarate was synthesized by esterification process. The synthesized starch glutarate was subjected to physical and micromeritic evaluation. The, fast dissolving tablets of Irbesartan were prepared by employing starch glutarate as a superdisintegrant in different proportions by using 23 factorial design and by direct compression method. All the preparedbatches of fast dissolving tablets 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). The starch glutarate prepared was found to be fine,free flowing amorphous powder it exhibited good swelling in water. Fourier transform infrared spectra (FTIR) and Differential scanning calorimetry (DSC) study indicated the absence of interaction between Irbesartan and starch glutarate. All the batches of fast dissolving tablets formulated by employing starch glutarate 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 optimized formulation F8 has the least disintegration time i.e., 30±0.02s. The in vitro wetting time was less (i.e., 90s) in optimized formulation F8. The cumulative drug dissolved in the optimized formulation F8 was found to be 99.15±0.56% in 10 min. Starch glutarate was found to be a superdisintegrant which enhanced the dissolution efficiency when combined with crospovidone, croscarmellose sodium, with the Irbesartan and hence it could be used in the formulation of fast dissolving tablets to provide immediate release of the contained drug within 15 minutes.
Cite this article:
A. Bharathi, K. Tanvija, D. Chandra Sekhar Naik. Design, Optimization and Evaluation of Irbesartan Fast Dissolving Tablets Emplyoing Novel Synthetic Superdisintegrants. Research J. Pharm. and Tech 2020; 13(5):2174-2180. doi: 10.5958/0974-360X.2020.00391.1
Cite(Electronic):
A. Bharathi, K. Tanvija, D. Chandra Sekhar Naik. Design, Optimization and Evaluation of Irbesartan Fast Dissolving Tablets Emplyoing Novel Synthetic Superdisintegrants. Research J. Pharm. and Tech 2020; 13(5):2174-2180. doi: 10.5958/0974-360X.2020.00391.1 Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-5-21
REFERENCES:
1. Suresh B, Rajender KM, Ramesh G, Yamsani MR. Orodispersible tablets: An overview. Asian J Pharm2008; 2:2-11.
2. Seager H. Drug delivery product and zydis-fast dissolving dosage form. J Pharm Pharmacol 1998; 50:375-82.
3. Abdelbary G, Prinderre P, Couani C, Taochim J, Reynier JP, Riccerelle P. The preparation of orally disintegrating tablets using a hydrophilic waxy binder. Int J Pharm 2004; 278(2):423-33.
4. Sastry SV, Nyshadham JR, Fix JA. Recent technological advances in oral drug delivery: a review. Pharm Sci Techol Today 2000; 3(4):138-45.
5. Lachman L, Libermann HA, Kanig JL. The theory and practice of industrial pharmacy. 3rdedition; 1991. p. 233-5.
6. Biradar S, Bhagavati S, Kuppasad I. Fast dissolving drug delivery system: A brief overview. Internet J Pharmacol 2005; 4:2. edition; 1991. p. 233-5.
7. Indurwade NH, Rajyaguru TH, Nakhat PD. Noval approach-fast dissolving tablets. Indian Drug 2002; 38(8):405-9.
8. The United States Pharmacopoeia 29, National Formulary 24, Asian Edition. Rockville, MD: United States Pharmacopoeia Convention, Inc; 2006. p. 1890.
9. Jacob S, Shirwaikar A, Joseph A, Srinivasan KK. Novel co-processed excipient of mannitol and microcrystalline callous for preparing fast dissolving tablet of Glipizide. Indian J Pharm Sci 2007; 69(5):633-9.
10. Hiremath JG, Shastry CS, Srinath MS. Pharmaceutical approaches of taste masking in oral dorage forms. Indian Drugs 2004; 41:253-7.
11. 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.
12. Battu SK, Michael AR, Soumyajit M, Madhusudan Y. Formulation and evaluation of rapidly disintegrating fenoverine tablets: effect of super disintegrants. Drug Dev Ind Pharm 2007; 33:1225-32.
13. Goel H, Vora N, Rana V. A novel approach to optimize and formulate fast disintegrating tablets for nausea and vomiting. AAPS PharmSciTech 2008; 9:774–8.
14. Puttewar TY, Kshirsagar MD, Chandewar AV, Chikhale RV. Formulation and evaluation of orodispersible tablet of taste masked doxylamine succinate using ion exchange resin. J King Saud University (Sci) 2010; 22:229–40.
15. Manohara P, Trivikrama Bhatlu M, Kiran Kumar P V, Bala Krishna N, Murali krishna Ranga. Formulation and evaluation of Irbesartan fast disintegrating tablets in the design Hordeum Vulgare Hull. Journal of Pharmacy Research 2012; 5:657-66.