DESIGN AND FORMULATION DEVELOPMENT OF FAST-DISSOLVING TABLETS OF IBUPROFEN USING NOVEL NATURAL SUPERDISINTEGRANT
Objective: The objective of the study was to evaluate Ocimum gratissimum mucilage as a novel superdisintegrant in the formulation of fast-dissolving tablets (FDT) of Biopharmaceutical Classification System-II drug (Ibuprofen) employing a 23 factorial design.
Methods: O. gratissimum mucilage was extracted by seeds and it was subjected to physical, chemical, and micrometric studies were evaluated. To establish FDT of ibuprofen with O. gratissimum mucilage as a superdisintegrants in different ratios using direct compression method employing 23 factorial design. All the formulation tablets were evaluated pre-compression and post-compression parameters like dissolution efficiency (DE%) percent of drug dissolved at 5 min.
Results: The mucilage was to be found fine, free-flowing crystalline powder, and excellent swelling nature in all suitable solvents and buffers. The Fourier transform infrared and differential scanning calorimetry studies were indicated to no interactions between ibuprofen and O. gratissimum mucilage. All the FDT formulated employing novel mucilage shows good quality with regard drug content (98.05±0.31–99.39±0.54), hardness (3.6– 4 kg/sq. cm), and friability (0.12–0.15%). The optimized formulation batch shows less disintegrant time (30±0.06). In vitro wetting time was less (i.e., 90 s) in optimized formulation F2. The water absorption ratio of the formulated tablets was found to be in the range of 99±0.56. The cumulative drug dissolved in the optimized formulation F2 was found to be 99% in 10 min.
Conclusion: O. gratissimum mucilage was found to be a novel superdisintegrant which enhanced the DE when combined with crospovidone and croscarmellose sodium; hence, it could be used in the formulation of FDT to provide immediate release of the contained drug within 5 min.
2. Dey P, Ghosh A. Wafers: An innovative advancement of orodispersible films. Int J Appl Pharm 2016;8:81-7.
3. Abdelbary G, Prinderre P, Eouani C, Joachim J, Reynier JP, Piccerelle P, et al. The preparation of orally disintegrating tablets using a hydrophilic waxy binder. Int J Pharm 2004;278:423-33.
4. Roy A. Orodispersible tablets: A review. Asian J Pharm Clin Res 2016;9:19.
5. Masih A, Kumar A, Singh S, Tiwari AK. Fast dissolving tablets: A review. Int J Cur Pharm Res 2017;9:8.
6. Biradar S, Bhagavati S, Kuppasad I. Fast dissolving drug delivery system: A brief overview. Int J Pharmacol 2005;4:2, 233.
7. Indurwade NH, Rajyaguru TH, Nakhat PD. Noval approach-fast dissolving tablets. Indian Drug 2002;38:405.
8. The United States Pharmacopoeia 29, National Formulary 24, Asian Edition. Rockville, MD: USPC, Inc.; 2006. p. 1890.
9. Jacob S, Shirwaikar A, Joseph A, Srinivasan KK. Novel coprocessed excipient of mannitol and microcrystalline callous for preparing fast dissolving tablet of Glipizide. Indian J Pharm Sci 2007;69:633.
10. Hiremath JG, Shastry CS, Srinath MS. Pharmaceutical approaches of taste masking in oral dorage forms. Ind Drug 2004;41:253.
11. Abdelbary A, Elshafeey AH, Zidan G. Comparative effects of different cellulosic-based directly compressed orodispersible tablets on oral bioavailability of famotidine. Car Poly 2009;77:799.
12. Battu SK, Repka MA, Majumdar S, Madhusudan RY. Formulation and evaluation of rapidly disintegrating fenoverine tablets: Effect of superdisintegrants. 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;9:774-81.
14. Jogala S, Ankathi L, Jarupula RN. Glimepiride fast disintegrating tablets: Formulation, evaluation and in vivo disintegration and dynamic studies. Int J Pharm Pharm Sci 2016;8:271.
15. Indian Pharmacopoeia Commission. Indian Pharmacopoeia.New Delhi: Indian Pharmacopoeia Commission; 2010. p. 218.
16. Kishore VS, Kumar DG, Sudheer B, Sandeep M. Design and development of fast dissolving tablets of ibuprofen. Res Rev Pharm Pharm Sci 2013;2:65.
17. Subrahmanyam CV. Text Book of Physical Pharmaceutics. 2nd ed. New Delhi: Vallabh Prakashan; 2005. p. 210.
18. Lachman L, Lieberman A, Kinig JL. The Theory and Practice of Industrial Pharmacy. 2nd ed. Mumbai: Varghese Publishing House; 1999. p. 67.
19. Govt. of India, Ministry of Health and Family Welfare. Indian Pharmacopoeia 2007. Vol. 1. Ghaziabad: The Indian Pharmacopoeia Commission; 2007. p. 177.
20. Padmaja B, Ramakrishna R, Goutham G. Formulation and evaluation of fast dissolving tablets of ranitidine hydrochloride. J Pharm Res 2015;9:165.
21. Anupama K, Shelly K, Neena B. Formulation and evaluation of mouth dissolving tablets of oxcarbazepine. Int J Pharm Pharm Sci 2009;1:12.
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.