Formulation, Development and Evaluation of Chewable Bi-layered Tablets for Treating Gastro Esophageal Reflux Disease
Abstract
The purpose of this research work was to formulate raft-forming chewable bilayer tablets of sodium alginate using a raft-forming agent along with gas-generating agents. Tablets were prepared by wet granulation and evaluated for raft strength, acid neutralization capacity, weight variation, % drug content, thickness, hardness, friability and in vitro drug release. Various raft-forming agents were used in preliminary screening. The amount of sodium alginate, amount of calcium carbonate and amount sodium bicarbonate were selected as variables. Raft strength, acid neutralization capacity and drug release at 30 min were selected as responses.Tablets containing sodium alginate were having maximum raft strength as compared with other raft-forming agents. Acid neutralization capacity and in vitro drug release of all factorial batches were found to be satisfactory. Prepared tablets were found to be pharmaceutically equivalent to the marketed product. It was concluded that raft-forming chewable bilayer tablets prepared using an optimum amount of sodium alginate, calcium carbonate and sodium bicarbonate could be an efficient dosage form in the treatment of gastro oesophageal reflux diseases.
Keywords: Chewable bilayer tablet, Sodium alginate, Raft forming agent, Acid Neutralizing capacity
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2. Bhavsar DN, Varde NM,Sini SC, Shah VH. Advances in grdds: raft forming system a review J. Drug Deliv Ther. 2012; 2(5):123-128.
3. Mandel KG, Daggy BP, Jacoby HI, Brodie DA. Review article: alginate raft formulations in the treatment of heartburn and acid reflux. Aliment Pharmacol Ther. 2000; 14:669-90.
4. Kapadia CJ, Mane VB. Raft forming agents: Antireflux formulation. Drug Dev Ind Pharm. 2007; 33:1350-61.
5. Washington N, Wilson CG, Greaves JL, Danneskiold SP. An investigation into the floating behaviour of a pectin-containing anti-reflux formulation by means of gamma scintigraphy. Scand J Gastroenterol. 1988; 23:920-4
6. Waterhouse ET, Washington C, Washington N. An investigation into efficacy of pectin based anti—reflux formulation-Aflurax. Int J Pharm. 2000; 209:7985.
7. Hampson FC, Jolliffe IG, Bakhtyari A, Taylor G, Sykes J, Johnstone LM, et al. Alginate–antacid combinations: Raft formation and gastric retention studies. Drug Dev Ind Pharm. 2010; 36:614-23.
8. Johnson FA, Craig DQ, Mercer AD, Chauhan S. The effects of alginate molecular structure and formulation variables on the physical characteristics of alginate raft systems. Int J Pharm. 1997; 159:35-42.
9. Mandelkar SV, Marathe SS, Devrajan PV. A novel raft-forming suspension using a natural dietary fibre. Int J Pharm. 1997; 148:117-21.
10. Kanaka DN, Prameela Rani A, RadhaMadhav B, Sai Mrudula B, Formulation and evaluation of pulsatile drug delivery system of salbutamol sulphate for chronotherapy of asthama. Int J Pharm Sci Bio Tech. 2010; 11:20-24.
11. Swati J, Mahesh G, Dhaval B, Bhanudas K, Aniruddha C. Formulation design and evaluation of chewable tablets containing h2 blocker. Int J Res Pharm Sci. 2010; 13:282-289.
12. Kathiresan K, Vijin P, Moorthi C, ManavalanR, Formulation and evaluation of loratadine chewable tablets. Res J Pharm. 2010; 14:763-774.
13. United States Pharmacopoeia 32, national formulary 24, 12601, Twinbrook Parkway, Rockville, MD 20852, 2006.
14. British Pharmacopeia, published by The Stationery Office on behalf of the Medicines and Healthcare Products Regulatory Agency (MHRA), 2007; 1384-1385.
15. Prajapati ST, Mehta AP, Modhia IP, Patel CN. Formulation and optimisation of raft forming chewable tablets containing H2 antagonist. Int J Pharm Invest. 2012; 2(4):176-182
16. Hampson FC, Farndale A, Strugala V, Sykes J, Jolliffe IG, Dettmar PW, Alginate rafts and their characterization. Int J Pharm. 2005; 294:137-147.
17. Washington N, Washington C, Wilson CG. Gastric distribution and residence time of two anti-reflux formulations. Int J Pharm. 1987; 39: 163-171.
18. https://www.webmd.com/heartburn-gerd/guide/understanding-gerd-treatment#1

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