Generic placeholder image

Current Drug Therapy

Author(s): Sangmesh Torne, A. Sheela* and N.C. Sarada

DOI: 10.2174/1574885514666190103140951

DownloadDownload PDF Flyer Cite As
Investigation of the Role of the Alkalizing Agent in Sodium Alginate Liquid Anti-reflux Suspension

Page: [53 - 60] Pages: 8

  • * (Excluding Mailing and Handling)

Abstract

Background: Anti-reflux formulation is one of the popular formulations across the globe in the pharmaceutical industry used specifically for the management of gastro-oesophageal reflux disease. But, this formulation is less explored with respect to research. Anti-reflux formulation has challenges to show its antacid functionality, which could have synergies in the management of refluxes in gastro-oesophageal reflux disease. Alkalizing agents act as antacid and improve the acid neutralization capacity in the anti-reflux formulation, and can be used appropriately as they affect raft strength beyond certain (optimum) limits.

Objective: The objective of this work is to investigate the significance of alkalizing agent in sodium alginate based on oral liquid anti-reflux suspension for the management of Gastro-oesophageal Reflux Disease (GERD).

Methods: In the present study, the formulation was prepared using sodium alginate along with different alkalizing agents like calcium carbonate and sodium bicarbonate at different levels. The formulation was further studied for in-vitro characterization like pH, viscosity, Acid Neutralization Capacity (ANC), thickness, formation speed, flotation, and raft strength.

Results: The formulation with a higher level of calcium carbonate as the alkalizing agent showed a positive effect on the acid neutralization capacity (20.83mEq) and raft strength (16.95g) as well. Whereas, the formulation with a higher level of sodium bi-carbonate (4.01%) showed improved acid neutralization (22.31mEq) but showed a negative effect on raft strengths (10.08g).

Conclusion: Based on the study, the optimum levels include 5% sodium alginate, 1.6% calcium carbonate and 2.67% sodium bicarbonate to achieve good liquid suspension formulation possessing good acid neutralization capacity as well as raft strength.

Keywords: Suspension, alginate, GERD, raft, in vitro, anti-reflux.

Graphical Abstract

[1]
Dutta U, Armstrong D. Novel pharmaceutical approaches to reflux disease. Gastroenterol Clin North Am 2013; 42(1): 93-117.
[http://dx.doi.org/10.1016/j.gtc.2012.12.001] [PMID: 23452633]
[2]
Hershcovici T, Fass R. Pharmacological management of GERD: where does it stand now? Trends Pharmacol Sci 2011; 32(4): 258-64.
[http://dx.doi.org/10.1016/j.tips.2011.02.007] [PMID: 21429600]
[3]
Fass R, Bautista J, Janarthanan S. Treatment of gastroesophageal reflux disease. Clin Cornerstone 2003; 5(4): 18-29.
[http://dx.doi.org/10.1016/S1098-3597(03)90096-2] [PMID: 15101492]
[4]
Yu-Min K, Wen-Hung H, Meng-Chieh W, et al. Recent advances in the pharmacological management of gastroesophageal reflux disease 2017; 62: 3298-319.
[5]
Farid M. When pharma meets nano or the emerging era of nano-pharmaceuticals. Pharm Anal Acta 2013; 4: 4.
[6]
Hampson FC, Farndale A, Strugala V, Sykes J, Jolliffe IG, Dettmar PW. Alginate rafts and their characterisation. Int J Pharm 2005; 294(1-2): 137-47.
[http://dx.doi.org/10.1016/j.ijpharm.2005.01.036] [PMID: 15814238]
[7]
Johnson FA, Craig DQM, Mercer A, et al. The use of image analysis as a means of monitoring bubble formation in alginate raft. Int J Pharm 1998; 170: 179-85.
[http://dx.doi.org/10.1016/S0378-5173(98)00143-4]
[8]
De Ruigh A, Roman S, Chen J, Pandolfino JE, Kahrilas PJ. Gaviscon Double Action Liquid (antacid & alginate) is more effective than antacid in controlling post-prandial oesophageal acid exposure in GERD patients: A double-blind crossover study. Aliment Pharmacol Ther 2014; 40(5): 531-7.
[http://dx.doi.org/10.1111/apt.12857] [PMID: 25041141]
[9]
Mandel KG, Daggy BP, Brodie DA, Jacoby HI. Review article: alginate-raft formulations in the treatment of heartburn and acid reflux. Aliment Pharmacol Ther 2000; 14(6): 669-90.
[http://dx.doi.org/10.1046/j.1365-2036.2000.00759.x] [PMID: 10848650]
[10]
Lee KY, Mooney DJ. Alginate: Properties and biomedical applications. Prog Polym Sci 2012; 37(1): 106-26.
[http://dx.doi.org/10.1016/j.progpolymsci.2011.06.003] [PMID: 22125349]
[11]
Elliott BM, Steckbeck KE, Murray LR, Erk KA. Rheological investigation of the shear strength, durability, and recovery of alginate rafts formed by antacid medication in varying pH environments. Int J Pharm 2013; 457(1): 118-23.
[http://dx.doi.org/10.1016/j.ijpharm.2013.09.034] [PMID: 24095816]
[12]
Washington N, Washington C, Wilson CG, et al. The effect of inclusion of aluminum hydroxide in alginate-containing raft forming antacid. Int J Pharm 1986; 28: 139-43.
[http://dx.doi.org/10.1016/0378-5173(86)90238-3]
[13]
Withington R. Assignee. Pharmaceutical compositions for use in the sup-pression of gastric reflux 1979. United State patent US4140760.
[14]
Ajala TO, Silva BO. The effect of pharmaceutical properties on the acid neutralizing capacity of antacid oral suspensions. J Pharm Investig 2015; 45: 433-9.
[http://dx.doi.org/10.1007/s40005-015-0188-x]
[15]
USP-29. 2017. http://www. pharmacopeia.cn/v29240/usp29nf 24s0_c301.html Acid Neutralizing capacity 301, (2017)United state pharmacopoeia
[16]
BP: alginate raft-forming oral suspension British Pharmacopoeia 2007; 3.