Sangmesh R. Torne, Sheela A., Sarada N. C.


Objective: The aim of this work to develop Ranitidine anti-reflux powder for controlled release suspension. The developed formulation is also assed for invitro anti-reflux characteristics.

Method: The formulation was optimized using sodium alginate as a gelling agent along with calcium carbonate, sodium bicarbonate, magnesium hydroxide, aluminium hydroxide as alkalizing agents and colloidal microcrystalline cellulose (MCC 105) as a suspending agent at various concentrations and arrived at an optimized formulation for its best quality attributes. To avoid initial release in water before administration, Ranitidine coated MCC sphere was incorporated into powder formulation and subjected to in vitro characteristics like raft strength, acid neutralizing capacity, pH, viscosity and dissolution study.

Results: The obtained results were assessed using Minitab 17 statistical software to conclude the study design. Formulation containing 750 mg alginate gives better raft strengths, acid neutralizing capacity as compared to other formulations. The ranitidine anti-reflux formulation containing 750 mg alginate shows zero order controlled release in the simulated gastric fluid (SGF) up to 10 hrs.

Conclusion: Stability study at ambient and accelerated conditions reveals that the optimized formulation is sufficiently stable up to 3 months. The developed therapeutic formulation can be very much useful in the management and treatment of gastro-oesophageal reflux disease (GERD) in comparison with existing anti-reflux formulation which has only reflux resistance action.


Suspension, Alginate, Gastro-oesophageal reflux disease, Raft, Controlled release, Ranitidine


Dutta U, Armstrong D. Novel Pharmaceutical Approaches to Reflux Disease. GastroenterolClin N Am2013;42:93–117.

Bennett R, Stanciu C. Alginate / Antacid in the reduction of Gastro-oesophageal reflux disease The Lancet 1974;109.[Internet]. [cited 2018 Jul 18] Available from http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(74)92340-X/abstract

Washington N, Washington C, Wilson G, Davis S. What is “Liquid Gaviscon”? A comparison of four international formulations. IntJPharm1986;34:105–9.

MandlekarV, MaratheS, DevarajanV. A novel raft-forming antacid suspension using a natural dietary fibre. IntJPharm1997;148:117–21.

Strugala V, Dettmar W, Thomas C. Evaluation of an Innovative Over-the-Counter Treatment for Symptoms of Reflux Disease: Quick-Dissolving Alginate Granules. ISRN Pharm2012:7.

MHRA, (2017). Medicines and Healthcare product Regulatory Agency, UK.,Public assessment report, Gaviscon 250 Chewable Tablets.[Internet] [cited 2018 Jul 18] Available from http://www.mhra.gov.uk/public-assessment-reports/

Hampson FC, Farndale A, Strugala V, Sykes J, Jolliffe IG, Dettmar PW. Alginate rafts and their characterisation. IntJPharm2005;294:137–47.

Sreejan M, Kanchi J, Kancherla RA, Laxmi KK. Alginate based raft forming tablets of enhanced bioavailability of tinidazole. Int J App Pahrma2017;9:3,55-60

Johnson FA, Craig DQM, Mercer A, Chauhan S. The use of image analysis as a means of monitoring bubble formation in alginate rafts. IntJPharm1998;170:179–85.

Harshil PS, Shailesh TP, Patel CN. Gastro retentive drug delivery system: from concept to commercial success. J Crit Rev 2017;4:2,10-21.

Richardson JC, Dettmar PW, Hampson FC, Melia CD. Oesophageal bioadhesion of sodium alginate suspensions: Particle swelling and mucosal retention. EurJPharmSci2004;23:49–56.

Fass R, Bautista J, Janarthanan S. Treatment of Gastroesophageal reflux disease. Clin Cornerstone2003;5:18–29.

Mandel KG, Daggy BP, Brodie DA, Jacoby HI. Review article: Alginate-raft formulations in the treatment of heartburn and acid reflux. Aliment PharmacolTher2000; 14:669–690.

Kerdsakundee N, Mahattanadul S, Wiwattanapatapee R. Development and evaluation of gastroretentive raft forming systems incorporating curcumin-Eudragit?? EPO solid dispersions for gastric ulcer treatment. Eur J PharmBiopharm2015;94:513–20.

Trivedi ND, Trivedi UN, Patel MM, Patel JK, Bhandari A. Preparation and Evaluation of floating matrix tablet of ranitidine. AmJDrug Disco Dev2011;1:8-23.

Washington N, Washington C, Wilson CG. Gastric distribution and residence time of two anti-reflux formulations. IntJPharm1987;39:163–71.

United State Pharmacopoeia (USP) 34 (National Formulary29), Chapter <301>, [Internet] Rockville, MD: Pharmacopoeial Convention; 2017. [cited 2018 Jul 18] Available from http://www.pharmacopeia.cn/v29240/usp29nf24s0_c301.html. asp

Washington N, Wilson CG, Davis SS. Evaluation of “raft-forming” antacid neutralizing capacity: in vitro and in vivo correlations. IntJPharm1985;27:279–86.

The British Pharmacopoeia commission, British Pharmacopoeia 2007, HMSO Publication; London; 2007,Vol.-3,664.

Sahoo BK, Mukherjee J, PalTK. Development and Validation of a High ¬ Performance Liquid Chromatographic Method for Bio Analytical Application With Ranitidine Hcl. Int J Pharm Pharm Sci2011;3:2–6.

Diane AAI, Patel R, Basit AW. Simple and universal HPLC-UV method to determine cimetidine, ranitidine, famotidine and nizatidine in urine: Application to the analysis of ranitidine and its metabolites in human volunteers. J Chromatogr B 2007; 860:235-40.

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