RANITIDINE CONTROLLED RELEASE ANTI-REFLUX SUSPENSION FOR GASTRO-OESOPHAGEAL REFLUX DISEASE AND ITS IN VITRO EVALUATION


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

Abstract


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.


Keywords


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

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