%0 Journal Article
%T Evaluation of an Innovative Over-the-Counter Treatment for Symptoms of Reflux Disease: Quick-Dissolving Alginate Granules
%A Vicki Strugala
%A Peter W. Dettmar
%A Edward C. M. Thomas
%J ISRN Pharmaceutics
%D 2012
%R 10.5402/2012/950162
%X Traditional antacids and alginate-based reflux suppressants are OTC products commonly used to treat reflux symptoms. There has been a lack of innovation of new formulations in this therapy area despite consumers finding established products unpalatable. Here we evaluate a novel product formulation which takes the form of quick-dissolving alginate granules in single-dose sachets (Gaviscon Direct Powder (GDP)). Market research and taste evaluation confirmed that reflux sufferers considered GDP to have good flavour and taste, no chalky aftertaste and dissolved rapidly in the mouth with 68% noting so within 10 seconds. GDP was considered convenient and easy to use. The consumer-driven product development was also shown to form a strong alginate raft in standardised in vitro conditions that met the specifications of the BP monograph (raft strength > 7.5£¿g). Gastric retention of GDP and a test meal was investigated in healthy volunteers using gamma scintigraphy in comparison to Liquid Gaviscon. Both products formed an alginate raft in the stomach above the test meal and emptied after the meal. The gastric retention of the GDP product was found to be noninferior to Liquid Gaviscon. In conclusion, the innovative GDP product formed an effective raft and was well liked by consumers. 1. Introduction There are a wide variety of over-the-counter (OTC) treatments that allow heartburn and indigestion sufferers to self-medicate. These take the form of simple antacids (e.g., Rennie), alginate-based reflux suppressants (e.g., Gaviscon), but also H2-receptor antagonists (e.g., Zantac) and proton pump inhibitors (e.g., Losec) that prevent acid secretion and are also available OTC. Here we focus on antacids and alginates only. Antacids, which primarily raise oesophageal pH and neutralise some stomach acid [1], are predominantly chewable tablets but are also available in liquids. Alginate products (which form a raft and suppress reflux) are usually suspensions of single- or double-strength alginate, but chewable tablet formats are also widely available. Antacids are often formulated for taste, convenience, and price, but alginate products have a more complex formulation that is necessary for the established efficacy of these products [2¨C5]. The presence of reflux symptoms (e.g., heartburn) is the biggest driver for using antacids, and there is no difference between use by men or women [6]. Data from the few formal studies that have been completed suggest that consumers do not report antacid/alginate formulations as being pleasurable or palatable [7¨C12]. These studies used
%U http://www.hindawi.com/journals/isrn.pharmaceutics/2012/950162/