Strugala Vicki, Dettmar Peter W, Thomas Edward C M
Technostics Ltd., Daisy Building, 2nd Floor, Castle Hill Hospital, Cottingham, East Yorkshire HU16 5JQ, UK.
ISRN Pharm. 2012;2012:950162. doi: 10.5402/2012/950162. Epub 2012 Dec 23.
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.
传统抗酸剂和基于海藻酸盐的反流抑制剂是非处方药产品，常用于治疗反流症状。尽管消费者发现现有产品口感不佳，但该治疗领域一直缺乏新配方的创新。在此，我们评估一种新型产品配方，其形式为单剂量小袋包装的速溶海藻酸盐颗粒（即盖胃平直接粉剂（GDP））。市场调研和口味评估证实，反流患者认为GDP味道不错，无白垩味余味，且在口中迅速溶解，68%的人指出在10秒内即可溶解。GDP被认为方便易用。消费者驱动的产品开发还表明，在符合英国药典专论规格（筏强度>7.5克）的标准化体外条件下，GDP能形成坚固的海藻酸盐筏。与液体制剂盖胃平相比，使用γ闪烁扫描技术在健康志愿者中研究了GDP和测试餐的胃内滞留情况。两种产品在测试餐上方的胃中均形成了海藻酸盐筏，并在餐后排空。发现GDP产品的胃内滞留情况不劣于液体制剂盖胃平。总之，创新的GDP产品形成了有效的筏，且深受消费者喜爱。
