OBJECTIVE This study was conducted to evaluate the taste and grittiness of two formulations of Riomet® ER (metformin hydrochloride for extended release [ER] oral suspension 100 mg/mL) differing only in their flavoring agents (strawberry and grape) in comparison with two commercially available immediate-release (IR) formulations of metformin, Riomet® Cherry (metformin hydrochloride oral solution 500 mg/5 mL) and metformin IR tablets (metformin hydrochloride IR tablets 500 mg), in healthy human subjects aged 10-70 years. METHODS Five comparison sets (i.e., Riomet® Cherry vs. Riomet® ER Strawberry; Riomet® Cherry vs. Riomet® ER Grape; metformin IR vs. Riomet® ER Strawberry; metformin IR vs. Riomet® ER Grape; and Riomet® Cherry vs. metformin IR) were evaluated. Riomet® ER was reconstituted as instructed on the label. Metformin IR tablets were crushed one at a time into a fine powder using a pharmaceutical pill crusher and mixed with 5 mL of water. A 2.5-mL dose of each product was administered to each subject. Subjects were instructed not to swallow any of the products. Each product in the comparison set was rated by the subjects for taste and grittiness according to a 7-point hedonic facial scale and a 5-point level of agreement scale. A comparison questionnaire was also completed by the subjects after evaluating each set. In all, 56 subjects were enrolled and 55 subjects completed the study. The taste preference was statistically evaluated. RESULTS AND CONCLUSIONS All Riomet® formulations were significantly preferred overall to metformin IR crushed tablets. Both the strawberry and the grape flavors of Riomet® ER tended to be preferred to Riomet® Cherry.

中文翻译：

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在健康受试者中评估Riomet®ER草莓，Riomet®ER葡萄，Riomet®樱桃和二甲双胍速释片的味道和松软度。

目的进行这项研究以评估两种Riomet®ER（缓释二甲双胍盐酸盐[ER]口服混悬液100 mg / mL）的味道和粘性，与两种市售产品相比，它们的调味剂（草莓和葡萄）仅不同现有的二甲双胍，Riomet®Cherry（盐酸二甲双胍口服液500 mg / 5 mL）和二甲双胍IR片（盐酸二甲双胍IR片剂500 mg）的速释（IR）制剂，适用于10-70岁的健康人类受试者。方法五个比较组（即Riomet®Cherry与Riomet®ER草莓；Riomet®Cherry与Riomet®ER葡萄；二甲双胍IR与Riomet®ER草莓；二甲双胍IR与Riomet®ER Grape；以及Riomet®Cherry与vs评估二甲双胍IR）。按照标签上的指示重新配制Riomet®ER。使用药用药丸破碎机将二甲双胍IR片剂每次一次破碎成细粉，并与5 mL水混合。向每个受试者施用2.5mL剂量的每种产品。指示受试者不要吞咽任何产品。根据7点享乐面部量表和5点协议量表，受试者对比较组中的每种产品的味道和松脆性进行评分。在评估每组后，受试者还填写了比较问卷。总共招募了56位受试者，其中55位受试者完成了研究。对口味偏好进行统计学评估。结果与结论总体而言，所有Riomet®制剂均明显优于二甲双胍IR压片。Riomet®ER的草莓和葡萄风味都比Riomet®Cherry更受青睐。