一项随机的试点研究,以评估新型液体配方的稳定性,味道和可口性
Amit Sawant1, Nazim Kanji1, Marcello DiMare2
1Quotient Sciences, Nottingham, UK.
Drug development and industrial pharmacy
|December 17, 2024
概括
开发了一种新的液体tenapanor配方,以改善慢性脏病和刺激性肠综合征患者的口感. 带有拉斯伯里风味,糖糖的版本显示出最佳的味道和可接受性.
科学领域:
- 制药科学 制药科学
- 药物的配方 药物的配方
- 患者报告的结果
背景情况:
- 帕诺尔是一种最小吸收的/交换器3的抑制剂.
- 它已被批准用于治疗便秘占主导地位的刺激性肠综合征和慢性病患者的高血症.
- 液体配方是必要的,因为难以吞药片,特别是对于儿科研究.
研究的目的:
- 为了开发一个稳定的液体配方的tenapanor.
- 评估不同甜味剂和风味组合的味道和可口性.
- 为未来的患者研究确定可接受的配方.
主要方法:
- 开发了一种液体十巴诺尔配方,目标度为5mg/mL.
- 使用缓冲剂,辅溶剂和防腐剂优化了溶解度和稳定性.
- 七种配方被评估的味道和可口性,健康的成年人使用一口-and-spit方法.
主要成果:
- 获得了稳定的天帕诺水溶液 (5毫克/毫升,pH值3.4),在2-8°C下稳定12个月.
- 含有糖和拉斯伯里风味的配方显示了最高的整体可接受性和改善的味道.
- 这种配方比没有甜味剂或调味剂的参考溶液更受欢迎.
结论:
- 一个稳定和可口的液体配方的tenapanor成功开发.
- 糖和拉斯伯里风味组合显著增强了味道和可接受性.
- 这种配方适合进入患者临床研究.
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