奥梅普拉即用口服溶液在肖邦基中的稳定性
Antonio Spennacchio1, Angela Assunta Lopedota1, Flavia Maria la Forgia2
1Department of Pharmacy - Pharmaceutical Sciences, University of Bari "Aldo Moro", Bari, Italy.
International journal of pharmaceutical compounding
|June 2, 2023
概括
一种使用氧-β-环素的新型奥梅普拉液体配方为无法吞药片的患者提供了稳定的选择. 这种临时解决方案为儿科和成人群体提供了可行的替代方案.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 药用化学 医学化学
背景情况:
- 奥梅普拉是一种质子抑制剂,用于治疗和胃食道逆流.
- 目前的剂量形式对包括儿童在内的特定患者群体构成挑战.
- 临时配方可以改善药物可用性.
研究的目的:
- 开发和描述一种即时的液体梅醇配方.
- 评估奥梅普拉在新型液基中的可溶性和稳定性.
- 为患有吞困难的患者提供替代剂型.
主要方法:
- 使用基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基基
- 在25°C时在指定的液体载体中对奥梅普拉的溶解性研究.
- 在4°C和25°C时对配方的物理化学稳定性评估.
- 使用高压液体色谱法进行分析.
主要成果:
- 在肖邦基中,来的内在溶解度在25°C时确定为5.33 mg/mL±0.23 mg/mL.
- 液体奥梅普拉制剂在4°C储存时表现出3个月的化学稳定性.
- 该配方在25°C时具有9天的有限保质期.
结论:
- 开发的临时液体奥梅普拉配方适用于儿科和成人患者.
- 这种配方克服了现有的剂量形式的局限性,提高了患者的遵守性.
- xypropyl-β-cyclodextrin为奥梅普拉提供了一种溶解媒介,使液体制备成为可能.
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