混合优化法在基于低聚六亚甲基胍氢化琥珀酸盐的滴眼液剂型的药物开发实施阶段中的应用
- 作者: Shatalov D.O.1, Akhmedova D.A.1, Ivanov I.S.1, Kirillova D.D.1, Koroleva Y.A.1,2, Minenkov D.S.3, Kedik S.A.1
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隶属关系:
- Russian technological university
- Institute of Pharmaceutical Technologies
- Ishlinsky Institute for Problems in Mechanics RAS
- 期: 卷 26, 编号 1 (2024)
- 页面: 35-50
- 栏目: Research paper
- ##submission.dateSubmitted##: 18.01.2024
- ##submission.dateAccepted##: 07.02.2024
- ##submission.datePublished##: 02.04.2024
- URL: https://journals.eco-vector.com/1682-7392/article/view/625402
- DOI: https://doi.org/10.17816/brmma625402
- ID: 625402
如何引用文章
详细
通过离散和持续优化以及随后的风险评估和技术工艺验证,证实了基于支链低聚六亚甲基胍氢化琥珀酸盐物质的滴眼液剂型的药物开发实施阶段的情况。进行了实验样品的开发,确定了关键的工艺和质量参数,进行了工艺特性的测量、参数配给、预测、验证实验、最佳配方的确定、眼药水生产中的风险评估和部分验证。在基于支链低聚六亚甲基胍氢化琥珀酸盐的滴眼液的制药开发过程中,进行了三个周期的优化(包括离散优化和连续优化)。结果确定了活性成分和辅助成分的最佳比例(支链低聚六亚甲基胍氢化琥珀酸盐0.05%、聚乙烯醇1%、磷酸盐缓冲盐水20%、氯化钠0.45%、纯净水 100%)。在对工艺流程进行风险分析审查后,确定了临界点。此外,还进行了部分验证,其积极的结果验证并确认了在制药开发的这 一阶段所做选择的最优性。总的来说,混合优化类型(离散和连续)可用于实施基于支链低聚六亚甲基胍氢化琥珀酸盐的滴眼液的药物开发,并通过一系列实验和风险评估进行了验证,而部分验证则可以验证研究结果。因此,药物开发是一个复杂而耗时的过程,而有限的功能并不总能快速找到最佳药物配方。数学建模方法和各种类型的优化方法可以作为实施药品开发各阶段的有效解决方案。
全文:
作者简介
Denis O. Shatalov
Russian technological university
编辑信件的主要联系方式.
Email: shat-05@mail.ru
ORCID iD: 0000-0003-4510-1721
SPIN 代码: 3453-9987
MD, Сand. Sci. (Pharm.), associate professor
俄罗斯联邦, MoscowDiana A. Akhmedova
Russian technological university
Email: diana.akhmedova.123@mail.ru
ORCID iD: 0000-0002-0951-939X
SPIN 代码: 4629-8311
assistant
俄罗斯联邦, MoscowIvan S. Ivanov
Russian technological university
Email: ivan.ivanov1994@gmail.com
ORCID iD: 0000-0002-1346-7588
SPIN 代码: 1899-6495
Сand. Sci. (Pharm.), researcher
俄罗斯联邦, MoscowDaria D. Kirillova
Russian technological university
Email: kirillova1541@mail.ru
ORCID iD: 0000-0002-3055-1116
SPIN 代码: 8996-2103
master’s student
俄罗斯联邦, MoscowYulia A. Koroleva
Russian technological university; Institute of Pharmaceutical Technologies
Email: jukka.hiden@bk.ru
ORCID iD: 0000-0001-8092-1990
SPIN 代码: 5517-8014
master’s student
俄罗斯联邦, Moscow; MoscowDmitry S. Minenkov
Ishlinsky Institute for Problems in Mechanics RAS
Email: minenkov.ds@gmail.com
ORCID iD: 0000-0001-6432-8134
SPIN 代码: 6424-1334
MD, Сand. Sci. (Phyis.), Сand. Sci. (Math.)
俄罗斯联邦, MoscowStanislav A. Kedik
Russian technological university
Email: kedik@mirea.ru
ORCID iD: 0000-0003-2610-8493
MD, Dr. Sci. (Tech.), professor
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