已批准的亲肠道产品中的辅助剂的比较及其最大每日暴露值
Miha Homar1, Špela Kalčič2, Gorazd Gorup3
1Lek d.d. Development Center Slovenia, Verovškova 57, 1526 Ljubljana, Slovenia; and miha.homar@gmail.com.
PDA journal of pharmaceutical science and technology
|August 23, 2024
概括
这项研究比较了美国,新西兰和爱尔兰的肠道助剂,在非美国市场发现了显著的市场差异和更高的最大每日暴露. 这些数据有助于配方科学家选择安全的辅助剂用于肠道药物.
科学领域:
- 制药科学 制药科学
- 药物的配方 药物的配方
- 监管科学 监管科学
背景情况:
- 父母肠道配方依赖辅助剂的稳定性和输送.
- 监管数据库提供了关于已批准的辅助剂的基本信息.
- 了解全球辅助剂的使用对于药物开发至关重要.
研究的目的:
- 分析和比较美国,新西兰和爱尔兰市场使用的肠道助剂.
- 为了呈现现实世界的数据,对亲肠道辅助剂的最大每日暴露 (MDEs).
- 确定特定市场的辅助剂趋势和潜在的安全影响.
主要方法:
- 2011年和2021年美国食品和药物管理局 (FDA) 注册的亲肠道配方的分析.
- 包括2021年来自新西兰 (Medsafe) 和爱尔兰 (HPRA) 的肠道辅助剂的真实数据.
- 计算和表现的最大每日暴露 (MDEs) 列出的亲肠道辅助剂.
主要成果:
- 在美国,新西兰和爱尔兰共确定了355种独特的肠道助剂.
- 只有90种辅助剂 (25.3%) 是三个市场共同的;187种 (52.7%) 是特定市场的.
- 来自新西兰和爱尔兰的每日最大暴露值往往高于FDA的无活性成分数据库 (IID) 的值.
结论:
- 在不同的全球市场中,门辅助剂的使用存在显著的异质性.
- 在非美国市场的MDEs较高,应考虑进行毒理学评估.
- 这种全面的全球辅助剂数据有助于配方科学家设计安全有效的亲肠道药物产品.
相关概念视频
Bioequivalence: Overview
949
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
949
Drug Concentration Versus Time Correlation
680
The plasma drug concentration-time curve is a crucial tool in pharmacokinetics, representing the drug's concentration in plasma at different time intervals post-administration. This curve illustrates the drug's journey from absorption into the systemic circulation, distribution to body tissues, and eventual elimination through excretion or biotransformation.
Two pivotal parameters are the minimum effective concentration (MEC) and the minimum toxic concentration (MTC). The MEC is the...
Two pivotal parameters are the minimum effective concentration (MEC) and the minimum toxic concentration (MTC). The MEC is the...
680
Routes of Drug Administration: Parenteral
1.9K
The administration of drugs via parenteral routes allows for direct drug introduction into the systemic circulation, resulting in high bioavailability because the medication bypasses the harsh conditions of the gastrointestinal tract and hepatic metabolism.
The intravenous route (IV) of drug administration can be further categorized into two types. The bolus injection administers the entire dose rapidly, while an intravenous infusion slowly delivers smaller doses steadily.
The IV route is often...
The intravenous route (IV) of drug administration can be further categorized into two types. The bolus injection administers the entire dose rapidly, while an intravenous infusion slowly delivers smaller doses steadily.
The IV route is often...
1.9K
Factors Influencing Drug Absorption: Pharmaceutical Parameters
123
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
123
Dosage Regimen: Fixed Dose
1.9K
Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
1.9K
Drug Distribution: Volume of Distribution
5.0K
The volume of distribution refers to the theoretical volume necessary to contain the entire amount of an administered drug at the same concentration observed in the blood plasma. The body's intracellular fluid compartment, which makes up two-thirds of the total body water, is contrasted with the extracellular fluid compartment—comprising plasma and interstitial fluid—that accounts for one-third. The volume of distribution can vary depending on the characteristics of the drug.
5.0K


