两种卡里普拉硬囊配方的生物等价性评估
Mamdouh R Rezk1, Kamal A Badr2, Ahmed Abd El Hamid Hosny3
1Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
Naunyn-Schmiedeberg's archives of pharmacology
|February 14, 2026
概括
一种新的通用卡里普拉辛囊,Vocarzine,证明与参考产品Reagila®具有生物等价性. 这一发现支持Vocarzine作为治疗精神分裂症和双相情感障碍的安全和潜在的节省成本的替代方案.
科学领域:
- 药理学和制药科学 药理学和制药科学
- 临床药房 临床药房
- 药物开发 药物开发
背景情况:
- 卡里普拉辛是一种治疗精神分裂症和双相I型情绪障碍的第三代抗精神病药物.
- 可访问和负担得起的配方对于患者的坚持至关重要,特别是在资源有限的环境中.
研究的目的:
- 与品牌参考产品 (Reagila®) 相比,评估一种新的通用卡里普拉硬囊 (Vocarzine) 的生物等价性,安全性和耐受性.
主要方法:
- 一个随机的,开放的,单剂量,两期,两序的交叉研究,涉及30名健康成年参与者.
- 使用验证的LC-MS/MS方法来确定Cmax和AUC0-72h的药理动力学分析.
- 如果几何平均比率的90%置信区间在80-125%范围内,就确定了生物等价性.
主要成果:
- 29名参与者完成了这项研究.
- 在Cmax (91.92% [85.07-99.33%]) 和AUC0-72h (92.85% [88.86-97.02%]) 的几何平均比率 (90% CI) 处于生物等效范围之内.
- 两种配方均表现出相似的安全性,其中轻微的恶心是最常见的不良事件;没有报告严重的不良事件.
结论:
- 通用Vocarzine硬囊在吸收速度和程度方面与品牌Reagila®卡里普拉辛硬囊具有生物相当性.
- 沃卡辛为卡里普拉辛治疗提供了一个安全,有效和潜在的节省成本的替代方案.
相关概念视频
01:18Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
340
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
340
01:16Bioequivalence: Overview
2.0K
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,...
2.0K
01:13Bioequivalence studies: Biowaivers
278
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
278
01:22Toughness and Hardness of Aggregate
648
Toughness and hardness are critical properties of aggregate materials used in concrete, particularly on pavement surfaces and industrial flooring subjected to heavy loads. Toughness is defined as the aggregate's resistance to failure by impact and is measured by the aggregate impact value (AIV). For this, the aggregate impact value test is performed, wherein the impact is delivered by a standard hammer, which falls freely under its own weight onto the aggregates. The aggregates fragment in...
648
01:17Equivalence: In Vitro and In Vivo Bioequivalence
256
Body:Bioequivalence studies are crucial in evaluating whether new drugs can match an approved one regarding pharmacological effects and clinical performance. These studies test if drugs, despite different dosage forms, share identical plasma concentration-time profiles. Three types of equivalence are central to these studies: chemical, pharmaceutical, and therapeutic. Chemical equivalence indicates that two or more drug products contain identical active ingredients in equal amounts.
256
01:16Bioequivalence Data: Statistical Interpretation
226
Body:The statistical interpretation of bioequivalence data is a significant aspect of pharmaceutical research. Bioequivalence refers to the absence of any significant difference in the rate and extent to which the active ingredient in pharmaceutical products becomes available at the site of drug action when administered at the same molar dose under similar conditions. This helps determine if different drug products have similar absorption rates, ensuring their interchangeability.Statistical...
226