在使用半自动化组合装置进行静脉注射药物的批量生产模拟期间,生产率和无菌过程评估
Ana C Riestra1,2, Jaione Grisaleña3, Naiara Telleria3
1Hospital Pharmacy Department, Fundación Onkologikoa, Donostia, Gipuzkoa, Spain.
概括
半自动化复合器件显著提高了静脉注射 (IV) 药物制备的效率,将吞吐量从每小时14个制剂增加到100个制剂. 这些设备还确保了复合性静脉注射药物的质量和无菌性,在测试的制剂中没有显示微生物生长.
科学领域:
- 制药技术 制药技术 制药技术
- 临床药房实践 临床药房实践
- 无菌产品制造业 无菌产品制造业
背景情况:
- 静脉注射 (IV) 药物制备可以使用组合装置进行优化,以提高生产率并最大限度地降低无菌组合的风险.
- 本研究评估了使用半自动设备 (Gri-fill;Grifols) 模拟的静脉注射药物的无菌复合的生产力和质量结果.
研究的目的:
- 为了评估一个半自动化组合装置的生产力,用于制备模拟的静脉注射药物.
- 为了评估使用半自动设备合成的静脉注射药物的质量和无菌性.
主要方法:
- 模拟批次的50-600种制剂,包括危险和非危险的药物,被复合.
- 评估的是制备速度,设备自主性,无菌工艺质量 (介质填充试验) 和最终产品无菌性.
- 包括不同复杂度的单成分和多成分制剂.
主要成果:
- 在78个工作小时内,总共完成了2024年的最终准备工作.
- 生产速度从1.3分钟/准备 (低复杂度) 到3.7分钟/准备 (高复杂度) 之间.
- 所有的媒介填充测试 (883) 显示没有微生物生长,所有无菌性测试 (114) 通过.
结论:
- 半自动复合装置可以达到14-100种制剂/小时的制备效率.
- 使用该设备的无菌过程始终表明没有微生物污染.
- 该设备提高了效率,并保持了无菌静脉注射药物制备的质量.
相关概念视频
01:09One-Compartment Model: IV Infusion
153
Intravenous (IV) infusion is often utilized when continuous and controlled drug delivery is necessary, such as during surgery or in the treatment of chronic diseases. This method offers numerous advantages, including immediate drug action, precise control over dosage, and bypassing the first-pass metabolism.
The one-compartment model for IV infusion uses mathematical equations to describe the rate of change in drug quantity in the body. At steady-state or infusion equilibrium, the drug input...
The one-compartment model for IV infusion uses mathematical equations to describe the rate of change in drug quantity in the body. At steady-state or infusion equilibrium, the drug input...
153
01:19One-Compartment Open Model for IV Bolus Administration: General Considerations
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The one-compartment model is a pharmacokinetic tool that models the body as a single, uniform compartment, facilitating the understanding of drug distribution and elimination. This model is particularly beneficial for intravenous (IV) bolus administration, where the drug rapidly circulates throughout the body.
The drug's presence in the body is defined by an equation representing the difference between the rates of drug entry and exit. Key parameters—elimination rate constant,...
The drug's presence in the body is defined by an equation representing the difference between the rates of drug entry and exit. Key parameters—elimination rate constant,...
158
01:09One-Compartment Open Model for IV Bolus Administration: Estimation of Elimination Rate Constant, Half-Life and Volume of Distribution
201
The one-compartment open model is a simplified approach used in pharmacokinetics to understand the distribution and elimination of a drug administered through an intravenous bolus. This model assumes rapid drug dispersal throughout the body and elimination using a first-order process. Key pharmacokinetic parameters, such as the elimination rate constant (k), half-life (t1/2), and the apparent volume of distribution (Vd), can be estimated from this model. The elimination rate is calculated...
201
01:18Two-Compartment Open Model: IV Bolus Administration
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The two-compartment model for intravenous (IV) bolus administration illustrates drug distribution in the body, subdividing it into central and peripheral compartments. This model operates on the concept of two-compartment kinetics. The drug's plasma concentration shows a bi-exponential decline following IV bolus administration, signaling the presence of two disposition processes: distribution and elimination.
The disparity between drug input and the sum of drug transfer rates between...
The disparity between drug input and the sum of drug transfer rates between...
397
00:56One-Compartment Open Model for IV Bolus Administration: Estimation of Clearance
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Clearance is a key pharmacokinetic parameter that quantifies the volume of body fluid from which a drug is entirely removed within a specific time frame. It is crucial in assessing how a drug is eliminated from the body and has critical clinical applications.
In the one-compartment open model for intravenous (IV) bolus administration, clearance is estimated by dividing the elimination rate by the plasma drug concentration. This equation leverages the elimination rate constant and the apparent...
In the one-compartment open model for intravenous (IV) bolus administration, clearance is estimated by dividing the elimination rate by the plasma drug concentration. This equation leverages the elimination rate constant and the apparent...
60
01:15Two-Compartment Open Model: IV Infusion
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A two-compartment model is a vital tool in pharmacokinetics, providing an essential understanding of drug behavior, especially for those administered via zero-order intravenous infusion. This model outlines two compartments: the central compartment, where elimination occurs, and the peripheral compartment.
The model illustrates the decrease in plasma drug concentration from the central compartment with a specific equation. It shows that under steady-state conditions, the drug's input rate...
The model illustrates the decrease in plasma drug concentration from the central compartment with a specific equation. It shows that under steady-state conditions, the drug's input rate...
193