相关实验视频

Updated: Jul 4, 2025

Methods Development for Blood Borne Macrophage Carriage of Nanoformulated Antiretroviral Drugs

Methods Development for Blood Borne Macrophage Carriage of Nanoformulated Antiretroviral Drugs

Published on: December 9, 2010

在人类临床研究中首次使用简单且不溶解矩阵开发一种即兴制剂配方,用于人类临床研究

Cheng W Chiang¹, Shijia Tang¹, Jasper Martijn Boonstra²

¹Small Molecule Pharmaceutical Sciences, Genentech Inc., 1 DNA Way, South San Francisco, CA 94080, USA.

International journal of pharmaceutics

|February 3, 2024

概括

临时制剂 (EP) 配方加速了药物开发. 一种用于GDC-6599的新型EP悬浮液表现出稳定性,口味掩饰性和高生物可访问性,支持早期临床试验.

科学领域:

制药科学制药科学
药物开发药物开发
配方科学科学配方科学

背景情况:

随机制剂 (EP) 配方对于加速用于早期人类研究的新化学实体 (NCE) 的开发至关重要.
开发NCE的稳定和生物可用配方在药物开发的早期阶段提出了重大挑战.

研究的目的:

为药物候选药物GDC-6599.9开发一种稳定且生物可用的即时制剂 (EP) 悬浮配方.
建立一个可通用的EP配方平台,为早期临床研究开发NCE.

主要方法:

开发了一种EP悬浮配方用于GDC-6599,使用甲基纤维素载体和丹酸用于口味掩饰.
纳入微晶纤维素,使悬浮体呈现一致和统一的安慰剂.
通过冲洗试验评估配方的一致性,稳定性,微生物质量和药物回收.
使用in silico建模和体外胃肠道吸收模拟进行生物制药评估.

主要成果:

成功开发了一个EP悬浮配方用于GDC-6599在广泛的度范围 (0.1-2.0毫克/毫升).
该配方表现出优异的均性,稳定性,并通过了微生物学测试.
通过体外和in silico评估证明药物在冲洗后的高回收率 (>99.8%) 和>90%的生物可访问性.
该EP配方成功支持早期I期临床研究队列.

结论:

为GDC-6599开发的EP悬浮配方是稳定的,生物可用,适合早期临床使用.
制定策略和评估工作流程为早期开发阶段的NCE提供了可概括的平台.
这种方法加速了进入人体研究的NCEs的配方开发过程.

关键词:

生物制药生物制药公司复杂化是一种复杂化.随时的准备随时的准备这是第一次在人体上进行研究.药品制造药品制造药品制造稳定的稳定性稳定的稳定性

更多相关视频

Fabrication of Extracellular Matrix-derived Foams and Microcarriers as Tissue-specific Cell Culture and Delivery Platforms

Fabrication of Extracellular Matrix-derived Foams and Microcarriers as Tissue-specific Cell Culture and Delivery Platforms

Published on: April 11, 2017

Utilizing an Orally Dissolving Strip for Pharmacological and Toxicological Studies: A Simple and Humane Alternative to Oral Gavage for Animals

Utilizing an Orally Dissolving Strip for Pharmacological and Toxicological Studies: A Simple and Humane Alternative to Oral Gavage for Animals

Published on: March 23, 2016

相关概念视频

Preclinical Development: Overview

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

Clinical Trials: Overview

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

Factors Influencing Drug Absorption: Pharmaceutical Parameters

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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...