推进干粉吸入器:基于载体的配方开发的完整工作流程
Rodrigo Amorim1, Navneet Sharma1, Molly Gallagher1
1Product Development, Lonza Advanced Synthesis, Lonza Group AG, Bend, OR 97701, USA.
Pharmaceutics
|February 27, 2026
概括
本研究介绍了一种Quality-by-Design (QbD) 框架,用于干粉吸入器 (DPI) 的开发,优化颗粒工程和混合,以实现可靠的呼吸道药物输送. 综合方法确保了从API表征到商业生产的可扩展制造.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 工艺工程是过程工程.
背景情况:
- 基于载体的干粉吸入器 (DPI) 是用于呼吸道药物输送的标准.
- 对于DPI来说,缺乏用于粒子工程和制造业扩展的综合框架.
研究的目的:
- 为基于运营商的DPI开发一个全面的质量设计 (QbD) 战略.
- 系统地链接喷射磨粉,配方和混合规模,以微化活性药物成分 (API).
主要方法:
- 氨酸API使用喷气削微化,以控制颗粒大小和固态特性.
- 实验设计 (DOE) 评估了API颗粒大小和乳糖罚款的空气动力学性能 (FPF) 和粉末流量.
- 开发了一种基于粒子速度的扩展方法,用于V-shell混合.
主要成果:
- 优化的喷气削产生了可吸入的API颗粒,其无形含量得到控制.
- 确定了一个设计空间,最大限度地提高了气溶和流动性 (API Dv90: 2.9-4.5μm).
- 低剪切混合和粒子速度缩放确保了卓越,可扩展的肺部输送 (FPF>60%) 和内容均性.
结论:
- 集成的 QbD 框架对于强大而可扩展的 DPI 产品开发至关重要.
- 粒子工程,配方和混合动力学的共同优化是必不可少的.
- 这种方法为DPI制造提供了一个高效,节省材料的途径.
相关概念视频
Inhaled Medications
901
Inhaled medications are crucial for managing chronic obstructive pulmonary disease (COPD) and asthma. They are essential for effective treatment and control, ensuring optimal respiratory health and well-being. Inhaled medication delivers drugs directly to the lungs, providing a rapid onset of action and reducing systemic side effects compared to oral or injectable medications. Three primary types of inhalation devices are used to administer these medications: nebulizers, metered-dose inhalers...
901
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
380
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...
380
Site-Targeted Drug Delivery Systems: Polymeric Carriers
59
Polymeric carriers enhance targeted drug delivery by increasing efficacy while minimizing off-target effects. These carriers comprise a biodegradable polymeric backbone integrated with functional elements that enable targeting, improve physicochemical properties, and regulate drug release.Targeting MechanismsThe targeting ability of polymeric carriers is mediated by a homing device, which is a molecular recognition component designed to selectively bind to specific tissues or cells. Monoclonal...
59
Drug Delivery: Miscellaneous Routes
889
Drug delivery methods like oral inhalation, nasal sprays, transdermal patches, eye drops, intravitreal injection, and rectal administration provide localized effects with reduced toxicity.
Oral inhalation and nasal sprays swiftly transfer drugs across the respiratory epithelium's mucosal layer. Inhaled glucocorticoids and bronchodilators directly target lung conditions such as asthma, while fluticasone nasal spray mitigates allergic rhinitis.
Transdermal patches transport drugs...
Oral inhalation and nasal sprays swiftly transfer drugs across the respiratory epithelium's mucosal layer. Inhaled glucocorticoids and bronchodilators directly target lung conditions such as asthma, while fluticasone nasal spray mitigates allergic rhinitis.
Transdermal patches transport drugs...
889
Modified-Release Drug Delivery Systems: Rate-Programmed I
53
Rate-programmed drug delivery systems (DDS) are designed to release drugs at specific, controlled rates to maintain consistent therapeutic levels. These systems are categorized based on their release mechanisms, including dissolution-controlled DDS, diffusion-controlled DDS, and combined dissolution-diffusion-controlled DDS.In dissolution-controlled DDS, the release rate depends on the slow dissolution of the drug itself or the surrounding matrix. Drugs with inherently slow dissolution rates,...
53
Factors Influencing Drug Absorption: Pharmaceutical Parameters
664
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...
664


