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空气动力学粒径分布 (APSD)

精确、稳健、一致、高效

空气动力学粒径分布 (APSD)

空气动力学粒径分布（APSD）对吸入器的疗效至关重要。它决定了药物在呼吸系统中的沉积位置以及吸收速度。较小的粒子能深入肺部且吸收更快，而过小的粒子则可能被呼出。精确的空气动力学粒径分布（APSD）确保药物送达目标区域，提升治疗效果。级联撞击式切割器用于测量APSD，是目前最受认可的方法。恒定且精准的APSD对于维持吸入器全生命周期内的药效与安全性至关重要。 MSP提供先进的工具，用于精确、稳健且高效的APSD测量，为可靠的吸入疗法提供支持。

精确测量粒径分布

在每次使用吸入器装置时，根据所治疗的病症，需要特定粒径粒子的稳定分布。每个吸入器剂量中的粒子粒径分布决定了药物在呼吸系统中的沉积位置及其被使用者吸收的速度。通常，粒子越小，其在呼吸系统中的穿透深度越深，吸收速度也越快。然而，过小的粒子可能未经沉积就被直接呼出。根据治疗目的和呼吸道内预期的沉积位置，正确的空气动力学粒径起着至关重要的作用。

稳健的APSD测定方法

测定 APSD 的方法有多种，例如激光衍射法和飞行时间法，但业内最普遍认可的做法是使用级联撞击式切割器。除了需要额外测试（如递送剂量均匀性测试(DDU)）来量化药物的整体质量平衡外，单个粒子的粒径分布必须在吸入器装置的整个生命周期内、装置与装置之间以及胶囊与胶囊之间保持在给定的公差范围内。 MSP提供能够精准、一致、可靠且高效地收集制药行业气溶胶的工具，分析其化学行业特性，并确保从研发到质量控制（QC）的全过程一致性。

监管指导

我们的APSD测试产品严格遵循美国药典(USP)和美国食品药品监督管理局(FDA)等主要监管机构制定的标准。它们专为满足吸入给药设备的严格标准而设计，确保口服吸入和鼻腔给药产品（OINDP）的APSD测试准确可靠。通过遵循这些全球性监管要求，我们为客户提供信心，确保其测试流程符合最高行业标准，助力产品开发和监管审批。

MDIs, DPIs, SMIs and Nebulizers

APSD of Inhaler Devices

Aerodynamic Particle Size Distribution (APSD) testing for inhaler devices, such as metered-dose inhalers (MDIs) and dry powder inhalers (DPIs), is crucial for determining how particles are dispersed and deposited in the respiratory tract. The size of the particles delivered by these devices influences where the drug is deposited—whether in the upper airways, lungs, or deep alveolar regions. APSD testing ensures that inhaler devices produce particles of the correct size range for optimal therapeutic effect, improving drug absorption and patient outcomes. This testing is typically conducted using cascade impactors or similar equipment, under conditions that replicate real-world use.

Nasal Sprays, Aerosol and Powders

APSD of Nasal Products

For nasal products, APSD testing is used to assess the size and distribution of particles delivered to the nasal passages, which is critical for localized drug delivery. Particle size affects how deeply the medication penetrates the nasal cavity and its effectiveness in treating conditions like rhinitis or sinusitis. APSD testing for nasal products helps manufacturers ensure that their devices deliver particles within the target size range to achieve the desired therapeutic effect without unnecessary drug wastage or discomfort for the patient. This testing is performed using simulated nasal inhalation conditions to replicate real usage patterns.

Replicating Tidal Breathing Conditions

APSD of Nebulizers

APSD testing for nebulizers evaluates the particle size distribution of the aerosol generated during extended treatments. Since nebulizers are used to deliver drugs over a prolonged period, it’s essential that the particles remain within the optimal size range to reach the desired regions of the respiratory tract. APSD testing ensures that nebulizers produce consistent particle sizes throughout the entire treatment, maximizing drug deposition in the lungs and improving therapeutic efficacy. The testing involves replicating tidal breathing conditions using a breathing simulator to accurately assess the performance of nebulizers under real-world use.

Frequently asked questions

Q. How often should I calibrate my inhalation testing equipment, and can I do it myself?

Calibration is recommended annually for several products. Some instruments can be self-calibrated using MSP's dedicated qualification tool kit, offering convenience and cost savings. For equipment that isn't self-serviceable, MSP provides reliable calibration services to ensure ongoing compliance with standards and peak performance. --- Learn More about how to keep your inhalation equipment in compliance.

Q. Why is Aerodynamic Particle Size Distribution (APSD) important for inhalers?

APSD determines where the drug lands in the respiratory system and how quickly it is absorbed. Smaller particles travel further into the lungs and are absorbed faster, enhancing therapeutic outcomes. Accurate APSD ensures the drug reaches the intended area, improving efficacy and safety.

Q. What methods are used to measure APSD?

APSD can be measured using various methods, such as laser diffraction and time of flight. However, the most widely accepted method in the industry is using cascade impactors, which provide precise and consistent measurements of particle size distribution.

Q. How does MSP ensure accurate and consistent APSD measurement?

MSP provides advanced tools designed to exceed high-quality tolerance specifications. Our impactors separate particles for analysis, adhering to USP guidelines. We also offer calibration services to maintain tool accuracy over time, ensuring reliable inhalation therapies.

Expand Your Inhalation Test Capabilities

The NGI+ enhances inhalation testing with improved corrosion resistance, efficient cleaning, and versatile applications, ensuring accurate and reliable results for nebulizers and biologics.

精确、稳健、一致、高效

空气动力学粒径分布 (APSD)

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