Accurate Particle Size Distribution
Within each dose of an inhaler device, a consistent distribution of specifically-sized particles is required depending on the condition being treated. The size distribution of the particles within each inhaler dose indicates where the drug lands within the respiratory system and how quickly it is dissolved into the user’s system. Typically, the smaller the particle, the further down the respiratory system it travels, and the faster it is absorbed. However, particles that are too small may be exhaled without impacting at all. Depending on therapeutic intent and desired deposition location in the respiratory tract, the correct aerodynamic particle size plays a crucial role.
Robust Methods for APSD Determination
There are several methods to determine APSD, such as laser diffraction and time of flight, but the most common industry-accepted practice is using cascade impactors. Beyond quantifying the overall mass balance of the drug, which requires additional testing such as Delivered Dose Uniformity Testing (DDU), the individual particulate sizing distribution must be within a given tolerance across the lifespan of the inhaler device, from device to device and capsule to capsule. MSP provides tools to accurately, consistently, robustly, and efficiently gather pharmaceutical aerosols to analyze their chemical characteristics and ensure consistency, from development to quality control (QC).
Regulatory Guidance
Our products for APSD testing are designed to fully comply with regulatory standards set by key authorities such as the United States Pharmacopeia (USP) and the U.S. Food and Drug Administration (FDA). They are engineered to meet stringent guidelines for inhalation drug delivery devices, ensuring accurate and reliable APSD testing for orally inhaled and nasal drug products (OINDP). By adhering to these global regulatory requirements, we provide customers with the confidence that their testing processes align with the highest industry standards, supporting product development and regulatory approval.
