From Particle Size to Performance: Understanding API Micronization for Inhalable Drugs

At Inke, we specialize in API micronization for inhalable drug formulations, combining advanced technology and deep scientific knowledge to ensure precise particle engineering for superior respiratory performance. API micronization is the process of reducing the particle size of an active pharmaceutical ingredient to the micrometer scale, typically below 10 microns. This controlled reduction enhances surface area, dissolution rate, and uniformity, which are critical factors in the formulation of inhalable drugs. 

Particle size reduction is achieved through mechanical or fluid energy methods that minimize variability and preserve the integrity of the API. The goal is to create consistent and stable particles capable of delivering predictable therapeutic effects when administered via inhalation. 

Why Micronization Matters in Inhalable Formulations 

In inhalable drug formulation, the aerodynamic performance of a product largely depends on its particle size distribution. Only particles within an optimal range—usually 1 to 5 microns—can effectively reach the lower respiratory tract. Micronization ensures that each particle is tailored for efficient lung deposition, improving bioavailability and reducing systemic side effects. 

Furthermore, micronization enhances the homogeneity of powder blends used in dry powder inhalers (DPIs) and metered-dose inhalers (MDIs), leading to better dose uniformity and stability over time. 

Common Techniques: Jet Milling and Beyond 

Among various micronization methods, jet milling stands out as the most widely used for respiratory APIs. This process uses high-velocity compressed gas to induce particle-to-particle collisions, achieving ultra-fine and uniform particle sizes without thermal degradation. Other techniques, such as spray drying or supercritical fluid processing, are also employed depending on the physicochemical properties of the compound and the desired inhalation profile. 

Quality Control in Micronized API Production 

Achieving consistent particle size and morphology requires rigorous in-process monitoring and quality control. Analytical tools such as laser diffraction, scanning electron microscopy (SEM), and specific surface area measurements are essential to verify particle uniformity and prevent agglomeration. Adherence to Good Manufacturing Practices (GMP) ensures that micronized APIs meet regulatory and performance standards for inhalable applications. 

Inke’s Expertise in Micronization Technology 

Achieving precision and reproducibility at scale 

With over two decades of experience, Inke leads the industry in precision API micronization expertise. Our proprietary technologies and controlled environments allow us to maintain exceptional reproducibility and stability, even in large-scale production. 

At Inke, we integrate R&D with GMP-certified manufacturing to deliver APIs with precise particle engineering, optimized for performance and compliance. Our ongoing commitment to innovation and sustainability positions us as a trusted partner in the global development of inhalable therapies. 

To collaborate with our experts or request tailored solutions, contact us.