Micronization can be defined as a process of reducing the average diameter of solid particles, and micronization is thus used in solid dose manufacturing.
API micronization involves many challenges, risks and considerations. Some of the most common challenges associated with API micronization are explored in detail below.
API micronization Challenges:
- The initial particle size of API to be micronized, which plays a role in achieving the desired particle size, can be challenging for Contract Development and Manufacturing Organizations (CDMOs) and pharmaceutical CMOs (contract manufacturing organizations) offering API manufacturing services.
- Reducing particle size carries the risk of altering the morphology of the drug molecule, resulting in different polymorphs, amorphous APIs, or a mixture of crystalline and amorphous APIs.
- Micronized materials are charged and this may lead to segregation, clumping, and other possible physical instabilities during long term storage or in the formulation, if it is not well controlled.
- Micronization may result in agglomeration of API particles (API agglomerate). Particle segregation and agglomeration are the two major problems that could arise during blending of different size powders.
- Even though the micronization process offers advantages among other techniques, it has some limitations as it generates dust, the materials possess poor flow properties which create formulation processing problems.
- Selecting the appropriate technique for API micronization remains challenging. It is a complex process, reliant on an experienced team well-versed in the advantages and disadvantages of various drug micronization strategies.
Although micronization can be considered a rather consolidated technology, the interest in improving process control and optimization has increased in the past few years. CDMOs and CMOs are currently investing in developing new API micronization technologies and making advancements to existing technologies in order to overcome the challenges associated with API micronization.