Micronization: an overview

In the pharmaceutical field, powders consist of a heterogeneous group of solid particles and can be considered the simplest pharmaceutical form as such and/or can be used to produce other formulations such as tablets, capsules, or suspensions. Generally, the particles are heterogeneous, differing in shape, size, and surface area: hence, powders are a collection of solid, dry, separated particles of regular shape and varying in size from 0.5 to 1000 μm and are the basis for the preparation of granules, tablets, and capsules.

The reduction of particle size below 100μm is a key process and requirement in laboratories and in small- and large-scale production. The benefits obtained from this operation are several: bioavailability, dispersion (aerosol) in pharmaceutical applications, dispersion, blending effect, adherence, long-lasting effect and silky touch for cosmetic applications, increased surface area for other applications.

What’s micronization?

Micronization is the technique for reducing the particle size of an excipient’s active ingredient. Its process is the state-of-the-art technique for reducing the particle size of an excipient’s active ingredient. It is used to meet the particle size requirements of APIs and excipients, parameters that are very often critical to the formulation of the finished product and necessary for achieving the desired bioavailability of the product.

It reduces particles down to the micrometer or, in some cases, nanometer (1/1000 of a micrometer) size and it can be used to improve the bioavailability of poorly soluble APIs by increasing particle surface area and accelerating dissolution rates. Micronization can also be used to improve formulation homogeneity and control particle size. A wide range of drug types, including solid dosage, injectable, ocular, and inhaled products, can benefit from micronization.

Which are the parameters that mainly impact a micronization process?

The mainly parameters that mainly impact the micronization process are the grinding pressure (including the injection pressure) and the feed rate given by the dosing system. Modifying this parameters can affect the energy that you can bring to the powder inside the chamber of micronization and increase or decrease the final PSD target.

CDMOs need a high level of flexibility when milling and/or micronizing High Potent APIs. Those APIs require different milling technologies??(mechanical or jet milling) and different mills. Also a high level of cleanability is a must.?

In addition CDMOs must provide the best ergonomic conditions for operators whose height difference can reach 50 cm (almost 2 feet) between the shortest and the tallest person.?

The solution is…Multimilling!?

FPS multi-milling Isolator features interchangeable mills (through interchangeable heads). ConeMill, PinMill, HammerMill, Loop Mill and Jet Mill can be used in the same Isolator chamber (one or two at a time, depending on the configuration).?Also a fully-integrated foldable platform is provided so that operators of all sizes can work at the perfect height.?

This platform is light and easy to be deployed when needed. Once the work is completed, it can quickly be folded and slid under the isolator, minimizing the footprint of the equipment.?

In a small space, you can use up to 4 different types of mills (mechanical mills like Hammer mill & Pin mill and jet mills like spiral or Q-mill). You can also work under ATEX conditions.

The milling system and the heads set are provided with an automatic gravimetric feeder which provides a constant feed rate. This assures a constant and uniform particle size at the output.?To assure the high level of ergonomic, a full wooden mockup test was performed at the End User site. Inside all the equipment (various mills, feeders, cyclones) were 3D printed to better simulate all the activities (Operations, Cleaning, Maintenance).??

And if your product is toxic, the multi-milling station can be integrated into an isolator to ensure maximum safety and efficiency.

Let us find the perfect fit for you!?Would you like to test a small batch of a new product? Schedule a trial in our MEC (Micronization Excellence Center): [email protected]

And... don't miss the opportunity to meet us!??

??63rd CIPM 13-15 | 13th - 15th November | Xiamen (China) | Booth 10-13

??ASSCA | 13th November | Novotel Milano Ca’ Granda?

??HPAPI Berlin (sponsored by Amistat Group) | 15th - 16th November | Berlin?

??Workshop | 20th - 21st November | Università Campus Biomedico Roma

???[email protected]