In the manufacture of pharmaceutical products, the preliminary stages frequently produce agglomerates – especially with mixtures of powders and liquids. For the further process, these lumps must be broken up and the raw materials reduced in size; this process is called API deagglomeration.
Why an agitator alone is not enough
A conventional agitator cannot reliably break up agglomerates. Modern process plants with integrated, powerful agitating and homogenising systems are, by contrast, ideally suited to this.
Their rotor/stator system reduces the solids in size optimally while increasing the surface area of the powder in the liquid. This produces agglomerate-free solutions within a few minutes.
Advantages of API deagglomeration
Breaking up the agglomerates makes the entire particle surface accessible to the liquid. This brings several advantages:
- Active ingredients dissolve more quickly and evenly
- Suspensions become more homogeneous
- Dosing accuracy increases
- For poorly soluble active ingredients, a finer particle size can improve the dissolution rate and thus the bioavailability
For true micronisation down to a few micrometres, jet mills, bead mills or high-pressure homogenisers are usually used. The rotor/stator homogeniser mainly takes care of deagglomerating, wetting and dispersing.
FAQ: API deagglomeration
What is API deagglomeration?
Breaking up agglomerates and lumps that form when powdered active ingredients are mixed with liquids. The aim is a fine, even distribution of every single particle.
Why is a normal agitator not sufficient?
An agitator generates hardly any shear forces. Agglomerates remain and powder nests form. Only the high shear in the rotor-stator gap of a homogeniser breaks them up reliably.
What are the benefits of good deagglomeration?
Shorter dissolving and process times, homogeneous distribution of active ingredients, higher dosing accuracy and a larger effective particle surface, which can improve dissolution rate and bioavailability.
How are powders best incorporated?
By vacuum powder induction directly into the shear zone of the homogeniser below the liquid level, so that every particle is wetted immediately.
Does SEEFRIED offer solutions for deagglomeration?
Yes, with process consulting, trial planning and suitable homogenising mixers, including used ones.