FAQs

Should I use extrusion and spheronization or layering to manufacture pellets?

There are two main ways to make small pellets for drug delivery:

  1. Drug layering onto inert starter (or seed) pellets that are bought commercially
  2. Extrusion and spheronization binding the active material in the substrate of the pellet from the beginning

There is no right or wrong way to make pellets. The most appropriate method for your particular application will depend on what you are trying to achieve and the resources and limitations that you have available.

The main differences are shown below:-

Extrusion and spheronization                 Layering
 A very fast process             Slow and laborious
 Pellets can be mixed in a single dose    Layers of different composition possible
 Higher drug content without size increase    High drug content increases pellet size
 Most popular method    Less used due to slow process
Powder to pellets in 30 minutes   Powder to pellets in several hours (minimum)

The main reason that the process of extrusion and spheronization a much more widely used technique than layering is the ability to produce quantities of products quickly.  In development and testing of formulations, new iterations of small batches (from about 30 g) of product samples for testing can be produced in about 30 minutes or so.  With layering often several hours are required to make a sample batches for trials.  Progress is slow with layering, and development can be prolonged.

This fast v’s slow situation in product development is then carried through to the production operations.   A small commercial manufacturing operation can often produce between 50 kg and 150 kg per hour of dry pellets ready for packing using Extrusion and Spheronization.  With the layering process a single batch of 20 to 30 kg might require up to 20 hours of the slow layering process to finish this smaller batch.  If significant quantities of pellets are required by layering then a significant amount of capital equipment and space will be needed.

Material in Caleva spheronizer bowl - a superior technique than layering

Product dossiers can be produced faster with Extrusion and Spheronization.

In summary, unless your product or situation actually requires the specific advantages of layering technology, for example, if you already have the equipment or some specific technical reason (but it is hard to see what these might be), then there seems no good reason to opt for the time consuming layering process.

This approach is reflected by the fact that most of the major drugs offered as pellet formulations are manufactured mostly by extrusion and spheronization.  This list of drugs includes…

Omeprazole
Venlafaxine
Propranolol
Esomeprazole
Diclofenac
Theophylline
Lansoprazole

..and many others.  For a more complete list of drugs offered as pellet formulations that are mostly made by extrusion and spheronization.  This list is not exhaustive and is an indication of what is possible.  

We are working closely with many partners in a wide variety of industries as well as pharmaceutical.   The industries where we are helping our customers to make pellets and extrudates are listed below. 

Catalysts
Petrochem
Zeolites
Biofuel
Ceramics
Polymers
Batteries
Nutraceutical
Aquaculture
Fish Food
Agriculture
Agrochemical
Biotech
Bone Filler
Food
Yeast
Flour
Cosmetics
Soaps and detergents

If you need more information or would like to discuss your objectives with us then please make contact (info@caleva.com) and we can set up a conversation without any commitment from your side.

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