Knowledge Base

How do I ensure consistency during scale up?

Consistency Measurement

A direct consistency measurement of a small sample (generally around 40 g) taken from a process as it is ongoing.  This allows for accurate comparisons to be made quickly, accurately, and repeatable way.

What characteristics should my extrudate have?

Extrusion and spheronization is not always completely straightforward.  A formulation required for spheronization needs to go through the following processes and achieve the following properties.

What are the standard processes in the manufacture of pellets?

Wet Granulation - Granules are formed by the addition of a granulation liquid onto a bed of powder under the influence of an impeller. This is typically carried out using a high-shear granulator or a simpler planetary mixer.

Should I use 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...

Do all extruders and spheronizers have the same level of performance?

Product yields (the percentage of the spheroids produced in a batch that are within the size range required) will never be 100%.

However, it is possible to achieve yields of greater than 98% if the formulation, process parameters and the equipment used are optimised. 

Formulation and process parameters are outside the control of Caleva, but the quality of the equipment used is our direct...

Coating pellets and tablets - can results be used in scale up?

We are often asked if parameters used for film coating of materials in the Mini Coater Drier can be used for “scale up” to production. The desire for a process to be scalable is understandable but it is not always feasible or relevant. 

A better therapeutic effect with spheroids

In many cases the main reason for the use of pellets in the manufacture of products is for its controlled release properties. However there are reasons to believe that pellets or spheroids in any case can offer a superior therapeutic effect even when modified release is not the prime objective.

Examples of the terminology used in spheronization and marumerization

Spheronization, marumerization, pelletization and micropelletization all mean the same thing. The manufacture of products in small spheres (spheroids) for use in pharmaceutical (pharma) and catalyst industries. Within each batch the spheroids are of regular shape and size and are quite dense. The products produced by these processes can be called spheroids, spheres, micro-spheres, pellets,...

Extruding with the E35

The Caleva Extruder 35 is capable of processing batch sizes from 250g to 5kg (wet weight) of product to create an hourly output of approximately 100kg (product dependent).

The E35 works with a large range of materials, including pharmaceutical materials, catalysts and agricultural products.

 

The Extruder

The screen used for extrusion can be configured to your needs, with different diameter...

Spheronizing with the S380

The Caleva Spheronizer 380 is capable of processing batch sizes from 250g to 5kg (wet weight) of product to create an hourly output of approximately 50kg.

The S380 works with a large range of materials, including pharmaceutical materials, catalysts and agricultural products.

The Spheronizer

The spheronizer disc used in this example is the Caleva 3mm x 3mm cross hatch pattern which comes as...

How can I be sure that the trials and development work that I do will give me comparable results when I need to scale up to production sizes?

Scale up of the spheronization process is relatively well known and understood. All of the Caleva extrusion and spheronization equipment is designed with scale up in mind.Our range of screw extruders have the ability to modify the density of your extrudate when this is important.
  • The smallest extruder we offer is the Caleva Multi Lab (CML) with an extruder attachment designed to work with...

Do you have heat generation issues with your extrusion process?

When talking with customers who manage production scale extrusion, I am often asked to comment on the amount of heat generated and the issues that this can cause. In reality, heat generation is just something that we have to live with as all extrusion processing will generate heat. The amount of heat generated will vary depending on:

  • The formulation of the product
  • The rate of extrusion
  • The...