We are often asked about the production capacity of our extrusion and spheronization systems. To provide this information there needs to be an understanding of the process parameters that will be used and that have been determined at the development stage. With that information, the advice that we give can be both meaningful and useful in the planning stages.If you have proven your concept at...
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.
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.
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.
There are two main ways to make small pellets for drug delivery:
- Drug layering onto inert starter (or seed) pellets that are bought commercially
- 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...
Product yields (the percentage of the spheroids produced in a batch that are within the size range required) will never be 100%.
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.
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.
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,...
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 screen used for extrusion can be configured to your needs, with different diameter...
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 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?
- The smallest extruder we offer is the Caleva Multi Lab (CML) with an extruder attachment designed to work with...
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