Knowledge Base

Caleva Study on the Importance of Granulation

Our customer, a major pharmaceutical, biotech & nutraceutical manufacturer with an extensive portfolio of products. For reasons of confidentiality we do not name them.

One of our Production Extruder & Spheronizer Systems for manufacturing on a large-scale was used in trials by the manufacturer, but the pellets produced were not acceptable. As the product was already registered, the...

A Brief Non-Technical Guide To Spheronization (Marumerization*)

What is Spheronization?

Spheronization is the process where extrudates (the output from an extruder) are shaped into small rounded or spherical granules. In practice these usually vary in size from 0.4 to about 3.0 mm. The use of these spheroids can be relevant for a wide variety of industries.

Why Consider Spheronization?

The products produced from this process can be useful in several ways:

Extrusion of small batches

The Caleva Multi-Lab (CML) can Mix/Granulate, Extrude and Spheronize all in one base unit.

This article is about the Extruder attachment that comes with the CML.

The Multi-lab is capable of working with a variety of materials from catalysts and pharmaceuticals, to agricultural products.

The Extruder

The extrusion attachment on the CML is in the form of a single screw extruder.  A variety of...

Possible issues with extrusion of small samples - how to resolve them

It is not possible to extrude and spheronize everything.  Extrusion and spheronization can be used on a wide range of products and formulations.  However, if you are having trouble extruding your formulations with the Caleva Multi Lab (CML) then please read this article.

Caleva offers extruder screws of different designs for use with the CML.  If you are having issues with the CML then the...

Opportunities for Mixer Torque Rheometry

Wet granulations are a useful precursor to many solid dosage formulations and as such are widely used in the pharmaceutical industry. Because of the diverse nature of pharmaceutical materials, granulation is often employed as an intermediate process to enhance flow and compaction properties and improve the final product performance. The properties of a wet granule have a critical effect on the...

Extruder dies | all sizes | variable density | quadrilobe | trilobe

In the process of extrusion, having different dies available to process your product is key to increasing your chances of development success.  This is why we offer a large range of dies to allow us to work with you to find the dies that best fit your formulation needs.

We offer die plates that are excellent for most uses, like our 1 x 1 mm die, however sometimes a more specialist die may be...

Extrusion of catalyst and petrochemical materials

An opportunity in laboratory extrusion with catalyst material.  We have recently had some considerable success with one of our customers working with the extrusion of small quantities of catalytic material.

Extruding catalyst materials for petrochemical and adsorption products

In collaboration with some of its users, Caleva have recently been successful in extruding of small quantities of catalytic material using the Caleva Multi Lab (the first steps of blending and mixing can also be completed in the same multilevel base machine) whilst increasing the surface area/volume ratio of the extrudate produced.

The Caleva Multi Lab is faster and easier to clean

The Caleva Multi Lab (CML) is faster and easier to clean than any comparable bench-top extrusion & spheronization equipment.

The best results in the minimum time for your formulation development

 

Guide to the optimum diameter to length ratio of extrudate fragments

Is there a guide to the optimum Length to Diameter ratio of the extrudate fragments?

In the calculations used to demonstrate the data it is assumed that the extrudate is an infinitely long strand. In this case the length of the extrudate has no influence on the data shown. In reality, extrudate is not infinitely long and as the individual strands of the extrudate produced become shorter, the...

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.

Formulation development - determine optimum powder to binder ratio

Multiple Addition Test

Binder liquid is added to a dry powder mix and the consistency is measured as the mixing and addition of binder progresses.

The consistency of the mix is measured at regular periods so that the relationship between the amount of liquid binder added to the mix and the consistency in the resulting formulation can be accurately shown.

What type of pharmaceutical or catalyst extruder do I need?

All extrusion processes require the generation of pressure within the material to be extruded. When materials are put under pressure heat is generated. This cannot be avoided but different extrusion types generate different amounts of heat. There are basically three different types of extruder and the one chosen may have far reaching implications on production operations. It is important that...

What pharmaceutical products or drugs can I make in pellet form?

A list of suggested uses for pellets in pharmaceutical applications. 

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. 

 

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...

Formulation development of catalyst materials zeolite and bentonite?

We always offer our potential users the opportunity to test their formulation with us in our lab. This is to ensure that installing our machines would be the right decision for their formulation development, and/or their production environment.

This short article has been written from notes that Dr Steve Robinson made during trials with catalysts sent to us by a customer and we achieved some...

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%.