The temperature of the mix during granulation processes is generally considered to be of minor significance in both formulation development and in large batch granulation despite the fact that in some locations ambient temperature can change significantly during the course of a working day.The MTR manual states that the bowl should be allowed to return to room temperature after washing. The...
Excipients from different batches or vendors may be variable in quality and it is often necessary to perform pre-formulation assessment for each batch of excipient received. In some cases, excipients from different vendors require comparative assessment of their equivalent functionality. In this type of assessment, the MTR can be an invaluable tool to evaluate the potential performance of the...
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 help you find the best options for your formulation.
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 needed. Our trilobe and...
Our new High Viscosity Mixing Blades, designed for making those sticky, viscous, difficult, granulations much simpler. Our design team have been working tirelessly to come up with a solution to a constantly asked question.
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.
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 (CML) is faster and easier to clean than any comparable bench-top extrusion & spheronization equipment.
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...
Variable Mix Time Test
It is well-known that a minimum amount of mixing is required to ensure consistent and repeatable product characteristics. What is often less considered is the possibility of over-mixing the product so that the characteristics of the resulting formulation undergo a change.
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.
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.
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 the...
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.
The Caleva MCD was originally designed for coating of very small batches of tablets. The original Mini Coater Drier was very efficient at this. However, as a response to several user comments and requests a new version was designed to allow users to also coat small samples of pellets over a range of industries. The original improved design specification that users were requesting was that...
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 to...
Our general tablet coater literature describes the coating capability of a tablet size of up to 10 mm. However, this refers to a diameter rather than a capsule style design in length. The Mini Coater Drier is incredibly versatile and really the limiting factor is generally a weight issue as opposed to size. It’s important to consider weight/batch size to ensure a good coating motion within the...
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...