Knowledge Base

How long should I granulate my materials?

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.

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.

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.

How to produce consistent formulations from different mixers

Customer Quote: Mr. K.S (Aurobindo)

"It is exciting to see the correlation between the two graphs and granulation end point". 

With a major pharmaceutical manufacturer, together we characterised all their various mixers to produce a consistent formulation.

To identify three important characteristics for wet mass materials, namely:

  • The Optimum moisture point
  • The mixing time required to reach...

Do excipients purchased from different vendors behave in the same way?

The Mixer Torque Rheometer can be used to assess the behaviour of excipients purchased from different suppliers.

Background

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...

The Caleva Family of Laboratory Equipment

Whilst you may have heard of Caleva and any one of its flagship pieces of equipment, we'd like to introduce you to the family of Caleva laboratory equipment that you may find helpful for your application in your industry sector.  Choose one process or choose all of them.  Select further functions as you need them.  This adaptable and future proof suite of equipment will allow you to obtain...

Inconsistent spheronization results with difficult active ingredient?

The following case study demonstrates how the Caleva Mixer Torque Rheometer.  The MTR-3 was an invaluable aid in a specific case. A manufacturer of generic Venlafaxine pellets was experiencing inconsistent results from their manufacturing line. The resultant product was variable in both usable yield (weight of acceptable pellets as a % of weight of granulation made), and dissolution profile....

Mixer Torque Rheometer used with Food Powders

Research Article University of Padova where their Caleva Rheometer was used

The Importance of End Point Detection Consistency

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Caleva Multi Lab & Bone Regeneration study Medical University Gdańsk

Drug-loaded mesoporous silica/calcium phosphate composites for bone regeneration

Adrian Szewczyk at Department of Physical Chemistry, Faculty of Pharmacy, Medical University of Gdańsk has kindly allowed us to introduce this paper that introduces a study of Drug-loaded mesoporous silica/calcium phosphate composites for bone regeneration.  

 

Agglomeration properties of gluten-free flours under water addition and shearing conditions

The different states of agglomeration were identified by the evolution of rheological properties under water addition and shearing conditions using a Caleva® mixer torque rheometer. 

How reproducible can measurements be of something that is not homogeneous?

The MTR-3 uniquely offers a means of characterising the rheological properties of a wet granulation by providing a quantitative value of the consistency of the material tested. The more traditional hand squeeze test, previously widely used, to measure or compare granulations, is falling into disrepute and is no longer considered appropriate for modern day industrial production or research...

Yield problems in production and quality control

One of the strengths of the Caleva Mixer Torque Rheometer (MTR-3) is that it can be used to verify the properties of wet powder mass samples taken during production in large scale mixer/granulator systems. It can be used simply as a quality control tool on a regular basis or specifically as an aid to problem solving. Small samples can be taken directly from production and within two minutes a...

How the Mixer Torque Rheometer resolved a tablet friability issue

Caleva worked closely with a well known producer of food supplements made from natural materials, plant extracts and other natural food sources.  Their tablet formulations work well and this nutraceutical company has a good reputation for their products.  Generally they do not encounter problems with tablets breaking or disintegrating during manufacture, packing or storage.

Determination of moisture requirement to prepare spheroids by extrusion-spheronization

Spheroids are popularly used in the design of multi-particulate drug delivery systems. Extrusion and spheronization is commonly employed to manufacture spheroids in the pharmaceutical industry. It is a multiple-step manufacturing process which could be summarized into the flow chart as shown in Figure 1.

Save Time and Cost in Formulation Development

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End Point Determination Using the Caleva Mixer Torque Rheometer

A company wished to move a formulation currently undergoing product development from small scale laboratory (with batches of 50 grams) to the next stage for a larger scale batch trial of 100 kg (scale–up).  The development had been started using a small Caleva Multi Lab bench top mixer (maximum batch capacity 50 gram of wet mass). This development had been successful and now additional samples...

Caleva Mixer Torque Rheometer - The importance of mixing time for your formulation development and production

It is well established and understood that one of the most important factors in the development of a formulation for both tableting and making pellets by extrusion and spheronization is the amount of liquid binder added to the formulation. What is less widely acknowledged is the importance of mixing and the mixing regime used. The concept of “granulation end point” is recognised but there is...