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Telephone:
44 1258 471122

 
 

Formulation Development in the Pharmaceutical (Pharma) Industry

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Binder / substrate interactions & pharmaceutical (pharma) formulation development.

 

The amount of binder added to powder to make the wet mass and the mixing time have a large influence on the final characteristics of pharmaceutical formulations.

 

Get the formulation right before you spheronise!

 

The correct binder/substrate ratio is vital. The optimum mixing time saves costs.

 

There are three main ways available to determine the optimum ratio and mix time:- 

 

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1.  Adding binder and testing by “eye and hand” to reach a estimated optimum ratio.

2.  The systematic investigation of a range of possible options with subsequent. testing of the final characteristics of tablets and spheroids (pellets)  produced. A project of several days duration

3.  Using the Caleva Mixer Torque Rheometer-2 and obtaining a quantifiable optimum ratio “within an hour”.

 

 

Using the Caleva Mixer Torque Rheometer is the only method that is objective, quantifiable and can be completed with a minimum of time. The result is that a greater number of possible options can be investigated with the same resources. 

The MTR-2 is an integral part of the Caleva Mini-kit. 



Contact us at
info@caleva.co.uk for more information or a demonstration.

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From powder to wet mass.

 

·   Do you need to determine the optimum liquid/binder concentration and the optimum mixing time (optimization of formulation parameters)?

·   Do you want the ability to use the results obtained as part of a scale up strategy?

·   Do you need to evaluate materials to determine formulation choices?

 

The Mixer Torque Rheometer-2 can be used as a key tool in these investigations. With the MTR-2 you can:-

 

·   Quickly, consistently and reproducibly determine the optimum binder mix.

·   Study the effect of mixing kinetics on your formulation.

·   Study the effect of multiple binder additions for formulation development and screening.

·   Structure and determine your scale up strategy mixing parameters

·   Study mixing kinetics using variable mix times.

 

 

 

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From wet mass to coated spheroids

 

With the extruder head attachment on the Mixer Torque Rheometer it is possible to make small quantities of extrudate (as little as 5g) that can be spheronized (pelletized) without wastage and by use of a minimum amount of material.

 

With the Microspheronizer you can produce as little as 5g of spheroids, evaluate the spheronization characteristics of various formulations and establish parameters for a structured scale up.

 

With the Fluid-bed Mini Coater Drier you can optimize film coating materials, reproducibly coat a few grams of spheroids and produce small samples of spheroids for pre-clinical trials

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 From wet mass to coated tablets.

 

The Mixer Torque Rheometer-2 will allow the optimum selection of materials, the optimization of binder content, the reproducible production of small quantities of granules and the planning of scale up procedures.

 

The Fluid-bed Tablet Mini Coater Drier will allow (with a minimum of material – as little as a single tablet) the evaluation of suitability of tablet coating materials, the optimization of the film coating material using a very small number of tablets and the coating of exactly the required number of tablets without wasting material.

 
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The hand squeeze test that cannot be quantified and is not reproducible.

 

 

 

 

Extrusion of a pharma product with a Extruder 20 with a 1mm screen.

 

 

The final result. A mix of two active ingredients in a single oral dosage.

 

 


If you are in Canada and would like more information about Caleva equipment for use in formulation development please contact our representative at;
AC Compacting LLC

 

 

 
Caleva Process Solutions Ltd.
Telephone: + 44 1258 47 11 22 / Fax: + 44 1258 47 11 33 / Email: info@caleva.co.uk
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