The reliable way to study formulation properties and predict how they’re going to perform in the manufacturing process
For over a century pharmaceutical manufacturers struggled with powder compression problems such as capping and lamination, powder sticking to punch surfaces or die wall, and insufficient mechanical strength to withstand stress in downstream processing.
Taking the guesswork out of tablet manufacturing assessments
Now there is a new laboratory tablet testing service to help you predict and avoid common manufacturing problems. This gives you the peace of mind that your formulation works and your material is the same quality as previous batches.
This will speed up your manufacturing process, reduce material costs and save you time and money. The service is ideal for manufacturers of generic products and vitamin supplements.
How is the material testing and analysis carried out?
The Gamlen Manufacturability Assessment enables users to make a simple assessment of powder properties based on small batches of tablets compressed under tightly controlled conditions using the Gamlen D series Powder Compaction Analyzer.
A batch of 15 or 25 tablets is prepared, three or five tablets at each of five compaction pressures. The tablets are broken in diametral compression, preferably using the Gamlen Tablet Tensile Analyzer (TTA). The data is copied into a spreadsheet, which then analyses the key Manufacturability attributes relating to compaction and lubrication, and automatically produces/tablets based on well-established literature values for the tablet key properties.
Full data are also presented so that the user can, if desired, make their own analysis of the findings.
We recommend collecting data on all development tablet samples to provide a database of information. This can be used at the early stages of development to assist in the evaluation of drug substance batches, formulas and processes.
It also forms a basis against which future batches of product can be assessed for consistency during process development, technology transfer and routine production.
The data set will be invaluable for identifying changes and trends in the manufacturing process as it is scaled up and put into production.
Enhanced Manufacturability Assessment for given sample
Includes Assessment 1 plus two dry granulation evaluation tests, and evaluation using our unique in house data analysis system which provides information on elasticity and plasticity and (in contrast to Heckel) ways of improving the product.
USP COMPACTION PROPERTIES
Advanced Manufacturability Assessment for given sample
Includes Assessment 1 plus two dry granulation evaluation tests.