How drug supplier compressibility evaluation can help make informed decisions

by Dipankar Dey at Gamlen Tableting Limited

Using the Gamlen Tablet Press, this study generated unique information on less than 1g of each drug substance tested. This could not have been produced any other way. It enabled client to make informed decisions about suppliers and their suitability. These principles have widespread applications in many areas.

A client asked us to evaluate two raw material suppliers in respect of compressibility and batch to batch variability. Samples of two batches of supplier 1 material were compressed (without any processing or the addition of lubricant). Compressibility of the two batches was very similar in the pressure range up to 500MPa (Figure 1), which is the normal maximum used during tableting.

Figure-1-Supplier-1-materia

 

 

 

 

 

 

 

 

 

Figure 1 Supplier 1 material compressibility batches 860 and 1451

Two batches of supplier 2 material were compressed. Their compressibility was substantially different, as can be seen in Figure 2.

Figure-2-Supplier-2-materia

 

 

 

 

 

 

 

 

 

Figure 2 Supplier 2 material compressibility batches 3004E and 4206

To assess the capping tendency of the different sources of material, the compaction pressure range was extended to up to 700MPa. This was possible because we were 2 using a special 3mm punch and die set which can withstand very high pressures. The strength of the tablets made from supplier 1 material decreased rapidly at compaction pressures above the normal range (Figure 3).

Figure-3-Capping-behaviour-

 

 

 

 

 

 

 

 

 

Figure 3 Capping behaviour of supplier 1 material

When supplier 2 material was compressed above the normal range, the capping profile observed was different for the two batches.

Figure-4-Capping-behaviour-

 

 

 

 

 

 

 

 

 

Figure 4 Capping behaviour of supplier 2 materials

Figure-5-Comparison-of-supp

 

 

 

 

 

 

 

 

 

Figure 5 Comparison of supplier 1 and 2 materials

On comparison (Figure 5) supplier 1 batches are less compressible but more consistent than supplier 2 batches.

 

Gamlen-Tablet-Press-laborat

 

 

 

 

 

 

 

 

 

Why use a Gamlen Tablet Press?

It can save you time, money and materials. People need help to study tablets under properly controlled conditions in a laboratory.

Michael Gamlen invented the Gamlen Tablet Press (GTP) to help you understand the relationship between the properties of your drug, formulation, and manufacturing process. When you do this you can develop better products more quickly, and improve productivity of your tablet manufacturing operations.

The GTP is the first machine designed to make tablets on a small scale at a user-specified compaction force. This force determines both the physical strength and the dissolution behaviour of the tablet. These are the key properties which ensure the tablet reaches the patient and delivers the drug.

The machine works by monitoring the force in real time using a PLC.  The punch force and punch position are displayed in real time on a computer which is also used to input the compaction conditions. Using the GTP we make tablets of extraordinary reproducibility and consistency, within 1-2% force, and with no wastage. Batch yields are >99%.

For the measurement of tablet breaking load, the press records both force and displacement during both compression and fracture, and also provides the ejection force profile associated with tablet ejection

In the scale-up of tablet production, the press can be used to determine the relationship between tablets developed at the bench-top scale using a few grams of material (often at the early development stage) and the final tablet manufactured on a rotary tablet press. The latter uses hundreds of kilograms of material, making process development difficult because of practical difficulties in experimentation; smaller and different shaped tablets can, however, be scaled to the final desired tablet design if TFS is used as the basis for comparison.

If you want better tablet products and processes you need the Gamlen Tablet Press.

Conclusion

This study generated unique information on less than 1g of each lot of drug substance tested, which could not have been generated in any other way. It enabled the client to make informed decisions about suppliers and their suitability. These principles have widespread applications in many areas.

Have a question? Like a quotation?
Like to see a Gamlen Tablet Press demo
or have batch tablet samples made?
Then emailmichael@gamlen.co.uk
or call us now on +44 115 912 4271

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