Reducing risk in tablet development and manufacture

Study carried out using Gamlen Tablet Press

This article describes how measuring material properties that relate directly to the final tablet product, including the inherent ability of materials to form tablets (compressibility) reduces the overall risk in tablet development and manufacture. A case study illustrates the benefits of rapid compressibility assessment.

Tablets remain the most widely used dosage form for drug products, but relatively little is known about how the properties of active pharmaceutical ingredients (APIs) or other raw materials (excipients) relate to the processing parameters used to make the final product. As a result, manufacturers encounter problems in developing an ideal tablet, one that satisfies both the intended therapeutic use and the need to manufacture it efficiently and economically.

In short, the risk entailed in developing and manufacturing tablets is unacceptably high, particularly as more drug products lose patent protection and competition from the generics industry grows. This article discusses how rapid compressibility testing can help formulate tablets that minimize cost and increase efficiency.

Risk Reduction






























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.

Download full article: Risk reduction in tableting

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