Compaction Simulator Enables Successful Production Transfer for Actavis

Using a compaction simulator, Quay Pharma has helped pharmaceutical manufacturer Actavis transfer tablet production of one of its top-selling drugs to a higher throughput tabletting machine.

Transfer of tablet production between machines is common as manufacturers seek to increase production or replace old equipment with newer models. However, due to the complex powder mechanics involved in tabletting, any changes in process that create increases in speed as well as the duration and/or force of compression, can sometimes lead to failure of a tablet formulation to work successfully on new equipment. Even minor amendments in tooling design lead to a change in the powder compaction properties and can result in failure of the tablets due to capping or lamination.

In order to help avoid these problems and ensure a smooth transfer between equipment, Quay uses an advanced MedelPharm compaction simulator, which can mimic any existing tablet press available on the market. The simulator has only one tabletting station with the punches being programmed to follow the force displacement profile of any tabletting machine. The tablets can be compressed at both low and high speed and it enables parameters such as compression force and speed to be recorded as well as ejection force.

For this study, tablets were compressed using the current machine profile and then using the new machine profile. Data was captured throughout the tabletting process to allow a thorough understanding of what impact the changes in compression profile were having on the finished tablet. From the data obtained, and using very small quantities of material, Quay was able to accurately assess the properties of the Actavis tablet and suggest how a revision in tooling would enable the tablet to be formed effectively on the new equipment, whilst maintaining the required throughput speeds.

“Quay’s knowledge and experience was invaluable in helping us to successfully transfer production and avoid the disruption that can occur during this process,” commented Steve Brown of Actavis.

The compaction simulator also offers a cost-effective means for optimising formulations for new drugs, minimising the amount of API used and helping to simplify the process for scaling up production of a new formulation for phase II clinical trials.  

Quay Pharma, +44 151 203 9800, enquiries@quaypharma.com, www.quaypharma.com.