Compaction Simulator and Emulation
An inherent material deformation is a main player of any low API load or high API load tablet formulation. Formulations with a right blend of plastic-elastic-fragmenting material is necessary to form a robust viable compact.
We will help you to understand API, excipient, and formulation response under real processing condition by emulating your production scale rotary press with a material sparing approach. We have state-of-the art Presster emulator, which can simulate any rotary press available in the market. This highly advanced instrumented emulator can acquire real time force-displacement data under any compression condition if necessary. Our well-renowned material scientists are expert to transform this data into valuable information with several mathematical approaches including current USP <1062> chapter.
We will help you to understand an inherent material deformation of active pharmaceutical ingredient (API) and finding a right combination of excipients and a tablet manufacturing process for a successful transformation of API into a robust tablet.
We understand that new lead molecules (API) are extremely expensive specifically in early development stage program. Therefore, getting maximum amount of valuable information with a minimum of API is extremely vital criteria for any testing in this phase. We always believe in ‘Material Sparing Approach’ for such testing. We ask you few grams of your API (If API load is about > 30%) and or formulation blend for testing. Once we know the tooling dimensions of your tablet and name of manufacturing machine, we will simulate your existing manufacturing conditions to understand the response of API and formulation by generating real time Powder Cardiogram.
This Powder Cardiogram will be a tool to understand the reasons and will predict the performance of your formulation under proposed experimental conditions. These sound scientific understanding of the formulation will help to decode possible scale-up issues. Such early interventions might avoid SUPAC and save both cost and time in your product launching.
Major Testing:
- Dynamic Heckel Parameterization
- Dynamic Shapirao’s Parameterization
- Dynamic Kawakita Parametrization
- Work Expenditures in Compression and Ejection Phase
- Strain Rate Sensitivity
- Lubrication efficiency Immediate
- Axial Recovery (Elastic Recovery)
