Combined process reduces exposure risk

Manufacturers of APIs may reduce the risk of exposure to highly toxic active ingredients, as well as saving money and time and improving the quality of their products using a new process from Collette, a member of Niro Pharma Systems. The new system performs crystallisation and granulation in a single pot, thereby eliminating the primary-secondary divide.

The production of APIs often includes a (re-)crystallisation step to obtain a powder with the correct characteristics, which is then dried for use in secondary pharmaceutical production, for example wet granulation. By using a single-pot processor for the (re) crystallisation step, the production of the API and its incorporation in the final formulation can be executed in one machine.

The API is loaded into the single-pot processor either in liquid form or as powder and then dissolved in the appropriate solvent. (Re-)crystallisation is executed using the vacuum system of the single-pot processor, using microwaves for extra energy input if required, and can be carefully controlled by an interaction of vacuum level, bowl temperature, product temperature and microwave energy input to obtain the correct crystallisation circumstances.

When the product has been crystallised and dried to the desired moisture content, the other ingredients of the final formulation can be added, and wet granulation and subsequent drying is executed in the same machine.

The process is said to offer major benefits with regards to containment of highly toxic active ingredients, eliminating cumbersome containment measures during packaging, storage and shipment of the API.