Innovation in Microsphere Formulation Processes

Related Vendors

TURCK GmbH

Glatt Ingenieurtechnik GmbH

Italvacuum, Srl

PSL UK

The devices used to inject the micro particles can be vial or prefilled syringe. In any case, the Microspheres stay separate from a liquid phase. They are stored away from the liquid phase as they are more stable in a solid form and last longer owing to their biodegradable characteristic.

There are two main steps during the formulation of medicine in Microspheres, first the upstream process consisting of creating the polymeric Microsphere particle s containing the active ingredient; then the downstream process which consists of filtering, classifying, drying and recovering the Microspheres in a sterile manner ready to be filled, packed and stored.

The downstream process became a problem for manufacturers to control because of the below challenges:

• How to accurately control the particle size,

• How to maintain the stability envelop during the whole process,

• How to scale up the H&D process to commercial manufacturing efficiently,

• How to maintain reproducability with maximum yield.

The existing technologies developed so far such as sieving or screen filtering and centrifugal sifting and lyophilisation are causing many problems. The following difficulties are mentioned by end users:

• Mesh blocking and difficult size classification

• Long drying time

• Breach of stability

• Difficult process scale-up

• Insufficient yield performance

• High investment for several technologies

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