Nanomi offers technology for the fabrication of monodisperse microspheres for parental, sustained released, drug delivery applications. Nanomi's proprietary microsieve™ emulsification process enables the cost efficient processing of a large variety of polymer/active combinations into microspheres, with unsurpassed predictability in size and performance. In many cases your existing product formulation can be used directly in our process.

Product morphology and encapsulation of active compounds

Microsieve™ emulsification results in monospheres in the micrometer range (C.V. ≈ 5 %) with high encapsulation efficiency and controlled release profiles. A large variety of polymers can be processed with dichloromethane as solvent (class III solvents are also available if desired). Proteins, peptides and poorly soluble drugs can be encapsulated reproducibly, and in a cost-effective manner.

Our activity portfolio includes microsphere fabrication with PLGA, PLLA, PLGA-PEG, PLGA-PCL, PMMA and PEG-PBT, and the encapsulation of antibodies, progesterone, doxycycline, cyclosporine A, and model compounds such as lysozyme, BSA and vitamin B12.

Size control

The predictability and accuracy of the particle size obtained by our process is excellent. The particle size depends only on the membrane used and is independent of the formulation. Size control benefits both the product (better injectability and therapeutic properties) and the patient (smaller needle gauges can be used, thereby resulting in less-painful injections).

SEM image of a needle with microspheres produced at Nanomi

At the same time, precise control of the particle size in non-vascular injectables is vital for suppressing immunoactivation. Nanomi's process also enables the production of microspheres with a precisely defined size, for use in intravascular delivery and embolic therapies.

Small processing volumes and mild process conditions

In comparison to traditional double emulsion techniques, microsieve™ emulsification enables the use of much smaller volumes to produce the desired product. Furthermore, low shear and low pressure at room temperature helps to preserve the functionality of the encapsulated compound and the carrier.

Enabling new products and therapies

Nanomi's flexible and customizable process makes new products and therapies possible, and transforms difficult to process formulations into novel drug delivery vehicles. Currently work is in progress to downscale particle size to the nano range.

Upscaling and GMP compatibility

The microsieve™ emulsification process can be conveniently scaled to any size by increasing the number of pores on our membranes. The currently available production scale is 1 kg/day. Work is in progress to integrate the process into a GMP-qualified fill-and-finish production line.

1. Microsieve™ emulsification C.V. ≈ 5%
2. Conventional method C.V. ≈ 25%