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FAQ

FAQ 2018-06-29T18:07:21+00:00

Precision Particle Fabrication® technology is the term for Orbis’ patented process to create uniform microspheres and microcapsules in a single-step process.

Yes. Orbis Biosciences exclusively owns or controls relevant patent rights. Our Co-founder and Chief Scientific Officer, Cory Berkland, is an inventor of this technology.

Scalable production rates are obtained using a modular, multi-nozzle approach. For example, a nozzle with ~100 individual jets creating particles 100 micron in diameter can achieve rates in the range of 1-10 kg per minute, depending on a number of factors, including the material and particle architecture. Production rates are particle size dependent, with larger particles and more jets both increasing production rates. Production rates are highest when matrix materials and active ingredients can be melted prior to Precision Particle Fabrication® technology processing while rates decrease as the level of solvent required to dissolve matrix and active ingredients increases.

The cost for producing microspheres and microcapsules using Stratum technology is very similar to the cost for emulsion polymerization processes, whereas the cost for producing microspheres and microcapsules using Optimum technology is very similar to the cost for spray congealing processes, including “spinning disc.” Lastly, the excipients used in Unisun’s film-forming agent are commonly available materials that are no more expensive than ingredients used in tableting pills.

Yes. For example, a dog study demonstrated the capability of an Orbis-fabricated microsphere depot to sustain NSAID blood levels with infusion-like kinetics, without ‘burst’ release. This study was published in the J. Vet. Pharmacol. Therap., 2011. We also have human clinical data on our taste-masked reverse enteric prednisone powder, which demonstrated bioequivalence in total body exposure to the reference listed tablet.

Generally speaking, the technology is amenable to any material that may be dissolved or melted without damaging the material itself or the ingredient to be encapsulated. Categorically, Precision Particle Fabrication® technology has been used to produce shells using celluloses, polysaccharides, polyesters, polyanhydrides, and other materials capable of being polymerized. The underlying process forms core-shell droplets wherein the shell material may be cured or solidified using a variety of approaches such as coacervation, phase separation, polymerization, cooling, etc.
A microsphere is a solid matrix particle whereas a microcapsule has an inner core and an outer shell. The active ingredient in a solid matrix particle is typically dissolved or melted in the same vessel as the active ingredient before Precision Particle Fabrication® technology processing into microspheres. The microcapsule core can be either liquid (oil or water) or solid and typically contains the active ingredient. The shell of a microcapsule is typically a polymer or wax. Precision control of shell thickness and density can be used to achieve the desired release kinetics of the core.
Orbis’ Precision Particle Fabrication® technology generates very little waste. In fact, approximately 80-90% or more of material put into the process becomes product.
No. Our proprietary Precision Particle Fabrication® technology does not require a secondary coating step to create microcapsules.
No. Unlike spray drying, Precision Particle Fabrication® technology does not use high-temperature gasses to dry slurries into particles. Instead, it creates uniform particles by the combination of a vibrating nozzle and a co-axial carrier stream. Particles exiting the nozzle can be captured in a variety of collection vessels and media including aqueous solutions and air. Importantly, however, Precision Particle Fabrication® is compatible with spray-drying machines to enable size uniformity of spray-dried particles.