Achieve accurate drug or vaccine delay for multiple doses in one injection.
Eliminate drug burst to lengthen drug release for long-lasting treatment.
Maintain drug release in the inner ear for a month without initial burst.
Get complete release after taste-masking in a titratable powder.
Match duration of extended release tablets with liquid suspensions.
Precise control of particle size and composition enable precise active pharmaceutical ingredient (API) release rates, including both immediate (IR) and extended (ER) release. Unlike other encapsulation techniques, optimμm technology’s precise control over microcapsule properties seals the drug inside small, palatable microcapsules that can then release drug (IR or ER) after contacting stomach acid to create a cost-effective platform for microencapsulating unpalatable APIs.
This microencapsulation strategy offers significant advantages for pediatric and geriatric drug reformulations. The simple, robust, and precise particle engineering allows for an unprecedented amount of control over the final product, which would improve dosing efficiency and efficacy and reduce adverse effects. This highly-flexible and customizable encapsulation platform provides a convenient means of masking the bitter flavor of many drugs while also establishing a delivery system that is adaptable to many patient-friendly formats. The ability to transport and store these particles in dry powder form also makes this a convenient solution for personalized dosing and patient-specific treatment strategies. This platform addresses numerous pediatric medicine issues, and the technology provides for patient-specific, accurate, and palatable dosing.
The stratµm technology produces physically controlled particles using a flexible and cost-effective single-step process with significant advantages over current particle fabrication technologies. Leveraged for injectable pharmaceuticals, the stratµm technology provides controlled release technology solutions for extended release formulations (continuous release for weeks, months, years) and pulsatile release formulations (no release until monthly time triggers). For extended release applications, stratµm’s uniform particles provide release accuracy for narrow therapeutic index drugs and minimize the initial drug burst for increased safety and efficacy. The batch-to-batch reproducibility is critical for achieving precise release profiles. For pulsatile release drugs, stratµm technology provides an accurate delay before the pulse so that multiple doses can be included in a single injection, which is particularly useful in vaccines and ocular therapies.
The stratµm technology is cost effective in that it is highly scalable, and capsules are created in a single step. The novel nature of the products and the cost-effective approach lend itself to creating the injectable products of tomorrow. The stratµm technology is currently being used in a number of therapy areas under development.
Orbis’s unisun delivery platform is a cost-effective intratympanic drug delivery system that is capable of sustaining drug levels in the inner ear cochlea for four weeks or longer. The primary advantage of the unisun platform is the ability to maintain precise drug concentrations in the inner ear perilymph fluid, free of the peak-to-trough variations characteristic of immediate release intratympanic injections that often lead to toxic concentration spikes and short durations of efficacy. In addition, unisun is administered as a one-time injection, offering healthcare providers a convenient and cost-effective administration procedure – one that is already performed in outpatient clinics nationwide – while sparing patients the pain associated with multiple injections spaced over several weeks. Further, unisun is a local delivery system that will avoid the side-effects – oftentimes severe enough to cause patients to discontinue treatment, resulting in further disease progression – associated with systemic drug delivery.
Orbis’s unisun platform consists of drug-loaded microspheres (produced using Orbis’s Precision Particle Fabrication technique) suspended in a novel fast film-forming agent. The film adheres the microspheres to the round window membrane – a drug permeable membrane that allows access to the inner ear perilymph fluid – while the microspheres precisely control drug release.
Comparison of Orbis Biosciences Platforms to other production methodsExisting methods used to produce microparticles are often costly and imprecise. For solid microparticles, the primary production methods are emulsion/solvent evaporation techniques and spray drying methods, both of which provide inadequate particle control and a limited release rate. Phase separation techniques are most common for fabrication of double-layered core-shell microparticles, but this method is not compatible with all materials and has limitations on the range of achievable architectures, release profiles, and shell thicknesses. Orbis technology platforms are comparable to emulsion/solvent methods in terms of production cost, but with a much greater degree of control over particle characteristics. While sieve fabrication and spray drying offer marginal improvements over emulsion methods in terms of controlling particle characteristics, they cannot compete with the level of precision available with the Orbis technology platforms and are comparatively expensive due to high maintenance and large material waste.
In comparison, the Orbis technology is a cost-effective process that readily translates to current production methods by integrating the Orbis nozzle with existing industrial collection vessels. Scale-up to multiple nozzles has been established by Orbis and combined with conventional industry collection vessels. Multi-nozzle technology thus allows for production rates that satisfy many needs. The technology is compatible with a wide variety of materials and offers dramatically better particle size and morphology control than conventional methods.