This PFI: AIR Technology Translation project focuses on translating innovative surface modification science with fluid-bed coating technology for producing fine drug nano-composite particles to fill current technology gap of lack of scalable and economically feasible methods to produce highly bioavailable drug composite particles that do not have a gritty mouth-feel, which is undesirable for patients with swallowing disorders. The translated science-based technology has the following unique features: very fast dissolution even for poorly water soluble drugs, a size small enough for incorporation into orally disintegrating dosages, and excellent flow and handing properties that provide exemplary performance using conventional robust processing methods that lead to efficient, scalable and cost-effective manufacturing when compared to the leading competing technologies such as spray drying and hot-melt extrusion for bioavailability enhancement, or freeze-dried fast disintegrating dosage forms in this market space.
The project accomplishes this goal by combining fundamental aspects of surface science to reduce cohesion of carrier particles and to stabilize nano-drug particles, which are 300 times smaller than the diameter of human hair, to preserve their large surface area resulting in a proof-of-concept highly bioavailable drug composite particle that is taste-masked, and is less than 50 microns, i.e., smaller than the diameter of human hair.
The partnership engages Catalent Pharma Solutions, a contract manufacturer, along with their pharmaceutical company clients to provide guidance in the technological as well as regulatory aspects of orally disintegrating dosage forms and other aspects such as patentability, market research, financing, and commercialization as they pertain to the potential to translate the science based technology along a path that may result in a competitive commercial reality. The final output of the commercialization is a robust manufacturing platform that is applicable to any poorly water soluble drug and forming fast dissolving drug-composite small particles that can be used in chewable tablets, syrups, strip-films or lozenges, targeting patients having swallowing disorders, thus increasing patient compliance. As a reference, the majority of newly discovered drugs are almost insoluble in water; while the market for dysphagia alone is currently over $3B/year.
The potential economic impact is expected to be well over $100M/year in the next five to fifteen years, which will contribute to the U.S. competitiveness in the pharmaceutical sector, since nanostructured particulates are produced via methods that have scalability, reproducibility, low cost, and high-yield, and the products will have better bioavailability, are smaller and are essential components of next generation pharmaceutical manufacturing. Similarly, it can have an impact on other industries; such as; food, agrochemical, nutrient delivery, cosmetics, as well as dental and bio-materials. The societal impact, long term, will be in robust manufacturing platform that leads to products that provide improved patient comfort, hence compliance, and improved performance using simple, cost-effective processes, as well as have the reduced-risk of using nano-particles through lack of associated exposure to factory workers.