DENVER – May 26, 2016 – NanoSphere Health Sciences, LLC, innovative developers of the industry-first, patent-pending NanoSphere Delivery System™, announced today positive pharmacokinetics (PK) and pharmacodynamics (PD) results for its nano-encapsulated THC intra-oral formula.
NanoSphere Health Sciences is the world’s first and only patent-pending nanoparticle delivery system for medical and recreational cannabis. Concentrated “NanoSpheres” deliver standardized profiles of whole plant cannabis extracts, purified cannabinoids and terpenes in convenient, microliter dosages with increased bioavailability, bioactivity and therapeutic potential. At the same time, the natural phospholipid spheres of nanoparticles decrease the adverse effects of cannabis. This is a major advancement in cannabis delivery technology.
“The PK data confirmed that our NanoSphere Delivery System has significant advantages over edibles and smoking in general. The nano-encapsulated THC is rapidly delivered into circulation in less than 10 minutes after administration,” said David Sutton, Chief Operating Officer of NanoSphere Health Sciences. "The data also supports our expectations that our product is rapidly absorbed through buccal and sublingual mucosa by intra-oral administration. We look forward to continuing our research and evaluations of our nano-encapsulated THC products in the months to come."
Highlights from the study:
- Measurable THC blood concentrations within 10 minutes.
- Peak THC blood levels that were 141%, 130%, 289% greater than 5mg oral, 5.4 mg Sativex® Spray and 5mg Namisol ® sublingual THC.
- Peak THC blood levels in 60 minutes, occurring 3.5x faster than oral ingested THC and Sativex® Spray .
- Significantly longer THC circulating half-life.
- High Peak THC levels and Low 11-OH-THC formation demonstrated NanoGel THC is absorbed into the blood stream sub-mucosally.
- Onset of pharmacodynamic effects under 10 minutes.
- Rapid cannabinoid distribution to the brain, peripheral tissues and receptors.
“Intra-oral delivered nanoparticle encapsulation of THC (NanoGel THC) demonstrated advantageous pharmacokinetic and pharmacodynamic characteristics that were significantly different from inhaling and ingesting cannabis and cannabinoid extracts. This represents a new delivery dose form of cannabis-based medicines that show advantages that signify therapeutic importance. Our NanoGel cannabinoids are the next generation and future of cannabis products,” said Dr. Richard Clark Kaufman, Chief Science Officer of NanoSphere Health Sciences.
“Among the main disadvantages of currently available THC methods of use are dosing difﬁculties due to unpredictable absorption and poor pharmacokinetic characteristics. NanoGel THC is a novel viscoelastic gel nanoparticle encapsulation of THC formulated for intraoral delivery, which improves THC absorption, distribution bioavailability and bioactivity. NanoGel THC establishes a high concentration gradient across the oral mucosa by intracellular and intercellular routes, favoring THC diffusion into the underlying tissue and absorption into the bloodstream,” said Dr. Kaufman.
NanoSphere’s cannabinoid products are uniquely designed to be administered intra-orally, intra-nasally and transdermally in precision dose-metered dispensers. The convenient-to-use liquid NanoGels bypass the GI tract and avoid 1st pass liver metabolism. The NanoSphere’s dynamic membrane structure efficiently transports cannabinoids into the circulatory system and across the cell membranes to bind endocannabinoid and synergistic receptors.
NanoSphere Health Sciences plans on launching its patent-pending products this summer in the U.S. and Canada for the recreational and medical cannabis markets with advanced, intra-oral and intra-nasal and transdermal formulas.