Lifestyle Delivery Systems Inc.(LDS) has begun outlining the protocols for clinical trials of its patent pending CannaStrips formula.
LDS’ chief medical officer, John Sanderson MD, having over 30 years of clinical research, clinical trial coordination and analysis experience, will oversee the protocols and operational aspects of the trials. The trials will be conducted in Canada with the specific goal of substantiating the efficacy of the CannaStrip delivery system. The company intends to submit the results of the clinical trials for consideration to Canadian health officials as an alternative delivery method for medicinal marijuana in Canada.
The clinical trials’ primary focus will be on three specific aspects of the delivery system. First, the time required from application onto the buccal membrane to the introduction of active ingredients into the blood stream. Second, the volume or percentage of active ingredients delivered into the blood stream and the length of time that those ingredients become bioavailable in the blood stream to the patient. Third, to determine the extent to which the ingredients can be directed to specific areas of the body and brain.
Brad Eckenweiler, CEO of Lifestyle Delivery Systems, states, “The value of these trials goes far beyond the Canadian marijuana market. The Company believes that clinical evidence supporting the goals for LDS technology will set regulatory expectations significantly higher for the control, effectiveness and safety of all marijuana products worldwide.”
The patent pending CannaStrips formula is unlike any other delivery method currently available. The current market has lookalike strips that in truth are simple sheeted material that act more like edibles and have little if any sublingual delivery capabilities. CannaStrips nano-engineered technology addresses the challenge of efficient transport of therapeutic molecules, including cannabis-derived bioactives, across the oral mucous barrier for systemic delivery into the bloodstream. Low viscosity pores or temporary channels are created which foster the rapid transfer of cannabis nanoparticles from the buccal surface into the circulation. Each particle is coated with a nano-envelope which chaperones its cargo to target tissues within the body. The net effect is improved bioavailability as well as enhanced efficacy.
Dr Sanderson, states, “While edibles overcome the health and safety issues of inhalation as a method of cannabis delivery, they are inherently far less efficient, as much of the therapeutic effect of the plant is lost to incomplete absorption and early liver disposal. These clinical investigations are an exciting next step that takes us from the laboratory trials to a more rigorous examination of the incremental benefits of this unique system of delivery which provides a third option that addresses concerns about both safety and efficacy.”
Lifestyle Delivery Systems Inc’s technology produces infused strips (similar to breath strips) that are not only a safer, healthier option to smoking but also a new way to accurately meter the dosage and assure the purity of the product.