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THE PHARMACOKINETIC STUDY
The study announced today was a pharmacokinetic study completed at accredited pre-clinical contract research organizations in Scandinavia. The study revealed significant positive effects on dogs. The study administered two different product formulations of CBD 25 mg/mL oil by a single oral administration in a four-way cross-over design to dogs. Product A was CBD25 with MCT-oil, and product B was CBD25 with the new LTT-oil based upon Solural Pharma's Lymphatic Targeting Technology (LTT). The CBD uptake was measured in the blood with these two different formulations in both a fasted and fed state. The MCT-oil (Medium-chain triglycerides) in Product A can be seen as a representative of the medical cannabis oil products on the European market today.
PAVING THE WAY TOWARDS PHARMA-GRADE MEDICAL CANNABIS
Generic medical cannabis products are available in several versions ranging from CBD (non-intoxicating), to THC and combinations of the two. These cannabinoids are mixed with standard oils like MCT-oil. Use of these standard oil products leads to unpredictable bioavailability which is ability of a drug or other substance to be absorbed and used by the body.
Challenge #1: Uptake
Low and inconsistent uptake of the drug in the blood across patients is a major and well-known challenge in the pharma industry, that applies to most drugs. This also applies to medical cannabis. Today, when patients are administrating traditional oil based medical cannabis, the metabolism will reduce the uptake of cannabinoids in the body. This means that a highly variable and often little part of the cannabinoids are actively delivered inside the patient with a therapeutic effect. This is creating problems to prescribe a steady dosage of the drug to patients. Also, the uptake in the blood is very different for each individual due to biological differences between patients.
What the study concludes:
- Improves uptake in the blood with a factor 2.6 (called "C-max") comparing fed MCT to fed LTT oil ingestion
- Improves uptake in the blood with a factor 15 (called "C-max") comparing fasted MCT to fasted LTT oil ingestion
- Improves uptake in the blood with a factor 34 when comparing fasted MCT-oil to fed LTT-oil ingestion
- Provides a lower inter-individual variation as LTT-oil is taken up more uniformly between individuals
Challenge #2: Onset of action
Onset of action is the duration of time it takes to reach maximum concentration of the drug in the blood after administration to the individual. Reaching the maximum (called "T-max") as fast as possible is important to help patients manage their treatment. For medical cannabis oil products, T-max is typically reached within hours depending on whether patients are fed or fasting. Predictability of onset time is critical to planning the dosing, and therefore the T-max should be identical regardless of the patient's food intake.
What the study concludes
- Fasted individuals with LTT-oil dosing reach maximum concentration faster (from 3,8 hours to 1,0 hour)
- Fed individuals with LTT-oil dosing reach maximum concentration faster (from 1,9 hours to 1,0 hour)
- Regardless of fed or fasted state, maximum concentration was reached in the same time with the LTT oil
"In our opinion, the new LTT-oil is truly groundbreaking for the entire industry of medical cannabis and for the patients globally" says
STENOCARE TO TAKE MAXIMUM ADVANTAGE
PLAN AND PATHWAY
The ambition is to introduce the first product within the next 18-36 months - pending regulatory approval from the health authorities. There are several important steps towards a commercial product, that include stability testing of the new product formulations and standardization according to regulatory requirements that apply in the individual target markets.
SUCCESS THROUGH PARTNERING
"We have had early conversations with our partners regarding the benefits with the LTT-oil. With the results from the study, we can be more precise in planning and scoping the opportunity. Even though bioavailability has been a key challenge for a long time in the medical cannabis industry, it is our experience that real data from a pharmacokinetic study regarding the topic has not been available until now. This puts
IMPORTANT PS: DAY TO DAY BUSINESS UNCHANGED
All of the above will take place as an activity of upgraded strategic importance. In parallel,
For additional information regarding
Thomas Skovlund Schnegelsberg, CEO Phone: +45 31770060 E-mail: presse@stenocare.com
About the new oil formulation technology
Stenocare and Solural have been cooperating on the development of an advanced medical cannabis oil formulation since
About STENOCARE A/S
STENOCARE A/S was founded in 2017 with the purpose of supplying medical cannabis to patients in Denmark and internationally. Stenocare was first to receive the Danish Medicines Agency's permission to import, distribute as well as cultivate and produce medical cannabis. STENOCARE sources its products from a number of carefully selected international high-quality suppliers and operates a unique, indoor state-of-the-art cultivation facility in Denmark, that has multiple levels of redundancy to safeguard quality and uniformity in a pesticide free production process.
www.stenocare.com www.stenocare.dk www.stenocare.se
About Solural Pharma
Danish Solural Pharma has strong expertise in pharmaceutical development and has many years of experience from world leading pharmaceutical companies in the development of new successful drugs. Solural Pharma has developed and their proprietary Lymphatic Targeting Technology to support the development of complete new and unique products showing excellent bioavailability.
https://news.cision.com/stenocare/r/breakthrough-results-from-new-medical-cannabis-oil-study,c3633546
https://mb.cision.com/Main/17551/3633546/1628649.pdf
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