Bergen op Zoom, The Netherlands - November 11t h, 2022
Stabican b.v., a leading drug delivery technology company, announces its developed
cannabidiol (CBD) drug substance exhibits a 5 – 8 fold increase of bioavailability compared
to that of a pharmaceutical standardized CBD oil. The bioavailability studies are part of
the in-house development of its proprietary drug delivery platform. Additionally, results
indicate that the metabolic profile has more favorable kinetics in terms of active
metabolites and peak plasma concentrations.
Starting in 2019, Stabican has focused on developing fine powders from cannabis extracts
with long shelf life, with dosages up to 80%. In 2021 the company established R&D and GMP
facilities in Bergen op Zoom, the Netherlands. The facilities are equipped with state-of-the-
art analytical equipment alongside pilot-scale production facilities.
The bioavailability data is generated as part of the ongoing development of the technology
and the lead product, a powder formulation of CBD with the high dosage of 70%. Studies
were performed at external labs using standard preclinical PK study protocols. The first
study results presented will be used to design larger preclinical studies, and eventually
clinical studies, with customers to establish the statistics necessary for an Investigation
Medicinal Product (IMP). Also, in vitro studies are ongoing to investigate precise metabolism
kinetics.
The proprietary drug delivery platform with IP covering a wide variety of plant extracts has
been validated for different cannabinoids, terpenes, lipid vitamins, oils, and plant-based
alkaloids. The resulting fine powder is readily incorporated in different dosage forms, e.g.
capsules, tablets, powder inhalers, creams, as well as consumer products like drinks, shakes, yoghurts. The API dossier is available with all data necessary for the Target Product Profile (TPP) and Investigational Medicinal Product Dossier (IMPD), including the proven safety profile of the product. Only GRAS substances are used which provide a fast route to market and clinic.
Recently, Stabican also confirmed superior shelf-life of the formulations from ongoing
stability studies. It is expected that drug substances and products using the technology will
exhibit a shelf-life of 3 years or more. Typical oil-based products, as those that were used as
a reference in the bioavailability studies, are not able to guarantee assay stability for these
time frames and these conditions. CBD in storage degrades oxidatively to D8-THC and CBN,
or even D9-THC which has a psychoactive effect not desirable in most CBD products. The
proprietary Stabican powders completely isolate the molecules from oxygen and moisture,
no related substances like THC have been identified in the samples on long-term storage.
Would you like to see more data, or get a sample? Contact Stabican at info@stabican.com,
or visit the website www.stabican.com.