Plant-based pharmaceutical-grade ingredients
Stabican offers pharmaceutical, food, and beverage companies a solution to current shelf-life stability-, solubility-, bioavailability- and processing problems of fat-soluble molecules with a strong focus on cannabis extracts and isolates (incl. Δ9-THC), psilocin, nicotine and vitamin A, D, E and K.
Our proprietary Active Pharmaceutical Ingredient Powder meets all the quality standards of the pharmaceutical industry and at the same time makes strong IP-protection of the API and the final product possible.
Our pharmaceutical grade ingredients can be used in a wide range of applications including sustained release oral solid dosage forms, semisolid, dry-powder inhalers (DPI), liquid formulations, E-liquids and transdermal applications.
Oral solid dosage forms
With the knowledge of our experienced team, we can adapt our product platform to the needs of our customers. Together with our trusted partners, we can work with you to ensure that your discoveries have a proof-of-concept that has speed and efficiency built in to accelerate your molecule’s journey to First-In-Human studies.
Stable at room temperature
The usage of standardized cannabis extracts in medicinal products has become common and popular. However, during the extraction, formulation and storage of the products, the active components are exposed to oxidation, hydrolysis, microbial attack and other environmental degradation which poses a problem of stability to the products. E.g. when Δ9-THC gets in contact with light, oxygen or room temperature it can degrade into CBN, a different active ingredient with a different biological activity. Most cannabinoids also suffer from poor and variable bioavailability.
The stability of drug formulations is aimed at ensuring that the drug product remains within the specifications established to ensure its identity, strength, quality and purity. Each ingredient, whether therapeutically active or inactive, in a dosage form, can affect stability. Stabican has developed a process and product that guarantees the physical and chemical stability of cannabis extracts at room temperature. Our process maintains the chemical composition of the used extracts and isolates. The oily and resinous cannabis extracts and isolates are converted into a solid powder, providing a product with reproducible bioavailability and improved the handling during manufacturing and storage.
Bridging the gap between molecule and drug
One of the most important issues hindering clinical research and drug product development, is oxidation and sensitivity to water exposure of most of the phytochemicals of interest. Δ9- tetrahydrocannabinol (THC), is known for its relative fast degradation by exposure to air, light, heat and water (vapor) 1 . A clinical study on the effects of THC on a certain disease requires solid statistics from a large study group, and therefore the dosage should be stable within tight tolerances. Considerable efforts have been devoted to protect the compound with packaging solutions, complex (cold) supply chains, or reducing time between extraction and dosing. This has led to a impractical or unacceptable, resource and capital intensive pharmaceutical solution. The state of art is dosing cannabinoids dissolved in oil, which is currently the major market share in medical cannabis. In unregulated sectors these oils are known to be unreliable in terms of stability and reproducibility of the dose. The very few products on the market that have undergone the severe pharmaceutical process of registration, eg. Sativex, are formulated with high amounts of solvents and alcohols.
Often various encapsulation methods are tried to achieve protection and stabilization of the cannabinoids.
Known methods include:
• Polymer micro- or nanospheres
The last 2 methods actually are ‘new APIs’, as changing the chemical nature of the active requires the product developer to undergo extensive pre-clinical work and toxicological studies. The rest of these methods involve using a large amount of excipients, like polymers, surfactants, lipids, etc. Bringing a product based on these methods to market involves lengthy studies, risk of side effects and reactions, and low chance of regulatory acceptance.
Stabican has developed a unique and proprietary technology to encapsulate any lipid-based active that is prone to oxidation and/or sensitive to water. Instead of putting the active in a large amount of foreign material, the technology generates a thin, closed shell at the micron-level. This means the active, being crystalline, solid, or liquid, is formulated into a fine particle powder, with a very high loading (25-75%).
This powder can be handled as any other API powder, stored at ambient conditions (up to 2 years) and formulated into a wide variety of drug products:
Dispersible powder in sachets.
Pills and chewing gums for sublingual, buccal or GI drug delivery.
Dry powder inhalers.
The lipid encapsulation materials that are used are
endogenous substances to the human body and are readily metabolized. All are considered as GRAS substances and sourced as standard pharmaceutical excipients, so they do not add any complexity to the API dossier or require toxstudies.
Additional benefits of complete closure by the shell are:
Prevention of evaporation.
Combination of multiple actives in 1 dose without interaction.
Bioavailability is a major issue in formulating most lipid actives, especially plant-based extracts and isolates. The human GI tract has typical defences for these actives, rightfully so, which leads to poor absorption and/or fast clearance of actives. Often, actives are metabolized before reaching the systemic circulation, the ‘first pass effect’. Cannabinoids like CBD exhibit this effect, which leads to very poor bioavailability (2% - 6%). Bioavailability is also often very variable, which can lead to risks of over- or underdosing, which is the case for the typical oil-based products on the market currently. Stabican is researching the bioavailability of its formulated actives and has reasons to believe the bioavailability of all actives can be greatly improved, as well as reducing the variability. This leads to low-dosed products with improved efficacy and safety.