Ascension Sciences’ expertise and formulation laboratory are repurposed from the cutting edge of genetic medicine. Small volume screening techniques allow Ascension Sciences to test more nanoparticle compositions, in less time and at lower costs for valuable cannabinoids (eg. CBG, CBN). Our library of proprietary formulations and compounds can help solve any number of drug delivery challenges. ASI’s R&D and formulation development services are an efficient option for research-driven firms that require the advantages of nanoparticle delivery for their active ingredients.
Work with Ascension Sciences’ expert R&D team to develop specific particles and formulations for your project needs. Given a Target Product Profile (TPP), we will delve into our own research to assess an appropriate starting point and excipient set to start screening formulation variables.We will hone in on the exact formula for your TPP by adjusting the formulation input parameters (mixing conditions, excipient ratios, concentrations), and mapping them to resulting particle characteristics (size, PDI, loading, release).
Nanoparticle Size, Quality & Stability Testing
Using dynamic light scattering (DLS), nanometer particle size and polydispersity (PDI) of an emulsion or nanoparticle is determined. For nanoparticle drug product development and also beverages that incorporate emulsions, these results can be used to understand the impact of mixing variables (eg. mixing speed, excipient ratios) on the size and quality of resulting particles. Measuring size and PDI over time is also used to determine the shelf-life of the particles.
Increasing surfactant concentration in the nanoemulsion creates increasingly larger particles while maintaining stability. Where PDI is below 0.2, nanoemulsions have a uniform particle size desirable for a consistent API delivery. Nanoparticle therapeutics often have PDI<0.1 seen here in the sub 180 nm particles.
Oil concentration is particularly important to study in emulsion systems. From low to high concentrations, particle size can vary and relates also to the surfactant concentration. The interdependence of all these pieces makes a target product profile particularly difficult to pin down.
Encapsulation Efficiency & Drug Loading
Encapsulation efficiency is used to understand how much active ingredient (cannabinoids) is found within each nanoparticle and how much is lost in the process of formulating. Process losses due to handling, container adhesion, surfactant make-up and excipient concentrations all have the potential to reduce the amount of cannabinoids in the particle.
Dissolution & Drug Release Profile
Dissolution is a bench test that quantifies the release of active ingredients from a particle in an environment mimicking physiological conditions (temperature, pH). The dissolution profile of a product can help predict how the active ingredients will reach the bloodstream, or how different formulations impart unique active ingredient release profiles (eg. fast-acting vs long-lasting).
Complete Nanoparticle Characterization
Bundling stability, encapsulation efficiency and dissolution consists of a complete nanoparticle characterization and work-up. Using all of our detection assays, and given the formulation parameters and reagents, we draw conclusions on how and why the nanoparticle is behaving as it is. Understanding the cause and effect of all the variables enables a robust analysis and provides confidence that the end product will be efficacious and safe.
Cannabinoid Concentration via ELISA
ELISA is a useful biochemistry detection technique for very low concentrations of cannabinoids. Using either tiny amounts of material or particles, or a very diluted solution, ELISA is able to detect down to 0.04 ng/mL, which is useful in dissolution studies or other applications where very low concentrations exist.
In vitro Cell Models
Caco -2 and buccal cell models (cells from the gut and mouth respectively) can offer interesting insights into nanoparticle efficacy and characteristics. These nanoparticle absorption assays are often used prior to going to in vivo studies to select lead formulations and further refine excipient selections to enhance tissue absorption and tissue penetration.
Validation of Data
Ascension Sciences is well equipped as a 3rd party laboratory to validate data from your internal R&D efforts. Repeatability and a second set of tests on a given sample can provide confidence and a clear conclusion on a given hypothesis. Our independent and confidential approach can efficiently remove the testing burden from your R&D where time can be better spent on the creative formulation development. Consider us as an extension of your R&D department.
Increasing the total flow rate in mixing the formulation reduces particle size. Achieving precise and repeatable particles is straightforward with our approach.
Flow rate ratio in the formulation step affects particle stability. Not all particles achieve a uniform size and PDI over time and it is important to know where the limits of the reagent and surfactant systems lie.
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