How does your technology enhance oral bioavailability?
We design formulations that are based on deep eutectic solvents. Our formulations present the API in predissolved form to the gastrointestinal fluids, which generates higher concentrations than those achievable via dissolution of the crystalline form. These enhanced concentrations increase the driving force for API absorption.
What are the key benefits of your technology?
There are four key benefits with our technology which when taken together produce the most compelling formulation;
- Significant bioavailability enhancement
- High drug loading
- Physically stable
- Simple and rapid manufacturing
What is the maximum API loading achievable using your technology?
This is obviously highly API-dependent, but generally our drug loadings are in the range of 15-30%. For APIs whose solubility is limited by high melting point (the so-called “brick-dust” APIs), our technology clearly outperforms traditional solubilisation technologies.
How are your formulations manufactured?
The API is mixed with the excipients under mildly elevated temperature until a homogenous solution is formed. This process is conducted using standard pharmaceutical mixers (for example the Ekato Unimix series of mixers).
What type of dosage forms can I develop from your formulation platform?
Our formulations are developed as liquids, and can be filled into capsules or used as such. Solidification of our formulations and subsequent tablet compression is also possible, but requires more complex manufacturing techniques.
Do your formulations show side effects?
Our deep eutectic solvents are constructed only from excipients with widely documented safety, such as sugars, sugar alcohols or amino acids. To design our formulations, we use a combination of three to five excipients, which improves tolerability as side effects are typically related to exceeding a threshold level for a single component.
Can I use your formulations in GLP-toxicity studies?
Yes, given the high API payloads achievable using our technology, our formulations are ideally suited to support GLP-toxicity studies or any other studies where high doses need to be administered. The viscosity of our formulations is compatible with gavage dosing.
How should I compare your technology to amorphous solid dispersions?
Our formulations can match the bioavailability enhancement of ASD’s but without the physical stability concerns and manufacturing complexity.
Can you also support clinical and commercial manufacturing of your drug products?
We do not have GMP-manufacturing capabilities in house at SeraNovo. GMP-manufacturing can either be conducted by our preferred suppliers or by a supplier of your choice. We guide technology transfer all the way through.
What is the regulatory status of your technology?
Since we do not make novel excipients but instead tailor-make formulations using existing excipients, regulators evaluate our formulations in the same manner as formulations based on established technologies.