How does your technology enhance oral bioavailability?
Our technology enables high drug-load liquid formulations for poorly soluble APIs. Dissolution from a liquid state into the aqueous environment is much faster and more complete when compared to dissolution from a solid state. Thus, a rapid highly supersaturated state is created upon contact with water. This is the main driver of absorption for BCS class II API's. Due to the compatibility of liquid formulations for high-throughput screens, we can find the most optimal combination of excipients (with limited amounts of API and time) to enable complete dissolution, stabilize the supersaturated state and enhance oral bioavailability.
What are the key benefits of your technology?
Our technology provides a range of five key benefits that combine to create a highly effective formulation. The include:
- Significant enhancement of bioavailability
- High drug loading
- Use of safe ingredients
- Physical stability
- Simple and rapid manufacturing
Together these advantages make our technology a compelling choice for optimizing drug delivery.
What is the maximum API loading achievable using your technology?
The drug loadings achieved by our technology typically range from 15-30%, but this can vary depending on the specific API being used. In cases where the solubility of an API is limited by its high melting point (commonly referred to as "brick-dust" APIs), our technology demonstrates superior performance compared to traditional solubilization technologies.
How are your formulations manufactured?
Our formulations can be manufactured with ease, as the process involves only mild heating and mixing until a homogeneous solution is achieved. This process can be readily scaled up using standard pharmaceutical mixers, such as the Ekato Unimix series of mixers. In fact, with a simple hot plate and overhead stirrer, we can manufacture 1 liter of formulation in just one afternoon, demonstrating the simplicity and efficiency of our manufacturing process.
What type of dosage forms can I develop from your formulation platform?
Our liquid formulations can be put into hard gel capsules made of HPMC or gelatin, as well as soft gel capsules, or they can be used as a liquid. While it is possible to solidify our formulations and make tablets through compression, this process requires more intricate manufacturing methods.
Do your formulations show side effects?
We use excipients in our formulations that are widely recognized as safe, including sugars, sugar alcohols, amino acids, and other excipients that have been approved by the FDA as non-active ingredients. In order to create our formulations, we combine three to five of these excipients, which helps improve tolerability as side effects are often linked to surpassing a certain threshold for a single component.
How should I compare your technology to amorphous solid dispersions?
Amorphous solid dispersions are commonly used to improve the bioavailability of active ingredients, but their physical instability poses a challenge. However, our formulations are capable of achieving the same bioavailability benefits as ASD's without the drawbacks of physical instability and complicated manufacturing processes.
Can you also support the clinical and commercial manufacturing of your drug products?
At SeraNovo, we do not possess in-house GMP-manufacturing abilities. Our simple manufacturing process enables the selection of almost any CMO. You can opt for GMP-manufacturing services from our preferred suppliers or choose a supplier of your preference. We provide guidance for technology transfer throughout the process.
What is the regulatory status of your technology?
Our approach involves customizing formulations using existing excipients instead of creating new ones. We do not create any novel excipients. Therefore, regulatory authorities evaluate our formulations similarly to those based on established technologies.
What is the timeframe for formulation development using SeraNovo's technology?
With our technology, we can develop prototype formulations that are ready for in vivo evaluation within a span of 4 weeks. This efficient timeline is made possible by conducting all development, analytical, and manufacturing work at a single integrated location, enabling swift execution. Our expertise in formulating similar APIs combined with a comprehensive assessment of the physiochemical properties of the new API allows us to expedite the process.
What is the amount of API needed to develop a formulation using your technology?
A quantity of 5g of API is commonly adequate for generating in vivo proofs of concept. Undoubtedly, the specific requirements may vary depending on factors such as drug loading and dosage. However, as a general guideline, 5g serves as a useful rule of thumb. In certain exceptional cases, we have successfully formulated APIs with as little as 1g. While this may necessitate some adjustments to the work packages, it is indeed feasible to create effective concepts with such small quantities.