Formulation Development

In 8 weeks' time we assess the utillity of our technology for your API. 

Formulation concepts are subsequently further optimised for dissolution performance, stability and manufacturability.

We are also flexible to discuss ways in which we can make our technology accessible for use in early drug discovery studies at your facilities.

We guide the technology transfer process all the way through.


Feasibility Study
Formulation Development
Preclinical trial material production
GMP production

1.
2.
3.
4.

Feasibility Study

In a feasibility study, we primarily focus on designing a deep eutectic solvent in which the API is highly soluble and that is physically and chemically stable. Based on the physicochemical profile of the API, we select a subset of candidate excipients from our library and screen these for deep eutectic forming ability. When formulation concepts that meet these criteria have been identified, we optimise for dissolution performance by incorporating excipients that keep the API in solution after release from the formulation, such as surfactants and polymers. 

 

The key deliverable of a feasibility study is a report with clear conclusions and recommendations for follow-up work. Small samples of prototype formulations to support further testing in your facilities can also be provided at this time.

Formulation Development

Building further on the results of the feasibility study, we optimise for dissolution performance, stability and manufacturability. The key deliverable of this stage is the definition of one or more formulation compositions that are ready for transfer to our preferred partner for further scale-up and production.

Preclinical trial material production

Batches of formulation to support preclinical studies are produced in our facilities in Leiden. We can support batch sizes from a couple of grams to multiple kilograms.

GMP production

Clinical manufacturing, packaging and labeling is taken care of by our network of preferred partners or by partners of your choice.
 

This website uses cookies to track the usage of it.

More info