Oral Formulation Development

Our Timeline

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 processability.

The unique formulation design is used to synthesize batches of Preclinical Trial Material using our cleanroom protocols and deliver you an in-vivo ready formulation in any variety of doses in capsules. 

We then coordinate the production of clinical trial material by our network of preferred partners.


Feasibility Study
Formulation Development
Preclinical Trial Material production
GMP production

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Feasibility Study

In a feasibility study, we first focus on designing a deep eutectic solvent in which the API is highly soluble and chemically stable. This involves the screening of a selection of constituents at multiple ratios. When systems that meet these criteria have been identified, we optimise for dissolution performance by evaluating the utility of disintegrants, surfactants and polymeric precipitation inhibitors. 

 

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 by the sponsor (for exampe in vitro dissolution or in vivo studies to compare performance against reference formulations) can also be provided.

Formulation Development

Building further on the results of the feasibility study, we optimise for dissolution performance whilst working towards a formulation that is physically and chemically stable, processable and capsule-compatible.

Preclinical Trial Material production

Directly following the formulation development phase, we can prepare formulations to support preclinical testing.

GMP production

Clinical manufacturing, packaging and labeling is taken care of by our network of preferred partners or by partners of your choice. Our team guides the technology transfer all the way through.
 

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