Maximising your chance of success for First in Man Supplies

There are many factors to consider in the development of a formulation for initial clinical evaluation. For traditional powder filled capsule products and tablets the success of the manufacturing process (reliability, yield, stability) and the performance of the formulation in vivo can be dramatically affected by API characteristics which are often outside the control of the formulator, at least in the early stages of API process development. For example batch to batch variation in particle size, shape, crystal habit, polymorphic form, density, moisture content can produce significant challenges in the manufacture of clinical supplies and can often complicate the interpretation of in-vivo pk results. Even for simple powder in capsule formulations which are becoming increasingly popular (and which are offered as a service by Encap) can sometime cause difficulties due to compatability issues between the API and the shell or delayed release of active which becomes trapped in the dissolving shell.

Due to the large body of experience with many molecules over 20 years Encap can review your drug molecule characteristics and can identify simple formulations which will de-risk the formulation and clinical manufacturing process and provide increased confidence that the clinical data will not be confounded by question marks over the formulation used.

We offer a free one day of consultancy to any interested parties.  This gives you the opportunity to discuss all aspects of your CMC development strategy with our team of analytical, formulation and process engineering experts.  If you would like more information about this offer then please contact rstewart@encapdrugdelivery.com