Feasibility programs
MeltDose® for your product – How to get started
LCP offers a customized development program to improve oral bioavailabity of drug compounds. A typical project starts with a three-month feasibility program where we take a given API and evaluate the possibilities to develop and manufacture using MeltDose®. In the next phase, which takes approximately three months, we deliver several non-GMP prototypes for animal trials. Next step is the GMP manufacture of clinical trial supplies for human trials, allowing you to be in clinical trials with your new MeltDose® based product within approximately nine months from start. Finally, we assist you in technical transfer to the facility of your choice. The entire process is illustrated in the diagram below.
MeltDose® Timelines:
Delivery of non-GMP samples for animal trials usually achieved in less than 6 months. Delivery of GMP samples for clinical trials usually achieved in less than 9 months
Cost-Effective and Flexible
- The cost of goods of the MeltDose® based tablets is comparable to that of conventional plain tablets
- MeltDose® can be used to create customized release profiles including immediate or controlled release and is suitable for enteric coating
- MeltDose® is a solvent-free, one-step process that can also be carried out in an inert atmosphere. The resulting granulate is suitable for direct compression to tablets