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Feasibility

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.


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