Improve Solubility - The Process
MELTDOSE® – HOW IT WORKS
The process patented as "Controlled Agglomeration" ** works by incorporating the drug substance with low water solubility into a "meltable" vehicle. It is then sprayed on an inert particulate carrier using fluid bed equipment.
The melt is solidified when deposed on the particle carrier, and thus captures the active drug in a solid dispersion either as a solid solution or in a nano-crystalline state. The particle size is then increased by controlling and optimizing the product temperature and feed rate of the melt.
The granulate can be directly compressed into tablets without additional processing steps besides blending with a lubricant. In addition, the technology allows for customization of the release profile, to create various profiles including immediate and controlled release versions.
Once in tablet form, the dissolution profile and the particle size of drugs manufactured using MeltDose® technology remain stable allowing for a long shelf-life.
** US Patent No. 7.217.431.
MeltDose® abstract from Annual CRS Meeting and Exposition, Copenhagen July 2009
MeltDose® abstract from Nanomedicine and Drug Delivery Symposium, Toronto November 2008
MeltDose® abstract from AAPS Annual Meeting and Conference, Atlanta November 2008
MeltDose® abstract from World Meeting on Pharmaceutics, Barcelona April 2008
MeltDose® uses only conventional equipment
Seen here is manufacturing scale of 100kg at Glatt
(GPCG30 fluid bed; Feed unit, 85 litres)
Scalable and Transferable
- MeltDose® employs conventional manufacturing equipment, does not require significant additional investment and is easily scalable to commercial batch sizes
- LCP can offer a custom-made technology transfer program to allow you to manufacture your own MeltDose® based products
- MeltDose® manufacturing process has already been established at leading CMOs in both Europe and USA