Performance
MELTDOSE® – IMPROVE DRUG SOLUBILITY AND YOU IMPROVE THE PATIENT’S QUALITY OF LIFE
Low bioavailability of poorly soluble drugs is a common problem in drug development and can have negative consequences for patients. Independent studies have shown that approximately 30% of existing drugs have poor absorption due to low water-solubility*. This is critical because the efficacy of a drug depends on how well the body absorbs and circulates the active substance to the treatment site. Low water solubility often results in large variations in the drug’s bioavailability and creates “food effect” or different absorption when the drug is taken with or without food.
Reduced bioavailability means the difference between getting too much medication or not enough. Too much medication can lead to adverse side effects while too little often results in reduced efficacy. These variations can compromise patient compliance and potentially diminish the quality of life for patients who depend on the effectiveness of their medication.
* Technology Catalysts International; Delivery of Poorly Soluble or Poorly Permeable Drugs, 4 ed.
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LCP-Tacro™ – Demonstrates clinical benefits which can be achieved with MeltDose®
- Increased bioavailability allowing lowering of the dose by up to 50%
- Lowering of the peak-to-trough ratio
- Ellimination of the high circadian variation of twice daily Prograf®
- Increased patient compliance via once daily dosing
MeltDose® is Commercially Viable
- The first MeltDose® based product, Fenoglide®, is approved by the FDA and marketed in the US
- Several MeltDose® based products are in late stage development and have already been manufactured on a commercial scale
- The MeltDose® manufacturing process has been inspected by the FDA and is fully validated in commercial scale
- The approval process is facilitated by the fact that MeltDose® uses exclusively GRAS excipients