Multi-API oral drug formulation
Multi-API oral drug formulation using Multiple-Unit Pellet Systems (MUPS)
MUPS or Multiple-Unit Pellet Systems is a formulation technology that offers advantages over conventional oral drug delivery systems. MUPS technology is used to produce compressed drug pellets with a spherical core containing the API(s) which is protected by one or more protective layers to control drug release.
Our formulation partner utilizes MUPS technology to formulate oral capsules of approved drugs or drug combinations. Compared to most oral delivery systems MUPS is associated with lower risk of irritation and toxicity even with high potency products. Furthermore, MUPS improves pharmacological properties such as increased bioavailability, and sustained release of drugs to avoid premature metabolism and elimination of drugs. MUPS also offers protection from gastric enzymes and fluids enabling oral delivery of otherwise acid-labile / pH sensitive drugs.
Impact & Benefits
Single pill formulation of incompatible API combinations is made possible
Increased bioavailability using MUPS technology could facilitate changes in dosage strength for reduction of side effects
Easy market access via hybrid or 505(b)(2) regulatory pathway
Exclusivity possible via innovative formulation
Extension of patent protection to prolong product life cycle e.g. patent continuation-in-part