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Multi-API oral drug formulation

Multi-API oral drug formulation using Multiple-Unit Pellet Systems (MUPS)

Multiple APIs that work synergistically together, but cannot be formulated into a single pill due to chemical incompatibility or instability?
A particular oral drug is at the end of its patent life cycle and the pharma company is looking to extend its life cycle via a formulation change or through API combinations that ensures higher efficacy and safety with an improved release profile?


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

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