Universal Oral Drug Delivery
Industry Pain Points
Lead optimization
Discovery
Pre-clinical
Phase 1
Phase 2
Phase 3
Market
4 in 10
9 in 10
Poorly soluble drugs
Causes of unsuccessful clinical translation:
1) Incompatibility of current excipients
2) Added risk/cost to develop novel dosages
Enabling formulation
Solvents
Fit-for-purpose capsule
Oral delivery system
Current technologies
Development milestones
Toxicology dosages
Accelerate optimization
FIH oral
dosages
Oral drug
product
With a single, universally compatible and effective solubility-enhancing excipient, clinical translation could be improved and accelerated!
Survey of formulation scientists' experiences with current excipients
Hindered drug development with excipients on the IID
8 in 10
3 in 10
Drug discontinuation due to excipient limitations
Expanding Oral Delivery
VeraMorph's DPOD platform removes barriers to oral delivery
DPODs are universally compatible with any drug, simplifying formulation
DPODs out-perform other oral delivery technologies over a large “sweet spot” to enable improved oral reformulations
Comparison of oral delivery technologies
Current technologies are compatible with a limited range of drug physicochemical properties:
Solid dispersions
Nanocrystals
Lipid formulations
Excipient limitations of current solubility-enhancing oral formulations
Current solubility-enhancing oral delivery technologies combine a drug with excipients using specialty processing techniques to make the drug more soluble by disrupting bonds between molecules.
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Current excipients have 2 major limitations that hinder effective solubility-enhancement:
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As "static materials", they have a set of properties that dictate compatibility with a drug and processing conditions
-
As individual molecules, they can be blended with a drug but their mobility also allows them to separate
These excipient deficiencies can lead to ineffective disruption of bonds between the drug and itself and/or water molecules that removes the ability to increase drug concentration in solution.
(nanocrystal)
Drug crystal
Unstable formulation
(amorphous dispersion)
Poor solubility is a result of strong bonds between drug molecules
Excipients will separate from drug molecules if not chosen appropriately
Excipients are used to disrupt those bonds
The DPOD Platform
Dissociating Polymeric Oral Dosage
DPODs are environmentally responsive cross-linked polymers with several unique benefits:
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DPODs are synthesized in the absence of drug, mitigating any concerns over chemical integrity
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The initially hydrophobic polymer contains nanopores, which spontaneously transform a drug into nanocrystals
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The cross-links remain stable until oral dosing, upon which they rapidly dissociate to release drug and polymers
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The resulting polymers are amphiphilic in nature to achieve and sustain high levels of supersaturation
Empty DPOD
Drug-loaded DPOD
Empty DPOD
Drug-loaded DPOD
DPOD drug release
The pre-formed polymer network maximizes drug compatibility
The polymer network templates and stabilizes drug nanocrystals
Polymers stabilize drug until and after release into solution
DPODs create an optimal combination of high drug loading, fast dissolution rate, and prolonged supersaturation to transform a poorly soluble drug substance into an effective oral drug product.
Product Pipeline
Diversified and Differentiated Product Portfolio
The broad compatibility of DPODs is being leveraged to develop a pipeline of highly differentiated oral reformulations and establish partnerships to translate more effective lead compounds for drug targets
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