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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

Problem
Opportunity

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.

  • Current excipients have 2 major limitations that hinder effective solubility-enhancement:

  1. As "static materials", they have a set of properties that dictate compatibility with a drug and processing conditions 

  2. 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:

  1. DPODs are synthesized in the absence of drug, mitigating any concerns over chemical integrity

  2. The initially hydrophobic polymer contains nanopores, which spontaneously transform a drug into nanocrystals

  3. The cross-links remain stable until oral dosing, upon which they rapidly dissociate to release drug and polymers

  4. The resulting polymers are amphiphilic in nature to achieve and sustain high levels of supersaturation

Empty DPOD

Drug-loaded DPOD

DPOD capsule.jpg

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. 

Platform

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

Pipeline

Support

Support
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