Technology Demonstration & Feasibility

The Focus and Expertise to Perfect Formulation and Development

The quality and experience of our scientists – most with a background in “Big Pharma” – gives us the ability to deploy innovative solutions at a cadence unrivaled in the CRO sector.

Most CROs can use spray drying to generate amorphous material, but we can use it to generate nanoparticles, coated particles, inhalable particles and more!

Unlike big CDMOs, we have the focus and expertise to perfect the formulation and development processes through extensive measurement of the material properties of the drug substances themselves, often making API even more rugged and reliable than the original requirements!

This ability to manipulate API properties on a “boutique” basis gives us a lot of advantages, including the ability to supply data rich submissions for eventual FDA approval.

Enabling Technologies to Improve Powder Flowability

Co-Precipitation Technology (CPT)

Adsorption

Moisture Activated Dry Granulation (MADG)

Dry/Wet Granulation

Hot Melt Extrusion (HME)

Spray Drying (SD)

Dry Particle Coating

Other Solubilization Techniques (LBDDS, SEDDS, etc.)

Enabling Technologies to Improve Solubility and/or Dissolution

Amorphous by Spray Drying (SD)

Amorphous by Precipitation

Amorphous by Adsorption

Nano-Particles

Co-Processing

Hot Melt Extrusion

Solubilized formulation

Continuous Process Evaluation

Powder Characterization

Unit Operation Testing

Equipment Modeling

Process Train Modeling

Implementation Strategy

Regulatory Strategy

Enabling Technology Equipment

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J-STAR Research helps pharmaceutical small molecule R&D programs succeed in all phases of development.