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 for Better Performance of Drug Products

Enabling technologies focused on improved powder flowability and enhanced drug solubility and dissolution rates are critical to J-Star’s development of better performing drug products.

Drug substance and formulation excipients need good flowability for quality performance; poor flowability can cause segregation, stratification and poor feeding, resulting in weight variation, poor content uniformity and other manufacturing issues. Our Enabling Technologies significantly improve powder flowability, thus reducing or eliminating these risks.

Orally administered drug substances need adequate aqueous solubility for dissolution in order to be absorbed and enter the blood stream, producing pharmacological effects. Thus, drug substance solubility is one of the most important physicochemical factors determining a drug’s suitability for development into a clinically applicable drug product. Unfortunately, up to 70% of new chemical entities (NCEs) have poor aqueous solubility. Developing drug candidates into viable drug substances (and drug products) thus remains a major challenge. J-Star’s Drug Product Development innovative solubilization approaches can help. By using specialized Enabling Technologies, we can enhance drug solubility and dissolution rates for better clinical performance.

Simultaneously, our team strives to develop simplified manufacturing processing approaches, which are anticipated to provide economic benefits as well as driving the emerging technology of Continuous Process.

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 (HME)

Solubilized formulation

Continuous Process Evaluation

Powder Characterization

Unit Operation Testing

Equipment Modeling

Process Train Modeling

Implementation Strategy

Regulatory Strategy

Enabling Technology Equipment