Great science. Innovative thinking. More progress, faster.

Creating solutions when traditional methods fail.

This typically includes the following steps:

  • Analysis of the physical system to determine what biorelevant measurables are needed and model processes that may occur
  • Experimental design to obtain the metrics
  • Data analysis and interpretation to derive results that can be utilized in formulation science and/or regulatory interactions

Complex dosage form evaluation

  • Design, bioequivalence, QA
  • Ophthalmic products
    • Physiologically relevant in vitro release testing (dissolution/release)
    • Drug distribution
  • Complex injectables—drug-protein complexes
    • Drug release and distribution
    • Manufacturing optimization
  • Develop QA tests for ophthalmics and other complex dosage forms

supersaturating formulations

  • Supersaturating oral dosage forms to measure the absorbable dissolved concentration profile
  • Screen for excipients that provide optimal bioavailability – can be done in any medium to predict performance in the GI fluids 
  • Applications include:
    • Polymer screening for amorphous solid dispersions
    • Nanoparticle delivery systems
    • Neat amorphous API
    • Lipid systems

Problem analysis

  • Complex formulation physical modeling and analysis
    • Ophthalmic products
    • Drug-protein injectables
    • Amorphous supersaturating formulations
  • Data generation for product development & regulatory evaluation
    • Dosage form in vitro and biopharmaceutical analysis to identify critical parameters
    • Experimental method development

Biorelevant In vitro dissolution/release tests

  • Customized release test development
  • Ophthalmic, intranasal, and injectable formulations
  • Supersaturated media precipitation/crystallization rates
  • Release from semi-solid formulations

Dosage design for poorly soluble drugs

  • Determine target absorption from pharmacokinetic data
  • Design target in vitro dissolution to optimize bioavailability
  • Solubilization formulation strategies and testing
  • Drug-protein/polymer binding and release kinetics

Alliances and Business opportunities

  • Ophthalmic and nasal products in the pipeline- ANDAs and NDAs
  • Developing manufacturing technologies for amorphous solid dispersions (patents pending)
  • Marketing partners
  • Work with pharma companies developing ANDAs and NDAs