Understanding the physical properties of your API is a critical first step in preparing for the technical challenges one may expect to encounter as the development journey begins.
With state-of-the-art equipment and world-class scientific experience, CoreRx Pharma can efficiently analyze your drug substance to elucidate potential paths for development.
In our hands, each analysis will generate important information concerning your molecule. We will then incorporate this data into our proprietary, early-assessment biomodel and perform a risk assessment with guidance for next steps in formulation and process toward a commercializable oral dosage form.
Based on this guidance, we can work together to define the next bodies of work to efficiently progress your program toward clinical studies in whatever technological path is subscribed.
I want to learn more about Pre-Formulation Solutions
What is the most important factor when beginning your drug development journey?
Speed, Flexibility, Quality?
A CDMO you can stick with, from Formulation to Commercial?
Direct interaction with world-class Scientists?
A Partner who always delivers their A-Team?
With CoreRx you don't have to choose.
What's Included?
Pre-Formulation Characterization
Physical characterization
- Crystallinity and polymorph form (Xray Diffraction)
- Visual appearance and crystal shape/habit (Polarized Light Microscopy)
- Identification (Fourier Transform-InfraRed Spectroscopy)
- Melting point, glass transition and enthalpies (modulated Differential Scanning Calorimetry)
- Moisture uptake and hygroscopicity (Dynamic Vapor Sorption)
- Water content (Karl Fisher)
- LogP and pKa determination
- Potency and related impurities (High Pressure Liquid Chromatography)
- Biorelevant aqueous solubilities (Simulate Gastric Fluid, Fasted State Simulated Intestinal Fluid, Fed Satee Simulated Intestinal Fluid, Bile Salt Micelle Partition Co-efficient)
- Process screening – organic solvent solubilities
Biomodeling
- Maximum absorbable dose
- BCS Classification
- Absorption rate limitation assessment
- Oral dosage form guidance and risk assessment
- Final Report
CoreRx Inc.
CoreRx Clearwater
14205 Myerlake Circle
Clearwater, FL 33760
Toll Free: 877.461.4448
Phone: 727.259.6950
Fax: 727.259.6971