Formurex systematically performs physicochemical characterization of the active pharmaceutical ingredient (API), often with limited amounts (mg-g). Our comprehensive physiochemical characterization studies help to determine the best formulation strategy for the client’s individual molecule. Some of the evaluations are.
Preformulation
Preformulation Studies
Solubility Evaluation: Aqueous/solvent, pH Solubility, Buffers, Bio-relevant media.- Solubility Enhancement: Co-solvency, Solubilization, Inclusion Complexation, Amorphous Solid Dispersions, Lipid Vehicles.
- Dissolution Enhancement: Size Reduction (Wet Milling Process).
- Stability Evaluation: Solution and Solid-State.
- Degradation studies: Acid/Base Hydrolysis, Oxidation, Thermal/Humidity, Photolysis.
- Morphology evaluation: Size and Shape using Optical Microscopy and Scanning Electron Microscopy (SEM).
- Thermal Evaluations: Melting Point using differential scanning calorimetry (DSC).
- Spectroscopy Evaluations: UV Spectroscopy and FTIR.
- Hygroscopic/Moisture Evaluation: Karl Fischer, Loss on Drying (LOD).
- Density Evaluation: Bulk Density, Tapped Density, Compressibility Index.
- Crystallinity/Amorphous Evaluations: X-Ray Powder Diffraction (XRPD).
- API Physical Tests: Flow Characteristics (Flodex), Particle Size Analysis, Sieve Analysis.
- Permeation Screening: Across synthetic membranes, biologic tissues (porcine buccal, sublingual, intestinal, and cadaver skin), and cell lines (CaCo2 - human colon cancer cell line).
- Permeation Enhancement: pH manipulation, permeation enhancers.
- Chemical Analysis: Assay and Impurities.
- Compatibility Studies: Drug-Drug interactions, Drug-Excipients interactions, Drug-Device Interactions, Container Closure Integrity Studies.
Pre-Clinical Formulation
Formurex will provide customized pre-clinical formulations for PK/PD, Tox studies, and Efficacy studies using non-GLP/GLP methodology.
- Neat API Powder/Liquid in Capsule/Bottle
- Solutions/Suspensions/Nano Suspensions/Emulsions
- Amorphous Solid Dispersions/ASD Blends in Capsules/Bottles
- API in Lipids in Capsules (Hard Gelatin/HPMC/Soft Gelatin)