Preformulation

Formurex systematically conducts comprehensive physicochemical characterization of active pharmaceutical ingredients (APIs), often utilizing limited quantities (mg–g). These in-depth studies are designed to inform and guide optimal formulation strategies tailored to each client’s unique molecule. The evaluations we perform include:

• 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-excipient 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)