AustinPx

Phase-appropriate formulation strategies for oral dosage forms including solutions, suspensions, tablets and capsules; bioavailability enhancement and controlled/modified release development.

Method development, forced-degradation studies, phase-appropriate qualification/validation, release testing and GMP stability studies using UPLC/HPLC, dissolution, Karl Fischer and other analytical techniques.

cGMP manufacture of drug product intermediates and finished oral dosage forms (powders, capsules, tablets, suspensions) for non-GLP, GLP toxicology and Phase I/II clinical studies including clinical packaging and labeling.

Feasibility screening and prototype generation across multiple enabling technologies (solvent-free fusion ASD, spray drying, HME, particle size reduction, lipid and complexation approaches) with prototype supply suitable for animal PK and further development.

Accelerated product development and manufacturing options to enable rapid first-in-human dosing (API-in-capsule/bottle, blend approaches, clinical suspensions) and planning for accelerated regulatory pathways.

Molecule characterization, preformulation testing, formulation for toxicology studies and formulation technology screening to support transition from discovery to IND enabling studies.