SERVICE

GRAM Laboratories offers services for conduct of preformulation studies.  These studies are performed to gather in-depth knowledge about the physical and chemical characteristics of the active ingredient and eventually aid in the development and optimization of a clinically relevant and thermodynamically more stable formulation.  Based on the eventual dosage form desired, preformulation studies may include:

• pH-solubility-stability profile
• Evaluation of solubility in various matrices
• Moisture uptake studies – Hygroscopicity
• Excipient compatibility studies
• Photostability evaluation
• Salt formation
• Oxygen compatibility studies
• Determination of pKa
• Compatibility with metal ions
• Forced Degradation Studies – acid, base, heat, etc.
• Differential Scanning Calorimetery Analysis
• Thermo Gravimetric Analysis
• Freezing Characteristics
• Eutectic Point Determination
• Glass Transition Temperature Determination

PREFORMULATION

EVALUATION

SERVICES: Preformulation Evaluation