PII offers a comprehensive pre-formulation service to:

• determine the physical and chemical characteristics of client compounds
• generate data that are a prerequisite to dosage form development
• identify the best form of drug substance and excipients to use in dosage form development

PII has experience in working with a variety of drug substances having a range of physico-chemical characteristics, such as:

• poorly aqueous soluble drugs by formulating into solutions; lipid based or micro/nano emulsions to improve solubility
• highly potent and cytotoxic drugs

 

Preformulation protocols are designed to meet each client’s requirements.

Pharmaterials, a PII company in Reading, UK, provides many of these services for our clients in Europe and the USA. Click here for further information.

Pre-Formulation Services:

Characterization of the drug substance Salt selection Polymorph screening Co-Crystal formation Solubility Screening Solubility Optimization Studies Particle size measurements Bulk and Tap Density assessment Physical and Chemical Stability of the Drug substance Chemical imaging Amorphous qualification Powder surface characterization

Moisture content FTIR Microscopy Forced Degradation studies Identification of degradation products Excipient characterization Drug/Excipient Compatibility Studies Crystal Morphology pKa determination Thermal Analysis by DSCX-Ray diffraction Raman Mapping Sorption/Desorption Studies

 

PII’s Hunt Valley facilities are DEA registered to handle schedule I to V controlled substances.