Scheme of Characterization

Parenteral Solubility, micellization, thermal stability, chemical stability, packaging component interaction (glass, stoppers), photostability, physical stress (particularly for protein drugs), buffer interactions, and viscosity. 

Oral solids Solubility, dissolution, polymorphism, chirality, particle size, powder flow, chemical stability, photostability, compressibility, hygroscopicity, and excipient interactions. 

Oral liquids Solubility, polymorphic conversions, chirality, excipient interactions, chemical stability, photostability, pH effects, and container interactions (e.g., type III glass). 

An appropriate combination of some, or all, of these tools may be applicable to a single-unit operation, or to an entire manufacturing process and its quality assurance. A variety of sophisticated softwares, such as RAPID-Pharma (2) are now available to consolidate many functions required to manage the initiatives related to PAT. 

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