Drug-excipient compatibility experimental design

The second approach is to perform traditional pre-formulational studies using full factorial or Plackett Burman experimental designs [15]. Here, the preferred analytical methodology tends to be thermal and spectroscopic, rather than chromatographic, although the latter methodologies are still utilised. Differential scanning calorimetry (DSC), isothermal calorimetry (ITC) or Fourier-transform infrared (FT-IR) spectroscopy have all been utilised successfully. 

In the typical dmg-excipient compatibility testing program, binary powder mixes are prepared by triturating API with the individual excipients. These powder samples, usually with or without added water and occasionally compacted or prepared as slurries, are stored under accelerated conditions and analysed by stability-indicating methodology, for example, HPLC, CE and so forth. This entire process takes considerable time and resources. 

Alternatively, samples are quickly screened by thermal methods, such as DSC or ITC. This alternative approach eliminates the necessity for stability set-downs hence cycle times and sample consumption are reduced. However, the data obtained are difficult to interpret and may be misleading false positives and negatives are routinely encountered [14]. 

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