Active pharmaceutical degradation pathways

While this is a very positive boundary condition for the development of low-dose formulations, the major drawback of the low-dose formulation range is, as mentioned earlier, the potential exacerbation of chemical instability of active pharmaceutical ingredients. Thus, stabilization techniques are of high interest to the formulator dealing with this formulation space. Specifically, stabilizers from various classes of antioxidants have been applied.23,24 It is obvious that the specific knowledge of potential and actual degradation pathways of the drug will be crucial for the development of stable formulations. 

The complexity of biological macromolecules when compared with small molecule therapeutics, differences in manufacturing, and the broad variety of potential degradation pathways lead to special requirements in quality assurance and analytical testing of pharmaceutical proteins. The product-related impurities are molecular variants formed during manufacture, storage, or use, and their properties are different from the desired product with respect to activity, efficacy, and safety. 

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