This Merck white paper examines the critical role of API stability in solid dose formulations. Unstable APIs can compromise patient safety, regulatory approval, shelf life, and drug economics. Factors like heat, moisture, oxidation, light, and excipient interactions often drive degradation. Excipients once thought inert can trigger reactions—e.g., lactose causing Maillard reactions or povidone introducing peroxides. Studies show excipient choice, impurity levels, and compression forces directly impact degradation (Figures 2–6). Case studies highlight how engineered excipients like Parteck® M enhance uniformity and stability, particularly for sensitive APIs such as atorvastatin.

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