Pharmaceutics Stability of Drugs and Dosage Forms

Factors Affecting Drug Stability

Topic overview

Start with the big picture

Stability is shaped by more than a drug’s intrinsic chemistry. Temperature can accelerate reactions and physical transformations, while pH and moisture may promote pathways such as hydrolysis. Light and oxygen can affect susceptible ingredients, and trace metals, buffers, solvents, concentration, and excipients can modify degradation behavior. Microbial contamination and mechanical stress may also compromise products. Packaging and headspace conditions influence exposure to moisture and oxygen, as well as losses through sorption or interactions with container materials. The full topic organizes these factors and their effects, offering a framework for understanding how formulation, processing, and storage conditions work together to influence pharmaceutical stability.

Learning objectives

What you'll learn

  • Describe how temperature can affect chemical degradation and physical transformations.
  • Explain how pH, moisture, light, and oxygen may influence drug degradation.
  • Identify formulation and environmental factors that can alter stability.
  • Recognize how packaging, headspace, microbial contamination, and mechanical stress affect dosage forms.
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