Pharmaceutics Stability of Drugs and Dosage Forms

Strategies to Enhance Drug Stability

Topic overview

Start with the big picture

Stability strategies begin with identifying likely degradation pathways and limiting the conditions that promote them. Packaging and storage can reduce exposure to oxygen, moisture, light, and heat, while buffers help maintain a formulation’s pH. Other approaches target specific risks: antioxidants address oxidative degradation, chelators bind trace metals, and reduced water activity can limit hydrolysis. Formulation choices may also provide protection, including salt or prodrug formation, microencapsulation, complexation, and controlled-release matrices. For sensitive products, temperature control and cryoprotectants or lyoprotectants can help during storage or freeze-drying. These methods are complementary rather than interchangeable; their suitability depends on the drug and dosage form.

Learning objectives

What you'll learn

  • Identify environmental factors that can promote drug degradation.
  • Explain how pH, temperature, and water activity relate to stability.
  • Describe how antioxidants and chelating agents address degradation risks.
  • Recognize packaging and formulation approaches that protect sensitive drugs.
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