Physical Degradation :
• Definition :
• It is the degradation which results into the change of physical
nature of drug. The formulation is totally changed by way of
appearance, organoleptic properties, hardness, brittleness,
particle size.
• Physical degradation includes:
• Loss of volatile components
• Loss of water
• Absorption of water
• Crystal growth
• Polymorphic changes
• Colour changes
• 1. LOSS OF VOLATILE COMPONENTS:
• Volatile components such as alcohol, ether, camphor, iodine, volatile
oil etc. escape from the formulation e.g. Nitroglycerine from drugs
evaporates.
Measures to Prevent Loss of Volatile
Components:
• Such products should be placed in well closed container.
• To decrease temperature as increase in temperature will increase
volatility, product should be placed in a cool place.
• 2. LOSS OF WATER:
• Loss of water from o/w emulsions thus the stability changes.
• Water evaporates from efflorescent salts such as Borax and sodium
bisulphate etc.
• Water evaporates causing crystal growth.
Measures to Prevent Loss of Water:
• Water loss may be prevented by storing the product in well closed
container.
• 3. CRYSTAL GROWTH:
• In solutions after super saturation of solvent crystal growth occurs
e.g. injection of calcium gluconate
• In suspension crystals settle down and caking occurs and suspension
becomes unstable e.g. ophthalmic preparations.
Prevention of Crystal Growth:
• In case of solutions stabilizers are employed.
• In case of suspension minimum temperature flocculation should be
managed.
• Incorporation of surface active agents.
• By increasing viscosity of suspending medium.
• 4. ABSORPTION OF WATER:
• Hygroscopic drugs such as glycerin suppositories absorb
• Water from atmosphere causing physical degradation.
Preventive measure for absorption of water:
• Product should be placed in well closed container.
• 5. POLYMORPHIC CHANGES:
• In polymorphic changes crystals form change. A stable crystal form is
lost.
• Measures to prevent polymorphic changes:
• Formulated product should contain a stable crystalline form of the
drug.
6. COLOUR CHANGES:
• Colour changes are of two types:
• Loss of color
• Development of color
• Loss of color is due to pH changes.
• Development of color is due to reducing agents, water and U.V rays.
• Prevention of Colour Changes:
• PH should not be changed.
• Exposure to light should be avoided.

Presentation (12).pptx

  • 1.
    Physical Degradation : •Definition : • It is the degradation which results into the change of physical nature of drug. The formulation is totally changed by way of appearance, organoleptic properties, hardness, brittleness, particle size. • Physical degradation includes: • Loss of volatile components • Loss of water • Absorption of water
  • 2.
    • Crystal growth •Polymorphic changes • Colour changes • 1. LOSS OF VOLATILE COMPONENTS: • Volatile components such as alcohol, ether, camphor, iodine, volatile oil etc. escape from the formulation e.g. Nitroglycerine from drugs evaporates.
  • 3.
    Measures to PreventLoss of Volatile Components: • Such products should be placed in well closed container. • To decrease temperature as increase in temperature will increase volatility, product should be placed in a cool place. • 2. LOSS OF WATER: • Loss of water from o/w emulsions thus the stability changes. • Water evaporates from efflorescent salts such as Borax and sodium bisulphate etc. • Water evaporates causing crystal growth.
  • 4.
    Measures to PreventLoss of Water: • Water loss may be prevented by storing the product in well closed container. • 3. CRYSTAL GROWTH: • In solutions after super saturation of solvent crystal growth occurs e.g. injection of calcium gluconate • In suspension crystals settle down and caking occurs and suspension becomes unstable e.g. ophthalmic preparations.
  • 5.
    Prevention of CrystalGrowth: • In case of solutions stabilizers are employed. • In case of suspension minimum temperature flocculation should be managed. • Incorporation of surface active agents. • By increasing viscosity of suspending medium. • 4. ABSORPTION OF WATER: • Hygroscopic drugs such as glycerin suppositories absorb • Water from atmosphere causing physical degradation.
  • 6.
    Preventive measure forabsorption of water: • Product should be placed in well closed container. • 5. POLYMORPHIC CHANGES: • In polymorphic changes crystals form change. A stable crystal form is lost. • Measures to prevent polymorphic changes: • Formulated product should contain a stable crystalline form of the drug.
  • 7.
    6. COLOUR CHANGES: •Colour changes are of two types: • Loss of color • Development of color • Loss of color is due to pH changes. • Development of color is due to reducing agents, water and U.V rays. • Prevention of Colour Changes: • PH should not be changed. • Exposure to light should be avoided.