D7 Flashcards
What is Degradation
Any change that adversely affects the properties of the medicine
If degradation occur changes could be
Chemical composition
Physical characteristics
Performance of medicine
Microbial contamination
First layer/ the container
Provides the main protection layer against the environmental factors like oxygen and light that cause degradation
Shelf life
The time over which a medicine in a specific pack remains stable when stored under the recommended conditions
Medicine pack combination provides stability
Expiry date
Use by date in the label
Storage conditions
Conditions under which medicines should be stored
Storage conditions
Conditions under which medicines should be stored
What is the definition of stability
The extent to which a medicine retains , within specified limits and throughout its shelf life , the same properties and characteristics that it possessed at the time of its Manufacture
The specified limits ensure quality safety and efficacy of a medicine
What is potency
Amount of drug remaining in the medicine after storing it
What is a stable medicine
BP and USP both allow 10% loss in most medicines over their shelf life
5% or 3% when there are toxic products
Stability test
Manufacture has to prove the product is stable
For the time they are claiming
Under their recommended conditions
Commonly 3 years when stored between 15-25 degree Celsius
What are the physical instabilities
Absorption
Diffusion
Evaporation
Particle size change
Separation
Solubility changes
What are the chemical instabilities
Oxidation
Photolysis
Hydrolysis
Enzymes from microbes
What are the consequences of instability
Changes in the rate of drug release from a medicine
Dose uniformity problems
Changes in colour smell and texture
Chemical degradation ( loss of potency and increase Of toxicity)
Microbial growth in medicines
What is hygroscopic
Marital that absorb moisture
