stability intro

Question 1

different types of stability

Answer 1

-chemically stable
-physical stable
-microbiologically stable

Question 2

dregration

Answer 2

-any change that adversely effects the properties of the medicine

eg.
-chemical compositions (amount of drug)
-physical characteristics
-preformance of medicine ( rate of drug release)
-microbrial contamination

Question 3

packaging

Answer 3

the first layer is the container this protects the medicine from the main environments factors eg oxygen and light

Question 4

shelf life

Answer 4

-the time over which the medicine stays stable in specific packaging and certain conditions

Question 5

stability definition according to (USP)

Answer 5

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 specific limits ensure quality, safety and efficiency

Question 6

potency

Answer 6

-the amount of drug remains in the medicine after strong it
- usually represented as a percentage of original drug content

stable potency is a limit of 10% loss and 3-5% where products are toxic over the shelf life

Question 7

what does the manufacturer have to do

Answer 7

-test stabilities and internationally agreed demos and humidities

-so they can get evidence on shelf life and storage conditions

Question 8

interdependence in reaching good stability is between

Answer 8

-pack design
-formulation
-drug stability
-storgae conditions

Question 9

consequences of instability

Answer 9

Changes in the rate of drug release from a medicine

Dose uniformity problems

Changes in the colour, smell and texture

Changes that you cannot detect easily
Chemical degradation
Loss of potency & therapeutic effect

Increase in toxicity & adverse effect (rare)

Microbial growth in medicines.

Question 10

hygroscopic

Answer 10

is a material that absorbs moisture and dissolves at surface and forms a lump which leads to slower drug release in powders

Question 11

does uniformity problems

Answer 11

-drugs are deficient or enriched in different areas of the medicines
-consequenses is the patient gets a variable does which can lead to overdose or underdose

Question 12

transportation problem

Answer 12

-movement and vibrations can separate bulk powders

Question 13

changes in colour, smell and texture can means…

Answer 13

They can also be a sign of microbial growth

Loss of drug and excipients

Loss of palatability
patient doesn’t want to take it

Medicine can’t be used
eg ointment too runny, suspension too thick to pour etc

Question 14

consequences of microbial growth

Answer 14

-Transfer of infection – can be serious with eyes

-Sickness & nausea

-Food poisoning

-Loss of drug and excipients

-Nasty smells and taste

-blood infections