SDF p1

Question 1

What is the purpose/function of the packing ?

Answer 1

• protection
• information
• presentation
• compliance

Question 2

Is primary or secondary packing required for external protection?

Answer 2

Secondary

Question 3

Is primary or secondary packing in direct contact with the medicine and if so how

Answer 3

Primary - has direct contact with medicine via bottle or bottle cap

Question 4

Is primary or secondary packing required for protection from external hazards

Answer 4

Primary

Question 5

On an ideal package what information would be included on it?

Answer 5

• route of administration
• legal requirements
• batch number
• expiry date
• storage information

Question 6

Packaging offers primary protects against hazards, such as: mechanical, physical, chemical and biological.

Mechanical damage occurs during manufacturing, packing, transportation and storage. What mechanical damage can occur?

Answer 6

Punctures
Vibrations
Shock

Question 7

Packaging offers primary protects against hazards, such as: mechanical, environmental, chemical and biological.

What are the environmental hazards which can occur

Answer 7

• light
• mostuire
• atmospheric gas
• temperature
• pressure

environmental - key for stability testing

Question 8

Packaging offers primary protects against hazards, such as: mechanical, environmental, chemical and biological.

What are the biological hazards which can occur?

Answer 8

• human interference
• infestation

Question 9

If chemical hazards occur, can this be overcome by packaging

Answer 9

No

Question 10

Package material

Glass - pros & cons?

Answer 10

Pros
• easily cleaned
• non reactive
• transparent
• good closure

Cons
• brittle
• heavy
• pH change
• damage from sterilisation

Question 11

Package material

Metal - pros & cons?

Answer 11

Pros:
• rigid: good for tablets, powders and liquids
• collapsible: good for tubes: toothpaste

Cons:
• inner coating will be required if producer is sensitive to aluminium

Question 12

Package material

Plastic - pros & cons?

Answer 12

Pros
• non breakable
• light weight
• low reactivity
. Low toxicity

Cons
• adsorption of material on plastic surface
• permeable to moisture, oxygen and CO2
• interaction with formulation
• poor resistance to damage

Question 13

Package material

Paper/card - pros & cons?

Answer 13

Pros
• physical protection
• can display information
• easily displayed and stored
• protection from light

Cons
• poor protection from moisture

Question 14

Blister packs - advantages & disadvantages

Answer 14

Advantages
• able to tell is dose has been taken
• calendar pack - better compliance

Disadvantage
• swallowing foil
• hard to open
• breakage of tablet
• expensive

Question 15

If a drug passes its shelf life, is it safe to consume

Answer 15

Yes, but the quality is not guaranteed

Question 16

Which drug is stable to all conditions

Answer 16

Calcium acetate

Question 17

Which drug is stable if handles correctly

Answer 17

Aspirin

Question 18

Which drugs is moderately unstable

Answer 18

Vitamins

Question 19

Which drugs is very unstable

Answer 19

Antibiotics

Question 20

Chemical factors affecting stability

Answer 20

• hydrolysis- 1st order reactions
• photolysis - compound broken down by light energy
• oxidation

Question 21

Stability testing is used to predict….

Answer 21

Shelf life

Question 22

A type of stability testing is Stress Testing, what extreme conditions is the drug exposed to?

Answer 22

• light
• humidity
• heat

Question 23

Another type of stability testing is Accelerated stability testing. What does the Arrhenius equation describe

Answer 23

The affect of temperature on the reaction rate constant