Pharmaceutical Packaging

Question 1

Pharmaceutical packaging is important in avoiding ____ of drugs

Answer 1

confusion

Question 2

What are the purposed of pharmaceutical packaging?

Answer 2

• to improve quality and efficacy
• to improve safety, integrity and solubility
• to facilitate mass transportation and production
• to provide accurate dose information
• to facilitate easy administration and application
• to increase patient compliance

Question 3

What are the common mechanical hazards on drugs?

Answer 3

• shock, compression, vibration, abrasion and puncture

Question 4

What are the common environmental hazards on drugs?

Answer 4

• moisture, temperature, light, pressure, atmospheric gas, solid particles

Question 5

What are the common biological hazards on drugs?

Answer 5

• microorganisms, animal contaminations

Question 6

What are the common chemical hazards on drugs?

Answer 6

• interaction between preparation and packaging materials

Question 7

What are the possible routes of contamination from solid dosage forms?

Answer 7

• light/oxygen
• moisture/temperature
• physical shock

Question 8

What are the possible routes of contamination from semisolid dose forms?

Answer 8

• microorganisms

- temperature/oxygen

Question 9

What are the possible routes of contamination from liquid dosage forms?

Answer 9

• light/oxygen

- microorganisms

Question 10

What is the major route of contamination from injections?

Answer 10

• closure failure

Question 11

What is the major route of contamination from aerosols?

Answer 11

• closure failure

Question 12

What is the major route of contamination from capsules?

Answer 12

• moisture

Question 13

What is the major route of contamination from suppositories?

Answer 13

• temperature

Question 14

What are some of the properties of glass as a closure that makes it useful in packaging?

Answer 14

• transparency
• easy cleaning
• effective closure
• high speed handling
• rigidity
• stickability
• chemical inertness
• fragility
• heavy weight

Question 15

Type 1 glass is preferred for ________. Why?

Answer 15

• injectables and parenterals
• this is because there are no alkali metal ions seeping
• it is considered to be neutral glass

Question 16

What is the problem with type 2 glass?

Answer 16

• there are alkali metals leaching into the solution

Question 17

Describe type NP glass?

Answer 17

• general soda lime glass, used for non-parenteral

- this is typically used for oral dosage forms

Question 18

What are the advantages of using a plastic over a glass as a container?

Answer 18

• lighter, not as fragile
• plastics are more durable
• flexible
• biocompatible
• fabric-ability (easy to mould and shape)
• wide selection
• light weight
• low cost

Question 19

What are the main disadvantages of using plastics over glass for packaging?

Answer 19

• print difficulty
• deformation
• heat sensitivity
• stability
• environmental hazards

Question 20

What are the various plastic types that can be used?

Answer 20

• polyethylene (various densities)
• polyvinyl chloride (un/plasticized)
• polypropylene (homo/co-polymer)
• polystyrene (general purpose or impact modified)

Question 21

What is the definition of adsorption?

Answer 21

• loss of active ingredients by physiochemical leaching

Question 22

What is the definition of desorption?

Answer 22

• leaching of plastic additives for potential toxicity

Question 23

What is the definition of permeation?

Answer 23

-moisture/gas penetration through plastic membrane

Question 24

What is the definition of photodegredation?

Answer 24

• affecting both active ingredients and plastic additives

Question 25

What is the definition of polymer modification?

Answer 25

- chemical changes due to environmental, additives or excipients

Question 26

Where are aluminum foil as a packaging material generally found?

Answer 26

- blister packaging with plastics for solid dosage forms

Question 27

What are aluminum bags used for generally as packaging?

Answer 27

- for granules/powders and patches

Question 28

What are aluminum canisters generally used for?

Answer 28

- for aerosols/inhalations

Question 29

What are metal can/pail/drums usually used for in packaging?

Answer 29

- for raw materials

Question 30

Both ______ rubber is used in packaging materials

Answer 30

natural and rubber

Question 31

What is natural rubber useful in?

Answer 31

- for reseal ability, good needle penetration

Question 32

What is synthetic rubber most useful for?

Answer 32

- slow aging, autoclaving resistance, moisture/gas impermeation

Question 33

What are some of the advantages of using paper/board as packaging materials?

Answer 33

- non toxic - recyclable - printability - light weight - low cost - wide availability/variety - moisture absorption - in-durability - low strength

Question 34

What is the difference between tamper resistance and child resistance?

Answer 34

Tamper resistance- packages with an indicator/barrier that provides visible evidence if previously tampered with - clear labeling indicates tamper proof features - character not affected by manufacturing/transport processing Child resistance - packages that have special designs preventing found children from opening - clear labeling with indicate child proof features - international standards

Question 35

When is unit dose packaging acceptable?

Answer 35

- appropriate for use multi-dosage regimes, long term use as reminders, and in patients that are not compliant - special manufacturing/packaging requirements - complex quality control procedures - higher manufacturing costs

Question 36

What does quality control of packaging consist of?

Answer 36

- visual inspection for defects/foreign substances

Question 37

What is the function of a pharmaceutical closure?

Answer 37

- resistance and compatibility with products at any positions - effective resolubility under any conditions - accurate dosing dispense - minimal exchange of air/moisture/vapor with the outside environment - capability for mass production - coordination with main containers

Question 38

What important information does a label/insert have to contain?

Answer 38

- ID of different products - active ingredients (dose, indication, PK, AE, administration) - excipients - storage conditions - expiry date

Question 39

What test is done to test the moisture gain in a compound?

Answer 39

- desiccant at high RH

Question 40

What test is done to test the weight loss in a compound?

Answer 40

- high temperature/ low RH

Question 41

What test is done to test plastic containers?

Answer 41

- cap removal torque