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Biopharmaceutics > Pharmaceutical Packaging > Flashcards

Pharmaceutical Packaging Flashcards

(41 cards)

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1
Q

Pharmaceutical packaging is important in avoiding ____ of drugs

A

confusion

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2
Q

What are the purposed of pharmaceutical packaging?

A
  • 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
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3
Q

What are the common mechanical hazards on drugs?

A
  • shock, compression, vibration, abrasion and puncture
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4
Q

What are the common environmental hazards on drugs?

A
  • moisture, temperature, light, pressure, atmospheric gas, solid particles
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5
Q

What are the common biological hazards on drugs?

A
  • microorganisms, animal contaminations
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6
Q

What are the common chemical hazards on drugs?

A
  • interaction between preparation and packaging materials
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7
Q

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

A
  • light/oxygen
  • moisture/temperature
  • physical shock
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8
Q

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

A
  • microorganisms

- temperature/oxygen

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9
Q

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

A
  • light/oxygen

- microorganisms

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10
Q

What is the major route of contamination from injections?

A
  • closure failure
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11
Q

What is the major route of contamination from aerosols?

A
  • closure failure
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12
Q

What is the major route of contamination from capsules?

A
  • moisture
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13
Q

What is the major route of contamination from suppositories?

A
  • temperature
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14
Q

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

A
  • transparency
  • easy cleaning
  • effective closure
  • high speed handling
  • rigidity
  • stickability
  • chemical inertness
  • fragility
  • heavy weight
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15
Q

Type 1 glass is preferred for ________. Why?

A
  • injectables and parenterals
  • this is because there are no alkali metal ions seeping
  • it is considered to be neutral glass
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16
Q

What is the problem with type 2 glass?

A
  • there are alkali metals leaching into the solution
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17
Q

Describe type NP glass?

Study These Flashcards
A
  • general soda lime glass, used for non-parenteral

- this is typically used for oral dosage forms

18
Q

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

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A
  • lighter, not as fragile
  • plastics are more durable
  • flexible
  • biocompatible
  • fabric-ability (easy to mould and shape)
  • wide selection
  • light weight
  • low cost
19
Q

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

Study These Flashcards
A
  • print difficulty
  • deformation
  • heat sensitivity
  • stability
  • environmental hazards
20
Q

What are the various plastic types that can be used?

Study These Flashcards
A
  • polyethylene (various densities)
  • polyvinyl chloride (un/plasticized)
  • polypropylene (homo/co-polymer)
  • polystyrene (general purpose or impact modified)
21
Q

What is the definition of adsorption?

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A
  • loss of active ingredients by physiochemical leaching
22
Q

What is the definition of desorption?

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A
  • leaching of plastic additives for potential toxicity
23
Q

What is the definition of permeation?

Study These Flashcards
A

-moisture/gas penetration through plastic membrane

24
Q

What is the definition of photodegredation?

Study These Flashcards
A
  • affecting both active ingredients and plastic additives
25
What is the definition of polymer modification?
- chemical changes due to environmental, additives or excipients
26
Where are aluminum foil as a packaging material generally found?
- blister packaging with plastics for solid dosage forms
27
What are aluminum bags used for generally as packaging?
- for granules/powders and patches
28
What are aluminum canisters generally used for?
- for aerosols/inhalations
29
What are metal can/pail/drums usually used for in packaging?
- for raw materials
30
Both ______ rubber is used in packaging materials
natural and rubber
31
What is natural rubber useful in?
- for reseal ability, good needle penetration
32
What is synthetic rubber most useful for?
- slow aging, autoclaving resistance, moisture/gas impermeation
33
What are some of the advantages of using paper/board as packaging materials?
- non toxic - recyclable - printability - light weight - low cost - wide availability/variety - moisture absorption - in-durability - low strength
34
What is the difference between tamper resistance and child resistance?
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
35
When is unit dose packaging acceptable?
- 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
36
What does quality control of packaging consist of?
- visual inspection for defects/foreign substances
37
What is the function of a pharmaceutical closure?
- 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
38
What important information does a label/insert have to contain?
- ID of different products - active ingredients (dose, indication, PK, AE, administration) - excipients - storage conditions - expiry date
39
What test is done to test the moisture gain in a compound?
- desiccant at high RH
40
What test is done to test the weight loss in a compound?
- high temperature/ low RH
41
What test is done to test plastic containers?
- cap removal torque

Biopharmaceutics (6 decks)

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