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Biopharmaceutics > Pharmaceutical Packaging > Flashcards

Pharmaceutical Packaging Flashcards

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?

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?

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?

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

What are the various plastic types that can be used?

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?

A
  • loss of active ingredients by physiochemical leaching
22
Q

What is the definition of desorption?

A
  • leaching of plastic additives for potential toxicity
23
Q

What is the definition of permeation?

A

-moisture/gas penetration through plastic membrane

24
Q

What is the definition of photodegredation?

A
  • affecting both active ingredients and plastic additives
25
Q

What is the definition of polymer modification?

A
  • chemical changes due to environmental, additives or excipients
26
Q

Where are aluminum foil as a packaging material generally found?

A
  • blister packaging with plastics for solid dosage forms
27
Q

What are aluminum bags used for generally as packaging?

A
  • for granules/powders and patches
28
Q

What are aluminum canisters generally used for?

A
  • for aerosols/inhalations
29
Q

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

A
  • for raw materials
30
Q

Both ______ rubber is used in packaging materials

A

natural and rubber

31
Q

What is natural rubber useful in?

A
  • for reseal ability, good needle penetration
32
Q

What is synthetic rubber most useful for?

A
  • slow aging, autoclaving resistance, moisture/gas impermeation
33
Q

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

A
  • non toxic
  • recyclable
  • printability
  • light weight
  • low cost
  • wide availability/variety
  • moisture absorption
  • in-durability
  • low strength
34
Q

What is the difference between tamper resistance and child resistance?

A

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
Q

When is unit dose packaging acceptable?

A
  • 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
Q

What does quality control of packaging consist of?

A
  • visual inspection for defects/foreign substances
37
Q

What is the function of a pharmaceutical closure?

A
  • 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
Q

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

A
  • ID of different products
  • active ingredients (dose, indication, PK, AE, administration)
  • excipients
  • storage conditions
  • expiry date
39
Q

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

A
  • desiccant at high RH
40
Q

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

A
  • high temperature/ low RH
41
Q

What test is done to test plastic containers?

A
  • cap removal torque

Biopharmaceutics (6 decks)

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