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Ceutics > Pharmaceutical Packaging > Flashcards

Pharmaceutical Packaging Flashcards

1
Q

What is the definition of pharmaceutical packaging?

A

The means of providing protection, presentation, identification, containment, information and convenience to encourage compliance with a course of therapy

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2
Q

What are some basic considerations that need to be addressed when selecting a satisfactory packaging system?

A 
Stability
Safety
Reproducibility
Integrity
Feasibility
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3
Q

What are the four different potential hazards?

A

Mechanical hazards
Climate hazards
Biological hazards
Chemical hazards

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4
Q

What are different types of mechanical hazards?

A

Shock
Compression
Vibration
Puncture/piercing

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5
Q

What are some climate hazards?

A 
Moisture
Temperature
Light
Atmospheric gasses
Pressure
Solid airborne particulates
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6
Q

What are some biological hazards?

A

Microbiological contaminants
Animal infestation
Human pilferage and adulteration

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7
Q

What are chemical hazards?

A

Chemical hazards may range from chemical reactions/interactions to chemical incompatibilities

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8
Q

What are the different types of packaging materials?

A 
Glass
Plastic
Metals
Rubber
Paper
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9
Q

How are the different type of glass classified?

A 
Based on the amount of alkali released from the glass when attacked by water under specific conditions
Type I
Type II
Type III
Type NP
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10
Q

What is type I glass?

A

Borosilicate glass, which releases the least amount of alkali
Used for sterile products or products that are alkaline or will become alkaline prior to drug administration

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11
Q

What is type II glass?

A

Soda-lime glass that has been dealkalized by surface treatment of the finished container
Used for products that will remain below pH 7

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12
Q

What is type III glass?

A

Same as type II minus the surface treatment

Used for packing solid dosage forms

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13
Q

What is type NP glass?

A

It releases the most amount of alkali and is used generally for non-parenteral formulations

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14
Q

When making glass containers, what are some aspects that need to be considered?

A

Thermal expansion properties during sterilization and freeze-drying should be carefully evaluated and measured
Container size and physical shape can influence its resistance to thermal and mechanical shocks
Certain specialized glass formulas may be required for different purposes

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15
Q

What are the four most economic plastic materials?

A

Polyethylene
Polyvinyl chloride
Polypropylene
Polystyrene

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16
Q

What are some common additives for plastic materials?

A 
Lubricants
Stabilizers
Plasticizers
Antioxidants
Antistatic agents
Dyes/pigments
17
Q

Plastic containers can possess their unique properties in terms of interactions between pharmaceutical ingredients and plastic components. What are some of these properties?

A 
Sorption
Desorption
Permeation
Photodegradation
Polymer modification
18
Q

What is sorption?

A

The bonding of a solute to a plastic, which is a physicochemical phenomenon related to the properties of the plastic and the structure of the solute

19
Q

What is desorption?

A

The leaching of plastic components into the contents of the container

20
Q

What is permeation?

A

The permeability of moisture, gas and light through the plastic material

21
Q

What is polymer modification?

A

Polymer modification results from interactions of plastic with pharmaceutical ingredients and/or processing methods

22
Q

What are the most common metals used in the pharmaceutical industry?

A

Aluminum and aluminum alloys

23
Q

How can a well-designed and elegantly presented package improve patient care?

A

It can enhance stability of the active ingredients, facilitate drug administration and improve patient compliance

24
Q

When is rubber (for the most part) used?

A

The closure of sterile products

Caps for the closure of glass containers containing aqueous, oil-based or powdered injectables

25
Q

What are the different types of special packaging mechanisms?

A

Tamper-resistant packaging
Child-resistant packaging
Compliance packaging

26
Q

What is a tamper-resistant packaging?

A

Packaging having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred

27
Q

What is child-resistant packaging?

A

Packing designed and constructed to be difficult for young children to open within reasonable time and that is not difficult for adults to use properly

28
Q

What is compliance packaging?

A

Pre-packed unit that provides one treatment cycle of the medication to both the pharmacist and the patient in a ready-to-use package

29
Q

What are some instruments for quality control of pharmaceutical packaging?

A 
Spectrophotometry
Chromatography
Thermal analysis
Gas transmission analysis
Leak detection
30
Q

What information should containers provide?

A

Tamper-resistant, child-resistant mechanisms
Special instructions for opening
Unit-dosing or multiple-dosing containers

Ceutics (8 decks)

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