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Biopharmaceutics > 12 - Pharmaceutical Packaging > Flashcards

12 - Pharmaceutical Packaging Flashcards

1
Q

Definition of pharmaceutical packaging

A

An economical means of providing presentation, protection, identification, information, containment, convenience and compliance for a pharmaceutical product during storage, carriage, display and use until such time as the product is used or administered

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2
Q

List some uses/purposes of pharmaceutical packaging

A
  • To retain quality and efficacy
  • To improve stability, safety and integrity
  • To facilitate mass production and transportation
  • To provide accurate drug use info
  • To facilitate easy administration and application
  • To increase patient compliance
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3
Q

Describe “Use Criteria” for pharmaceutical packaging

A
  • Types/amounts of dosage forms
  • Properties of medications/excipients
  • Methods of manufacture/transportation/administration
  • Interactions between preparations and packaging materials
  • Approaches of drug use info and identification
  • Costs of mass production
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4
Q

Common Hazards:

Describe mechanical hazards

A
  • shock
  • compression
  • vibration
  • abrasion
  • puncture
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5
Q

Common Hazards:

Describe environmental hazards

A
  • moisture
  • temperature
  • light
  • pressure
  • atmospheric gases
  • solid particulates
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6
Q

Common Hazards:

Describe biological hazards

A
  • microorganisms

- animal contaminations (insects, rodents)

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7
Q

Common Hazards:

Describe chemical hazards

A

-interaction between preparation and packaging materials

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8
Q

List some potential problems with solid dosage forms

A
  • light/oxygen
  • moisture/temperature
  • physical shock
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9
Q

List some potential problems with semisolid dosage forms

A
  • microorganisms

- temperature/oxygen

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10
Q

List some potential problems with liquid dosage forms

A
  • light/oxygen

- microorganisms

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11
Q

List some potential problems with injections

A

closure

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12
Q

List some potential problems with aerosols

A

closure

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13
Q

List some potential problems with capsules

A

moisture

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14
Q

List some potential problems with suppositories

A

temperature

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15
Q

List some potential problems with volatile drugs

A

closure

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16
Q

List some potential problems with hygroscopic drugs

A

moisture

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17
Q

List some potential problems with photosensitive drugs

A

light

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18
Q

How do you manage light-sensitive drugs?

A

use amber bottles

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19
Q

How do you manage oxygen-sensitive drugs?

A

make container air tight or single doses

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20
Q

How do you protect against microorganisms?

A

preservative

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21
Q

How do you protect against temperature?

A

special storage instructions (fridge)

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22
Q

Common Materials:

What is glass used for?

A

all purposes

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23
Q

Common Materials:

What are plastics used for?

A

all purposes

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24
Q

Common Materials:

What are metals used for?

A

mostly for aerosols, ointments or special purposes

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25
Q

Common Materials:

What is rubber used for?

A

mostly for parenterals

26
Q

Common Materials:

What is paper/board used for?

A

external packaging

27
Q

List some special materials

A
  • metered-dose valves
  • cork
  • wax
  • inert gases
  • glue
  • additives
28
Q

Describe qualities of glass

A
  • transparency
  • easy cleaning
  • effective re-closure
  • high-speed handling
  • rigidity
  • stackability
  • chemical inertness
  • fragility
  • heavy weight
29
Q

There are 4 glass types:

What are they based on?

A

based on how much alkali is released from the glass

30
Q

There are 4 glass types:

Describe Type 1

A

Neutral glass:

  • preferred for parenterals
  • no alkali being released into drug product
  • made mostly from silica
31
Q

There are 4 glass types:

Describe Type 2

A

Surface-treated soda glass:

  • contains sodium ions which are alkali
  • will leech into drug product, increasing pH making it more basic
  • surface treated to reduce alkali being leeched out
32
Q

There are 4 glass types:

Describe Type 3

A

Soda or alike glass:

  • same as type 2 kind of
  • untreated
  • more alkali will be released
33
Q

There are 4 glass types:

Describe Type NP

A

General soda-lime glass, used for non-parenteral:
-for oral dosage forms
-not afraid of the leak of the alkali
(like solid oral dose forms will not absorb the alkali leech)

34
Q

Describe some relevant issues with pharmaceutical packaging

A
  • Thermal expansion
  • Light penetration
  • Additive leakage
  • Size and shape
  • Sealing methods
  • Handling conditions
35
Q

Advantages of plastics?

A
  • Durability
  • Flexibility
  • Biocompatibility
  • Fabricability (easy to make, mold and shape)
  • Wide selection
  • Light weight
  • Low cost
  • Not as fragile as glass
36
Q

Disadvantages of plastics?

A
  • Print difficulty (can’t print directly onto it or etch into it)
  • Deformation
  • Heat sensitivity
  • Stability
  • Environmental hazard
37
Q

List some plastic types

A
  • Polyethylene
  • Polyvinyl chloride
  • Polypropylene
  • Polystyrene
  • Lubricants
  • Stabilizers
  • Plasticizers
  • Antioxidants
  • Antistatic agents
  • Anti-slip agents
  • Colorants
38
Q

Problems with plastics?

A
  • Adsorption: loss of active ingredients by physicochemical binding (drugs can bind to plastics and lose some of the active ingredient)
  • Desorption: leaching of plastic additives for potential toxicity
  • Permeation: moisture/gas penetration through plastic membrane
  • Photodegradation: affecting both active ingredients and plastic additives
  • Polymer modification: chemical changes due to environmental, additives or excipients
39
Q

Precautions with metals?

A
  • Parenteral incompatibility with plastic materials should be thoroughly evaluated beforehand
  • Hospital admixtures should be carefully handled to avoid rug loss through infusion bags
  • Use of plastics for volatile and organic substances might result in strength changes
40
Q

List some qualities about Metals

A
  • strength
  • durability
  • temperature resistance
  • impermeability to moisture/gas/light/odor/bacteria
  • chemical activity
  • higher cost
  • special fabrication
  • heavy weight
41
Q

Metals are being replaced by ______ where feasible

A

plastics

42
Q

Metal Special Applications:

What is aluminum foil used for?

A

blister pack with plastics for solid dosage forms

43
Q

Metal Special Applications:

What are aluminum bags used for?

A

granules, powders, and patches

44
Q

Metal Special Applications:

What are tin collapsible tubes used for?

A

Ophthalmic preparations

45
Q

Metal Special Applications:

What are aluminum canisters used for?

A

aerosols and inhalations

46
Q

Metal Special Applications:

What are metal cans/pails/drums used for?

A

raw materials

47
Q

Both ____ and ____ rubber are used

A

natural and synthetic

48
Q

Describe natural rubber

A
  • resealability

- good needle penetration

49
Q

Describe synthetic rubber

A
  • slow aging
  • autoclaving resistance
  • moisture/gas impermeation
50
Q

What can be a potential incompatibility of rubber?

A

adsorption/desorption of active ingredients/additives

51
Q

Describe paper/board (for external packaging)

A

Advantages:

  • non-toxic
  • recyclable
  • printable
  • light weight
  • low cost
  • wide availability/variety/use purpose

Disadvantages:

  • moisture absorption
  • indurability
  • low strength
  • not primary packaging materials
52
Q

Describe Tamper-Resistant Packaging

A
  • packages with an indicator/barrier than provides visible evidence if previously tampered
  • clear labeling indicating tamper-proof features
  • tamper-proof character not affected by manufacturing/transport processing
  • patients/consumers awareness of tamper-proof features
53
Q

Describe Child-Resistant Packaging

A
  • packages that have special designs preventing young children from opening
  • clear labeling indicating child-proof features
  • international standards for many products
  • the elderly may have difficulty in handling child-proof packages due to weakness or other conditions
54
Q

List some points about unit-dose drugs

A
  • portability
  • appropriate for use in multi-dosage regimens, long-term use as reminder, and in patients who are not compliant
  • special manufacturing/packaging requirements
  • complex quality control procedures
  • higher manufacturing cost
55
Q

Quality control consists of 2 parts; describe them

A

1) Visual inspection for defects/foreign substances

2) Nondestructive methods

56
Q

Quality control:
Nondestructive methods:
List some

A
  • Spectrophotometry: identification
  • Chromatography: residues/additives
  • Thermal analysis: temperature impacts
  • Gas transmission: closure capability
  • Physical test: strength/durability
57
Q

What are the functions of proper packaging closure?

A
  • Resistance and compatibility with products at any positions
  • Effective resealability under any conditions
  • Accurate dosing dispense
  • Minimal exchange of air/moisture/vapor with outside environment
  • Capability for mass production
  • Coordination with main containers
58
Q

Describe some testing measures for packaging closure

A
  • Desiccant at high RH: moisture gain
  • High temperature/low RH: weight loss
  • Water seepage or leakage under vacuum
  • Cap-removal torque: plastic containers
  • Proof-resistant mechanisms
59
Q

What are labels/inserts important for?

A
  • Contains important and essential info for safe drug administration
  • Identification of different products

Common info required:

  • active ingredient
  • dose
  • indication
  • PK
  • adverse effects
  • administration
  • storage conditions
  • expiry date
60
Q

Describe a pharmacist’s role in packaging

A
  • Repacking of prescriptions in community pharmacies is common
  • Plastic containers are normally used
  • Pay attention to size, color, closure mechanisms, drug use info for better results
  • Use containers that keep drugs stable and compatible
  • Prepared to answer questions that are related to various packaging materials

Biopharmaceutics (4 decks)

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