12 - Pharmaceutical Packaging Flashcards
(60 cards)
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
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
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
4
Q
Common Hazards:
Describe mechanical hazards
A
- shock
- compression
- vibration
- abrasion
- puncture
5
Q
Common Hazards:
Describe environmental hazards
A
- moisture
- temperature
- light
- pressure
- atmospheric gases
- solid particulates
6
Q
Common Hazards:
Describe biological hazards
A
- microorganisms
- animal contaminations (insects, rodents)
7
Q
Common Hazards:
Describe chemical hazards
A
-interaction between preparation and packaging materials
8
Q
List some potential problems with solid dosage forms
A
- light/oxygen
- moisture/temperature
- physical shock
9
Q
List some potential problems with semisolid dosage forms
A
- microorganisms
- temperature/oxygen
10
Q
List some potential problems with liquid dosage forms
A
- light/oxygen
- microorganisms
11
Q
List some potential problems with injections
A
closure
12
Q
List some potential problems with aerosols
A
closure
13
Q
List some potential problems with capsules
A
moisture
14
Q
List some potential problems with suppositories
A
temperature
15
Q
List some potential problems with volatile drugs
A
closure
16
Q
List some potential problems with hygroscopic drugs
A
moisture
17
Q
List some potential problems with photosensitive drugs
A
light
18
Q
How do you manage light-sensitive drugs?
A
use amber bottles
19
Q
How do you manage oxygen-sensitive drugs?
A
make container air tight or single doses
20
Q
How do you protect against microorganisms?
A
preservative
21
Q
How do you protect against temperature?
A
special storage instructions (fridge)
22
Q
Common Materials:
What is glass used for?
A
all purposes
23
Q
Common Materials:
What are plastics used for?
A
all purposes
24
Q
Common Materials:
What are metals used for?
A
mostly for aerosols, ointments or special purposes
25
Common Materials:
| What is rubber used for?
mostly for parenterals
26
Common Materials:
| What is paper/board used for?
external packaging
27
List some special materials
- metered-dose valves
- cork
- wax
- inert gases
- glue
- additives
28
Describe qualities of glass
- transparency
- easy cleaning
- effective re-closure
- high-speed handling
- rigidity
- stackability
- chemical inertness
- fragility
- heavy weight
29
There are 4 glass types:
| What are they based on?
based on how much alkali is released from the glass
30
There are 4 glass types:
| Describe Type 1
Neutral glass:
- preferred for parenterals
- no alkali being released into drug product
- made mostly from silica
31
There are 4 glass types:
| Describe Type 2
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
There are 4 glass types:
| Describe Type 3
Soda or alike glass:
- same as type 2 kind of
- untreated
- more alkali will be released
33
There are 4 glass types:
| Describe Type NP
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
Describe some relevant issues with pharmaceutical packaging
- Thermal expansion
- Light penetration
- Additive leakage
- Size and shape
- Sealing methods
- Handling conditions
35
Advantages of plastics?
- Durability
- Flexibility
- Biocompatibility
- Fabricability (easy to make, mold and shape)
- Wide selection
- Light weight
- Low cost
- Not as fragile as glass
36
Disadvantages of plastics?
- Print difficulty (can't print directly onto it or etch into it)
- Deformation
- Heat sensitivity
- Stability
- Environmental hazard
37
List some plastic types
- Polyethylene
- Polyvinyl chloride
- Polypropylene
- Polystyrene
- Lubricants
- Stabilizers
- Plasticizers
- Antioxidants
- Antistatic agents
- Anti-slip agents
- Colorants
38
Problems with plastics?
- 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
Precautions with metals?
- 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
List some qualities about Metals
- strength
- durability
- temperature resistance
- impermeability to moisture/gas/light/odor/bacteria
- chemical activity
- higher cost
- special fabrication
- heavy weight
41
Metals are being replaced by ______ where feasible
plastics
42
Metal Special Applications:
| What is aluminum foil used for?
blister pack with plastics for solid dosage forms
43
Metal Special Applications:
| What are aluminum bags used for?
granules, powders, and patches
44
Metal Special Applications:
| What are tin collapsible tubes used for?
Ophthalmic preparations
45
Metal Special Applications:
| What are aluminum canisters used for?
aerosols and inhalations
46
Metal Special Applications:
| What are metal cans/pails/drums used for?
raw materials
47
Both ____ and ____ rubber are used
natural and synthetic
48
Describe natural rubber
- resealability
| - good needle penetration
49
Describe synthetic rubber
- slow aging
- autoclaving resistance
- moisture/gas impermeation
50
What can be a potential incompatibility of rubber?
adsorption/desorption of active ingredients/additives
51
Describe paper/board (for external packaging)
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
Describe Tamper-Resistant Packaging
- 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
Describe Child-Resistant Packaging
- 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
List some points about unit-dose drugs
- 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
Quality control consists of 2 parts; describe them
1) Visual inspection for defects/foreign substances
| 2) Nondestructive methods
56
Quality control:
Nondestructive methods:
List some
- Spectrophotometry: identification
- Chromatography: residues/additives
- Thermal analysis: temperature impacts
- Gas transmission: closure capability
- Physical test: strength/durability
57
What are the functions of proper packaging closure?
- 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
Describe some testing measures for packaging closure
- 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
What are labels/inserts important for?
- 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
Describe a pharmacist's role in packaging
- 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
