12 - Pharmaceutical Packaging Flashcards
Definition of pharmaceutical packaging
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
List some uses/purposes of pharmaceutical packaging
- 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
Describe “Use Criteria” for pharmaceutical packaging
- 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
Common Hazards:
Describe mechanical hazards
- shock
- compression
- vibration
- abrasion
- puncture
Common Hazards:
Describe environmental hazards
- moisture
- temperature
- light
- pressure
- atmospheric gases
- solid particulates
Common Hazards:
Describe biological hazards
- microorganisms
- animal contaminations (insects, rodents)
Common Hazards:
Describe chemical hazards
-interaction between preparation and packaging materials
List some potential problems with solid dosage forms
- light/oxygen
- moisture/temperature
- physical shock
List some potential problems with semisolid dosage forms
- microorganisms
- temperature/oxygen
List some potential problems with liquid dosage forms
- light/oxygen
- microorganisms
List some potential problems with injections
closure
List some potential problems with aerosols
closure
List some potential problems with capsules
moisture
List some potential problems with suppositories
temperature
List some potential problems with volatile drugs
closure
List some potential problems with hygroscopic drugs
moisture
List some potential problems with photosensitive drugs
light
How do you manage light-sensitive drugs?
use amber bottles
How do you manage oxygen-sensitive drugs?
make container air tight or single doses
How do you protect against microorganisms?
preservative
How do you protect against temperature?
special storage instructions (fridge)
Common Materials:
What is glass used for?
all purposes
Common Materials:
What are plastics used for?
all purposes
Common Materials:
What are metals used for?
mostly for aerosols, ointments or special purposes
Common Materials:
What is rubber used for?
mostly for parenterals
Common Materials:
What is paper/board used for?
external packaging
List some special materials
- metered-dose valves
- cork
- wax
- inert gases
- glue
- additives
Describe qualities of glass
- transparency
- easy cleaning
- effective re-closure
- high-speed handling
- rigidity
- stackability
- chemical inertness
- fragility
- heavy weight
There are 4 glass types:
What are they based on?
based on how much alkali is released from the glass
There are 4 glass types:
Describe Type 1
Neutral glass:
- preferred for parenterals
- no alkali being released into drug product
- made mostly from silica
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
There are 4 glass types:
Describe Type 3
Soda or alike glass:
- same as type 2 kind of
- untreated
- more alkali will be released
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)
Describe some relevant issues with pharmaceutical packaging
- Thermal expansion
- Light penetration
- Additive leakage
- Size and shape
- Sealing methods
- Handling conditions
Advantages of plastics?
- Durability
- Flexibility
- Biocompatibility
- Fabricability (easy to make, mold and shape)
- Wide selection
- Light weight
- Low cost
- Not as fragile as glass
Disadvantages of plastics?
- Print difficulty (can’t print directly onto it or etch into it)
- Deformation
- Heat sensitivity
- Stability
- Environmental hazard
List some plastic types
- Polyethylene
- Polyvinyl chloride
- Polypropylene
- Polystyrene
- Lubricants
- Stabilizers
- Plasticizers
- Antioxidants
- Antistatic agents
- Anti-slip agents
- Colorants
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
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
List some qualities about Metals
- strength
- durability
- temperature resistance
- impermeability to moisture/gas/light/odor/bacteria
- chemical activity
- higher cost
- special fabrication
- heavy weight
Metals are being replaced by ______ where feasible
plastics
Metal Special Applications:
What is aluminum foil used for?
blister pack with plastics for solid dosage forms
Metal Special Applications:
What are aluminum bags used for?
granules, powders, and patches
Metal Special Applications:
What are tin collapsible tubes used for?
Ophthalmic preparations
Metal Special Applications:
What are aluminum canisters used for?
aerosols and inhalations
Metal Special Applications:
What are metal cans/pails/drums used for?
raw materials
Both ____ and ____ rubber are used
natural and synthetic
Describe natural rubber
- resealability
- good needle penetration
Describe synthetic rubber
- slow aging
- autoclaving resistance
- moisture/gas impermeation
What can be a potential incompatibility of rubber?
adsorption/desorption of active ingredients/additives
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
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
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
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
Quality control consists of 2 parts; describe them
1) Visual inspection for defects/foreign substances
2) Nondestructive methods
Quality control:
Nondestructive methods:
List some
- Spectrophotometry: identification
- Chromatography: residues/additives
- Thermal analysis: temperature impacts
- Gas transmission: closure capability
- Physical test: strength/durability
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
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
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
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
