Pharmaceutical Packaging Flashcards
Pharmaceutical packaging is important in avoiding ____ of drugs
confusion
What are the purposed of pharmaceutical packaging?
- 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
What are the common mechanical hazards on drugs?
- shock, compression, vibration, abrasion and puncture
What are the common environmental hazards on drugs?
- moisture, temperature, light, pressure, atmospheric gas, solid particles
What are the common biological hazards on drugs?
- microorganisms, animal contaminations
What are the common chemical hazards on drugs?
- interaction between preparation and packaging materials
What are the possible routes of contamination from solid dosage forms?
- light/oxygen
- moisture/temperature
- physical shock
What are the possible routes of contamination from semisolid dose forms?
- microorganisms
- temperature/oxygen
What are the possible routes of contamination from liquid dosage forms?
- light/oxygen
- microorganisms
What is the major route of contamination from injections?
- closure failure
What is the major route of contamination from aerosols?
- closure failure
What is the major route of contamination from capsules?
- moisture
What is the major route of contamination from suppositories?
- temperature
What are some of the properties of glass as a closure that makes it useful in packaging?
- transparency
- easy cleaning
- effective closure
- high speed handling
- rigidity
- stickability
- chemical inertness
- fragility
- heavy weight
Type 1 glass is preferred for ________. Why?
- injectables and parenterals
- this is because there are no alkali metal ions seeping
- it is considered to be neutral glass
What is the problem with type 2 glass?
- there are alkali metals leaching into the solution
Describe type NP glass?
- general soda lime glass, used for non-parenteral
- this is typically used for oral dosage forms
What are the advantages of using a plastic over a glass as a container?
- lighter, not as fragile
- plastics are more durable
- flexible
- biocompatible
- fabric-ability (easy to mould and shape)
- wide selection
- light weight
- low cost
What are the main disadvantages of using plastics over glass for packaging?
- print difficulty
- deformation
- heat sensitivity
- stability
- environmental hazards
What are the various plastic types that can be used?
- polyethylene (various densities)
- polyvinyl chloride (un/plasticized)
- polypropylene (homo/co-polymer)
- polystyrene (general purpose or impact modified)
What is the definition of adsorption?
- loss of active ingredients by physiochemical leaching
What is the definition of desorption?
- leaching of plastic additives for potential toxicity
What is the definition of permeation?
-moisture/gas penetration through plastic membrane
What is the definition of photodegredation?
- affecting both active ingredients and plastic additives
What is the definition of polymer modification?
- chemical changes due to environmental, additives or excipients
Where are aluminum foil as a packaging material generally found?
- blister packaging with plastics for solid dosage forms
What are aluminum bags used for generally as packaging?
- for granules/powders and patches
What are aluminum canisters generally used for?
- for aerosols/inhalations
What are metal can/pail/drums usually used for in packaging?
- for raw materials
Both ______ rubber is used in packaging materials
natural and rubber
What is natural rubber useful in?
- for reseal ability, good needle penetration
What is synthetic rubber most useful for?
- slow aging, autoclaving resistance, moisture/gas impermeation
What are some of the advantages of using paper/board as packaging materials?
- non toxic
- recyclable
- printability
- light weight
- low cost
- wide availability/variety
- moisture absorption
- in-durability
- low strength
What is the difference between tamper resistance and child resistance?
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
When is unit dose packaging acceptable?
- 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
What does quality control of packaging consist of?
- visual inspection for defects/foreign substances
What is the function of a pharmaceutical closure?
- 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
What important information does a label/insert have to contain?
- ID of different products
- active ingredients (dose, indication, PK, AE, administration)
- excipients
- storage conditions
- expiry date
What test is done to test the moisture gain in a compound?
- desiccant at high RH
What test is done to test the weight loss in a compound?
- high temperature/ low RH
What test is done to test plastic containers?
- cap removal torque
