Pharmaceutical Packaging Flashcards
What is the definition of pharmaceutical packaging?
The means of providing protection, presentation, identification, containment, information and convenience to encourage compliance with a course of therapy
What are some basic considerations that need to be addressed when selecting a satisfactory packaging system?
Stability Safety Reproducibility Integrity Feasibility
What are the four different potential hazards?
Mechanical hazards
Climate hazards
Biological hazards
Chemical hazards
What are different types of mechanical hazards?
Shock
Compression
Vibration
Puncture/piercing
What are some climate hazards?
Moisture Temperature Light Atmospheric gasses Pressure Solid airborne particulates
What are some biological hazards?
Microbiological contaminants
Animal infestation
Human pilferage and adulteration
What are chemical hazards?
Chemical hazards may range from chemical reactions/interactions to chemical incompatibilities
What are the different types of packaging materials?
Glass Plastic Metals Rubber Paper
How are the different type of glass classified?
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
What is type I glass?
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
What is type II glass?
Soda-lime glass that has been dealkalized by surface treatment of the finished container
Used for products that will remain below pH 7
What is type III glass?
Same as type II minus the surface treatment
Used for packing solid dosage forms
What is type NP glass?
It releases the most amount of alkali and is used generally for non-parenteral formulations
When making glass containers, what are some aspects that need to be considered?
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
What are the four most economic plastic materials?
Polyethylene
Polyvinyl chloride
Polypropylene
Polystyrene
What are some common additives for plastic materials?
Lubricants Stabilizers Plasticizers Antioxidants Antistatic agents Dyes/pigments
Plastic containers can possess their unique properties in terms of interactions between pharmaceutical ingredients and plastic components. What are some of these properties?
Sorption Desorption Permeation Photodegradation Polymer modification
What is sorption?
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
What is desorption?
The leaching of plastic components into the contents of the container
What is permeation?
The permeability of moisture, gas and light through the plastic material
What is polymer modification?
Polymer modification results from interactions of plastic with pharmaceutical ingredients and/or processing methods
What are the most common metals used in the pharmaceutical industry?
Aluminum and aluminum alloys
How can a well-designed and elegantly presented package improve patient care?
It can enhance stability of the active ingredients, facilitate drug administration and improve patient compliance
When is rubber (for the most part) used?
The closure of sterile products
Caps for the closure of glass containers containing aqueous, oil-based or powdered injectables
What are the different types of special packaging mechanisms?
Tamper-resistant packaging
Child-resistant packaging
Compliance packaging
What is a tamper-resistant packaging?
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
What is child-resistant packaging?
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
What is compliance packaging?
Pre-packed unit that provides one treatment cycle of the medication to both the pharmacist and the patient in a ready-to-use package
What are some instruments for quality control of pharmaceutical packaging?
Spectrophotometry Chromatography Thermal analysis Gas transmission analysis Leak detection
What information should containers provide?
Tamper-resistant, child-resistant mechanisms
Special instructions for opening
Unit-dosing or multiple-dosing containers
