Pharmaceutical Packaging Flashcards
Define pharmaceutical packaging
Defined as the means of providing protection, presentation, identification, containment, information and convenience t encourage compliance with a course of therapy
The criteria for selecting a satisfactory packaging system for products are established by addressing this checklist.
Stability: minimize/prevent instability factors such a s light, oxygen, moisture and microorganisms
Safety: should not contribute to drugs actions pharmacologically and toxicologically
Reproducibility: characterization of materials should remain the same, regardless of different handling and processing conditions
Integrity: ensure safety and quality of enclosed product
Feasibility: readily available and cost-effective materials
What are the four categories of potential hazardous conditions that can compromise safety and quality of product?
Mechanical, climatic, biological, and chemical.
Shock, compression, vibration and puncture are all four potential hazards in what category?
Mechanical hazards
Moisture, temperature, light, atmospheric gas, pressure and solid airborne particulates are all what type of hazard?
Climatic hazard
What kind of changes can moisture cause?
Physical (softening and hardening of solid preparations) and chemical (hydrolysis, premature disintegration or dissolution)
Can also act as carrier for contaminants
What are temperatures effects on products?
High temperatures exert accelerated effects on chemical deterioration of a substance
What can carbon dioxide access lead to in some products?
Can lead to pH changes in liquid preparations
Microbiological contaminants, animal infestation and human pilferage are what kind of potential hazard?
Biological Hazards
What can be used to eliminate microbiological contaminants like bacteria, molds and yeast?
Preservatives in certain dosage forms as well as reasonably clean containers so sterility can be maintained
How does packaging relate to chemical hazards?
Interactions and incompatibilities between dosage components and packaging materials
This is regarded as a material of absolute barrier for pharmaceutical products and is a container of choice form many dosage forms.
Glass, can change its chemical composition to adjust its chemical behaviour and radiation protective properties.
What are the four types of classification in accordance to?
In accordance to the amount of alkali released from the glass when attacked by water.
Describe all four types of glass.
Type I: borosilicate, release least amount of alkali. For sterile products or alkaline preparations
Type II: soda-lime glass, has been dealkalized by surface treatments, suitable for products that remain below pH 7
Type III: contains bulk composition of Type II without pretreatment, for solid dose packaging
Type NP: glass that releases the most amount of alkali, used for non-parenteral formulations.
Why is color incorporated into glass containers?
Generate additional protective effects and product identification
Amber glass provide resistance to light radiation, which is appropriate for photosensitive preparations
List the considerations for pre made glass containers?
Thermal expansion: sterilization and freeze-drying should not effect sealing and integrity
Container size and physical shape: resistance to thermal and mechanical shocks
Specialized glass formulas: ex) cerium oxide must be added to glass containers subject to irradiation, no barium or calcium for interaction.
What are the four most economic plastic materials?
Polyethylene
Polyvinyl chloride
Polypropylene
Polystyrene
What are some additives incorporated into plastic formulas and why?
Lubricants: improve the of processibility
Stabilizers: retardation of material degradation
Plasticizers: enhancement of flexibility and resiliency
Antioxidants: prevent oxidation
Anti static: reduce surface static charge
Dyes/pigments: for product identification or protection
The bonding of a solute to a plastic can be determined by measuring the loss of the solute to the plastic at equilibrium under constant temperature
Sorption
This indicates the leaching of plastic components into the contents of the container and can result in container collapse, product discolouration and precipitation
Desorption
What influences desorption so rate and extent?
Properties of preparation to be packaged, conditions of pH, temperature and storage
Regarded to as the permeability of moisture, gas, and light through plastic material and can be a two-way phenomenon.
Permeation
Photodegradation readily takes place due to what?
Special functional groups of the polymers. Additional protection methods must be employd, like adding pacifying agents, using aluminum foil or secondary light-resistant packaging.
This results from interactions of plastic with pharmaceutical ingredients and/or processing methods and can lead to cracking of the packaging, loss of elasticity and functionality.
Polymer modification
What are the most commonly used metals in the pharmaceutical industry?
Aluminum and aluminum alloys
How is chemical reactivity reduced in metals?
Special coatings applied to the interior surface of the metal containers.
What is rubber normally used for?
To supplement parts in various packing containers not primary packaging material
What is the majority of rubber usage associated with?
Closure of sterile products (caps and closures of glass containers containing aqueous, oil-based or injectable powders)
Rubber gaskets can also be found in aerosols and MDI’s
What needs to be done to make rubber a appropriate material?
Excipients and additives are incorporated to improve sealability, reistance to processing and aging properties.
Will contain more additives than plastic therefore must carefully investigate potential incompatibility and interactions.
This is composed of cellulose obtained form vegetable fibres.
Paper and board
What are paper-based materials normally used for in pharmaceutical packaging?
Secondary pharmaceutical packaging (labels, inserts, bags, trays and boxes)
What are some advantages and disadvantages of paper and board?
Advantages: nontoxic, inexpensive, recyclable and printable
Disadvantages: mechanical durability, resistance to heat/fire, moisture penetration
Packaging having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that something has occurred.
Tamper-Resistant packaging
What may a tamper resistant package involve?
An immediate system (container and closure) or a secondary system (carton or container) that provide visual indication of package integrity.
Where do issues with tamper resistant products arise?
Geriatric patients who have difficulty in opening packages
This special packing mechanism provides for packaging designed and constructed to be difficult for young children to open
Child-resistant packaging
Pre-packed unit that provides one treatment cycle of the medication to both the pharmacist and the patient in ready-to-use packaging
Compliance packaging
What are the two primary purposes of compliance packaging?
Facilitates healthcare professional to conduct patient education
Help patients remember taking medications correctly at home.
*used in chronic medications and for geriatrics
Visual inspection of packaging surfaces is used for quality control. What are some special instruments used for QC as well?
Spectrophotometery Chromatography Thermal analysis Gas transmission analysis Leak detection
The effects of long term storage conditions, such as temperature, humidity and material aging can conveniently be monitored without altering test samples by this process.
Multiple internal reflectance Spectrophotometry, relying on a beam of radiation
This is useful in identifying and quantifying residues of leaked materials?
Chromatography
This measures physical changes in a material as a function of temperature.
Thermal analysis, useful in QC of glass and plastic packing
Can test folds, creases, seals, printing and closures with no pressure differentials for water vapor, CO and ethylene oxide
Gas transmission analysis
What is the information that should be provided with packaging and/or labelling?
Containers: tamper-resistant mechanism, special instructions for opening, unit dosing or multiple dosing containers
Labels: use indications; components of active ingredients and non-medicinal ingredients, expiration date, adverse effects, storage
