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Biopharmaceutics 2 > Pharmaceutical Packaging > Flashcards

Pharmaceutical Packaging Flashcards

1
Q

Define pharmaceutical packaging

A

Defined as the means of providing protection, presentation, identification, containment, information and convenience t encourage compliance with a course of therapy

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2
Q

The criteria for selecting a satisfactory packaging system for products are established by addressing this checklist.

A

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

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3
Q

What are the four categories of potential hazardous conditions that can compromise safety and quality of product?

A

Mechanical, climatic, biological, and chemical.

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4
Q

Shock, compression, vibration and puncture are all four potential hazards in what category?

A

Mechanical hazards

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5
Q

Moisture, temperature, light, atmospheric gas, pressure and solid airborne particulates are all what type of hazard?

A

Climatic hazard

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6
Q

What kind of changes can moisture cause?

A

Physical (softening and hardening of solid preparations) and chemical (hydrolysis, premature disintegration or dissolution)
Can also act as carrier for contaminants

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7
Q

What are temperatures effects on products?

A

High temperatures exert accelerated effects on chemical deterioration of a substance

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8
Q

What can carbon dioxide access lead to in some products?

A

Can lead to pH changes in liquid preparations

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9
Q

Microbiological contaminants, animal infestation and human pilferage are what kind of potential hazard?

A

Biological Hazards

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10
Q

What can be used to eliminate microbiological contaminants like bacteria, molds and yeast?

A

Preservatives in certain dosage forms as well as reasonably clean containers so sterility can be maintained

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11
Q

How does packaging relate to chemical hazards?

A

Interactions and incompatibilities between dosage components and packaging materials

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12
Q

This is regarded as a material of absolute barrier for pharmaceutical products and is a container of choice form many dosage forms.

A

Glass, can change its chemical composition to adjust its chemical behaviour and radiation protective properties.

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13
Q

What are the four types of classification in accordance to?

A

In accordance to the amount of alkali released from the glass when attacked by water.

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14
Q

Describe all four types of glass.

A

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.

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15
Q

Why is color incorporated into glass containers?

A

Generate additional protective effects and product identification
Amber glass provide resistance to light radiation, which is appropriate for photosensitive preparations

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16
Q

List the considerations for pre made glass containers?

A

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.

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17
Q

What are the four most economic plastic materials?

A

Polyethylene
Polyvinyl chloride
Polypropylene
Polystyrene

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18
Q

What are some additives incorporated into plastic formulas and why?

A

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

19
Q

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

A

Sorption

20
Q

This indicates the leaching of plastic components into the contents of the container and can result in container collapse, product discolouration and precipitation

A

Desorption

21
Q

What influences desorption so rate and extent?

A

Properties of preparation to be packaged, conditions of pH, temperature and storage

22
Q

Regarded to as the permeability of moisture, gas, and light through plastic material and can be a two-way phenomenon.

A

Permeation

23
Q

Photodegradation readily takes place due to what?

A

Special functional groups of the polymers. Additional protection methods must be employd, like adding pacifying agents, using aluminum foil or secondary light-resistant packaging.

24
Q

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.

A

Polymer modification

25
Q

What are the most commonly used metals in the pharmaceutical industry?

A

Aluminum and aluminum alloys

26
Q

How is chemical reactivity reduced in metals?

A

Special coatings applied to the interior surface of the metal containers.

27
Q

What is rubber normally used for?

A

To supplement parts in various packing containers not primary packaging material

28
Q

What is the majority of rubber usage associated with?

A

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

29
Q

What needs to be done to make rubber a appropriate material?

A

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.

30
Q

This is composed of cellulose obtained form vegetable fibres.

A

Paper and board

31
Q

What are paper-based materials normally used for in pharmaceutical packaging?

A

Secondary pharmaceutical packaging (labels, inserts, bags, trays and boxes)

32
Q

What are some advantages and disadvantages of paper and board?

A

Advantages: nontoxic, inexpensive, recyclable and printable
Disadvantages: mechanical durability, resistance to heat/fire, moisture penetration

33
Q

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.

A

Tamper-Resistant packaging

34
Q

What may a tamper resistant package involve?

A

An immediate system (container and closure) or a secondary system (carton or container) that provide visual indication of package integrity.

35
Q

Where do issues with tamper resistant products arise?

A

Geriatric patients who have difficulty in opening packages

36
Q

This special packing mechanism provides for packaging designed and constructed to be difficult for young children to open

A

Child-resistant packaging

37
Q

Pre-packed unit that provides one treatment cycle of the medication to both the pharmacist and the patient in ready-to-use packaging

A

Compliance packaging

38
Q

What are the two primary purposes of compliance packaging?

A

Facilitates healthcare professional to conduct patient education
Help patients remember taking medications correctly at home.
*used in chronic medications and for geriatrics

39
Q

Visual inspection of packaging surfaces is used for quality control. What are some special instruments used for QC as well?

A 
Spectrophotometery 
Chromatography
Thermal analysis
Gas transmission analysis
Leak detection
40
Q

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.

A

Multiple internal reflectance Spectrophotometry, relying on a beam of radiation

41
Q

This is useful in identifying and quantifying residues of leaked materials?

A

Chromatography

42
Q

This measures physical changes in a material as a function of temperature.

A

Thermal analysis, useful in QC of glass and plastic packing

43
Q

Can test folds, creases, seals, printing and closures with no pressure differentials for water vapor, CO and ethylene oxide

A

Gas transmission analysis

44
Q

What is the information that should be provided with packaging and/or labelling?

A

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

Biopharmaceutics 2 (7 decks)

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