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Pharmacy Year 2 > Stability and packaging > Flashcards

Stability and packaging Flashcards

1
Q

State the main types of chemical instability

A

Photodegration
Oxidation
Isomerisation/polymerisation
Hydrolysis
Formation of adduct and complexes
Polymorphic changes
Temperature

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2
Q

What is stability?

A

“Stability of a pharmaceutical product is a relative concept that is dependant on the inherent stability if the active substance, excipients and dosage form, plus the protectiveness of the container closure system and the recommended storage conditions.” Pharmaceutics 5th edition (Aulton & Taylor)

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3
Q

What issues are linked with stability?

A

Issues linked to:
The API.
The excipients.
The processing to make a medicine.
The packaging.
The storage conditions.

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4
Q

What are the main types of physical instability?

A

Appearance
precipitation/ particle size
Rheology
Water content
pH
SDF - tablet strength and dissolution
Suspension - redispersibility/resuspension

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5
Q

Other than physical and chemical instabilities what other instabilities are there?

A

Packaging related - adsorption, absorption, leaching

Microbiological

Incorrect storage of use

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6
Q

What are processing instabilities for SDFs only?

A

Oxidation

movement of particles in mixing.

movement of particles in granulation

Hydrolysis

use of aqueous granulating solution and extensive mixing

Relative Humidity of the air.

Thermal Instabilities

Drying of granulation

Generation of heat in compression

Use of heat in the coating process

Melting of suppository components

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7
Q

How can you avoid instabilities for SDFs?

A

IDENTIFY CAUSE

Air (oxidation)
Water (hydrolysis)
Thermal degradation
Light degradation

REMOVE CAUSE
Use nitrogen blanket over process
Avoid granulation
Remove the need for using heat
Determine problematic wavelengths and use special light fitting without the offending wavelength.

REDUCE EFFECT

Add anti-oxidants to formulation
Reduce water content in granulating solution
Dehumidify the environment
Use lower temperatures (non-aqueous granulation).
Minimise the length of time the materials are handled in the presence of light.

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8
Q

How do you overcome chemical instabilities for hydrolysis with liquid and semi-solid dosage forms?

A

form a complex
drug with appropriate solubility, but with enhanced stability.

Modify chemical structure
attach appropriate substituent groups to improve stability. Must ensure therapeutic effect is not affected.

Solubilise drug within molecules
Make an emulsion

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9
Q

How do you overcome chemical instabilities for oxidation with liquid and semi-solid dosage forms?

A

Removal of oxygen by
Using well filled containers.
Boiling water immediately before use.
Use of inert gases to displace air above the product.

protection from light
Energy from light can be used to power the oxidation process.
Packaging methods are used to protect from light.
Wraparound labels
Cartons
Opaque containers
Light resistant containers.
UV resistant films on clear glass containers.

pH control
oxidation produces hydrogen ions.
An acidic pH will help prevent oxidation
(pH 3 – 4).

Solubilisation

oxygen is less soluble in a oily component than in an aqueous.
So dissolving the drug in an oil to produce an emulsion will protect it from oxidation.

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10
Q

How do you overcome chemical instabilities for microbial spoilage with liquid and semi-solid dosage forms?

A

Include preservatives to prevent growth once product is in use.
Manufacture in a suitable environment.
Parabens and phenoxyethanol.

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11
Q

What are some packaging instabilities?

A

The drug is not sufficiently protected by the packaging.
Resistant to the ingress of air or moisture.
Sufficiently opaque for a photosensitive product.
Not sufficiently robust to prevent physical damage.

The packaging has materials which could leach out into the product.
Tends to be a problem with liquid products.
Contents of liquid filled capsules could interact with the gelatine.
Suppositories made using fatty bases could absorb components from the plastic packaging.

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12
Q

How is stability testing tested?

A

Performulation Studies
Stress testing (short time, high temps, high humidity) drug only. Looking for likely drug degradation pathways.

Binary Mixes
1:1 ratio of drug and excipients.
Tested at high temp or using DSC.
Can have tertiary mixtures.

Formulation and container development
Multiple times on various formulation.
Actual storage conditions, time and testing regime dependant on formulation

Post-authorisation studies
To support licencing applications (at least 3 batches, at least 1/10th of full scale, both actual time and accelerated conditions).
Also GMP studies ongoing for a proportional number of batches of product throughout full shelf-life.

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13
Q

What are the reasons for packaging?

A

Product identity
Protect product
patient compliance
Presentation of information
Tamper protection and child resistance
Patient loyalty

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14
Q

What primary packs are available for liquids?

A

Glass
Good protection from moisture if hermetically sealed.
Clear or amber glass - light protection afforded when using amber glass.
Round, classic metric bottle or fluted.
Three main types of glass. (type I, II or III)

Aluminium bottles
same moisture protection as glass, better light protection.
Internal surface must be lacquered to prevent interactions.
Not common in UK – more often in US.

Plastics
polyethylene terephtalate (PET), polyvinyl chloride (PVC), polypropylene, polyethylene, polyethers and their derivatives.
Opaque plastic bottles provide some light protection, but not as good as amber glass or metal containers.
Moisture protection dependant on polymer used.

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15
Q

What primary packs have you got for semi-solids?

A

Glass - jars only
only used when materials would react with plastics or as a marketing tool in cosmetics.
Used for dispensing of extemp preparations.

Plastic - both jars and tubes
As on previous slide.
Extensive testing required to ensure no incompatibilities are present.

Metal - both jars and tubes
Extruded aluminium used.
Lacquered internal surface

Plastic and aluminium composites - most common

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16
Q

What are the additional requirements for bottles?

A

Cap standard screw cap, ratchet style (child resistant) or tamper-evident (tear-off section or break-seal type).

Foil - tamper-evident seal

SHrink sleeve - tamper-evident

Ullage take up - (inserts to take up additional space in bottles).

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17
Q

What sealing methods are there?

A

Bottles and jars – screw caps or push on lids.
May have tamper evident seals attached to the neck (paper with plastic and foil).
Tubes have a number of closing options.
Aluminium tubes – single fold, double fold or saddle back fold.
Plastic and composite (metal & plastic) – heat sealed

Ampoules are heat sealed and vials have rubber seals with aluminium safety caps

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18
Q

What are some liquid and semi-solid filling methods?

A

Volumetric filling – adjustable cylindrical pumps or fixed measuring cylinders

Level filling – filling through a tube with another at the required level removing excess.

Weigh filling – container on a balance, tared then filled to the correct weight.

19
Q

Plastic single piece packs - blow fill seal technology used for? adv?

A

Used for parentals

Specialised and expensive

Not suitable for heat
sensitive products.

20
Q

What are primary packs and how are they sealed?

A

Pressed base with
heat sealed lidding foil.
Tablet clearance (variations in tablet/capsule thickness).
Sloping sides (for mould release).
Perforations (for unit dose use).
Space to ensure seal integrity and provide area for data to be printed.

Lidding materials
Applied by heat and pressure.
Can print variable data onto lidding foil (batch number and expiry date etc).
Sealing pattern required to ensure a complete seal is formed – either diamond or single point indentations

21
Q

How are blister packs manufactured?

A

Either produced by heat and pressure (to top surface) or vacuum (to bottom surface) - Thermoformed.

Blister pockets are created by stretching of packaging material and this results in walls and base being thinner than the unstretched material.

OR

Simply by the use of pressure to the top surface – Mechanically formed.

Coated films are prone to cracking under stress, therefore steep sided pockets cannot be formed. All pockets have a 45° angle from vertical.
Therefore pockets and blister strips are significantly larger than with thermoformed blister packs.

21
Q

How are blister packs manufactured?

A

Either produced by heat and pressure (to top surface) or vacuum (to bottom surface) - Thermoformed.

Blister pockets are created by stretching of packaging material and this results in walls and base being thinner than the unstretched material.

OR

Simply by the use of pressure to the top surface – Mechanically formed.

Coated films are prone to cracking under stress, therefore steep sided pockets cannot be formed. All pockets have a 45° angle from vertical.
Therefore pockets and blister strips are significantly larger than with thermoformed blister packs.

22
Q

How are blister packs filled?

A

Pick & place systems – suction pads or mechanical grippers pick up product and place it into the pockets of the blisters.

Guided filling – product guided down tubes and filled into pockets of blisters as they pass beneath.

Random filling – products are brushed from hopper into formed blisters which are passing beneath.

23
Q

What types of labelling do you get?

A

Partial wraparound – only part of the total distance around the container is covered

Total wraparound – label covers the whole distance around the container and there is usually a small overlap (improves adhesion). Used when space is limited and also helps with light protection

Panel labelling – for large containers where space is not an issue.

Security labelling – tamper-evident seals. Holographic images are used to make counterfeiting more difficult. These are the taped-security labels on the ends of cartons

24
Q

How do you label?

A

Applied dependant on type of pack:

Variable data printed using hot foil, ink jet or laser printers

Roll on type – rotation of bottle / container pulls label and it is then rolled or swept onto the container (round containers only).

Pick & place – suction arm picks up label and transfers it to flat surface of container using a blast of air (flat faced containers only).

25
Q

What are secondary containers?

A

OUTER CARTONS - blisters, strip packs and bottles are generally packed into an outer carton.

CARTON ALSO CONTAINS PIL - patient information leaflet

CARTON PROVIDES - physical stability during transport of packs to location of sale or supply.
space for patient information.
convenient means of transferring primary container from seller to customer.

26
Q

WHat is the quality assessment?

A

Ensure what is stated on the label is what is in the container.

Corrrect quantity

Damage to the container

Sterile products other considerations.
Sterility.
Particulates

Bottles
cap torque testing.
Seal is appropriate.

Whole packaging operation closely monitored therefore little specific quality testing on final product.

27
Q

What are strip packs?

A

Films are composed of paper, aluminium base foil and plastic laminates
Choice of material or combination is dependant on level of moisture protection required.
Product sandwiched between two layers of film – product creates pockets.

28
Q

Problems with blister packs?

A

Banana shaping –
Longitudinal or transverse distortion occurring as a result of difference in expansion co-efficients of forming and lidding materials.

Overcome by addition of straightening ribs.

29
Q

What is integrity testing involve?

A

Start of run – empty blisters tested.
Placed into a container filled with coloured liquid.
Pressure applied for set time.
Check if any liquid in pockets.
Can also do with vacuum and visually check for bubbles escaping during test period.
Repeated at set periods during filling process with product filled blisters

30
Q
  1. State four reasons why packaging of medicines is required.
A
31
Q
  1. Explain the terms ‘primary pack’ and ‘secondary pack’ in terms of the purpose and composition.
A
32
Q
  1. State the main options available for the packaging of medicines.
A
33
Q
  1. Briefly describe the advantages and disadvantages of at least two of the packaging options described above.
A
34
Q
  1. State the purpose of paper in the primary packaging of medicines.
A
35
Q
  1. Explain the types of physical instability seen in solid dosage forms on storage.
A
36
Q
  1. Briefly describe the process of blister pack integrity testing and state why this type of test is carried out.
A
37
Q
  1. Briefly describe the application of wraparound or rotary labelling.
A
38
Q
  1. State the four types of glass available for use in the packaging of medicines. Explain their specific uses and the main types of interactions which can occur during their use.
A
  1. Explain the following types of instability within medicines:
    a. Hydrolysis.
    b. Oxidation.
    c. Dimerisation & polymerisation.
    d. Isomeric change.
    e. Photodegradation.
    f. Chemical incompatibility.
39
Q
  1. Explain how each of the following parameters affect the stability of medicines and how these effects may be minimised:
    a. Temperature.
    b. Solvents.
    c. Acid and base catalysis.
    d. Ionic strength.
    e. Light.
    f. Oxygen.
A
40
Q
  1. Explain the difference between ‘adsorption’ and ‘absorption’.
A
41
Q
  1. State why it is important to exclude microorganisms from medicines.
A
42
Q
  1. State the main requirements of an anti-microbial preservative.
A
43
Q
  1. Explain the formulation and packaging factors which affect the effectiveness of antimicrobial preservatives within medicines.
A

Pharmacy Year 2 (33 decks)

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