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PY349 > Product Preservation 1 > Flashcards

Product Preservation 1 Flashcards

1
Q

Pharmaceutical products must be stable and meet GMP requirements for quality, safety, efficacy and be acceptable to patients. What does GMP stand for?

A

Good manufacturing practices

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2
Q

The activities of contaminating organisms in a product can…

A
  • lead to product spoilage, rendering the product unfit for use, and undermining its efficacy.
    It can also cause a health hazard to patients and users of the product.
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3
Q

Is a spoilage organism more dangerous in a food or medicine?

A

Medicine!

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4
Q

What are preservatives used and not used for?

A
  • Used to prevent possible contamination during storage, limit growth of contaminants and prevent spoilage.
  • Should NOT be used to deal with contamination/ spoilage from heavily contaminated raw materials or poor manufacturing process
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5
Q

Contamination is defined as

A

the introduction of organisms into or onto a product

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6
Q

Does contamination always lead to spoilage?

A

NO

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7
Q

What are 4 sources of contamination?

A
  • raw materials
  • manufacturing sources
  • environment
  • in-use (storage and use)
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8
Q

Raw material contamination examples?

A

Water

Excipient and active ingredients (especially natural)

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9
Q

What is RAW water contaminated with and what should it be free from?

A
  • typically water borne bacteria (genera)
  • other MOs may be present
  • SHOULD BE FREE FROM faecal coliforms e.g. E.coli
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10
Q

How can you achieve purified water? What processes?

A
  • reverse osmosis
  • distillation
  • ion exchange
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11
Q

After production of purified water, what is it treated by?

A

Filtration or UV light

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12
Q

What organism grows on purified water?

A

Pseudomonas aeruginosa

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13
Q

How is purified water STERILISED?

A

Autoclave

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14
Q

In order to prevent bacteria multiplying and increasing the endotoxin load, what temperature is water stored at? (for sterile medicines?)

A

> 80 degrees

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15
Q

Spore forming organisms are common on mined minerals and ___ materials of ______ origin

A

raw

plant

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16
Q

Environmental contamination may come from?

A
  • Air

- Personnel

17
Q

What are sources of human contamination? (From what body part?) and give examples of the bacteria that colonise there.

A

Skin scales

  • Staphylococcus aureus and other staphylococci
  • Pseudomonas aeruginosa
  • Streptococcus pyogenes
  • Micrococci

Saliva

  • Streptococci
  • Bacteroides spp

Gut bacteria

  • Faecal coliforms (e.g. Escherichia coli)
  • Bacteroides spp
18
Q

On manufacturing sources; equipment, how is a bacterial biofilm formed?

A
  1. adhesion of proteins to surface, initial reversible attachment of bacteria to surface
  2. irreversible attachment of bacteria and formation of micro-colonies
  3. Production of exopolysaccharide matrix and recruitment of other species.
  4. Consolidation of multispecies biofilm
  5. sloughing of outer layers
19
Q

Examples of contamination while in use?

A
  • During storage

- In use by patient, consumer, nurse or doctor

20
Q

What are some other factors affect the risk of contamination and spoilage?

A
  • type and size of microbial inoculum
  • storage and temperature
  • packing design
  • nutritional factors, moisture content and water activity
  • duration of use/ storage of product
21
Q

Consequences of contamination… how can you tell it is contaminated?

A
  • visible growth (e.g. fungal colonies, turbidity, colour change)
  • organoleptic properties (smell/ taste weird, tactile effects; grittiness)
  • loss of active ingredient/ excipients
22
Q

What are some toxic effects/ health hazards? What is it caused by and what can it cause?

A
  • Production of toxins: LPS, exotoxins, myotoxins

- can cause infection in patients.

23
Q

LPS is inactive through the _____ route but serious effects if enter the bloodstream through infusions or ______; can induce septic and fatal febrile shock

A

oral

injections

24
Q

In hospitals contamination of ____ dose products can serve as vehicles for spread of disease

A

multi

25
Q

What are some strategies for preserving products?

A
  • pH manipulation
  • water activity manipulation
  • low temp storage
  • use of preservatives
26
Q

pH can be manipulated to ______ to reduce risk of spoilage. Useful for ___ and some domestic products but less useful for ______.

A

more than 8
foods
pharmaceuticals

27
Q

Aw: a parameter that describes the amount of free water in a solution (water activity). Therefore, the ______ the Aw , the better

A

lower

28
Q

No organisms are expected to growth at an AW of ____ or below. These products may not need addition of preservatives

A

0.5

29
Q

Problems with modulation of Aw for preservation (“dry” products)

A
  • To use Aw for preservation, the Aw must be maintained throughout the life of the product
  • Difficult to predict changes in Aw during storage
  • Many dry products are ‘hygroscopic’ and absorb water
  • Water may condense on the surface of dry products during storage e.g. steamy bathroom
30
Q

How can you overcome the problem of Aw stability with hygroscopic drugs?

A
  • Add film coat to limit water reuptake

- package in foil strips to prevent uptake of moisture (most expensive but more effective)

31
Q

Problem with Aw reduction in relevance to efficacy of preservatives?

A

May reduce efficacy of preservatives e.g phenol and paraben

32
Q

What are some commonly used esters?

A
  • Acids and Esters e.g. sorbic acid; pH
33
Q

Properties of ideal preservative

A
  • broad spectrum of antimicrobial activity
  • rapid antimicrobial action/ rate of kill
  • chemically stable and effective at all pH conditions
  • compatible with excipients and packaging materials
  • cheap and safe

PY349 (20 decks)

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