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PH2107 Formulation Science 1 > Practical > Flashcards

Practical Flashcards

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1
Q

Potable water meaning

A

Tap water - taken from mains supply and suitable for drinking

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2
Q

What is potable water suitable for?

A

Internal and external preparations

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3
Q

What is potable water not suitable for?

A
  • injectable preparations
  • ophthalmic preparations (for eyes)
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4
Q

What is purified water?

A

Distilled potable water

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5
Q

When would purified water be used instead of potable?

A
  • when mains water comes from storage tank
  • if mains water unsuitable for formulation
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6
Q

What is purified water used for?

A

Internal and external preparations including ophthalmic preps

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7
Q

Which kind of water is PREFERRED for external preparations?

A

Purified

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8
Q

For what reasons might the means water be unsuitable for a preparation?

A
  • water contains high levels of dissolved or undissolved solids
  • water has high or low pH
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9
Q

What must be done with purified water before use?

A

Freshly boiled and cooled

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10
Q

Why must purified water be boiled and cooled before use?

A

Likely to be contaminated with microorganisms

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11
Q

What sort of water must be used for injectable medicines?

A

Water for injections BP

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12
Q

When preparing a liquid formulation, what must be the first step?

A

Establish the solubility of the ingredients in the diluent(s)

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13
Q

For what two reasons is it necessary to make a small extra amount of product?

A
  • as an ‘excess’ to allow for losses in production
  • as an ‘overage’ i.e. to ensure the entire dose can be withdraw from a single-dose container and administered to the patient
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14
Q

For sorts of formulation would an ‘excess’ be necessary?

What percent more more product is recommended?

A

Creams, ointments, suppositories

30-50%

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15
Q

For what sort of formulations would an ‘overage’ be necessary?

What % more product is recommended?

A

Injections

10%

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16
Q

Why are preservatives included in formulations?

A
  • to protect against microbial growth
  • to extend shelf lives
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17
Q

Why is it better not to include preservatives in oral medicines for children?

A

Preservatives have been known to cause adverse effects

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18
Q

What does BP stand for?

A

British Pharmacopoeia

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19
Q

When was chloroform removed from the BP?

A

2016

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20
Q

What are preservative-free products at a greater risk for?

A

Microbial growth

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21
Q

How can the risk of microbial growth in preservative-free products be reduced?

A
  • single-use containers
  • sterilisation
  • shorter shelf lives
  • refrigerated storage
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22
Q

A product designated by the BP as being ‘freshly prepared’ is usually prepared assigned how long of a shelf life?

A

14 days

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23
Q

A product designated by the BP as being ‘recently prepared’ is assigned how long of a shelf life?

A

28 days

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24
Q

A product’s expiry date cannot be later than the what?

A

The expiry date of the ingredients

25
Q

How do you decide an appropriate expiry date for a product if no shelf life is available from a monograph?

A

Base it on the products’ stability and risk of microbial contamination

26
Q

What is the most common shelf life given to extemporaneously produced solutions, suspensions and emulsions?

A

14 days or 7 if preservative-free

27
Q

Products containing what can be classed as ‘self-sterilising’?

A
  • > 15% alcohol
  • > 85% syrup
  • high conc of sugar plus polyol
28
Q

How o you assign an expiry to a self-sterilising product?

A

As if a preservative is present

29
Q

What is the common shelf life of semi-solids e.g. ointments and creams?

A

7-14 days

30
Q

What is the common shelf life of solids e.g. suppositories?

A

28 days if no water present

31
Q

What is the BP?

A

Reference source for the quality control of medicines in the UK

32
Q

What two pharmacopoeia’s have legal status in the UK?

A
  • British
  • European (PhEur)
33
Q

What is Martindale: The Complete Drug Reference used for?

A

Detailed info on nomenclature, physical and pharmaceutical properties, adverse effects, use of drugs, etc etc

34
Q

What is Article 65?

A

Lists all excipients that could have an effect on the patient

(Must always be listed on a medicine’s label if present or at above listed ‘threshold’ concentration)

35
Q

What are the electronic balances capable of weighing in the lab?

A

Between 100mg and 200g

36
Q

What are the electronic balances capable of weighing in the lab?

A

Between 100mg and 200g

37
Q

If a quantity of less than 100mg is required what is needed?

A

A dilution or titration

38
Q

What are the required characteristics to measure out a weight of excipient of less than 100mg?

A
  • minimum of 100mg
  • multiple of 10
39
Q

If we need 30mg of an excipient, how much might you weigh out?

A

120mg because
- over 100g
- multiple of 30

40
Q

How do you decide how much diluent to use?

A

Consider

  1. The multiplication factor e.g. for 30mg it was 30mg x 4 for 120mg so try to use a volume divisible by 4
  2. The volume available in the final product
    E.g. working formula: drug to 30mg, syrup 25ml, water to 50ml (here the volume of drug-containing vehicle must be 25ml or less bc 50-25)
  3. Solubility of drug (see martindale or BP)
    (Easier to select volume of diluent that will allow drug to dissolve)
41
Q

Why must a measure be clean and dry before measuring liquid?

A

Greasy measures will give a flattened, inaccurate meniscus

42
Q

Why must a bottle of liquid be shaken?

A

To ensure we obtain a homogenous mixture

43
Q

Solutions should not be made in a measure unless you are certain of what?

A

That the solid will dissolve in the available amount of solvent, as it may require heating and solute may be lost when transferring to suitable container

44
Q

Many excipients have more than one use. what factors can help decide why an excipient has been included?

A
  • type of product being made
  • concentration of excipient
45
Q

What is one advantage of using natural products in a formulation?

A

Usually cheaper than synthetic products

46
Q

What are the disadvantages to using natural products in a formulation?

A
  1. Can suffer from batch-batch variation more than synthetics, semi-synthetics
  2. More of a risk for spore and/or microbial contamination
47
Q

How can the risk of microbial contamination be accounted for when using natural products in formulations?

A
  • use for short shelf-life products
  • use antimicrobial preservative
48
Q

What are some examples of polysaccharides used as viscosity modifiers?

A
  • tragacanth
  • alginates
  • acacia gum
  • starch
  • xanthan gum (Keltrol)
49
Q

What can polysaccharide viscosity modifiers be used to form?

A
  • viscous, thixotropic, pseudoplastic preparations
  • internal or external preparations (though sometimes too sticky for external)
50
Q

What are some disadvantages to polysaccharides as viscosity modifiers?

A
  • quite narrow pH stability ranges
  • used mainly for short shelf-life products as usually natural
51
Q

Why are acacia and starch often used in combo with tragacanth?

A

They do not give very viscous systems alone

52
Q

What are some examples of water-soluble celluloses as viscosity modifiers?

A
  • sodium carboxymethylcellulose
  • methyl cellulose
  • hydroxyethylcellulose
  • microcrystalline cellulose
53
Q

What are some characteristics of water-soluble celluloses as viscosity modifiers?

A
  • semi-synthetic polysaccharides with varying chain lengths
    LONGER chain lengths = INCREASED viscosity
  • stable over wide pH ranges
  • some are non-ionic so suitable for use with ionic additives
54
Q

What are some examples of hydrated silica’s ad viscosity modifiers?

A
  • bentonite
  • hectorite
  • magnesium aluminium silicate AKA Veegum
55
Q

What are some advantages to hydrated silicas as viscosity modifiers?

A
  • natural products therefore relatively cheap
  • can be used for internal and external meds
  • readily absorb up to 12 times their own mass of water, forming thixotropic gels
56
Q

What are two other commonly used viscosity modifiers?

A
  1. Carboxypolymethylene
  2. Colloidal silicon dioxide
57
Q

What are some characteristics/considerations of carboxypolymethylene as a viscosity modifier?

A
  • synthetic
  • usually used externally
  • forms very high viscosity product between pH 6 and 11 only
58
Q

What are some characteristics/considerations of colloidal silicon dioxide as a viscosity modifier?

A
  • aggregates in water to form a 3D product
  • can be used in non-aqueous suspensions
59
Q

What are some characteristics/considerations of colloidal silicon dioxide as a viscosity modifier?

A
  • aggregates in water to form a 3D product
  • can be used in non-aqueous suspensions

PH2107 Formulation Science 1 (2 decks)

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