Extemporaneous Dispensing 3 Flashcards

1
Q

Commonly encountered products

A

• Solutions

– Homogenous liquid preparations containing one or more dissolved substances

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2
Q

Considerations for solutions

A
• Solubility of solid constituents
– Reference sources?
• Solvent to be used
• Temperature
• pH
– Affects stability of final product
• Preservative?
• Flavourings
• Colourings
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3
Q

Solutions – standard method

A
  1. Weigh out and measure all ingredients using appropriate equipment
  2. Calculate the minimum volume of solvent
    necessary to dissolve the least soluble ingredient and put roughly this amount of solvent in a flat bottomed beaker
  3. Add the soluble ingredients in ascending order of
    solubility (i.e. least soluble ingredient first, most soluble last) and stir until dissolved
  4. Transfer the solution to an appropriate conical measure
  5. Rinse the beaker with more of the solvent and add the rinsings to the conical measure
  6. Add any flavourings (usually aromatic products such as peppermint emulsion)
  7. Make up to the final volume with solvent and stir
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4
Q

Supsensions

A

• Preparations where one (or more) of the active constituents is suspended in the disperse phase

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5
Q

Considerations for suspensions

A
• Solubility of solid constituents
– Reference sources?
• Solvent to be used
• Temperature
• pH
– Affects stability of final product
• Preservative?
• Flavourings
• Suspending agent
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6
Q

Suspending agents

A
• Tragacanth BP
– Usually 0.2% w/v for suspensions
• Compound Tragacanth Powder BP
– Acacia BP 20%, Tragacanth BP 15%, Starch BP 20%, Sucrose BP 45%
– Too sticky for external products
– Usually 2% w/v for suspensions
• Xanthan gum
– Very soluble in cold water
– Can be used up to 2% w/v
• Methylcellulose
– Semi-synthetic polysaccharide
– Can be used between 0.5% to 2% w/v
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7
Q

Other suspending agents

A
  • Acacia gum
  • Guar gum
  • Sodium alginate
  • Starch
  • Hydroxymethylcellulose
  • Sodium carboxymethylcellulose
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8
Q

Suspensions – standard method

A
  1. Weigh out and measure all ingredients using
    appropriate equipment
  2. Calculate the minimum volume of solvent necessary to dissolve any soluble ingredients and put roughly this amount of solvent in a flat bottomed beaker
  3. Add the soluble ingredients in ascending order of
    solubility (i.e. least soluble ingredient first, most soluble last) and stir until dissolved
  4. Mix any insoluble ingredients with a pestle and mortar using the doubling up method
  5. Add a small amount of the solution prepared in steps 1 to 3 to the mortar
  6. Mix to form a smooth paste using the pestle
  7. Continue adding small quantities of the solvent until a pourable consistency is achieved
  8. Transfer the contents of the mortar to a conical measure of a suitable size
  9. Rinse the mortar with more solvent and add the rinsings to the conical measure
  10. Add any flavourings (usually aromatic products such as peppermint emulsion)
  11. Make up to the final volume with solvent and stir
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9
Q

Expiry dates – solutions and suspensions

A
BP 2005 recommendations
• ‘Freshly prepared’
– ‘must be made not more than 24 hours before it is issued for use’
– No preservative
– Two week expiry
• ‘Recently prepared’
– ‘deterioration is likely if the preparation is stored for longer than about 4 weeks at 15oC to 25oC
– Preservative
– Four week expiry
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10
Q

Creams and Ointments

A
  • Incorporation of solids (usually insoluble) into base
  • Incorporation of liquids into base
  • Dilution of concentrated product with suitable base
  • Very rare that bases have to be made from scratch
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11
Q

• Trituration

A

– Incorporation of finely divided insoluble powders or liquids into a base

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12
Q

Levigation

A

– Incorporation of coarse insoluble powders into base

– “Wet grinding”

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13
Q

• Fusion

A

– Melting of bases before addition of other ingredients
– Need to know melting points of ingredients
– Start with highest melting point and then cool

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14
Q

Creams / Ointments standard method For fine powders:

A
  • Weigh all ingredients using an appropriate balance
  • Place powder in centre of glass ointment slab
  • Using the doubling up technique incorporate into the base, avoiding air pockets
  • Spread thinly on the tile to check for even mixing
  • Pack into an appropriate sized ointment jar and weigh
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15
Q

Creams / Ointments standard method

For coarse powders

A
  • Weigh all ingredients using an appropriate balance
  • Place powder in centre of glass ointment slab
  • Using a small amount of the base, grind the powder until a fine paste is achieved
  • Spread thinly on the tile to check for lumps
  • Once a fine paste is achieved, incorporate into the remaining base using the doubling up technique avoiding air pockets
  • Spread thinly on the tile to check for even mixing
  • Pack into an appropriate sized ointment jar and weigh
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16
Q

Creams / Ointments dilutions –

standard method

A

• Weigh all ingredients using an appropriate balance
• Place the product to be diluted in centre of glass ointment slab
• Using the doubling up technique incorporate into the
base, avoiding air pockets
• Spread thinly on the tile to check for even mixing
• Pack into an appropriate sized ointment jar and weigh

17
Q

Expiry for creams and ointments

A

• The standard expiry date is 3 months from the
date of manufacture.
– This is because the cream/ointment bases contain
preservatives in their formulae.
– The exception to this is for diluted creams (not
ointments) where the expiry date becomes one month from the date of manufacture.
– This is because creams are generally diluted with
aqueous cream and the extra aqueous environment is
more susceptible to bacterial growth

18
Q

Licensed Products - label requirements

A
  • Name of the patient
  • Name and address of the pharmacy
  • Date of dispensing
  • Name of the product (or common name) inc strength and formulation if required
  • Directions for use
  • Cautionary and advisory labels
  • Precautions for use
  • KOOROSOC

• Expiry date
– ‘Use before….’ (Add a specific date DD/MM/YYYY)
– ‘Do not use after….’ (Add a specific date DD/MM/YYYY)
• Storage conditions
– ‘Protect from light’
– ‘Store in a fridge
• There are some common warning labels that may need to be included:
– ‘Not to be taken’,
– ‘Do not swallow’
• For anything that should not be swallowed
– ‘For external use only’
– ‘For rectal use only’
– ‘Shake the bottle’

19
Q

Unlicensed Products label requirements

A

• All of the above AND
• the quantitative particulars of the product must also be on the label.
– This can be expressed as a % or the quantities used.