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PHA223 > injection formulations > Flashcards

injection formulations Flashcards

1
Q

What is a parenteral liquid?

A

a sterile preparation of drugs for injection through one or more layers of the skin/mucous membrane

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2
Q

types of formulation for IV

A

solution
suspension
emulsion
powder for reconstitution (POR)

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3
Q

max volume given IV

A

20ml

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4
Q

types of formulation for IV infusion

A

solution
emulsion
POR

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5
Q

max volume given SC

A

1ml

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6
Q

Why is SC given slowly?

A

painful if quick

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7
Q

What does volume for IM depend on?

A

muscle mass of the patinet

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8
Q

max volume given IM

A

5ml

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9
Q

max volume given intradermal (ID)

A

0.2ml

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10
Q

What can be used as a bulking agent?

A

water for injection
water misicible organic solvents
oily vehicles
enhance solubilisation

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11
Q

What is water for injection?

A

free from microbial, pyrogen and particulate contamination

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12
Q

problems with water miscible organic solvents

A

irritation and toxicity

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13
Q

examples of water miscible organic solvents

A

alcohol
glycerin
peopylene glycol
liquid PEGs

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14
Q

What should oliy vehicles not contain?

A

mineral oils

-> not metabolised in the body

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15
Q

examples of oily vehicles

A

arachis oil

ethyl oleate

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16
Q

Why are oily vehicles given slowly?

A

can be painful

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17
Q

What reduces viscosity of oily vehicles?

A

warming the preparation before administration

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18
Q

problems with oily vehicles

A

depot effect

high consistency

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19
Q

What route are oily vehicles given?

A

IM

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20
Q

examples of surfactants used

A

Tween 80
Solutol HS15
Cremophor EL

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21
Q

What do buffers do?

A

adjust the pKa of drugs

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22
Q

What tonicity should solution for injections be?

A

isotonic - same osmotic pressure to tissue fluids

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23
Q

What is the freezing point depression of blood?

A

0.52 degrese celcius

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24
Q

What depresses the freezing point of solution?

A

the presence of solute in pure solvent

-> more concentrated, lower freezing point

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25
Q

What is freezing point depression proportionate to?

A

molar concentration of solute

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26
Q

NaCl that’s isotonic

A

0.9%

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27
Q

hypotonic solution into blood

A

cells swell and burst -> haemolysis

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28
Q

hypertonic solution into blood

A

cells shrink -> vein sclerosis (reversible)

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29
Q

tonicity of a small volume IV solution

A

slightly hypertonic

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30
Q

tonicity of an IV infusion

A

isotonic

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31
Q

tonicity of a intrathecal solution and why?

A

isotonic

-> can cause headache and vomiting otherwise

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32
Q

tonicity of an IM solution

A

isotonic or slightly hypertonic

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33
Q

tonicity of an ID solution and why?

A

isotonic -> to prevent skin irritation

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34
Q

tonicity of a subcutaneous injection

A

isotonic - less painful

can be mildly hypertonic/hypotonic

35
Q

What can be used to adjust tonicity of preparations?

A 
tonicity modifiers:
- sodium chloride
- glucose
- dextrose
- mannitol
buffers
antioxidants
36
Q

What pH prevents bacterial growth?

A

pH < 4

pH > 8

37
Q

pH for mould

A

it survives acidic pH

38
Q

What can happen if the pH is less than 3?

A

irritation
inflammation
pain
phlebitis

39
Q

What can happen in the pH is greater than 9?

A

necrosis

40
Q

pH for SC solution

A

pH 3-9

41
Q

What can happen if the pH is not correct for intrathecal (IT) solution?

A

aseptic meningitis

-> should be pH 7-7.6

42
Q

pH for small volume IV and IM

A

pH 2-12

  • > wider range
  • > large buffer capacity of blood
43
Q

pH for SC solution

A

pH 3-9

44
Q

What is added to adjust pH?

A

acid - HCl

bases - NaOH

45
Q

examples of preservatives

A

benzyl alcohol
thimerosal
parabens

46
Q

What are antioxidants and examples?

A

oxygen radical scanvegers

  • alpha tocopherol
  • BHT
47
Q

What do chelating agents do and examples?

A

inactivate metal ions oxidation by complexation

  • EDTA
  • sodium diedetate
48
Q

larger drug crystals in parenteral solution

A

longer to depot effect

more painful

49
Q

Ideal drug particle diameter for parenteral solutions

A

5-10 micrometers

50
Q

How to prevent needle blockade?

A

isodiametric shape for drug particles

-> roughly spherical

51
Q

How to promote particle wettability/dispersion

A

non-ionic surfactants

52
Q

3 ways to prevent agglomeration and caking

A
  1. control flocculation - partially deflocculated
  2. adjust sedimentation rate
  3. optimise consistency
53
Q

droplet size for parenteral emulsion and why they’re this size

A
  1. 5 - 1 micrometer
    - > to minic chylomicra, the natrual fat transporter
    - > larger size > 3 micrometers can cause thrombosis
54
Q

problems with emulsion stability

A

coalescence on storage (need non-toxic emulsifying agents - lecithin, Tween 80)

55
Q

small volume containers for single dose

A

container not resealable on opening
no preservatives
volume in excess of indicated vol to allow correct volume to be withdrawan with syringe

56
Q

examples of single dose containers

A

pre-filled syringe
cartridges
fusion-sealed ampoules

57
Q

multi-dose container/vials

A

container fixed with rubber closure
aluminium sealed and plastic capped
allow needle penetration
need preservative

58
Q

examples of large volume containers

A

glass bottle

PVC collapsible bag and polyethene container

59
Q

2 materials that are used for containers

A

glass

plastic

60
Q

How are glass containers packaged?

A

heat sealing

packed under vacuum

61
Q

type 1 glass

A

borasilicate with low leachability

  • autoclavable
  • can withstand high pH
62
Q

type 2 glass

A

made from soda-lime
leachable
resistant to acid and water

63
Q

type 3 glass

A

soda-lime
leachable
- commonly used for powder preparations

64
Q

How are plastic containers made?

A

blow-fill seal procedure

not packaged under vacuum

65
Q

examples of plastic containers

A

PVC
polyethylele
polyolefin

66
Q

problems with plastic containers

A

adsorption to container wall

leaching of plasticiser into content

67
Q

What is the sterilisation process?

A

killing and removal of microbes

68
Q

2 types of sterilisation

A

terminally and non-terminally sterilisation (aseptic filling)

69
Q

When is dry heat sterilisation used?

A

if the melting point of the solute is over 200 degrese celcius

70
Q

What sterilisation is used for heat labile powders?

A 
ethylene oxide (EO)
ionisation radiation (IR)
71
Q

sterilisation for oily vehicles

A

dry heat (DH)

72
Q

sterilisation for aqueous and thermolabile liquid

A

autoclave

73
Q

sterilisation for aqueous but thermolabile liquid

A

filtration with cellulose nitrate or polycarbonate membrane
cutoff of 0.22 um diameter for microbial
5um for paticulate (large particles)

74
Q

What does an anchor paddle do in the mixing process?

A

minimises sticking of material to container walls

75
Q

mixing speeds

A

1-20 rps

76
Q

2 flow patterns in mixing

A
  1. axial - propeller (liquid flows in 1 direction)

2. raidal - gear plate (more turbulence)

77
Q

What can vortex formation in mixing do?

A

suck in air during mixing

78
Q

How to avoid votrex formation during mixing?

A

verticle baffles put around container wall of mixing vessel

  • > alters flow pattern
  • > reduces vortex formation
79
Q

What is clarification?

A

removal of solid from liquid ….?????

80
Q

2 types of filters used in clarification

A

pressure filter

cartridge filter

81
Q

What does a presure filter so?

A

calrifies viscous liquids

eg. concentrating prtein formulations

82
Q

What does a cartdige filter do?

A

removes low level of contaminant before bottling

83
Q

3 ways to prepare isotonic solutions

A
  1. use tabulated freezing point depression (triangle Tf)
  2. determine freezing point depression of drug/excipient
  3. calculate NaCl equivalent (E) using L iso value
84
Q

calculation: how to preparean isotonic colution using tabulated freezing point depression values

A
  • find the freezing point depression value for the required solution (% of the given value)
  • compared to blood and NaCl: 0.52% at 0.9%, the % you have and x
  • > find x
  • x = the % of NaCl required to give an isotonic solution

PHA223 (43 decks)

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