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Pharmaceutics Year 2 > Section 7 - Parenterals 2 > Flashcards

Section 7 - Parenterals 2 Flashcards

1
Q

What are large volume parenterals packaged in?

A

Glass or plastic

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2
Q

Are large volume parenterals preserved?

A

Never

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3
Q

What are large volume parenterals primarily used for?

A

Volume and electrolyte replacement by IV route

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4
Q

What is the volume of large volume parenterals for IV solutions?

A

100-1000 mL

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5
Q

What is the normal daily intake of water for adults?

A

50 mL/kg

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6
Q

What are the most common components in fluid replacement?

A

Sodium chloride and dextrose

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7
Q

What is an example of a hypotonic, isotonic, and hypertonic fluid replacement?

A
  • Hypotonic = 0.45% sodium chloride
  • Isotonic = 0.9% sodium chloride
  • Hypertonic = D10W
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8
Q

How are electrolyte solutions available?

A

In concentrates, which must be diluted and added to large volume parenterals

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9
Q

What are electrolyte solutions used for?

A
  • Electrolyte deficiency

- Restore pH balance

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10
Q

Why is sodium lactate used for acidosis?

A

Lactic acid is used in the Kreb’s cycle, which produces CO2, which turns into carbonate to help w/ acidosis

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11
Q

What are 2 examples of drugs that require a loading dose?

A

Heparin and lidocaine

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12
Q

Is sodium chloride or dextrose a better option to hydrate a person and why?

A

Dextrose b/c will be metabolized through the Kreb’s cycle

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13
Q

What is mannitol 10% or 20% used for?

A

Osmotic diuretics as an infusion

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14
Q

What is sodium carbonate 5% used for?

A

Treatment of acidosis

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15
Q

What is alcohol 10% in dextrose used for?

A

Methanol or ethylene glycol intoxication

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16
Q

What is the function of dextrans?

A

Plasma expanders

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17
Q

Which blood products are given as LVP?

A

Albumin, fresh-frozen plasma, whole blood

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18
Q

When can large volume parenterals exceed 1000 mL?

A
  • LVP-like products that are not meant for IV administration

- Peritoneal dialysis solutions, parenteral nutrition solutions, irrigation solutions

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19
Q

What must be determined when preparing a small volume parenteral?

A
  • Route of administration
  • Selection of vehicle
  • Required added substances
  • Appropriate container and closure
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20
Q

What is the volume for IM injections?

A

Below 10 mL

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21
Q

Which route shouldn’t be used if drug requires prolonged release?

A

IV

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22
Q

What are the most common vehicles used for SVP?

A

Aqueous, aqueous w/ co-solvents, or non-aqueous

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23
Q

Which vehicle is most desirable for SVP?

A

Aqueous, but drug solubility may be an issue

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24
Q

Which co-solvents are used w/ non-polar substances to increase water solubility?

A

Alcohol, glycerol, propylene glycol, or polyethylene glycol

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25
Q

What are the uses of co-solvents?

A
  • Increase solubility

- Prevent chemical degradation

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26
Q

What are some disadvantages to co-solvents?

A
  • Tissue irritation (if given IM)
  • Dilution may cause drug to come out of solution
  • Potential toxicities if given in large dose
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27
Q

What is another way to increase solubility besides co-solvents?

A

Non-ionic surfactants (ex: span, tween, cremophor, labrasol)

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28
Q

What are the common concentrations of surfactants?

A

0.05-0.5%

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29
Q

Why are ionic surfactants not generally used?

A

Irritation or damage to membranes

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30
Q

What must be evaluated when using surfactants?

A

Safety, tissue tolerance, and hemolytic activity

31
Q

What do surfactants do at low concentrations?

A

Can adsorb to the surface of the drug molecule and give the drug some polar properties

32
Q

What do surfactants do at high concentrations?

A

May orient into concentrated polar and non-polar centres and form micelles

33
Q

What are cyclodextrins?

A

Oligomers of glucose

34
Q

What do cyclodextrins do?

A
  • Can exert solubilizing effect by forming stable inclusion complexes
  • Amphipathic w/ exterior being hydrophilic while interior is hydrophobic
35
Q

Which cyclodextrins can be used for parenterals?

A

Modified or substituted

36
Q

What effect does an oil vehicle have on drug solubility?

A

Metabolizable vegetable oils may increase drug solubility

37
Q

Oily injections are intended for ____ use

A

IM

38
Q

Can oils provide prolonged/sustained release?

A

Yes

39
Q

Which substances are often added to parenterals to improve efficacy, elegance, and stability?

A
  • Buffers
  • Antioxidants
  • Antimicrobial agents
  • Tonicity adjusters
40
Q

What are buffers used for in parenterals?

A
  • Enhance stability and/or solubility

- Resist pH changes on storage

41
Q

What can pH above 9 cause?

A

Tissue necrosis

42
Q

What can pH below 3 cause?

A

Pain and/or phlebitis

43
Q

What are common buffers used in parenterals?

A

Citrate, acetate, phosphate, and tromethamine

44
Q

What effect does citrate on thiamine (vitamin B1)?

A

Increases degradation rate of thiamine

45
Q

What effect do phosphates have on phenethicillin?

A

Increases degradation of phenethicillin

46
Q

What effect do phosphates have on citrate?

A

Calcium will precipitate

47
Q

What is buffer capacity?

A

Number of moles of strong acid/base which has to be added to 1000 mL of buffer to cause a change of 1 pH unit

48
Q

How can you make a drug less vulnerable to oxidation?

A
  • Lowering pH by addition of H ions
  • Chelating agents
  • Protection from light
  • Replacement of air w/ inert gas
  • Slightly acidic pH
  • Addition of antioxidants
49
Q

What do antioxidants do?

A

Have higher oxidation potential than the drug, so are preferentially oxidized

50
Q

What are common antioxidants used in parenterals?

A

Bisulfites and ascorbic acid

51
Q

When can antioxidants not be used?

A
  • LVPs, intrathecal, or intraocular injectables

- Avoided or used w/ caution in young children

52
Q

What do bisulfites react w/?

A
  • Formation of insoluble salts when bisulfites oxidize to sulfate
  • Bisulfate reacts w/ aldehyde functional groups
53
Q

Antimicrobial agents must be added to parenterals in _____

A

Multi-dose containers

54
Q

When are antimicrobial agents not to be used?

A
  • LVPs, intrathecal, or intraocular injectables

- Avoided or used w/ caution in young children

55
Q

What must be done to ensure an effective concentration of antimicrobial agents is maintained?

A
  • Must ensure packaging doesn’t adsorb to the point where the [ ] is ineffective
  • Ensure no other component may inactivate the antimicrobial
56
Q

What are some common antimicrobial preservatives used in parenterals?

A

Benzalkonium chloride, benzyl alcohol, parabens, phenol, and chlorocresol

57
Q

What is the easiest way to determine quantity of tonicity adjuster needed?

A

Sodium chloride equivalent method

58
Q

What is the easiest way to determine quantity of tonicity adjuster needed if the product is buffered?

A

White-Vincent method

59
Q

What are examples of tonicity adjusters?

A

Sodium chloride, dextrose, mannitol, glycerol

60
Q

What can be added if a product is hypertonic and is to be administered by IM route?

A

Local anesthetic (ex: benzyl alcohol)

61
Q

What are the 4 categories for the antimicrobial effectiveness test?

A

1) Parenterals, ophthalmics, otics, sterile nasal products made w/ aqueous bases or vehicles
2) Topically used products w/ aqueous bases or vehicles; non-sterile nasal products; emulsions and products applied to mucous membranes
3) Oral products other than antacids made w/ aqueous bases or vehicles
4) Antacids made w/ aqueous base

62
Q

What is done to the product during the antimicrobial effectiveness test?

A

Product in original container inoculated to provide 10^5 - 10^6 colony forming units per mL of product

63
Q

When should the effectiveness of a preservative system be retested?

A

Any time the formulation is changed

64
Q

What are the functions of containers for parenterals?

A
  • Facilitate manufacture
  • Maintain product integrity
  • Allow inspection of product
  • Permit shipping and storage
  • Provide for convenient clinical use
65
Q

What are the 3 types of glass recognized by the USP?

A

1) Borosilicate, least reactive (best but most expensive)
2) Soda lime glass treated w/ sulfate, sulfite, or sulfide to make it less reactive (used for products that remain below pH 7 during shelf life)
3) Soda lime glass untreated (used for dry powders which require reconstitution)

66
Q

What container is usually used for products which are light-sensitive?

A

Amber glass

67
Q

What is a disadvantage to amber glass containers?

A

Ions of iron or manganese can be extracted from the glass and function as catalysts for oxidation of the drug

68
Q

What are rubber closures used for?

A

Parenteral products

69
Q

What are some problems w/ closures?

A
  • Leaching of materials into products
  • Adsorption of product
  • Particulate contamination from container/closure combination
70
Q

Which physical properties are important in selection of closure?

A
  • Compression set (good plastic/elastic properties to ensure leaf-proof fit)
  • Flexibility
  • Hardness (soft enough to allow easy passage of needle
  • Resistance to passage of water vapor
  • Resealability
  • Tackiness (don’t want closures to stick together or clump)
71
Q

Which plastics are used for packaging parenterals?

A

PVC and polyethylene

72
Q

What are advantages to plastics?

A

Light weight, break resistant

73
Q

What are disadvantages to plastics?

A
  • Moisture and gas permeability
  • Leaching
  • Adsorption of drug material

Pharmaceutics Year 2 (17 decks)

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