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Dosage Forms II > Exam 2 Parenteral Products 2 > Flashcards

Exam 2 Parenteral Products 2 Flashcards

1
Q

Why can you never inject plain water (aka SWFI) directly into the bloodstream?

A

it will produce lysis of the cells → hemolysis!

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2
Q

What are the different parenteral routes of administration?

A
  1. intravenous (IV)
  2. intramuscular (IM)
  3. subcutaneous (SC)
  4. intradermal
  5. intraperitoneal (IP)
  6. intraspinal
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3
Q

Are all injectables IV products?

A

NO → IV products are injectables but not all injectables are IV products

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4
Q

What are characteristics of IV route of administration?

A
  1. very rapid
  2. straight to the blood
  3. good for irritant drugs
  4. suitable for large volumes
  5. least forgiving → most stringent route
  6. drug must be dissolved → has to be in a liquid form
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5
Q

How do intramuscular, subcutaneous, intradermal, and intraperitoneal routes of administration compare to intravenous?

A

more forgiving than intravenous since it is not injected directly into the bloodstream

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6
Q

How does intraspinal route of administration compare to intravenous?

A

intraspinal is very delicate and have to be more careful than intravenous

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7
Q

What is a rule of thumb for the different routes of administration?

A

if it is okay for IV, it will most likely be okay for the other routes

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8
Q

Where do the different routes of administration inject to?

A

intramuscular → all the way into the muscle
intravenous → straight to the vein
subcutaneous → where the hair follicles are, fat right under the dermis
intradermal → just below the skin

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9
Q

What are the attributes of intra-spinal injections?

A
  1. has the right potency
  2. is properly labeled
  3. is sterile
  4. is free of particles
  5. is free of pyrogens
  6. is isotonic
  7. has physiological pH
  8. has no preservatives
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10
Q

Why do intra-spinal injections have more requirements than other parenteral products?

A

intra-spinal injections basically go straight to the brain

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11
Q

What is the importance of the requirements of parenteral products?

A

these attributes have important implications on what parenteral vehicles we use and how we use them

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12
Q

What are common aqueous isotonic vehicles?

A
  1. 0.9% (w/v) NaCl solution → aka normal saline (NS) or saline
  2. 5% (w/v) dextrose solution → aka D5W
  3. bacteriostatic sodium chloride injection → normal saline with antimicrobial preservatives
  4. Ringer’s solution → normal saline with K+ and Ca2+ in approximate physiological concentrations
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13
Q

Which are the two most common aqueous isotonic vehicles?

A

0.9% (w/v) NaCl solution and 5% (w/v) dextrose solution → used all the time and can mostly be used interchangeably but about 10% have to be a specific one

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14
Q

Which sterile solutions are isotonic?

A

normal saline (NS), 5% dextrose in water (D5W), and 2.5% dextrose in half normal saline (D2.5W/0.5NS)

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15
Q

What is the purpose of the vehicle?

A

it is the liquid that is carrying the active ingredient (drug)

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16
Q

What are some examples of water miscible solvents (cosolvents)?

A

ethyl alcohol, polyethylene glycol (PEG), propylene glycol (PG)

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17
Q

What is the purpose of cosolvents?

A
  1. used to solubilize drugs
  2. can also slow down hydrolysis
  3. often for intramuscular injection
  4. but also used in IV preparations
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18
Q

At what concentrations can PEG be used?

A

PEG can be used IV at concentrations as high of 40% (v/v)

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19
Q

At what concentrations can ethyl alcohol be used?

A

ethyl alcohol can be used up to about 10% (v/v)

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20
Q

Why is there a difference in the concentrations of PEG compared to ethyl alcohol that can be used?

A

they have different hemolytic potentials → in blood, can kill RBCs but in IM, can kill other cells

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21
Q

Can straight liquid oil be injected into veins?

A

NO → straight liquid oil cannot be injected into veins because it is effectively an embolus that can block blood vessels

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22
Q

Why are oil emulsions okay for IV injection?

A

oil is distributed into small droplets that are even smaller than red blood cells → won’t clog blood vessels since oil droplets are very very small so there is no risk of embolism

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23
Q

Are emulsions the same thing as suspensions?

A

NO → they are not equal to one another → however, oil based solutions for IM injection are acceptable and do exist (just not for IV)

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24
Q

What are some important takeaways about oil vehicles?

A
  1. oil solution ≠ oil emulsion
  2. oil vehicles must not be injected directly into veins
  3. an emulsion contains oil, but it is not oil → mostly water
  4. some emulsions (like total parenteral nutrition TPN) are administered by the IV route
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25
Q

What are some characteristics and properties of antimicrobial preservatives?

A
  1. have to be hydrophobic
  2. used for multiple dose preparations → more than 1 administration
  3. antimicrobials are not very effective in non-aqueous (oil based) formulations
  4. has compatibility issues → some excipients inactivate antimicrobial preservatives
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26
Q

What are some examples of antimicrobial preservatives?

A
  1. benzyl alcohol → 0.9% is the most common
  2. parabens → combination of methyl and propyl-parabens, 0.18% and 0.02% respectively → but not used as much
  3. cresol → like phenol
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27
Q

What are some examples of excipients that can inactivate antimicrobial preservatives?

A

polysorbate (through micelles) and PVP complex-like formation

28
Q

What is the most common antimicrobial preservative?

A

benzyl alcohol

29
Q

What is the rule regarding the use of antimicrobial preservatives in parenteral products?

A
  1. if multiple use → MUST contain antimicrobial preservatives
  2. if single use → MUST NOT contain antimicrobial preservatives
30
Q

What is the moral of the story regarding antimicrobial preservatives?

A
  1. if you are going to be punching holes in a sterile container to administer the drug contained in it more than once, you better have some antimicrobial preservative in it
  2. any sterile product intended for multiple dose use must contain antibacterial preservative
  3. single dose = single use → no preservative as it is a single use container
31
Q

What are some things to note about preservatives?

A
  1. benzyl alcohol 0.9% is the most commonly used antimicrobial preservative
  2. it is generally safe to use but some are allergic to it
  3. DO NOT USE benzyl alcohol in neonates → can produce gasping syndrome
  4. do not use preparations containing preservatives in neonates
  5. preparations intended for the intra-spinal route of administration must be free of preservatives
32
Q

Why did the Avastin incident cause blindness in people?

A

single dose vial was used multiple times → since it has no preservatives, it caused bacterial infections in people which caused blindness

33
Q

Why are pH buffers included in parenteral products?

A

to address solubility and/or stability issues with the drug → prevents the pH from changing and is used for the drug as its stored as is in the vial before being put into the body

34
Q

What is physiological pH?

A

about 7.4

35
Q

When using pH buffers, what concentration should be used?

A

use them at as low concentration as necessary

36
Q

What are some commonly used buffers?

A
  1. citrates → some caution since safe by IV (substrate in the citric acid cycle) but very irritating by IM or SC routes
  2. acetates
  3. phosphates → considerable caution, potentially fatal danger
37
Q

What are some things to keep in mind about pH buffers?

A
  1. citrate can be injected intravenously without a problem
  2. however, citrate injected by the IM or SC routes can be very irritating
  3. phosphate and calcium combined have a strong tendency to precipitate and the result can be fatal
  4. HOWEVER → phosphate and calcium need to be given together in TPN preparations
38
Q

Do all parenteral products have physiological pH?

A

no → example is Versed (Midazolam) that is a pH of 3

39
Q

Why exactly are buffers used in parenteral products?

A
  1. buffers are used to “force” the pH to remain at a fixed value
  2. unbuffered solutions are quickly diluted into physiological pH → the reason why you want buffers as dilute as possible (use the lowest concentration as possible) so the physiological pH takes over asap
40
Q

Why are buffers sometimes necessary?

A

the solubility or stability of the drug makes buffers sometimes necessary → buffers usually have to do with the drug staying on the shelf in the vial

41
Q

What are 3 other components of parenteral products?

A
  1. antioxidants
  2. chelating agents
  3. tonicity agents
42
Q

What are some examples of antioxidants?

A
  1. metabisulfite salts → low pH
  2. bisulfite → intermediate pH
  3. sulfite → high pH
  4. ascorbic acid (vitamin C)
43
Q

What is a chelating agent?

A
  1. enhances antioxidant’s effect
  2. sequester trace metals → get rid of trace metals so catalytic effect is not there and it slows down the reaction
  3. the most common is sodium EDTA
44
Q

What are some examples of tonicity agents?

A
  1. normal saline
  2. D5W
  3. glycerol
45
Q

Which tonicity agents are used most of the time?

A

normal saline and D5W

46
Q

Are all parenteral products isotonic?

A

no → TPN for example is hypertonic (more concentration than ideal)

47
Q

What should you do is the parenteral product does not quite match physiological pH or the CSP is not quite isotonic?

A
  1. inject small volumes (aka dilute)
  2. inject slowly (aka dilute)
  3. inject into central vein (aka dilute since veins are close to the heart so there is lots of blood volume so drug will be diluted since the large blood volume is much larger than the injected amount)
48
Q

Why are containers also considered components of parenteral products?

A

containers and closures are in direct contact with the product → these are considered “ingredients” of the product

48
Q

What is the most commonly used material for containers?

A

glass (although it is gradually being replaced by plastic)

49
Q

What are the different types of glass?

A

Type I, Type II, and Type III → use type I to minimize problems!

50
Q

What are the different kinds of containers for parenteral products?

A
  1. vials
  2. ampules
  3. IV bags
51
Q

What are some things to know about vials?

A
  1. can be glass or plastic
  2. a flip off cap or metal cover (not as commonly used anymore) protects the rubber stopper but does not guarantee sterility when first exposed → need to be sterile so wipe it with alcohol swab!
52
Q

What are some things to know about ampules?

A
  1. made out of glass
  2. single use containers
  3. provide completely tight, uniform containment → no stopper or rubber
  4. usually comes pre-scored so you can just break it/flip it open
53
Q

What are some things to know about IV bags?

A
  1. usually comes as a gravity set with a piggyback container where the medication is and a large volume container which is D5W or normal saline → gravity is the driving force
  2. the piggyback container with the medication is usually set higher than the large volume container of NS or D5W so the piggyback container has higher hydrostatic pressure and can be pushed faster into the patient and then the NS or D5W will finish off and take over
54
Q

With an IV set, what is the drop number/drop conversion factor?

A

the number is the number of drops needed to make 1 mL → gives a pretty good idea of the flow rate (but is not exact)

55
Q

What are the two different kinds of syringes?

A
  1. luer lok

2. luer tip

56
Q

What are some things to know about the luer lok syringe?

A
  1. is more common
  2. required for hazardous drugs but can also be used for anything
  3. has a thread for screwing the needle in → more user friendly
57
Q

What are some things to know about the luer tip syringe?

A
  1. not as common → used for insulin injections
  2. is cheaper
  3. slides in and out → a problem if someone is not experienced since needlesticks are more prone to happen
58
Q

Does every part of a syringe have a name?

A

YES → the tip, calibration marks, carrel, plunger piston, final edge of the plunger piston, top collar, plunger, ribs, flat end (lip)

59
Q

How do you read a syringe?

A
  1. use the final edge of the plunger piston to read the volume (don’t mind the pointy tip of the plunger piston)
  2. accuracy is 1/2 of the smallest division
60
Q

What are some things to know about needles?

A
  1. commercially available in sterile over-wrap packing

2. many sizes that is characterized by two numbers → gauge and length

61
Q

What is the gauge of the needle?

A

refers to the diameter of the bore → the higher the gauge, the smaller the bore diameter (ranges from 13 to 27 in which 13 is the widest and 27 is the thinnest)

62
Q

What is the length of the needle?

A

how long the needle shaft is ranging from 3/8’’ to 3.5’’

63
Q

How would you read the needle size of 18G31/2?

A

means gauge is 18 and the length of the needle shaft is 3 and 1/2 inches

64
Q

What is the most important thing to do with filter needles?

A

filter needles MUST be used when using ampules → MUST USE A FILTER NEEDLE WITH AN AMPULE because can have many tiny pieces of glass when breaking an ampule so the filter stops/filters the glass pieces

65
Q

Where is the filter located on a needle?

A

right under the hub that connects to the needle shaft

66
Q

What is the bevel of the needle?

A

used like a tool → at an angle with respect to the surface

Dosage Forms II (20 decks)

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