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Pharmaceutics > Parenterals 2 > Flashcards

Parenterals 2 Flashcards

1
Q

What constitutes a large volume parenteral (LVP)

A
  • it is packaged in volumes larger than 100 mL
  • single dose units
  • packaged in class or plastic
  • never preserved with antimicrobial agents
  • primarily used for volume and electrolyte replacements by IV route
  • maximum volume 1000 mL
  • usually administered continuously at a rate set in mL/h
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2
Q

What variance does homeostatic mechanisms maintain total body water at?

A

within 1%

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3
Q

What is the daily intake of fluid for adults?

A

50 ml/kg

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4
Q

What can the fluid balance be upset due to?

A
  • den be upset due to reduced intake or unusual lose (shock. third spacing, trauma)
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5
Q

What are the most common components in fluid?

A

-sodium chloride and dextrose (D-glucose monohydrate)

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6
Q

What are some things that can commonly cause electrolyte unbalances?

A
  • vomiting, dehydration, diarrhea, and trauma
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7
Q

Must electrolyte solutions be diluted before they are added to an LVP?

A

Yes, they must be

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8
Q

Can electrolytes be used to restore pH?

A

Yes, they can be

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9
Q

What are the ways that drugs are administered to reach a stable concentration?

A
  • some drugs require continuous administration following a loading dose to maintain therapeutic serum levels
  • may be added to LVP and infused but compatibility and stability must be considered
  • when given IV rate is also an issue since some toxicities are related to serum concentration
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10
Q

What are blood products and what are they used for?

A
  • many blood products are given as LVP
    • albumin, fresh frozen plasma, whole blood
  • not used for drug admin
  • managed by Canadian blood services
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11
Q

What are some examples of LVP-like products which are not meant for IV administration but must also be sterile and particulate and pyrogen free?

A
  • peritoneal dialysis solutions
  • parenteral nutritional solutions
  • irrigation solutions
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12
Q

What are small volume parenterals?

A
  • injectable products packaged in volumes of 100 mL or less
    • formulation required knowledge of physical, chemical and biological properties of drug and applications of this knowledge
    • must determine the: route of administration, selection of the vehicle, required added substances, and an appropriate container and closure
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13
Q

If the dose requires volumes greater than ___ the IM route is not useful

A

10 mL

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14
Q

If drug is ___ to tissues IM route is contraindicated

A

irritating

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15
Q

If drug requires ____ IV is not practical

A

prolonged release

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16
Q

What consideration is taken when selecting a vehicle?

A
  • generally may be aqueous, aqueous with co-solvents or non-aqueous
  • aqueous is most desirable but drug stability is often an issue here
  • water physiologically compatible and high dielectric constant and polarity allow dissolution of ionizable functional groups and hydrogen bonding facilitates dissolution of alcohols, aldehydes, ketones and amines
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17
Q

What would the purpose of co-solvents be?

A
  • aids with solubility and stability
  • non-polar substances have limited solubility in water and a co-solvent such as alcohol, glycerol, propylene glycol or polyethylene glycol may be required to effect solution
  • co-solvents prevent chemical degradation especially by hydrolysis
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18
Q

What are some of the disadvantages of co-solvents?

A
  • tissue irritation
  • dilution may cause the drug to come out of the solution
  • potential toxicities if given in a larger dose
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19
Q

What is the purpose of a surfactant?

A
  • solubility may be increased by the use of non-ionic surfactants such as Span, Tween, Cremophor
    • these are generally used in a concentration of 0.05 to 0.5%
    • ionic surfactants are not generally used due to irritation or damage to the membranes
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20
Q

Cyclodextrins are oligomers of ____

A

glucose

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21
Q

How do cyclodextrins work?

A

they exert their effects by forming stable inclusion complexes
- amphipathic with the exterior being hydrophilic while interior is hydrophobic

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22
Q

Oil vehicles in injections are especially good for what?

A
  • to provide prolonged or sustained release due to depot formation in the muscle tissue
    (can also emulsify using surfactants to form product which can be given IV)
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23
Q

What are some of the purposed of added substances in a product?

A
  • helps with safety, efficacy, elegancy, stability
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24
Q

What do these extra added substances include?

A

Buffers
Antioxidants
Antimicrobial agents
Toxicity adjusters

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25
Q

What are buffers used for?

A
  • may be used to enhance stability and/or solubility but also to resist pH changes or storage
  • buffers should have the capacity to maintain pH yet should adjust pH to that of aloof (pH=7.4) following administration
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26
Q

What can a pH above 9 cause?

A
  • can cause tissue necrosis
27
Q

What can a pH below 3 cause?

A

can cause pain and phlebitis

28
Q

What does a buffer generally consist of? What are some common buffers?

A

consists of a weak acid or a base along with its salt

- common buffers are citrate, acetate, phosphate and tromethamine

29
Q

Then buffer may alter properties of the product such as…?

A
  • solubility and stability
30
Q

Degradation of ____ increases in the presence of citrate

A

thiamine (vit B1)

31
Q

Degradation of ____ increases in the presence of phosphate

A

phenethicillin

32
Q

___ will precipitate in the presence of phosphates at certain pH values

A

calcium

33
Q

What are some common methods of preventing oxidation?

A
  • chelating agents
  • protection from light
  • replacement of air with inert gas, a slightly acidic pH or via the addition of antioxidants
34
Q

How do antioxidants prevent the compound from oxidation?

A
  • often have higher oxidation potential than the drug and are preferentially oxidized
  • used along or in combination
35
Q

What compounds can you not use an antioxidant with?

A

you cannot use with LVP, intrathecal or intraocular injectables

36
Q

There is a formation of ____ when bisulfites oxidize to sulfate

A

insoluble salts

37
Q

There is a reaction of bisulphate with ____ functional groups

A

aldehyde

38
Q

Like antioxidants, antimicrobial agents are not be to added to what?

A

LVPs, intrathecals, or intraocular injectables

39
Q

Antimicrobial agents are to be avoided or used with caution in what group of people?

A

young children

40
Q

What are some examples of tonicity adjusters?

A
  • ideally, parenteral should be isotonic but often not possible since high drug concentrations are needed to keep the volume small
  • can compromise by dilution the solution in an IV administration
  • easiest method of determining the quantity of tonicity adjusters is not use NaCl equivalent method
  • best to use the White-Vincent method if the product is buffered
41
Q

What are some of the agents used as tonicity adjusters?

A

sodium chloride, dextrose, mannitol, and glycerol

42
Q

The antimicrobial effectiveness test is in what USP?

A

USP 51

43
Q

How does the antimicrobial effectiveness test work?

A
  • product samples are inoculated with a controlled quantity of specific microorganisms
  • test them compares the level of microorganisms found on a control sample vs the test samples over a period of 28 days
  • the product in the original container is inoculated to provide between 1x10^5 and 1x10^6 colony forming units per mL of product (at various intervals, depending on the category, samples are taken and the number of cf. is determined using the plate-count method)
  • any growth over the allotted amount for any of the indicated microorganisms means that the preservative in the product is not effective and the product fails the test
44
Q

How many categories are there for the antimicrobial effectiveness test?

A

4

45
Q

What does category 1 cover?

A
  • parenterals, ophthalmics, otics, sterile nasal products made with aqueous bases or vehicles
46
Q

What does category 2 cover?

A
  • topically used products made with aqueous bases or vehicles, non-sterile nasal products, emulsion and products applied to mucous membranes
47
Q

What does category 3 cover?

A

oral products other than antacids mad with aqueous bases or vehicles

48
Q

What does category 4 cover?

A

antacids made with an aqueous base

49
Q

What is the allotted bacteria and yeast/mold counts for category 1?

A

Bacteria: on day 7 not less than 1.0 log reduction from initial count, day 14 not less than 3.0 log reduction and on day 28 no increase from day 14
Yeast: on days 7,14,and 28, no increase from the original count

50
Q

What is the allotted bacteria and yeast/mold counts for category 2?

A

Bacteria: on day 14, not less than 2.0 old reduction from initial count and on day 28 no increase from day 14
Yeast/mold: on days 14 and 28 no increase from the original count

51
Q

What is the allotted bacteria and yeast/mold counts for category 3?

A

Bacteria: on day 14 not less than 1.0 log reduction from initial count and on day 28 no increase from day 14
Yeast/mold: on days 14 and 28 no increase from original count

52
Q

What is the allotted bacteria/yeast/mold count for category 4?

A

on days 14 and 28 no increase from the original count

53
Q

What function do containers for parenterals serve?

A

they facilitate manufacture, maintain product integrity (includes stability, sterility and freedom from particulates), allow inspection of product, permit shipping and storage, provide convenient clinical use

54
Q

What are the three types of containers recognized by the USP?

A
  • type 1: borosilicate and is the least reactive as measured by an alkalinity test run on powdered samples (the best but also the most expensive)
  • types 2 and 3: soda lime glass with type 3 having been treated with sulphate, sulphate or sulphide to make it less reactive (type 2 is used for products which remain below pH 7.0 during shelf life)
  • type 3 can be used for dry powders which require reconstitution and then are immediately removed
55
Q

What kinds of glass is amber glass mostly used for?

A

used for products which are light sensitive

56
Q

What must be determined before amber glass is used for a product?

A

need to determine that leaching does not occur over the shelf-life of the product

57
Q

What is that USP chapter for specifying the testing of glass containers? Plastic containers? Performance testing containers?

A

USP chapter 660 = glass
USP chapter 661 = plastic
USP chapter 671 = performance testing

58
Q

What does USP 660 test for?

A

tests light transmission, chemical resistance and tests for alkalinity

59
Q

What are polymeric materials generally used for? What additives are generally used?

A

generally used for the rubber closures for parenteral products
- additives include accelerators, activators, plasticizers, etc

60
Q

Specifications and tests for closures are described in which USP?

A

USP 381 - elastomeric closures for injections

61
Q

What are some common problems with closures?

A

leaching of materials into the product, adsorption of product, particulate contamination from the container/closure combination

62
Q

What are some of the physical properties important in the selection of closures?

A
  • compression set: good plastic/elastic properties to ensure a good leak-proof fit
  • flexibility: coring may occur when the needle passes through the closure
  • hardness: soft enough to allow the easy passage of the needle. Route of administration must be considered - some routes require a narrow gauge
  • water vapour transition: resistant to passage of water vapour
  • resealability: reseal well when needle is withdrawn
  • tackiness: do not want closures to stick together or clump
63
Q

Plastics like ___ and ___ may be used for packaging parenterals

A

PVC and polyethylene

64
Q

What are the advantages of plastics? Disadvantages?

A

Advantages: light weight, break resistant
Disadvantages: moisture and glass permeability, leaching and adsorption of drug material

Pharmaceutics (11 decks)

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