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Drew 924 > Sterile Products for Injection > Flashcards

Sterile Products for Injection Flashcards

1
Q

What are the advantages of parenteral administration?

A

1) fast drug action
2) prolonged, high, tightly controlled [drug]
3) 1st pass avoided
4) drug poorly absorbed any other way

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2
Q

Disadvantages of parenteral administration?

A

1) sterile technique
2) professional admin
3) irritation, toxicity, pain
4) difficult to correct error

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3
Q

What is the most invasive method?

A

IV > IM > SQ

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4
Q

What method requires most skill?

A

IV > IM >SQ

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5
Q

What methods gives most rapid onset?

A

IV&raquo_space; IM, SQ

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6
Q

What method causes most pain?

A

IM > IV > SQ

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7
Q

How long for IV mixing in body?

A

4-5 minutes

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8
Q

USP requirements for parenteral admin:

A

1) sterile
2) non-pyrogenic
3) particulate matter…

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9
Q

Which routes must have isotonic products?

A

intrathecal, IV infusion

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10
Q

What is the osmolarity of blood?

A

275 - 300 mOsm/kg

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11
Q

What is particulate requirement for SVPs?

A

1) no visible particles
2) 10 um: less than 3000
3) 25 um: less than 300

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12
Q

What is particulate requirement for LVPs?

A

1) no visible particles
2) 10 um: less than 12/mL
3) 25 um: less than 2/mL

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13
Q

What USP chapter regulates particulates in IV products?

A

788

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14
Q

How is particulate matter regulated for parenterals?

A

only regulated for IV products

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15
Q

How large is capillary lumen?

A

5 - 20 um

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16
Q

What is diameter of RBC?

A

10 um

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17
Q

What are the 3 layers of blood vessels?

A

tunica intima, intermedia, adventitia

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18
Q

Body water makes up how much of TBW?

A

60 %

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19
Q

What percentage of blood is venous?

A

75%

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20
Q

What percentage of blood is arterial?

A

20%

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21
Q

What percentage of blood is in capillary system?

A

5%

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22
Q

What is pH of blood?

A

7.4 with heavy buffer

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23
Q

On what is blood volume dependent?

A

physical activity

NOT AGE

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24
Q

What percentage of TBW does blood make up in men (women)?

A

6-8% (5-7%)

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25
Q

What is the protein concentration in blood?

A

65 - 80 g/L

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26
Q

What proteins are present in blood?

A

1) albumin (primarily)
2) a/b-globulins
3) glycoprotein
4) hormones
5) esterases
5) DNAse

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27
Q

What are the consequences of RBC crenation?

A

clotting; clogging of spleen

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28
Q

What interactions dictate drug-albumin binding?

A

H, ionic, hydrophobic interactions

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29
Q

To what proteins can drugs bind in the blood?

A

1) albumin
2) acidic glycoproteins
3) lipoproteins

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30
Q

What substances does albumin normally handle?

A

fatty acids, bilirubin

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31
Q

What is meant by “bound drug”?

A

fraction of drug bound by NON-COVALENT interaction in SPECIFIC TISSUE

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32
Q

What are the 2 tunnel catheter products discussed?

A

1) TriFusion

2) Port-a-Cath

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33
Q

What is the care for the TriFusion tunnel cath?

A

saline & heparin lock rinse BID

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34
Q

How do TriFusion & Port-a-Cath differ?

A

TriFusion has external access port

Port-a-cath is totally implanted

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35
Q

What is the advantage of Port-a-Cath?

A

1) opens directly at heart for max dilution

2) minimal infection risk

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36
Q

Describe infusion via TriFusion.

A

1) 3 lines = 3 drugs @ 3 different rates
2) 3 lines turn into 1
3) often used for pheresis treatments

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37
Q

How many doses to steady state for intermittent (piggy-back) infusion?

A

4-5

38
Q

What muscles are used for IM injection?

A

1) Deltoids
2) ventrogluteal
3) dorsogluteal
4) vastus lateralis

39
Q

Which muscle is targeted for self-IM administration?

A

vastus lateralis

40
Q

What compounds are commonly injected IM?

A

1) hormones
2) vaccines
3) antibiotics

41
Q

What accounts for IM blood-level variability?

A

1) vascularity
2) blood flow
3) fraction of mass as fat
4) fraction of mass as muscle

42
Q

How does vascularity influence absorption in IM injection?

A

increased vascularity –> increased absorption

43
Q

How does blood flow influence absorption in IM injection?

A

increased flow –> increased absorption

44
Q

How can blood flow be increased?

A

1) irritation
- - hypertonic
- - extreme pH
- - irritating cosolvent (acetate)
2) inflammation via muscle damage

45
Q

How can blood flow be decreased?

A

vasoconstrictors (applied with local anesthetic)

46
Q

How does fat-fraction affect absorption?

A

Fat less densely vascularized

– longer tmax, lower Cmax

47
Q

What is the volume of an LVP?

A

> 100mL

48
Q

What chapter regulates LVP/SVP volume?

A

32

49
Q

What are common uses for LVPs?

A

1) fluid replacement
2) TPN
3) IV admin vehicle

50
Q

Advantages of plastic bag for LVP:

A

1) lightweight
2) hard to break
3) no venting required

51
Q

Disadvantages of plastic bag for LVP:

A

1) permeability to O2, H2O
2) leaching of plasticizer
3) interaction with PVC / polyolefin

52
Q

How are LVPs supplied?

A

plastic or glass

53
Q

What are the advantages to glass bottles for LVP?

A

1) resistance to chemical interaction
2) impermeable to gas & microbes
3) transparent
4) easy cleaning & sterilizing

54
Q

What are disadvantages to glass for LVP?

A

1) weight
2) breakage
3) light
4) venting

55
Q

What are containers for SVP?

A

1) ampule
2) vial
3) pre-filled syringe

56
Q

What is the max volume for ampule?

A

50 mL

57
Q

What material is commonly used to supply pre-filled syringes?

A

glass

58
Q

What are the necessary considerations for a pre-filled syringe?

A

1) proper storage (light, T, security)
2) abuse or injury thru disposal
3) pharmacist-provided pre-fill

59
Q

What drugs are commonly dispensed in a pre-filled syringe?

A

1) insulin
2) small MW heparin (lovenox)
3) Imitrix for migraine

60
Q

What are the types of glass?

A

1 - 3, NP

61
Q

What is Type 1 glass’ material?

A

Borosilicate

62
Q

What is Type 2 glass’ material?

A

Treated Soda Lime

63
Q

What is Type 3 glass’ material?

A

Untreated Soda Lime

64
Q

What is Type 4 glass’ material?

A

General Purpose Soda Lime

65
Q

Describe Type 1 glass

A

borosiliate

    • any pH
    • steam sterilized
    • most expensive
66
Q

Describe Type 2 Glass

A

treated soda lime

    • steam sterilized
    • SO2 treated
    • neutral/acidic solns
67
Q

Describe Type 3 Glass

A

untreated soda lime

    • non-aqueous systems
    • dry-heat sterilized
68
Q

Describe Type NP glass

A

General purpose soda lime

    • oral products only
    • cheap
69
Q

What is defined as “light-resistant?”

A

no more than 10% of incident light radiation 290 - 450 nm

70
Q

What is max capacity for single-use glass container?

A

1 L; slight over-fill ok

71
Q

What is max capacity for multi-dose glass container?

A

30 mL unless waiver present

72
Q

What is max capacity for irrigation glass containers?

A

no limit

73
Q

What type of plastic is used for blood products?

A

PVC

74
Q

What type of plastics are used for LVP?

A

1) PVC
2) polyesters
3) polyolefin

75
Q

What type of plastics are used for SVP?

A

polycarbonate

76
Q

What type of plastics are used for syringes?

A

1) polyethylene (HDPE)

2) polypropylene

77
Q

What type of plastics are used for administration sets?

A

1) tubing is PVC

2) spike is nylon

78
Q

What type of plastics are used for catheters?

A

1) teflon

2) polypropylene

79
Q

What types of plastics are “very flexible?”

A

1) PVC
2) polyesters
3) polyolefin

80
Q

What types of plastics are “semi-rigid?”

A

1) teflon

2) polypropylene

81
Q

What types of plastics are “rigid?”

A

1) polyethylene
2) polypropylene
3) polycarbonate

82
Q

What percentage of light passes thru polycarbonate?

A

90%

83
Q

What percentage of light passes thru PVC & Polystyrene?

A

75%

84
Q

What percentage of light passes thru polypropylene & polyethylene?

A

70%

85
Q

Which plastic is most permeable?

A

PVC

86
Q

Which plastic is least permeable?

A

Polyethylene

87
Q

Rank plastics by permeability (PVC, polypropylene, polyethylene)

A

Most = PVC
— Polystyrene
Least = Polyeth

88
Q

What is Ka relating to IM injection?

A

partitioning into plasma

89
Q

What types of IM solutions can act as suspensions?

A

Hydrophobic drug in solution w/ co-solvent

– slow dissolution step

90
Q

What are the sites for SQ injection?

A

varies sites on torso, thigh, tricep

91
Q

Why is needle size important for SQ injection?

A

needle length varies by BMI & gender

Drew 924 (16 decks)

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