Parenterals Flashcards

Exam 1 content

1
Q

USP chapter numbers > 1000

A

Recommendations (nice to have)

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2
Q

USP chapter numbers < 1000

A

ENFORCEABLE (must follow)

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3
Q

USP 797

A

Pharmaceutical compounding, law of compounding sterile preparations

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4
Q

USP 800

A

Hazardous drugs- handling in healthcare settings

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5
Q

What does parenteral mean?

A

Products administered by injection and involves all injectable products

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6
Q

Parenteral Route

A

Introducing drugs into the body outside the GI tract and can be used to administer drugs to a specific body/organ

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7
Q

Considerations about Parenteral Products

A

-requires an injury to the body
-bypasses the body’s natural defense
-makes the body vulnerable
-must meet certain requirements

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8
Q

What requirements do parenterals must meet?

A

-right potency
-properly labeled
-sterile
-pyrogen free
-particle free

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9
Q

What does sterile mean?

A

parenteral formulations must be FREE of microbial organisms

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10
Q

What ways is sterilization achieved?

A

-steam (autoclave)
-filtration (bacteria retentive membrane)
-dry heat (oven)
-gas (ethylene oxide)
-irradiation (gamma rays)

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11
Q

What are pyrogens?

A

bacterial endotoxins and “produce” fever and sometimes septic shock and are remnants from microorganisms

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12
Q

What do particles do?

A

-can trigger immune response, produce damage to the lungs, kidneys and can kill people

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13
Q

Types of parenteral products

A

-Solutions ready for injection
-Suspensions ready for injection
-Emulsions

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14
Q

Solutions ready for injection

A

Dry, soluble preparations ready to be combined with a solvent before use

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15
Q

Suspensions ready for injection

A

Dry, insoluble preparations ready to be combined with a vehicle before use

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16
Q

Emulsion Parenterals

A

Liquid concentrates ready for dilution prior to administration

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17
Q

“for”

A

Don’t use it as is; you have to do something to it before injecting

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18
Q

LVP

A

“Large Volume Parenteral”, single dose injections packaged in a container containing MORE 100mL

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19
Q

Small Volume Parenterals

A

100 mL or less

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20
Q

Vehicles

A

Solvents/mediums for the administration of therapeutic agents (water is preferred vehicle)

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21
Q

Water for injection (WFI)

A

Pyrogen free, non-sterile, single use sealed container

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22
Q

Sterile Water for injection (SWFI)

A

Pyrogen free, sterile, and in containers not larger than 1000 mL
NEVER INJECT DIRECTLY INTO THE BLOODSTREAM (can cause lysis of the cells)

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23
Q

Bacteriostatic Water for Injection (BWFI)

A

Pyrogen free sterile with antimicrobial agent added

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24
Q

Intravenous (IV)

A

Very rapid, straight to the blood, good for irritant drugs, good for large volumes

25
Q

Common aqueous ISOTONIC vehicles

A

-0.9% NaCl solution (normal saline)
-5% Dextrose Solution (D5W)
These are isotonic
-Bacteriostatic sodium chloride injective (normal saline w/antimicrobial preservatives)
-Ringers solutions (normal saline with K+ and Ca2+)

26
Q

Components of parenteral products (vehicles)

A

Water miscible solvents, used to solubilize drugs, slow down hydrolysis reactions (makes them less “water” like), used in IM and sometimes IV

27
Q

Water miscible solvents (cosolvents)

A

-Ethyl alcohol
-Polyethylene glycol (PEG)
-Propylene glycol (PG)

28
Q

Should you inject straight liquid oil into veins?

A

NO! it can cause an embolus

29
Q

What type of oil is okay for IV injection?

A

Oil emulsions since the oil droplets are smaller than red blood cells not oil SOLUTIONS

30
Q

Are oil-based solutions okay for IM injections?

A

Yes, they do exist

31
Q

Should benzyl alcohol be used in neonates?

A

No, it can produce gasping syndrome

32
Q

Should antimicrobial preservatives be used intra-spinally

A

No

33
Q

Why should pH buffers be in a parenteral product?

A

Address solubility and stability issues

34
Q

What are some common used buffers?

A

-Citrates (safe by IV irritating by IM or SC)
-Acetates
-Phosphates (potentially fatal danger)

35
Q

Should you combine phosphate and calcium?

A

No, they have a strong tendency to precipitate and the result can be fatal

36
Q

Benefits of diluted buffers?

A

Diluted buffers allows the physiological pH takes over asap

37
Q

What is the most commonly used material for containers?

A

Glass, but slowly being replaced by plastic

38
Q

Types of glass

A

Three types of glass, type I, type II, Type III
-type I is used to minimize problems

39
Q

Concerns with a flip off cap

A

Does not guarantee sterility when first exposed, so you must sterile wipe it

40
Q

Characteristics of ampuls

A

-made of glass
-SINGLE use containers
-provide hermetic, uniform containment
-there a seal that is easily broken near the neck

41
Q

Luer Lok

A

Required for hazardous drugs, has a screw tip

42
Q

How do you read volume in a syringe?

A

Use the final edge of the plunger piston to read the volume, approximate to the closest 1/2

43
Q

What are the two numbers that characterize the needle?

A

Gauge and Length

44
Q

What does the gauge of the needle measure?

A

-Refers to the DIAMETER of the bore
-HIGHER the gauge the SMALLER the bore diameter

45
Q

What does the length of the needle measure?

A

-How LONG the needle is

46
Q

What needle should be used with ampules?

A

Filter needles

47
Q

IV being the “least forgiving”

A

-Generally if an excipient is acceptable for IV, it’s acceptable for other parenteral routes
-Some excipients that are acceptable for IM (as an eg;) are totally unacceptable for IV

48
Q

Routes of IV administration

A

-Bolus (push/shot)
-Infusion(longer time mins to hours)
-peripheral vein
-central vein
-continuously (one bag)
-intermittent (bag that goes on and off)

49
Q

Phlebitis

A

Inflammation from irritation of the tunica intima (inside wall) of the vein
-moderate to severe discomfort
-may take days to months to subside
-limits veins for future therapy

50
Q

Thrombosis

A

Formation of a blood clot (thrombus) in the vein
-pain, swelling, pulmonary embolism

51
Q

Thrombophelebitis

A

Combination of a blood clot in the vein and inflammation of the vein

52
Q

Setup for CONTINOUS IV infusion

A

Usually uses one bag (typically LVP)

53
Q

Setup for INTERMITTENT IV infusion

A

Uses a piggyback set up with a ‘Y’ injection site

54
Q

Routes of IM administration

A

Deltoid, Thigh, Gluteal (2, 5, 5 mL)
characterized by an absorption step and onset is not always faster than the oral route

55
Q

Routes of SC administration

A

-volume does. not exceed 1.5 mL
-absorption is slower than IM due to lower vascularization
-called hypodermoclysis

56
Q

Routes of INTRA SPINAL administration

A

Intrathecal and epidural

57
Q

Intrathecal

A

-Into the subarachnoid space and CSF
-BOLUS administration
-meds have a higher potency due to no bypassing membranes

58
Q

Epidural

A

-Into the space at the thoracic or lumber level between the dura mater and the vertebral canal
-Bolus OR continuous administration
-in the caudal level in neonates

59
Q

What are the special requirements for intra-spinal?

A

-is sterile
-free of particles
-free of pyrogens
-must be isotonic
-must have physiological pH
-cannot have preservatives