Parenterals

Question 1

USP chapter numbers > 1000

Answer 1

Recommendations (nice to have)

Question 2

USP chapter numbers < 1000

Answer 2

ENFORCEABLE (must follow)

Question 3

USP 797

Answer 3

Pharmaceutical compounding, law of compounding sterile preparations

Question 4

USP 800

Answer 4

Hazardous drugs- handling in healthcare settings

Question 5

What does parenteral mean?

Answer 5

Products administered by injection and involves all injectable products

Question 6

Parenteral Route

Answer 6

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

Question 7

Considerations about Parenteral Products

Answer 7

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

Question 8

What requirements do parenterals must meet?

Answer 8

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

Question 9

What does sterile mean?

Answer 9

parenteral formulations must be FREE of microbial organisms

Question 10

What ways is sterilization achieved?

Answer 10

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

Question 11

What are pyrogens?

Answer 11

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

Question 12

What do particles do?

Answer 12

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

Question 13

Types of parenteral products

Answer 13

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

Question 14

Solutions ready for injection

Answer 14

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

Question 15

Suspensions ready for injection

Answer 15

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

Question 16

Emulsion Parenterals

Answer 16

Liquid concentrates ready for dilution prior to administration

Question 17

“for”

Answer 17

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

Question 18

LVP

Answer 18

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

Question 19

Small Volume Parenterals

Answer 19

100 mL or less

Question 20

Vehicles

Answer 20

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

Question 21

Water for injection (WFI)

Answer 21

Pyrogen free, non-sterile, single use sealed container

Question 22

Sterile Water for injection (SWFI)

Answer 22

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

Question 23

Bacteriostatic Water for Injection (BWFI)

Answer 23

Pyrogen free sterile with antimicrobial agent added

Question 24

Intravenous (IV)

Answer 24

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

Question 25

Common aqueous ISOTONIC vehicles

Answer 25

-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+)

Question 26

Components of parenteral products (vehicles)

Answer 26

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

Question 27

Water miscible solvents (cosolvents)

Answer 27

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

Question 28

Should you inject straight liquid oil into veins?

Answer 28

NO! it can cause an embolus

Question 29

What type of oil is okay for IV injection?

Answer 29

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

Question 30

Are oil-based solutions okay for IM injections?

Answer 30

Yes, they do exist

Question 31

Should benzyl alcohol be used in neonates?

Answer 31

No, it can produce gasping syndrome

Question 32

Should antimicrobial preservatives be used intra-spinally

Answer 32

No

Question 33

Why should pH buffers be in a parenteral product?

Answer 33

Address solubility and stability issues

Question 34

What are some common used buffers?

Answer 34

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

Question 35

Should you combine phosphate and calcium?

Answer 35

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

Question 36

Benefits of diluted buffers?

Answer 36

Diluted buffers allows the physiological pH takes over asap

Question 37

What is the most commonly used material for containers?

Answer 37

Glass, but slowly being replaced by plastic

Question 38

Types of glass

Answer 38

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

Question 39

Concerns with a flip off cap

Answer 39

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

Question 40

Characteristics of ampuls

Answer 40

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

Question 41

Luer Lok

Answer 41

Required for hazardous drugs, has a screw tip

Question 42

How do you read volume in a syringe?

Answer 42

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

Question 43

What are the two numbers that characterize the needle?

Answer 43

Gauge and Length

Question 44

What does the gauge of the needle measure?

Answer 44

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

Question 45

What does the length of the needle measure?

Answer 45

-How LONG the needle is

Question 46

What needle should be used with ampules?

Answer 46

Filter needles

Question 47

IV being the "least forgiving"

Answer 47

-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

Question 48

Routes of IV administration

Answer 48

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

Question 49

Phlebitis

Answer 49

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

Question 50

Thrombosis

Answer 50

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

Question 51

Thrombophelebitis

Answer 51

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

Question 52

Setup for CONTINOUS IV infusion

Answer 52

Usually uses one bag (typically LVP)

Question 53

Setup for INTERMITTENT IV infusion

Answer 53

Uses a piggyback set up with a 'Y' injection site

Question 54

Routes of IM administration

Answer 54

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

Question 55

Routes of SC administration

Answer 55

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

Question 56

Routes of INTRA SPINAL administration

Answer 56

Intrathecal and epidural

Question 57

Intrathecal

Answer 57

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

Question 58

Epidural

Answer 58

-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

Question 59

What are the special requirements for intra-spinal?

Answer 59

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