Parenteral Products I

Question 1

IV qualities

Answer 1

Very rapid
Straight to blood
Good for irritant drugs
Suitable for large volumes
Least forgiving
Drug must be dissolved

Question 2

Parenteral Routes of admin

Answer 2

IV
IM
SubQ
Intradermal
Intraperitoneal (IP)
Intraspinal - VERY delicate

Question 3

Parenteral products needs

Answer 3

Right potency
Properly labeled
Sterile
Free of particles
Free of pyrogens
Isotonic
Physiological pH

Question 4

Intraspinal injections needs

Answer 4

Has the right potency
Is properly labeled
Is sterile
Is free of particles
Is free of pyrogens
Is isotonic
Has physiological pH Has no preservatives

Question 5

Common aqueous isotonic vehciles:

Answer 5

0.9% (w/v) NaCl Solution (Normal saline)
5% (w/v) Dextrose Solution (aka D5W)

Question 6

Sterile solutions: all are sterile but

Answer 6

Not all are isotonic

Question 7

Components of parenteral products: Vehicles

Answer 7

Water miscible solvents (cosolvents)
-Ethyl alcohol
Polyethylene glycol (PEG)
-Propylene glycol (PG)
Used to solubilize drugs
Can also slow down hydrolysis reactions
Often for IM injection
But also used in IV preparations

Question 8

Water miscible solvents - cosolvents

Answer 8

PEG can be used IV at concentrations as high of 40% (v/v)
Ethyl alcohol can be used up to 10% (v/v)

Question 9

Oils as injectables

Answer 9

Straight liquid oil IV is a BIG NO
Oil emulsion is ok for IV injection
Oil is distributed into small droplets that are even smaller than RBCs
No risk of embolism
Solution is NOT emulsion
Oil based solutions for IM injection are acceptable and do exist

Question 10

Emulsions

Answer 10

Emulsion CONTAINS oil, but is not oil
Some emulsions (P.N.) are administered by IV route

Question 11

Antimicrobial Preservatives

Answer 11

Used for multi dose preparations
Benzyl Alcohol 0.9% is the most common preservative
Parabens: Combination of methyl and propyl parabens, 0.18% and 0.02%
Cresol
Compatibility issues

Question 12

T/F: antimicrobials are not very effective in non-aqueous (oil base) formulation

Answer 12

True

Question 13

Parenteral preps-antimicrobial

Answer 13

ONLY preps intended for multiple use are allowed to contain an antimicrobial preservative (in the US)

Question 14

Big points on antimicrobial preservatives

Answer 14

If you are going to be punching holes in a sterile container to administer the drug contained in it more than once, you need some type of antimicrobial preservative
Any sterile product intended for multi dose MUST contain antibacterial preservative
Single dose = single use

Question 15

Preservatives recall:

Answer 15

Benzyl alcohol 0.9% is the most commonly used
Generally safe - some people are allergic
DO NOT USE benzyl alcohol in neonates - can produce gasping syndrome
Do not use preps containing antimicrobial preservatives in neonates
Preps intended for the intra-spinal route of admin MUST BE FREE of antimicrobial preservatives

Question 16

pH buffers

Answer 16

Address solubility and or stability issues with the drug
Use at lowest concentration as necessary

Question 17

Common buffers:

Answer 17

Citrates - some caution. Safe by IV, very irritating by IM or SC routes
Acetates
Phosphates - considerable caution. Potentially fatal DANGER (look for phosphate and calcium together)

Question 18

Keep in mind pH

Answer 18

Citrate can be injected IV no problem - IM or subq irritating
-Phosphate and calcium combined have a strong tendency to precipitate and the result can be fatal
Caution: phosphate and calcium need to be given together in PN preps

Question 19

Buffers: more

Answer 19

Buffers are used to force the pH to remain at a fixed value
Unbuffered solutions are quickly diluted into physiological pH
That is why you want buffers as dilute as possible, so the physiological pH takes over asap

Question 20

Antioxidants and Chelating agents

Answer 20

-Antioxidants
Metabisulfite salts - low pH
Bisulfite - intermediate ph
Sulfite - high pH
Ascorbic acid
-Chelating agents
Most common: sodium EDTA
Enhance antioxidant’s effect
Sequester trace metals