FPS Exam 2 > Parenteral > Flashcards

Parenteral Flashcards

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1
Q

What are Injections?

3 - type of prep, administration

A
  1. Sterile
  2. pyrogen-free preparations
  3. intended to be administered parenterally.
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2
Q

What does ‘Parenteral’ prefix and suffix mean?

A

Para = outside; enteron = intestino.

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3
Q

What is ‘Pyrogen’?

A

Fever-producing organic substance arising from microbial contamination.

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4
Q

What are the 4 Common routes of injectable drug administration?

A

Intravenous (IV), Intramuscular (IM), Subcutaneous (SC or SQ), Intradermal (ID).

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5
Q

What are the 3 Devices for Parenterals?

A
  1. Hypodermic needles,
  2. Syringe
  3. needles.
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6
Q

What are the 3 parts of Hypodermic needles?

A

Hub + shaft + bevel.

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7
Q

What is the relationship between the needle gauge and diameter of the needle shaft?

A

The larger the number, the smaller the diameter.
13 (largest diameter) to 28.

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8
Q

What is the Bevel of a Needle?

A

Bevels are slanting edges cut into needle tips to facilitate injection through tissue or rubber vial closures.

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9
Q

When are Short-bevel needles used?

A

When only shallow penetration is required.

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10
Q

What kind of bevel do intravenous injections use?

A

Short-bevel needles.

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11
Q

What are Regular-bevel needles suitable for?

A

Subcutaneous and intramuscular injections.

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12
Q

What are the 3 basic parts of a Syringe?

A

Barrel, plunger, and tip.

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13
Q

What is the barrel of a syringe?

A

A tube that is open at one end and tapers into a hollow tip at the other end.

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14
Q

What is the plunger of the syringe?

A

A piston-type rod with a slightly cone-shaped top that passes inside the barrel of the syringe.

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15
Q

What does the tip of a syringe provide?

A

The point of attachment for a needle.

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16
Q

What are the 3 common types of syringe tips?

A

Slip-Tip®, Luer-Lok®, and eccentric.

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17
Q

What are the 6 advantages of Parenteral routes of administration?

A
  1. Emergency
  2. rapid drug action
  3. uncooperative or unconscious patients
  4. unreliable absorption from GI tract
  5. inactivation or destruction from GI tract
  6. low concentration of drug required.
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18
Q

What are the 6 Disadvantages of Parenteral routes of administration?

A
  1. Increased chances for adverse reaction
  2. medications difficult to withdraw
  3. invasive
  4. difficult to manufacture
  5. sterility requirements
  6. needs health professionals.
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19
Q

What are the 4 Dosage forms for Parenterals ROUTE?

A
  1. Aqueous
  2. aqueous-alcohol solutions
  3. vegetable oil solutions
  4. powders to make solutions.
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20
Q

What is the 4 USP Official types of materials that can be administered via Injections?

A
  1. Liquid drugs or solutions
  2. dry solids powders - reconstituted with suitable vehicles into liquids for injection
  3. injectable suspension
  4. injectable emulsion.
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21
Q

What is the definition of Injectable emulsions?

A

Liquid preparations of drug substances dissolved or dispersed in a suitable emulsion medium.

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22
Q

What is the definition of Injectable suspension?

A

Liquid preparations of solids suspended in a suitable liquid medium.

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23
Q

What is the USP number for classifying injectables?

A

USP <1>.

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24
Q

What does USP <1> classify injectables as?

A
  1. SVPs - < 100 mL
  2. LVPs > 100 mL.
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25
How can Small Volume Parenterals (SVPs) be given?
Rapidly in a small volume.
26
What are SVPs a type of injection known as?
A bolus.
27
How much are SVPs provided for IV, IM, & SQ?
IV, IM - up to 4ml, SQ - 2ml.
28
What can SVP be added to?
LVPs
29
What are SVPs packaged in? 5
1. Vials 2. ampoules 3. cartridge 4. syringes 5. bottles
30
What are examples of SVPs? | 3
1. **Solutions** ready for Injection 2. **suspensions** ready for injection 3. **Dry soluble **pdts w/ no excipients but ready to be combined w/ a **solvent** just prior to use
31
What are Large Volume Parenterals (LVP) usually administered in?
100 ml - 1 L per day by slow IV drip
32
What do Common uses of LVP solutions include? | 3
1. Patient entering or recovering from surgery 2. replenishing body fluids and electrolytes 3. total parenteral nutrition (TPN).
33
Do LVP solutions have bacteriostatic agents or other additives/excipients & why or why not?
No, because of large volume.
34
What must Pharmacists be aware of when using LVPs?
The physical and chemical compatibility of additives present in an LVP.
35
For Water for injection, USP, what must it be?
Pyrogen-free.
36
Does Water for injection, USP, have to be sterile?
No unless if used in drug production which will be sterilized.
37
For Sterile Water for Injection, USP, what must it be?
Pyrogen-free and low endotoxin level
38
Can Sterile Water for Injection, USP, contain preservatives?
No.
39
What is Sterile Water for Injection, USP, used to do?
Reconstitute sterile powders for injection.
40
What is Bacteriostatic Water for Injection, USP?
SWFI with an antimicrobial agent – benzyl alcohol 0.9%.
41
When is Bacteriostatic Water for Injection, USP not used and what should be used instead?
If > 5ml is needed, then use sterile water.
42
What are susceptible to toxic effects of benzyl alcohol?
Neonates.
43
For Sodium chloride Injection, USP, what is the solution?
Sterile isotonic solution 0.9%.
44
What does Sodium chloride Injection USP not contain?
Antimicrobial agents.
45
What does Bacteriostatic Sodium Chloride Injection, USP contain?
Benzyl alcohol.
46
What is Bacteriostatic Sodium Chloride Injection, USP not used in?
Neonates.
47
What does Benzyl alcohol cause in premature infants?
Gasping syndrome, organ failure and death.
48
What are some solvents and Vehicles for Injections that are Non-aqueous?
Vegetable oils, Alcohol, Polyethylene glycols, Propylene glycol, Ethyl oleate, Isopropyl myristate, Dimethylacetamide, Glycerin.
49
How should vegetable oils be stored?
Need to remain clear when cooled to 10° C to ensure stability and clarity of the injectable product during refrigeration.
50
What’s a warning when using vegetable oil?
Allergic reactions to specific oils, must be non-irritating and nontoxic.
51
What are some types of vegetable oils?
Corn oil, Cottonseed oil, Peanut oil, Sesame oil, Olive oil, Castor oil.
52
When is Glycerin used for parental solutions?
If a drug has limited water solubility or is susceptible to hydrolysis.
53
How must glycerin be given for parental solutions?
IM.
54
What are 7 Characteristics of a Diluent for parental solutions?
Stability at various pH levels, viscosity, boiling point for sterilization, miscibility with body fluids, low vapor pressure, ease of purification and standardization, does not contain mineral oil or paraffin.
55
What does the USP permit for added substances in parental solutions?
Antibacterial preservatives, buffers, solubilizers, antioxidants and other substances to increase stability and are harmless.
56
What do Multidose vials (MDV) require?
An antimicrobial unless the drug itself is bacteriostatic.
57
What are Preservatives potentially like at high levels?
Toxic or irritating on injection.
58
What are the 5 Methods of Sterilization?
Steam Sterilization, Dry Heat Sterilization, Sterilization by Filtration, Gas Sterilization, Sterilization by Ionizing Radiation.
59
What must products have to be for Steam sterilization?
Stable at this temperature and stable to moisture.
60
What is needed to sterilize using Steam sterilization?
Water.
61
What is MOA in steamed sterilization?
Bacteria are coagulated and destroyed.
62
What is not appropriate for steam sterilization?
Products - Oils, fats, oleaginous preparations, powders.
63
What does Dry heat sterilization require?
Higher temperatures and longer time than moist heat.
64
What is the relationship between time and temperature for dry heat sterilization?
Time increases as temperature decreases due to stability of the substance.
65
What is Dry heat sterilization used for?
Oils, glycerin, petrolatum products, some powders that are not effectively sterilized by moist heat.
66
What is the Filtration MOA?
Physical removal of micro-organisms by adsorption on the filter medium or by a sieving mechanism.
67
What is Filtration used for?
Heat-sensitive solutions.
68
Is 0.22 micron sterile?
Yes, since the smallest bacterium is 0.2 micron.
69
What is the Filtration size issue?
Some drugs are removed from the solution if the filter is too small.
70
Should Biologics be filtered?
No, unless instructed to by the manufacturer.
71
For Gas sterilization, the gas is very flammable unless what?
Unless it’s diluted with CO2 or other inert gas.
72
What is the MOA of Gas sterilization?
Thought to sterilize by interfering with the metabolism of the bacterial cell.
73
Why do catheters, needles, and plastic disposable syringes undergo gas sterilization?
Due to great penetrating qualities of ethylene oxide.
74
What type of sterilization do Heat labile enzyme preparations undergo?
Gas sterilization.
75
What do Heat labile enzyme preparations include?
Antibiotics.
76
How does gamma irradiation work?
High-energy photons are emitted from an isotope source (Cobalt 60) producing ionization radiations that damage the DNA and other cellular structures.
77
What is gamma irradiation used for?
Can effectively sterilize a wide variety of products composed of different materials.
78
What is Gamma radiation ideal for? | 3
1. Sterilization of single-use medical supplies 2. elimination of organisms from pharmaceuticals 3. sterilization of tissue/biological based products.
79
What are the Sterility Testing of Product?
Rabbit pyrogen test, Limulus Amebocyte Lysate (LAL) test, Bacterial Endotoxins Test USP.
80
What is the goal of Bacterial Endotoxins Test USP?
Prevent introduction of endotoxins in the preparation
81
What is the Most commonly used Sterility Testing of Product?
Most commonly used today (more sensitive).
82
What is the most commonly used sterility testing of product?
LAL
83
What happens during the Rabbit pyrogen test?
1. drug is injected into a lab rabbit 2. IF temp increases - positive for endotoxins.
84
What are the 4 Quality Standards & Requirements for injections?
Sterile, pyrogens or bacterial endotoxins limit, label, added substances.
85
What must the labels of injections include?
Lists names and amounts of all ingredients, and permits viewing container contents.
86
What are some added substances for injections?
Antimicrobial preservatives; GRAS solvents, pH buffers, **tonicity** agents, stabilizers, antioxidants; colorings prohibited.
87
What is the packaging for Single Dose Container?
No preservatives – vials or ampules.
88
What is the packaging for Multiple Dose Container?
Requires a bacteriostatic chemical – benzyl alcohol or methyl paraben.
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