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Sterile solution dosage forms Flashcards

Exam 2 Content (Pinal's Lectures)

1
Q

Aseptic Technique

A

Manipulation of materials in such a way as to avoid accidental introduction of microorganisms

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2
Q

What areas is aseptic technique used?

A

Surgical and Pharmacy (pharmacy is more stringent)

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3
Q

USP 797

A

used for ALL injectables

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4
Q

USP 800

A

used for HAZARDOUS drugs, if they are injectable then they also fall under USP 797

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5
Q

Three sources of aseptic technique contamination

A

-people (main source)
-equipment
-environment

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6
Q

How do we take care of contaminations?

A

-environment: control it (set standards for first air)
-equipment: sterilize it and sanitize it (disinfection)
-people: train, garb, develop good habits, test them (once a year min.)

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7
Q

Training and Knowledge

A

More experience doesn’t mean that you’re doing it right

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8
Q

PEC

A

primary engineering control/laminar flow LAFW

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9
Q

Laminar flow

A

streamline flow of a fluid in which the fluid moves in layers without turbulence

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10
Q

HEPA filtered

A

VERY CLEAN (ISO Class 5)
-has <100 particles per 0.5 microns per cubic foot

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11
Q

Horizontal flow

A

-type of laminar flow hood
-air is blowing on your face
-easier to make someone confident

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12
Q

Vertical flow

A

-type of laminar flow hood
-air is coming from ABOVE the hood
-used for HAZARDOUS drugs (so it doesn’t blow back in your face)

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13
Q

Isolators

A

closed system, nothing is exposed to the outside environment

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14
Q

Critical site

A

-a point where microorganisms are other contamination could enter a parenteral product
-ex: hole when piercing a rubber stopper

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15
Q

Direct compounding area

A

-critical area
-space between the HEPA filter and the critical site
-must keep uninterrupted laminar air flow in this area (First air)

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16
Q

Is the laminar flow hood a sterile environment?

A

No, it is VERY CLEAN but not sterile

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17
Q

First air

A

the air exiting the HEPA filter in a unidirectional air stream

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18
Q

OsmolaLity

A

the concentration of particles dissolved in solution (osmoles of solute per kg of solvent)

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19
Q

OsmolaRity

A

-number of osmoles of a solute in a LITER of solvent
-whether they dissociate
-measured by an osmometer

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20
Q

Osmosis

A

-diffusion of water
-water flows from HIGH concentration (of water) to LOW concentration (of water) to DILUTE the more solute concentrated side
-semipermeable membrane

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21
Q

Iso-osmotic

A

-maintaining and possessing a uniform tension or tone of the cellular membrane of the cell
-same m-particles and concentration of the BLOOD SERUM

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22
Q

Isotonic

A

cells will stay alive
-is something is isotonic, then the cell will be able to tolerate that concentration

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23
Q

What are the two ways that concentration equalizes?

A

Diffusion and Osmosis

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24
Q

Diffusion

A

-SOLUTE moves from HIGH to LOW
-permeable membrane

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25
What kind of membrane do cell membranes have?
semipermeable (some things can cross, others can't)
26
Impermeable
nothing goes through (cell starves)
27
Permeable
everything goes through (cell ends as an empty shell and dies)
28
Do cells want to fold or expand?
FOLD, if a HYPOtonic vehicle is administered then it can burst the cell
29
How do you measure the osmolarity and osmolality of a preparation?
Osmometer through the use of colligative properties
30
What are the colligative properties?
-freezing point depression -lowering of vapor pressure -OSMOTIC PRESSURE -elevation of boiling point
31
m-particle
molecules or ions (not the chemical nature of the dissolved materials)
32
Are colligative properties integrated?
Yes, if you know one property then you can figure out the other properties
33
When can osmolarity and osmolality be used interchangeably?
at LOW concentrations, dangerous if we treat them at HIGH concentrations
34
What is the serum osmolality?
275 - 310 mOsmol/kg 275 is D5W and 310 is normal saline (demonstrating a wide range)
35
Tonicity
refers to the effect on LIVING cells
36
What is the relationship between iso-osmotic and isotonic
-if a solution is isotonic then it is also osmotic -mixing iso-osmotic solutions, the solution will stay iso-osmotic -mixing isotonic solutions you get an isotonic solutions
37
Are normal saline and D5W interchangeable?
they are both isotonic but NOT interchangeable (check the monograph/package insert)
38
What will happen if you add an iso-osmotic solution to dissolve a large amount of drug?
you will get a HYPERosmotic solution
39
Which is better, a HYPER-osmotic solution or a HYPO-osmotic solution?
HYPER-osmotic solution since it will shrink cells, while HYPO-osmotic solutions will burst the cells -iso-osmolarity is always desirable though
40
Peripheral
-accessed through needles -uses over the needle catheter (helps stabilize)
41
Central
-peripherally-inserted central catheter (used for long doses of treatment or long term treatment) -surgically implanted
42
For storage uses, how are emulsions stored?
glass vials (haven't figured out how to store in plastic bags)
43
What are the peripheral access administration sets?
basic set add-a-line set volume-control set
44
Basic administration set
has only ONE y-site
45
Add-a-line set
-has TWO y-sets -good to administer drugs that don't mix/like to interact with other drugs
46
Volume-control set
-characterized with a long plastic container -used for volume control and dilution -good for accuracy
47
Benefits of ADD-vantage system
-characterized by a vial and bag with seals -maintains sterility and aseptic technique when mixing drugs -decreases the risk of contamination
48
Disadvantages of ADD-vantage system
more expensive
49
What are the two types of administration sets?
Macrodrip (standard) Microdrip
50
Characteristics of a macrodrip
-delivers large quantities -faster rates (10, 15, 20 gtt/mL)
51
Characteristics of a microdrip
-delivers smaller quantities -60 gtt/mL -used in pediatrics -also used for patients that need a small/closely regulated amounts of IV solution
52
What are the components of resistance to flow?
-tubing (thin diameter = tougher to go through) -in-line filter ("a wall" might oppose the flow) -viscosity of IV fluid (challenging to push through small tubing) -length of tubing (longer tubing = increased friction) -venous backpressure (position of the patient)
53
Excess volumes of parenteral products
-the labeled mL is not the exact amount (it will contain more to ensure they can pull the exact amount) -viscous liquids have more excess - >50mL solutions will have a constant error
54
What things influence the drop conversion factor?
-viscosity of the CSP -surface tension -density
55
Uses of Central Venous Therapy
-infusion of LVPs (since it can be diluted quickly) -multiple infusions -long-term infusion therapy ((avoid being sticked more) -infusion of irritation medications such as potassium (due to quick dilution) -Parenteral nutrition
56
PICC (peripherally inserted central catheter)
-inserted through the arm and is inserted into the SUBCLAVIAN VEIN -a very complex insertion -can also be inserted through the neck into the jugular vein
57
Central vein catheter (CVC)
-surgically implanted -can have multiple lumens (allowed to give multiple medications through the same line)
58
What are the two common names of central lines?
-Hickman -Brovaic
59
Characteristics of the Hickman catheter
-requires surgical insertion (inserted through the chest into the subclavian vein) -has a dacron cuff
60
Dacron cuff
-used in Hickman catheters -plugs the hole so bacteria can't enter the hole -keeps the catheter in place -biocompatible (to avoid an immune response)
61
What is a Vascular Access Port
-surgically implanted and goes under the skin (no exposure to the outside world) -pay attention to the SEPTUM
62
What needle is required in Vascular Access Ports
a NON-CORING NEEDLE (right angle?)
63
Advantages of Central Venous Therapy
-access to central veins -rapid infusion of LVPs -draw blood and measure CV pressure -reduced need for repeated vein punctures -reduced risk of vein irritation when giving irritable drugs
64
Risks of Central Venous Therapy
-sepsis -thrombus formation -perforation of vessel and adjacent organs -air embolism
65
Disadvantages of Central Venous Therapy
-cost -requires more skill to insertR
66
Risks of infusion
-stenosis (narrowing of the vein) -thrombus (clot) -venous occlusion -chemical inflammation (phlebitis) and pain
67
What are two instruments that are used to control flow?
Controllers (not used as much anymore) Pumps (standard)
68
Characteristics of infusion controllers
-powered by gravity -controls the speed by opening and closing
69
Characteristics of infusion pumps
-powered devices -has a wide range of pressures that accounts for vein and artery (2-12 psi) -always to check the pump, don't set it up and leave
70
Features of infusion pumps
-volumetric delivery (independent of vascular back pressure, infusion composition, and tubing resistance) -has alarms (ONLY ALRMS WHEN SOMETHING IS WRONG WITH THE PUMP NOT SITE OF ADMINSTRATION)
71
Syringe Pumps
-very useful for giving intermittent IV medications -gives good control for small volume infusions -useful for pediatric patients
72
Patient controlled analgesia (PCA)
-given for cancer patients where they push the button to administer pain meds
73
Ambulatory pumps
-for shorter use -external pump -used to measure sugar and administer drugs
74
Implantable pumps
-for chronic users -internal implantation

Dosage Forms II (8 decks)

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