Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

ceutics concepts > chapter 15 > Flashcards

chapter 15 Flashcards

1
Q

injections

A

sterile (absence of living organisms KILL THEM ALL)

pyrogen free
- pyrogens are fever-producing organic substances arising from microbial contamination

administered parenterally by health professions (except insulin)

liquid preparations that are drug substances or solutions (insulin injection)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

parental routes of administration

A

intravenous route
- directly into circulation

intramuscular route
-muscle mass, mid-deltoid area and gluteus medius

subcutaneous route
-subcutaneous tissue beneath skin layers
- arm or thigh

intradermal route
-the most superficial skin layer

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

intravenous route

A

bolus
- single, small-volume injection

infusion
-slow, large volume
-continuous
-intermittent

aqueous solutions
-no precipitated drug after injection (emboli)
-fat emulsion for caloric sources (vs glucose)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

intramuscular route

A

deep into skeletal muscle
-gluteal or lumbar muscles
-minimized hitting nerve or blood vessel

solutions (aqueous or oleaginous) & suspensions
-low drug solubility
-sustained drug action
-suspension of penicillin G benzathine (7-10 days)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Subcutaneous route

A

loose subcutaneous tissue
-small volumes (2 mL or less)

sites
-forearm, upper arm, thigh etc

aqueous solutions

suspensions
-depot or repository for prolonged action

pellets
-implantation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

intradermal route

A

corium of skin

very small volume (0.1 mL)

sites
-arm and back

diagnostic measures
-tuberculin testing
allergy testing

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

injectable emulsion

A

liquid preparation of drug substance dissolved or dispersed in a suitable emulsion medium

ex. Propofol

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

injectable suspension

A

liquid preparation of solid suspended in a suitable liquid medium

ex. Methylprednisolone acetate suspension

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

for injectable suspension

A

dry solid that yields preparation rules in all respects to the requirements for injectable suspensions

ex. imipenem and cilastatin for injectable suspension

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

parenteral injections

A

are always sterilized, must meet sterility standards and exceed allowable endotoxin limits

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

solvents and vehicles for injections

A

water (distillation, filtration, others)
-water for injection
-sterile water for injection
-bacteriostatic water for injections

sodium chloride
-sodium chloride injection
-bacteriostatic sodium chloride injection

ringer’s injection
-NaCl, KCl and CaCl2 (physiologic fluids)
-lactated ringer’s injection

dextrose

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

nonaqueous vehicles for injections

A

fixed oils
-must be of vegetable origin
-must be liquid at room temp (unsaturated)
-free acids (muscle irritation)
-corn oil, cottonseed oil, peanut oil, sesame oil

water miscible substances
-glycerin, polyethylene glycols, propylene glycol, alcohol

other (lesser used)
-ethyl oleate, isopropyl myristate, dimethylacetamide

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

added substances

A

drug

isotonic agents
-NaCl, dextrose

buffer agents
-chemical degradation

antimicrobial
-thimerosal, benzoyl alcohol

antioxidants
-sodium bisulfite (aqueous)
-ascorbic acid (aqueous)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

sterilization

A

sterility
-absence of life

sterilization
-complete destruction of all viable organisms

disinfectant
-substance used on inanimate objects to render them noninfectious

antiseptic
-substance used to prevent sepsis

pyrogen
-fever producing substance

considerations in sterilization
-application of adequate sterilization treatment
-verification that the materials are sterile
-protection of the sterile material
-delivery, opening, and use of the sterile material without entrance of contamination

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

methods of sterilization

A

-steam sterilization
-dry heat sterilization
-filtration
-gas sterilization
-ionizing radiation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

steam sterilization

A

-moist heat in the form of saturated heat under pressure (autoclave)
-most reliable method for destruction of ALL microorganisms
-kills by result of coagulation of some protein in the cell (bacteria easier than spores)
-121.5 C for 20 min, 15 psi

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

dry heat sterilization

A

-sterilizing ovens
-microorganism death by oxidation process
- good for dry glassware, petroleum jelly, mineral oils, talcum powder, some dry powders
- typical at 150 C to 170 C for no more than 2 hours
-not all drugs stable at this temp

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

filtration

A

-for solutions that can’t be heated
- filters work by interlacing pores bacteria or particles become entrapped in pores then removed
-0.22 micron (viruses less than 0.025 micron)
- millex filter unit

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

gas sterilization

A

-destruction of all living microorganisms with a chemical in a gaseous or vapor state (ethylene oxide or propylene oxide)
-advantages/disadvantages (penetrates)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

ionizing radiation

A

-UV light
-gamma radiation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

pyrogens

A

-cause febrile reactions
- gram negative bacteria (endotoxins/lipopolysacchride)
-gram positive bacteria (endotoxins)
-can be destroyed (using heat 250C for 4 hrs or barium hydroxide filter)
-pyrogen test (USP rabbit test)
-endotoxin test (limulus polyphemus or horseshoe crab)

22
Q

industrial preparation of parental products

A

formulation
-solvents, additives

preparation
-pyrogens, sterilization

packing
-type of dosing
-type of packing

special packing
-Mix-O-vial
-ADD-vantage

23
Q

containers

A

types of dosing
-single dose containers
-multiple dose containers

types of packaging
-ampuls
-vials
-pre-filled syringes

24
Q

ampuls

A

oldest type of parenteral product containers made up entirely of glass

ampul sealing

intended for single use only
-opened by breaking the glass at a score line on the neck

product must be filtered before administration
-because glass particles may become dislodged during opening

25
Q

vials

A

glass/plastic containers closed with rubber stopper and sealed with an aluminum crimp

advantage over ampuls
-multiple doses (w/bacteriostatic agent)
-easier to remove the product
-eliminate the risk of glass particle contamination

disadvantage
-rubber stopper may become cored
-multiple withdrawals may cause microbial contamination

glass containers
-type 1 (borosilicate)
chemical resistant, low thermal coefficient of expansion
-type 2 (soda-lime treated glass)
lower concentration of migratory oxides that 3, treated with sulfur oxide to dealkalize the internal surface, solution pH less than 7
-type 3 (soda-lime glass)
-good for anhydrous liquids or dry substances

plastic containers
-plastic polymers (PVC or polyolefin)
-PVC is flexible and nonrigid
-polyolefin is semi-rigid and can be stored upright
-advantages over glass (unbreakable, easier storage, reduced weight, improved safety)

26
Q

packaging of injections

A

infusion solutions
-for continuous infusion of fluids or drugs

small volume parenterals (SVP)
-volume less that 100 mL

large volume parenterals (LVP)
-volume of 100 mL or greater

27
Q

laminar flow hood

A

highly efficiency particulate air filters

classified as federal class 100
-no more than 100 particles sized 0.5 um or larger per cubic ft of air

types
-vertical and horizontal

28
Q

labelin of injections

A

-name of preparation
- for liquid preparation, the % content of drug or amount of drug in specified volume
-dry preparation, amount of active ingredient present and volume of liquid to be added to make solution or suspension
-route of administration
-statement of storage conditions and expiration date
-name of manufacturer and distributor
-identifiable lot number that yields the complete manufacturing history (manufacturing, filling, sterilizing, and labeling operations)

29
Q

quality control

A

sterility test

pyrogen test

clarity test
-size range
-number of particles
-methods of monitor (coulter counter)

leaker test
-ampuls

USP official tests for parenterals

30
Q

Chapter <797>

A

published in fall of 2003

went into effect January 1, 2004

addresses compounding, preparation and labeling of sterile drug preparations

31
Q

compounding sterile preparations

A

use of cleaner facilities

specific training and testing of compounding personnel in principles and practices of aseptic manipulations

evaluation and maintenance of air quality in the compounding area

sound knowledge of sterilization

principles and practives of solution stability

32
Q

factors of compounding sterile preparations

A

-status components incorporated in the preparation
-process utilized in preparing the preparation
-performance of the personnel involved in the preparation
-environmental conditions under which the process is performed

33
Q

minimizing the source of contamination

A

primary engineering controls
-horizontal flow clean benches
-vertical flow clean benches
-biological safety cabinets
-barrier isolators

secondary engineering controls
-provide a buffer zone or buffer room as a core for the location of the workbenches
-have the cleanest work surfaces (horizontal/vertical workbench or biological safety cabinets/isolators)

34
Q
A
35
Q

air quality

A

-must provide at least ISO Class 5 quality of air which sterile ingredients and components are exposed
-ISO Class 5 quality air means that the number of particles having a particle size 0.5 um and larger contained in the environment doesn’t exceed 3520 particles per cubic meter

36
Q

Compounding personnel

A

USP requires personnel to:
-perform antiseptic hand cleansing and disinfection of non-sterile compounding surfaces
-select and appropriate protective gloves, goggles, gowns, masks, and hair and shoe covers
-use laminar flow hoods, barrier isolators, and other contamination control devices
-identify, weigh and measure ingredients
-manipulate sterile products aseptically, label and quality inspect compounded sterile preparations

37
Q

sources of contamination

A

-solid and liquid matter from compounding personnel and objects
-non-sterile components incorporated before terminal sterilization
-inappropriate conditions within compounding areas
prolonged pre-sterilization procedures with aqueous preparations
-non-sterile dosage forms used in compounding

38
Q

low risk compounding

A

-compounded with aseptic manipulation entirely within ISO class 5 or better air quality environment using only sterile ingredients, products, components, and devices
-only transfer measuring and mixing manipulations with closed or sealed packaging systems performed promptly and attentively

examples
-single transfer of sterile dosage forms from containers as ampules, bottles, bags and vials using sterile syringes with needles
-single transfer of sterile dosage from ampules require filtration to remove any glass particles
-manually measuring mixing no more than three manufactures products to compound drug admixtures and nutritional solutions

39
Q

medium-risk compounding

A

-multiple individual or small doses of sterile products are combined to prepare compounded sterile preparation that is administered to one or more patients on multiple occasions
-includes complex aseptic manipulations besides single-volume transfer
-requires unusually long duration that is required to complete dissolution
-don’t contain broad spectrum bacteriostatic substances and administered over several days (internally worn or implanted diffusion device)

examples:
-compounding TPN fluids using manual or automated devices where there are multiple injections; has attachments/detachments of nutrient source products
-filling reservoirs of injection and infusion devices with multiple sterile drug products and evacuation of air before dispensed and store them at ambient temps (between 25C to 40C)
-transfer of volumes from multiple ampuls or vials into a single sterile container

40
Q

high risk compounding

A

-nonsterile ingredients or non-sterile devices employed before terminal sterilization: baths and soaks for live organs and tissues; implants, inhalations, injections, powders for injection, irrigations, metered sprays and ophthalmic and otic preparations
-sterile ingredients/components/devices are exposed to air quality less than ISO Class 5 and storage in an environment less than ISO class 5 of opened or partially used packages of manufactured sterile products lacking antimicrobial preservatives
-preparations are exposed for at least 6 hours before sterilization

example:
-dissolving non-sterile bulk drug and nutrient powders to make solutions and then terminally sterilized
-measuring and mixing sterile ingredients in non-sterile devices before sterilization is performed

41
Q

devices for insulin

A

-insulin pens
-insulin infusion pump

42
Q

rapid acting insulin

A

insulin lispro
-compatible with ultralente and NPH
insulin aspart
-compatible with none

43
Q

short acting insulin

A

regular insulin
-compatible with all

44
Q

immediate acting insulin

A

isophane (NPH) insulin
- compatible with regular

insulin-zinc (lente)
- compatible with regular and semilente

45
Q

long acting insulin

A

insulin-zinc extended (ultralente)
- compatible with regular and semilente

insulin glargine
- compatible with none

46
Q

mixture insulin

A

-isophane/regular insulin 70/30, 50/50.75

-NPL/lispro mix 75/25

47
Q

large volume parenterals

A

only used for infusions not injections

amino acid
-fluid and nutrient replenisher

dextrose injection, USP
-fluid and nutrient replenisher

dextrose and sodium chloride injection
-fluid, nutrient, electrolyte replenisher

mannitol injection
-diagnostic aid in renal function; diuretic; fluid and nutrient replenisher

ringer’s injection
-fluid and electrolyte replenisher

lactated ringer injection
-systemic alkalinizer; fluid and electrolyte replenisher

sodium chloride injection
-fluid and electrolyte replenisher; isotonic vehicle

48
Q

special consideration for parenteral therapy

A

standardization of intravenous concentrations

look alike products

adsorption of drugs

absorption of drugs

handling and disposal of chemotherapeutic agents for cancer

49
Q

irrigation and dialysis

A
  • sterile products and manufactured by the same standards as intravenous preparations
    -not intended for infusion into venous system

types
-topical administration
packaged in pour bottles and intended for irrigating wounds, moistening dressings and cleaning vaginal instruments

-infusion of irrigation solutions
commonly used for many surgical patients (perfuse tissues, remove blood or clear field of view) and decrease risk of infection

-dialysis solutions
used in patients with disorders such as renal failure or poisoning, remove waste materials/serum electrolytes/and toxic products from the body

ex. peritoneal dialysis and hemodialysis

50
Q

peritoneal dialysis

A

-hypertonic dialysate is infused into the peritoneal cavity by a surgically implanted catheter

-contains dextrose and electrolytes; dialysate removes harmful substances by osmosis and diffusion

-after a specialized dwell period then the solution is removed

-antibiotics and heparin may be added to the dialysate

51
Q

hemodialysis

A

-patients blood is transfused through a dialyzing membrane unit that removes the harmful substances from patients vascular system

  • after passing through the dialyzer the blood reenters the body via a vein

-this method is more likely to send the person to THE HEAVEN because it could get contaminated since blood actually leaves the body

ceutics concepts (4 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions