chapter 15 Flashcards
injections
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)
parental routes of administration
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
intravenous route
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)
intramuscular route
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)
Subcutaneous route
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
intradermal route
corium of skin
very small volume (0.1 mL)
sites
-arm and back
diagnostic measures
-tuberculin testing
allergy testing
injectable emulsion
liquid preparation of drug substance dissolved or dispersed in a suitable emulsion medium
ex. Propofol
injectable suspension
liquid preparation of solid suspended in a suitable liquid medium
ex. Methylprednisolone acetate suspension
for injectable suspension
dry solid that yields preparation rules in all respects to the requirements for injectable suspensions
ex. imipenem and cilastatin for injectable suspension
parenteral injections
are always sterilized, must meet sterility standards and exceed allowable endotoxin limits
solvents and vehicles for injections
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
nonaqueous vehicles for injections
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
added substances
drug
isotonic agents
-NaCl, dextrose
buffer agents
-chemical degradation
antimicrobial
-thimerosal, benzoyl alcohol
antioxidants
-sodium bisulfite (aqueous)
-ascorbic acid (aqueous)
sterilization
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
methods of sterilization
-steam sterilization
-dry heat sterilization
-filtration
-gas sterilization
-ionizing radiation
steam sterilization
-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
dry heat sterilization
-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
filtration
-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
gas sterilization
-destruction of all living microorganisms with a chemical in a gaseous or vapor state (ethylene oxide or propylene oxide)
-advantages/disadvantages (penetrates)
ionizing radiation
-UV light
-gamma radiation
pyrogens
-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)
industrial preparation of parental products
formulation
-solvents, additives
preparation
-pyrogens, sterilization
packing
-type of dosing
-type of packing
special packing
-Mix-O-vial
-ADD-vantage
containers
types of dosing
-single dose containers
-multiple dose containers
types of packaging
-ampuls
-vials
-pre-filled syringes
ampuls
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
vials
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)
packaging of injections
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
laminar flow hood
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
labelin of injections
-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)
quality control
sterility test
pyrogen test
clarity test
-size range
-number of particles
-methods of monitor (coulter counter)
leaker test
-ampuls
USP official tests for parenterals
Chapter <797>
published in fall of 2003
went into effect January 1, 2004
addresses compounding, preparation and labeling of sterile drug preparations
compounding sterile preparations
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
factors of compounding sterile preparations
-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
minimizing the source of contamination
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)
air quality
-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
Compounding personnel
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
sources of contamination
-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
low risk compounding
-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
medium-risk compounding
-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
high risk compounding
-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
devices for insulin
-insulin pens
-insulin infusion pump
rapid acting insulin
insulin lispro
-compatible with ultralente and NPH
insulin aspart
-compatible with none
short acting insulin
regular insulin
-compatible with all
immediate acting insulin
isophane (NPH) insulin
- compatible with regular
insulin-zinc (lente)
- compatible with regular and semilente
long acting insulin
insulin-zinc extended (ultralente)
- compatible with regular and semilente
insulin glargine
- compatible with none
mixture insulin
-isophane/regular insulin 70/30, 50/50.75
-NPL/lispro mix 75/25
large volume parenterals
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
special consideration for parenteral therapy
standardization of intravenous concentrations
look alike products
adsorption of drugs
absorption of drugs
handling and disposal of chemotherapeutic agents for cancer
irrigation and dialysis
- 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
peritoneal dialysis
-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
hemodialysis
-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
