reasons for concerns
-study after study has shown that uncontrolled environments are still in use
-inadequate controls increase the incidence of medication errors
*incorrect ingredients
*incorrect strengths of ingredients
*contamination with pathogens
*contamination with pyrogens
about USP chapters
- Chapters with number > 1000 – Recommendations (nice to have)
- Chapters with number < 1000 – Enforceable (must follow)
USP 797
- It is the law of compounding sterile
(parenteral) preparations (admixtures) - Every pharmacist must be familiar with it, as it
is part of your general knowledge - If you have anything to do with parenteral
products, you must be able to interpret USP
<797> and apply it - The CoP has a license for Purdue students to
access the document from USP
parenteral products
- From a strict etymological point of view, the term
parenteral means “other than through the GI tract” - In practice however, the term is restricted to
products administered by injection - The conventional meaning of the term involves all injectable products
what are the requirements for parenterals
-sterile
-particle free
-pyrogen free
considerations about parenteral products
- Administration of the therapeutic agent requires an injury to the body
- Administration bypasses the body’s natural defense barriers
- Administration makes the body vulnerable
- Must meet some stringent requirements
compounding sterile preparations in all dosage forms
-has the right potency
-is properly labeled
how is sterilization achieved
- Steam (autoclave)
- Filtration (bacteria retentive membrane)
- Dry heat (oven)
- Gas (ethylene oxide)
- Irradiation (gamma rays)
where do pyrogens come from
For the most part, they are remnants form microorganisms
what are pyrogens
Also called bacterial endotoxins, are contaminants that “produce fever.” They can also produce septic shock
septicemia
infection of the blood
septic shock
acute reaction to bacterial endotoxins
why do sterile preparation need to be particle free
- Foreign particles can trigger immune response
- Can produce damage to the lungs
- Can produce damage to the kidneys
- Can and have killed people
types of parenteral products
- Solutions ready for injection
- Dry, soluble preparations ready to be combined with a solvent before use
- Suspensions ready for injection
- Dry, insoluble preparations ready to be combined with a vehicle before use
- Emulsions
- Liquid concentrates ready for dilution prior to
administration
drug injection
Liquid preparations that are drug substances or
solutions thereof.
drugs for injection
Dry solids or liquid preparations that, upon
the addition of suitable vehicles, yield solutions conforming in all respects to the requirements for Injections
drug injectable suspension
Liquid preparations of solids suspended in a suitable liquid medium
drug injectable emulsion
Liquid preparations of drug substances dissolved or dispersed in a suitable emulsion medium
drug for injectable suspensions
Dry solids that, upon the addition of suitable vehicles, yield preparations conforming in all
respects to the requirements for Injectable Suspensions.
for means
don’t use it as is; you have to do something to it before injecting
LVP
-large volume parenteral
-single dose injections packaged in container containing more than 100mL
small volume parenterals
100mL or less
vehicles of parenteral products
- Solvents or mediums for the administration of therapeutic agents
- Whatever the vehicle, it must meet USP standards for the pyrogen (aka bacterial endotoxin) test
- “Water” is the most common vehicle used in parenteral products
- Water is actually the preferred vehicle
WFI
-water for injection USP
-pyrogen free, non sterile, single use sealed containers
