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dosage 2 > lecture 3 > Flashcards

lecture 3 Flashcards

1
Q

reasons for concerns

A

-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

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2
Q

about USP chapters

A
  • Chapters with number > 1000 – Recommendations (nice to have)
  • Chapters with number < 1000 – Enforceable (must follow)
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3
Q

USP 797

A
  • 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
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4
Q

parenteral products

A
  • 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
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5
Q

what are the requirements for parenterals

A

-sterile
-particle free
-pyrogen free

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6
Q

considerations about parenteral products

A
  • 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
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7
Q

compounding sterile preparations in all dosage forms

A

-has the right potency
-is properly labeled

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8
Q

how is sterilization achieved

A
  • Steam (autoclave)
  • Filtration (bacteria retentive membrane)
  • Dry heat (oven)
  • Gas (ethylene oxide)
  • Irradiation (gamma rays)
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9
Q

where do pyrogens come from

A

For the most part, they are remnants form microorganisms

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10
Q

what are pyrogens

A

Also called bacterial endotoxins, are contaminants that “produce fever.” They can also produce septic shock

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10
Q

septicemia

A

infection of the blood

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11
Q

septic shock

A

acute reaction to bacterial endotoxins

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12
Q

why do sterile preparation need to be particle free

A
  • Foreign particles can trigger immune response
  • Can produce damage to the lungs
  • Can produce damage to the kidneys
  • Can and have killed people
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13
Q

types of parenteral products

A
  • 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
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13
Q

drug injection

A

Liquid preparations that are drug substances or
solutions thereof.

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14
Q

drugs for injection

A

Dry solids or liquid preparations that, upon
the addition of suitable vehicles, yield solutions conforming in all respects to the requirements for Injections

14
Q

drug injectable suspension

A

Liquid preparations of solids suspended in a suitable liquid medium

15
Q

drug injectable emulsion

A

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

16
Q

drug for injectable suspensions

A

Dry solids that, upon the addition of suitable vehicles, yield preparations conforming in all
respects to the requirements for Injectable Suspensions.

17
Q

for means

A

don’t use it as is; you have to do something to it before injecting

18
Q

LVP

A

-large volume parenteral
-single dose injections packaged in container containing more than 100mL

19
Q

small volume parenterals

A

100mL or less

20
Q

vehicles of parenteral products

A
  • 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
20
Q

WFI

A

-water for injection USP
-pyrogen free, non sterile, single use sealed containers

21
Q

SWFI

A

-sterile water for injection USP
-pyrogen free, sterile, packed in sealed containers not larger than 1000mL

22
Q

BWFI

A

-bacteriostatic water for injection USP
-pyrogen free, sterile with antimicrobial agents added

23
Q

SWFI is _______ but never ever _____

A

-pharmacologically/biologically safe, sterile, particle free, pyrogen free
-never inject plain water directly into the blood stream

dosage 2 (6 decks)

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