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PHCY 512 Exam #2 Questions with Correct Answers
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PHCY 512 Exam #2 Questions with Correct Answers
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PHCY 512 Exam #2 Questions with Correct AnswersAbsolute bioavailability Correct Answer-AUC of given dosage form /
AUC of IV
Relative bioavailability Correct Answer-AUC of given dosage form /
AUC of another dosage form
When completing a ANDA and proving generic bioequivalence, the
____________ bioavailability is used Correct Answer-Relative
bioavailability; comparing similar dosage forms (no oral generics for IV
drugs)
To establish bioequivalence, the CI should fall within ________% of the
averages Correct Answer-80-125%
What are the 2 primary advantages of extended release dosage forms?
Correct Answer-Avoids fluctuations (peaks/troughs) in concentration of
drug
- Decreases dosing frequency
What is the rate-limiting step for:
- Immediate-release drugs
- Extended-release drugs Correct Answer-- Absorption across the
biological membrane
- Release of drug from dosage form
,What dosage form features a semi-permeable membrane that allows GI
fluids to enter, releasing drug through a precise orifice? Correct Answer-
Osmotic system (OROS)
Enteric coated tablets dissolve at ___ pH Correct Answer-higher pH
(found deeper in GI tract in colon, large intestines)
Reservoir device Correct Answer-Polymeric membrane allows
controlled diffusion of drug out
Matrix devices
- Main MoA Correct Answer-Allows H20 in, solid drug dissolves from
surface layer, then layer by layer
- Primarily *diffusion* (Fick's law)
- Polymeric nanoparticles use this
Dissolution system
- Main MoA Correct Answer-Polymer dissolves slowly, thus slowly
releasing drug layer
- *Dissolution* controlled by thickness/release rate of polymer
- example is enteric coated
Ion exchange systems
- Examples Correct Answer-Ion exchange resin allows complexation in
GI tract + drug release (displaced by ions)
,- Ex: taste masking, sustained/rapid release, stability, powder processing
- pH variability in body impacts
Ion exchange is a _________ (absorption, adsorption) phenomonenon
Correct Answer-Adsorption due to electrostatic forces
Factors affecting bioavailability
- Drug
- Patient Correct Answer-Drug: physiochemical properties, rate of in
vivo dissolution, complexation, permeability
Patient: age, weight, GI integrity, food, drugs, pH, metabolism,
physiological status
What is the common term used to describe dosage forms that deliver
drug more slowly/precisely than others? Correct Answer-*Extended
release*
What is the difference between sustained and controlled release?
- Which offers better precision? Correct Answer-Sustained: lasts longer
Controlled: absolute control, *very steady (zero order)*
Concerns with extended release dosage forms? Correct Answer-- Ghost
pills: *spooky insoluble parts* of controlled release dosage form seen in
stool
- Patients w/ *increased GI motility* have decreased bioavailability
, - ER forms may contain *large amounts* of drug
- *Dose dump* if mechanism destroyed + *prolonged toxicity*
OROS concerta Correct Answer-- 22% of drug in capsule
- 3 sections (swelling agent pushes drug out of hole)
- SWIMming with possibilities
Disadvantage of OROS dosage forms Correct Answer-May stick to
intestines, releasing all of drug in a small, concentrated area of intestines
(GI bleed, irritation, etc)
Plant virus particle delivery system
- Ex
- Pros
- MoA Correct Answer-- CPMV (cow pea mosaic virus)
- *Benign, easy to manufacture*
- Passes thru GI intact, into blood
- Attach tumor-targeting molecules (signal peptides) to surface +
encapsulate drug
TRUE/FALSE
Generics can utilize different delivery methods than brand medications,
so long as both are IR or XR Correct Answer-FALSE; *must* use the
same delivery system -- if they want to use a novel one, start fresh with
NDA
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