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Dosage Forms Exam 2
Which skin layer presents the major barrier for transdermal drug delivery? - CORRECT ANSWER
stratum corneum If a patch falls off, a new patch should be put to a different skin location to continue drug release.
Why? - CORRECT ANSWER the new patch may have altered drug delivery rate if applied to the
prior skin location (due to compromised skin barrier) Which of the below is NOT an advantage of transdermal drug delivery? A) fast action B) self administration C) needle free, painless deliver D) avoids harsh environment of GI tract and first pass metabolism
E) ease of cessation in case of drug overdose - CORRECT ANSWER A) fast action
A patient is prescribed NicoDerm patch therapy with 14 mg for weeks 1-6 folloed by 7 mg for weeks 7-8. Which of the below is the right advice? (select all) A) after removal of prior patch, new one can be applied to same location B) after removal of prior patch, new patch can be applied to a different location where no patch has been applied C) after removal of prior patch, new patch can be applied to a location where a patch was removed 7 days ago D) after removal of prior patch, new patch can be applied where a patch was removed 3 days ago -
CORRECT ANSWER B) after removal of prior patch, new patch can be applied to a different location
where no patch has been applied C) after removal of prior patch, new patch can be applied to a location where a patch was removed 7 days ago
describe advantages of transdermal drug delivery - CORRECT ANSWER -self-administration
-needle free, painless delivery -avoids harsh environment of GI tract and first pass metabolism
-ease of cessation in case of drug overdose -sustained release -large skin surface area for application
How soon can a patch be applied to a previously used skin location? - CORRECT ANSWER 7 days
later The first generation of TDD systems takes advantage of drug's inherent ability to pass through the stratum corneum layer. Only about a dozen small lipophilic drugs can be successfully delivered with the first generation. Which strategies have been used to enhance TDD in the second generation of systems? A) chemical enhancers B) iontophoresis C) ultrasound
D) all of the above - CORRECT ANSWER
Name the strategies used to enhance transdermal drug delivery in the second generation of TDD
systems - CORRECT ANSWER -chemical enhancers (water, ethanol, PEG, or DMSO)
-physical enhancers such as heat, ultrasound, and iontophoresis
What drugs can be delivered by first generation TDD? - CORRECT ANSWER only about a dozen
small lipophilic drugs Which of the below drugs may be suitable for TDD? A) drug with aqeuous solubility of 0.01 mg/mL B) drug with log partition coefficient of - C) drug with MW <= 500 Da
D) drug with daily dose of 500 mg - CORRECT ANSWER C) drug with MW <= 500 Da
name the 6 physicochemical properties of drugs suitable for TDD - CORRECT ANSWER -good
lipophilicity with log partition coefficient (1-3) -sufficient aqueous solubility (> 0.1 mg/mL) -MW <= 500 Da
F) increased water solubility - CORRECT ANSWER C) increased target binding affinity
name the benefits/advantages of using nanopharmaceutical drugs - CORRECT ANSWER -increased
circulation time -targeted tumor delivery -improved therapeutic efficacy -reduced dosing frequency from extended release -reduced toxicity -increased water solubility -reduced immunogenecity
Nanopharmaceuticals can be used for passive tumor targeting because of.... - CORRECT ANSWER
enhanced permeability and retention effect (tumor cells have big gaps and cannot drain drug properly)
Where is doxorubicin encapsulated in DOXIL and what type of nanopharmaceutical is it - CORRECT
ANSWER inner core; liposome
doxorubicin is a ___-soluble drug - CORRECT ANSWER water
Which is NOT an advantage of formulation of Doxirubicin into liposomal dosage forms? A) reduced cardiotoxicity B) increased circulation time C) reduced immunogenicity
D) increased bioavailability - CORRECT ANSWER C) reduced immunogenicity
name the 3 advantages of formulating doxorubicin into liposomal dosage forms - CORRECT
ANSWER -reduced cardiotoxicity
-increased circulation time -increased bioavailability
what type of nanoparticle is mainly used for DNA/RNA delivery - CORRECT ANSWER lipid
nanoparticles (LNPs) What type of nanoparticle is Cabenuva, the first extended-release injectable for adults with HIV? -
CORRECT ANSWER nanocrystal
What component binds DNA/RNA to form complexes in formulation of lipid nanoparticles (LNPs) at
acidic pH? - CORRECT ANSWER ionizable lipids
why are PLGA NPs or MPs prepared as a lyophilized form? - CORRECT ANSWER drugs will release
during storage if PLGA NPs or MPs are prepared as a liquid form
name advantages of protein PEGylation - CORRECT ANSWER -mask proteins from immune
recognition -reduce protein aggregation -prevent proteolytic degradation -prolong circulation time and half-life Which statement about micelles is NOT right? A) micelles can be formed by surfactants or ampiphilic polymers B) micelles are mainly used for poorly-water soluble drug delivery C) micelles form above critical micelle concentrations
D) micelles expose hydrophobic portion to the aqueous environment - CORRECT ANSWER D)
micelles expose hydrophobic portion to the aqueous environment
Micelles are mainly used for ______ drug delivery - CORRECT ANSWER poorly water-soluble
micelles form ___ the critical micelle concentration - CORRECT ANSWER above
Micelles can be formed by ____ or _____ - CORRECT ANSWER surfactants or amphiphilic block-
copolymers Which of the below long-acting dosage forms induces the most extended release?
Which of the below long-acting injectables utilizes PLGA or PLA polymers to induce sustained drug release? A) oil depot B) microsphere depot C) in situ forming gel D) nanocrystal suspension
E) B & C - CORRECT ANSWER E) B&C
microsphere depot and in situ forming gel Lupron Depot and Consta Depot are based on PLGA microsphere technologies and both are supplied as a lyophilized powder form. Why are they not supplied as a ready-for-injection liquid form? -
CORRECT ANSWER Liquid form releases drugs during storage
INVEGA SUSTENNA, INVEGA TRINZA, and INVEGA HAFYERA all contain polysorbate 20. What is the
function of polysorbate 20? - CORRECT ANSWER to stabilize the nanocrystal drugs in the
suspension (surfactant!) Patient A was recently diagnosed with schizophrenia and was prescribed with oral paliperidone. The patient was found to tolerate oral paliperidone well. After 4 mnths, which of the below extended- release dosage forms can the patient be prescribed? A) INVEGA SUSTANNA B) INVEGA TRINZA C) INVEGA HAFYERA
D) Any of the above - CORRECT ANSWER A) INVEGA SUSTANNA
What is the most popular route of delivery of long-acting nanocrystal dosage forms - CORRECT
ANSWER IM
When SARS-CoV-2 entered respiratory airway cells, which might contribute to protection? a) Antibodies
b) Cytotoxic T lymphocytes c) A+B
d) None of the above - CORRECT ANSWER b) cytotoxic T lymphocytes
(they attack pathogen-infected cells) Diabetic patient A is afraid of needle-based insulin delivery. Which kind of below device(s) can you recommend to patient A? A) insulin syringe B) insulin pen C) needle-free jet injector D) insulin pump E) Afrezza (pulmonary) F) C & E
G) all of the above - CORRECT ANSWER F) C & E
jet injector and Afrezza
Why do vaccines protect pathogens that are encountered later on? - CORRECT ANSWER Because
vaccine-induced memory cells persist until pathogen encountering Which statement about storage of biologics drugs is NOT right A) most of biologics drugs are stored in the refrigerator B) some biologics drugs are stored in the freezer C) never expose biologics drugs to high temperatures at 37C and above
D) thawed biologics drugs, if not used, can be put back in the freezer for future use - CORRECT
ANSWER D) thawed biologics drugs, if not used, can be put back in the freezer for future use
Biologics drugs are easy to aggregate and lose activity. Which of the below surfactants is often added to stabilize biologics? A) Triton X- B) Cremophor EL
-aptamers *****
Vaccine antigens are often ____________ of pathogens. - CORRECT ANSWER proteins
Where are the protective immune responses produced after vaccination - CORRECT ANSWER
draining lymph nodes
what type of vaccine has the best immunogenicity? - CORRECT ANSWER live-attenuated
When preparing protein-based biologics drugs, vigorous agitation should be avoided. This is
because... - CORRECT ANSWER vigorous agitation generates bubbles and reduces withdrawable
volume excessive agitation can also damage quaternary structure Exondys 51 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation of the DMD gene. Exondys 51 is an antisense oligonucleotide that target to exon 51 region to correct the reading frame of mRNA that leads to production of a shorter but functional protein. Exondys 51 has an elimination half-life of 3-4 hours. Why is Exondys 51 is prescribed for
once weekly but not once daily treatment? - CORRECT ANSWER The produced functional protein
lasts even after Exondys 51 has been cleared (3-4 hour half life) Which statement about biologics is NOT right? A) biologics are susceptible to the environment and often need stabilizers B) biologics are mainly subjected to injection deliveries C) biologics don't need to be sterile
D) biologics are generally macromolecules or complex systems - CORRECT ANSWER C) biologics
don't need to be sterile Diabetic patient B has a busy working schedule and often forgets to inject insulin according to
schedule. Which insulin delivery device can you recommend to patient B? - CORRECT ANSWER
artificial pancreas Some school kids are afraid of needle-based flu shots. Which delivery methods of flu vaccines do you recommend to them?
a) Needle-free Jet Injectors b) Nasal sprays c) Intradermal microinjection systems d) A or B
e) None of the above - CORRECT ANSWER d) A or B
jet injectors or nasal spray which flu vaccines do you recommend to people aged 65 and older? A) high dose flu vaccine B) MF59-adjuvanted flu vaccine C) Fluzone quadrivalent D) A or B
E) none - CORRECT ANSWER D) A or B
high dose or MF59-adjuvanted
Which type of vaccine has the best safety profile - CORRECT ANSWER subunit vaccine
what is the difference between osmolarity and osmolality - CORRECT ANSWER osmolarity is
number of mOsmol/LITER. osmolality is mOsmol/kg
___% NaCl is isotonic - CORRECT ANSWER 0.
Describe what sodium chloride equivalent (E) mecorrect answer - CORRECT ANSWER the amount
of NaCl that is osmotically equivalent to 1 g of the drug ex: if pilocarpine has an E of 0.24, then 1g of pilocarpine= 0.24g NaCl
mOsmol= ___ x _____ - CORRECT ANSWER mmol x number of particles
what packaging strategy is used to overcome oxidation - CORRECT ANSWER addition of
antioxidants or oxygen scavengers (absorbers)
what packaging strategy is used to overcome microbial growth - CORRECT ANSWER addition of
antimicrobials (preservatives) t or f: Primary pharmaceutical packaging is essential for maintaining the safety, efficacy, and stability of medical products. Primary pharmaceutical packaging materials need to be inert to drug or drug
components. - CORRECT ANSWER true
Homatropine hydrobromide has a sodium chloride equivalent of 0.17. How much volume of isotonic
buffer can be made from 0.5 g homatropine hydrobromide powder? - CORRECT ANSWER 9.44 ml
1 mmol sodium citrate provides ___ mEq Na - CORRECT ANSWER 3
sodium citrate= Na3C6H8O What can you do to increase drug stability? A) add stabilizer during formulation B) choose the right packaging material C) store drugs at the recommended temperature and moisture levels
D) all of the above - CORRECT ANSWER D) all of the above
A solution contains 3 mmol/L sodium citrate. What's the osmolarity of the solution? Assume
complete dissociation - CORRECT ANSWER 12 mOsmol/L
-sodium citrate= Na3C6H8O7= 3 Na and 1 citrate -3 mmol x 4 particles= 12 mOsmol
t or f: polymorphism of API is a type of chemical instability - CORRECT ANSWER false, physical
t or f: accelerated stability testing is often conducted alone to determine drug stability - CORRECT
ANSWER false
An opthalmic drug exhibits first order degradation. How much drug is remaining after 120 days? initial concentration is 5 mg/ml,
k= 0.0005/day - CORRECT ANSWER 4.71 mg/mL
What type of drugs use metallic packaging? - CORRECT ANSWER NON-PARENTERAL ONLY
T or F: matrix and reservoir type patches may be cut to reduce drug dose - CORRECT ANSWER
false, the drug is not evenly dispersed throughout the patch. only drug-in-adhesive patches can be cut
what are the 2 major routes of TDD - CORRECT ANSWER transcellular and intercellular
Lidoderm patch belongs to? A) single layer drug-in-adhesive B) multi-layer drug-in-adhesive C) matrix type
D) reservoir type - CORRECT ANSWER C) matrix type
LA dosage forms are used to treat... - CORRECT ANSWER birth control, chronic infection,
schizophrenia, central precocious puberty, tumor recurrence after surgery
types and subtypes of implants - CORRECT ANSWER -pellet
-polymer: biodegradable or nonbiodegradable -> matrix or reservoir type
name the 4 types of injectable LA forms - CORRECT ANSWER -microsphere depot
-oil depot -in situ gel forming -nanocrystal suspension
Which statement about liposomes and lipid nanoparticles is NOT correct? A) Liposomes use ionizable lipid while nanoparticles use phospholipids to make nanoparticles B) Liposomes are lipid bilayer structure, while LNPs are not lipid bilayer structure C) PEGylation is a common modification for both liposomes and LNPs
D) Cholesterol can be used to increase rigidity of liposomes and LNPS - CORRECT ANSWER A)
Liposomes use ionizable lipid while nanoparticles use phospholipids to make nanoparticles Onpattro takes advantage of lipid nanoparticles to deliver _______ (the type of active drug) to treat hereditary transthyretin-mediated (hATTR) amyloidosis. A) DNA B) mRNA C) Antisense DNA
D) siRNA - CORRECT ANSWER D) siRNA
Which statement about PLGA polymers is NOT correct? A) PLGA polymers are synthetic and nonbiodegradable B) PLGA polymers can be hydrolyzed into lactic acid and glycolic acid and have good safety in vivo C) PLGA polymers can be used to make nanoparticles or microspheres for drug delivery D) PLGA nanoparticles and microspheres are often supplied as a lyophilized form and need to be
reconstituted before administration - CORRECT ANSWER A) PLGA polymers are synthetic and
nonbiodegradable
