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Dosage Forms II RH > Exam 3 - Multiple Choice > Flashcards

Exam 3 - Multiple Choice Flashcards

1
Q

lyophilization is conducted at _____ to remove water by _____

a. high temp and high pressure; evaporation
b. high temp and high pressure; sublimation
c. low temp and low pressure; sublimation
d. low temp and low pressure; evaporation

A

c. low temp and low pressure; sublimation

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2
Q

what is an “allogeneic” cell transfer therapy?

a. cell therapies made with the patient’s own cells
b. a therapy wherein cell donor and recipient (patient) are the same
c. a therapy wherein cell donor and recipient (patient) are different
d. a therapy where cells can be infused independent of the type of disease

A

c. a therapy wherein cell donor and recipient (patient) are different

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3
Q

what is the drug tocilizumab used in CAR-T therapy for?

a. It stimulates CAR-T cells to more effectively kill cancer cells
b. It is used in lymphodepletion
c. To mitigate cytokine release syndrome
d. To help T cells expand and proliferate

A

c. To mitigate cytokine release syndrome

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4
Q

What is a largely unwanted by-product of lymphodepletion in patients prior to immune reconstitution in the context of CAR-T therapy?
a. Graft-versus-host disease and CAR-T rejection
b. Loss of absolute lymphocyte counts
c. Loss of regulatory T cells
d. Increased numbers of circulating T cells

A

b. Loss of absolute lymphocyte counts

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5
Q

Which of these is NOT a function or characteristic of the extracellular region of a chimeric antigen receptor?

a. It is made from an antibody fragment
b. It stimulates cells to divide and persist when infused
c. It directs the cell to recognize a specific cancer antigen
d. It binds to a cancer cell

A

b. It stimulates cells to divide and persist when infused

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6
Q

Most FDA-approved cell therapy products are for which indication:

a. Hematopoietic cell transplantation
b. Cell-based tissue regeneration
c. CAR-T therapy
d. Immunotherapy

A

a. Hematopoietic cell transplantation

(FDA-approved stem cell therapies in the US are for hematopoietic stem cell transplantation and FDA-approved cell-based therapy products are for blood cancers. These are the only stem cell therapies approved in the US as of now.)

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7
Q

Autologous cell-based therapies have a number of benefits compared to allogeneic therapies, but the disadvantage is that:
a. They can induce graft-versus-host disease
b. They are difficult to source in large numbers
c. They require higher dosages
d. They do not need to be regulated as drugs

A

b. They are difficult to source in large numbers

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8
Q

In the context of sourcing immune cells for adoptive transfer, what is one strategy that can potentially be employed to decrease the risk of graft-versus-host disease?
a. Engineer cells with chimeric antigen receptors
b. Do not use T cells from cancer patients
c. Source cells from more closely-matched donors
d. Irradiate cells prior to infusion

A

c. Source cells from more closely-matched donors

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9
Q

According to the graph concerning salmon calcitonin, which one of the following descriptions is correct
a. Salmon calcitonin is least stable at pH 3-4
b. The formulation ideal for drug stability is also most comfortable for patients when administered
c. Additives improve the stability of calcitonin
d. The rate of calcitonin degradation is pH-dependent
e. All of the above is correct

A

d. The rate of calcitonin degradation is pH-dependent

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10
Q

All of the following statements are true of monoclonal antibodies (mAbs) EXCEPT:
a. mAbs have light and heavy chains
b. mAbs are small proteins (~30,000 Da)
c. mAbs have beta sheet structures
d. mAbs have disulfide bonds

A

b. mAbs are small proteins (~30,000 Da)

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11
Q

A protein drug that consists of a monoclonal antibody linked to a potent, small molecule cytotoxin is called
a. A chimeric protein
b. An antibody-drug conjugate
c. A fusion protein
d. A PEGylated protein

A

b. An antibody-drug conjugate

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12
Q

In protein drug formulations, “preferential exclusion” refers to:
a. Excipients
b. A manufacturing process
c. Receptor binding
d. Syringes

A

a. Excipients

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13
Q

Which of the following components of a pre-filled syringe is most likely to increase the aggregation of a protein drug?
a. Luer lock
b. Needle cap
c. Syringe lubricant
d. Finger grip

A

c. Syringe lubricant

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14
Q

Common dosage forms for biologics include all of the following EXCEPT:
a. Solution for injection
b. Auto-injectors
c. Pre-filled syringe
d. Buccal patches
e. Lyophilized powder for reconstitution

A

d. Buccal patches

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15
Q

Which of the following is NOT the advantage of solution formulations of biologics as compared to other common dosage forms?
a. Simplest formulation
b. Least expensive to manufacture
c. Convenient for hospital personnel since they do not require reconstitution
d. Reduced rates of chemical and physical degradation
e. Can be inspected visually prior to administration

A

d. Reduced rates of chemical and physical degradation

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16
Q

Which of the following is NOT relevant to the stability of lyophilized protein products?
a. Lyophilization can cause protein instability by freeze-concentration
b. Lyoprotectants or cryoprotectants are used to inhibit perturbation of protein structure during lyophilization
c. Lyophilized products should be shaken to accelerate reconstitution
d. Once reconstituted, biologics are less stable than the lyophilized forms
e. Reconstituted solution of lyophilized proteins should be visually inspected for the presence of particles

A

c. Lyophilized products should be shaken to accelerate reconstitution

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17
Q

For drug activity to achieve systemic action via transdermal delivery, it must reach [A] ____________ layer in the skin, which [B] ____________.
a. [A] stratum corneum; [B] is a main barrier to permeation
b. [A] stratum corneum; [B] contains cells that get nutrition from other layers
c. [A] viable epidermis; [B] is a source of skin color and tanning
d. [A] dermis; [B] contains pain sensors and leaves scars if injured
e. [A] dermis; [B] consists of dead cells and lipid

A

d. [A] dermis; [B] contains pain sensors and leaves scars if injured

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18
Q

Which one of the following is LEAST relevant to transdermal delivery?
a. Drugs with a molecular weight < 1000 Da and high oil/water partition coefficients are suitable for transdermal delivery.
b. Hydrated skin is easier for a drug to penetrate than dry skin
c. Reducing agents such as ascorbate or dithiothreitol can enhance skin permeability by disrupting disulfide bonds of proteins in keratinized cells
d. Transdermal delivery is suitable for drugs with high dose requirement
e. Organic solvents such as azone or dimethyl sulfoxide increase the skin permeability by disrupting the ordered lipid bilayer structure of stratum corneum

A

d. Transdermal delivery is suitable for drugs with high dose requirement

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19
Q

The following products are applied on skin. However, one of them aims to have an effect on a different location (system vs. local) than others. Which one is it?
a. ALACORT – hydrocortisone cream
b. Benzo-Jel – anesthetic gel
c. Burt’s Bees Medicated Lip Balm – with beeswax, camphor, menthol, clove oil, anise, eucalyptus, spearmint and lemon balm
d. ADVANCED SKIN LIGHTENING SERUM – hydroquinone gel
e. Exelon rivastigmine patch

A

e. Exelon rivastigmine patch

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20
Q

Consider the FDA memorandum and the Blackbox warning of Xulane patch. Which of the following is desirable advice for a patient prescribed a transdermal patch?
a. Encourage the use of clear (transparent) patch to reduce patient’s resistance to medication
b. A transdermal patch may be cut into several pieces and placed on different parts of the body to increase the bioavailability of a drug
c. Within the recommended areas of application, patches may be applied rotating the area to avoid skin irritation
d. A transdermal patch may be substituted for oral dosage forms as long as they contain the same drug and the same dose
e. When a new patch is applied, the old patch may be left on the skin as long as it stays in order to maximize the bioavailability of a drug

A

c. Within the recommended areas of application, patches may be applied rotating the area to avoid skin irritation

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21
Q

Which one of the following is most difficult to deliver via transdermal patches
a. Human growth hormone
b. Estradiol
c. Fentanyl
d. Nitroglycerin
e. Scopolamine

A

a. Human growth hormone

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22
Q

Which of the following is relevant to mucus (choose TWO. No partial credit)
a. Covers nearly all entry points to the human body except for the parts covered by skin
b. Consists of mostly water, glycoproteins, lipids, and inorganic salts
c. Has no charge due to the high content of lipid components
d. Has constant thickness throughout the body
e. Contains mucin, which is a positively charged low molecular weight peptide

A

a. Covers nearly all entry points to the human body except for the parts covered by skin
b. Consists of mostly water, glycoproteins, lipids, and inorganic salts

(e is wrong because mucin is negatively charged)

23
Q

Of the following, which one is most suitable for the delivery of a drug that requires fast onset of systemic action (e.g., nitroglycerin for acute angina attack)
a. Topical cream
b. Transdermal patch
c. Sublingual tablet
d. Buccal patch

A

c. Sublingual tablet

24
Q

Which of the following is incorrect?
a. Buccal layer is less permeable than sublingual layer.
b. Actiq (fentanyl citrate, lozenge on a stick) is designed for transmucosal or gastrointestinal absorption.
c. Buccal patches are not suitable for drugs with low potency.
d. Oral mucosa is a suitable route for the delivery of large hydrophilic molecules.
e. Mucosal delivery helps avoid first pass metabolism of a drug

A

d. Oral mucosa is a suitable route for the delivery of large hydrophilic molecules.

25
Q

Oravig is a buccal tablet delivering miconazole (anti-fungal agent), indicated for the treatment of oropharyngeal candidiasis in adults. The handling instruction includes the following step. What is the purpose? Hold the ORAVIG tablet in place by applying a slight pressure with your finger on the outside of your upper lip for 30 seconds.
a. To avoid tasting the drug.
b. To help disintegrate the tablet.
c. To accelerate dissolution of the tablet.
d. To make the tablet stick to the gum.
e. To avoid damaging the buccal mucosa.

A

d. To make the tablet stick to the gum.

26
Q

Fentora is an effervescent tablet which rapidly releases fentanyl into the buccal pouch and is used to treat breakthrough pain in opioid-tolerant cancer patients. Which one of the following is true?
a. Fentora can be taken with water like regular tablets if a patient prefers
b. Fentora can be either chewed or melted in the mouth
c. Fentora may be substituted for Actiq, another transmucosal dosage form of fentanyl, at equal dose (microgram to microgram)
d. Fentora may be placed between cheek and gum or under the tongue

A

d. Fentora may be placed between cheek and gum or under the tongue

27
Q

Which one of the following is NOT relevant to the respiratory region of the nose?
a. It is the main site for systemic drug delivery.
b. It has a surface area of ~150 cm2.
c. It provides direct access to the central nervous system.
d. It is well vascularized.
e. It is covered with mucus that provides a physical and enzymatic barrier to drug delivery.

A

c. It provides direct access to the central nervous system.

28
Q

Encapsulated cell technology (ECT) implants consist of genetically modified cells that are encapsulated in a section of semi-permeable hollow fiber membrane. The implant has a suture loop at one end to anchor it to the sclera in the vitreo-retinal body inside the eye. The current product is 6 mm in length, roughly the size of a grain of rice. What is the role of membrane in this device?
a. Prevents the loss of therapeutic protein from the device
b. Allows for immune cells to enter the device
c. Allows for the influx of oxygen and nutrients
d. Allows for the controlled release of therapeutic cells
e. None of the above

A

c. Allows for the influx of oxygen and nutrients

29
Q

The Port Delivery System with ranibizumab (PDS) is long-acting drug delivery system designed to deliver ranibizumab continuously into the vitreous for the treatment of patients with wet age-related macular degeneration. The PDS includes a permanent refillable implant that is surgically inserted through a small incision in the sclera and pars plana. The following describes the role of each component. Which is correct?
a. Extrascleral flange – anchors the implant in the sclera
b. Self-sealing septum – allows for implant refills
c. Implant body – contains reservoir of ranibizumab
d. Porous metal release control element – controls the rate of drug diffusion from the implant into the vitrous
e. All of the above

A

e. All of the above

30
Q

NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, etonogestrel and ethinyl estradiol. Based on information in the packaging insert and your knowledge of a NuvaRing from class, which one of the following is considered LEAST relevant to NuvaRing?
a. It is a reservoir-diffusion system showing zero-order release kinetics.
b. It consists of a drug reservoir and rate-limiting membrane.
c. It will maintain constant drug levels for 3 weeks.
d. Drug is systemically absorbed via the vaginal epithelial membrane.
e. It shows an initial burst release of drug followed by a decreasing drug release rate.

A

e. It shows an initial burst release of drug followed by a decreasing drug release rate.

31
Q

which is NOT true concerning mAbs?

a. examples include Humira, Herceptin, and Avastin
b. mAbs are glycoproteins with high beta-sheet content
c. antigen binding occurs through the constant domain rather than the variable domain
d. the molecular weight of an intact mAb is ~150,000 daltons
e. mAbs are comprised of light and heavy chains

A

c. antigen binding occurs through the constant domain rather than the variable domain

32
Q

which is NOT a common dosage form for biologics?

a. solution for injection
b. autoinjectors
c. transdermal patches
d. pre-filled syringe
e. lyophilized powder for reconstitution

A

c. transdermal patches

33
Q

which of the following is NOT the advantage of solution formulations of biologics as compared to other common dosage forms?

a. simplest formulation
b. least expensive to manufacture
c. does not require reconstitution; convenient for hospital personnel
d. can be inspected visually prior to administration
e. lowest rates of chemical and physical degradation

A

e. lowest rates of chemical and physical degradation

34
Q

for protein drugs in solution, aggregation can be accelerated by: (select ALL that apply)

  1. exposure to hydrophobic solid surfaces
  2. exposure to the air-liquid interface
  3. oil droplets suspended in the solution
  4. agitation

a. 1, 2
b. 1, 2, 3
c. 2, 3
d. 1, 3, 4
e. 1, 2, 3, 4

A

e. 1, 2, 3, 4

35
Q

in protein drug formulation, a “preferentially excluded” excipient:

a. preferentially binds to a protein drug to stabilize its structure
b. is prohibited by the FDA
c. is a naturally occurring ligand for a protein drug
d. promotes interaction of water with the protein surface

A

d. promotes interaction of water with the protein surface

36
Q

biologics in pre-filled syrings, autoinjectors, and pens may undergo aggregation more than solution formulation. What contributes to the greater risk of protein aggregation? (select ALL that apply)

  1. higher surface-to-volume ratio
  2. lower total volume
  3. syringe lubricants
  4. oil droplets

a. 1,2
b. 1,2,3
c. 2,3
d. 1,3,4
e. 1,2,3,4

A

e. 1,2,3,4

37
Q

which is NOT true?

a. lyophilization is a process that removes water from pharmaceutical liquid products by sublimation
b. lyophilized powder products are more time-consuming to manufacture than solutions
c. lyophilization occurs at low temp and low pressure
d. lyophilized formulations cannot be used in pre-filled syringes
e. lyophilization usually improves drug stability and extends the storage shelf-life of a product

A

d. lyophilized formulations cannot be used in pre-filled syringes

38
Q

which one of the following is LEAST relevant to the stability of lyophilized protein products?

a. lyophilization can cause protein instability by freeze-concentration
b. lyoprotectants or cryoprotectants are used to inhibit perturbation of protein structure
c. lyophilized products should be shaken to accelerate reconstitution
d. in general, lyophilized products are more stable than solution products
e. refrigerated storage is not usually needed

A

c. lyophilized products should be shaken to accelerate reconstitution

39
Q

which penetration enhancement method uses high voltage (short) to create transient pores in the skin?

a. iontophoresis
b. electroporation
c. ultrasound
d. prodrugs

A

b. electroporation

40
Q

which penetration enhancement method uses low voltage electrical current to drive charged drugs through the skin?

a. iontophoresis
b. electroporation
c. ultrasound
d. prodrugs

A

a. iontophoresis

41
Q

which topical drug delivery system is in liquid phased trapped in matrix of a natural or synthetic polymer?

a. pastes
b. creams
c. gels
d. rigid foams

A

c. gels

42
Q

which is not applicable to Sustol (granisetron extended release polymer formulation)?

a. it is indicated for the prevention of acute and delayed nausea and vomiting associated with chemotherapy
b. when injected subQ, Sustol forms a depot in the subdermal layer
c. the polymer content of Sustol, tri(ethylene glycol)poly(orthoester), has a high glass transition temperature (>body temp)
d. the polymer depot undergoes hydrolysis, releasing granisetron in a consistent and sustained manner over an extended period

A

c. the polymer content of Sustol, tri(ethylene glycol)poly(orthoester), has a high glass transition temperature (>body temp)

43
Q

which one is NOT relevant to the stratum corneum?

a. mortar & brick model
b. dead cells
c. main barrier to drug permeation
d. functions as a lipid barrier
e. most permeable to hydrophilic molecules

A

e. most permeable to hydrophilic molecules

44
Q

which layer of the skin does the following describe?

-Living cells w/o capillaries
-Cells get nutrition from the underlying layer with capillaries
-Source of skin and tanning

a. stratum corneum
b. living (viable) epidermis
c. dermis
d. hair follicles
e. sweat glands

A

b. living (viable) epidermis

45
Q

which of the following is most difficult to deliver via transdermal patches?

a. estradiol
b. fentanyl
c. erythropoietin
d. nitroglycerin
e. rivastigmine

A

c. erythropoietin

46
Q

the glass transition temperature (Tg) of a polymer is affected by various factors. Which of the following is NOT true?

a. all other things being equal, a longer polymer has a higher Tg
b. bulky side chains increase the Tg of a polymer
c. all other things being equal, crosslinked polymers have a higher Tg than linear polymers
d. plasticizer increase the mobility of polymer chains and increases the Tg of a polymer
e. moisture absorbed to the polymer decreases the Tg of a polymer

A

d. plasticizer increase the mobility of polymer chains and increases the Tg of a polymer chain

47
Q

reaching which layer of skin produces pain and scarring?

a. viable epidermis
b. stratum corneum
c. dermis
d. hair follicles and sweat glands

A

c. dermis

48
Q

which is NOT true for the drug delivery via oral mucosa?

a. rapid drug absorption and onset of action
b. suitable for delivery of drugs with low potency
c. avoids first pass effect
d. easy to remove when necessary
e. suitable for delivery of lipophilic drugs

A

b. suitable for delivery of drugs with low potency

49
Q

compared to multi-use vials, pre-filled syringes and pens offer the following advantages EXCEPT:

a. easier to transport than vial and syringe
b. increased patient compliance
c. reduced potential for protein aggregation
d. reduced risk of product contamination
e. reduced risk of dosage error

A

c. reduced potential for protein aggregation

50
Q

what is polylactic acid in Lupron Depot?

a. protein
b. synthetic polymer
c. polysaccharide
d. synthetic peptide
e. amino acid

A

b. synthetic polymer

(it controls the drug release rate by slow degradation)

51
Q

An eye product product contains Gelrite gellan gum as a viscosity enhancer. This agent is added to address one of the following formulation challenges in ocular drug delivery:

a. limited room for pH adjustment
b. limited room for modifying ionic strength of the solution
c. vision impairment
d. short residence time in the eyes
e. blood-brain-barrier

A

d. short residence time in the eyes

52
Q

consider a vaginal ring delivering etonogestrel and ethinyl estradiol (NuvaRing). Which is NOT true?

a. drug release rate is constant
b. delivers the two hormones over 3 weeks
c. drugs are absorbed to the blood stream via vaginal mucosa
d. drug concentrations in plasma show peaks and troughs

A

d. drug concentrations in plasma show peaks and troughs

53
Q

true or false: stem cells and stem cell-derived products involve immune cells

A

false

54
Q

what are totipotent stem cells?

A

each cell can develop into a new individual

Dosage Forms II RH (7 decks)

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