Final 1 Flashcards

1
Q

With regards to API, which of following is ALWAYS true?

a. API binds appropriate cellular target and performs chemistry in body
b. API manufactured by chemical synthesis
c. API is a small molecule
d. API provides targeting to app organ/cell type

A

d. API provides targeting to app organ/cell type

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2
Q

In general, what is the impact on the relative stability of making a solution of a drug substance compared to the solid/particulate form?

a. it will be less stable
b. there will be no change
c. it will be more stable
d. you would never make a solution of a solid drug substance

A

a. it will be less stable

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3
Q

In a soft gel capsule, the API can be presented in ___

a. outer shell
b. a solid fill
c. a liquid fill
d. all of the above

A

c. a liquid fill

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4
Q

When choosing whether to produce tablets or capsules, what is one consideration is the speed at which the dosage forms can be produced?

a. Capsules and tablets are manufactured at about the same rate
b. Tablets are manufactured more slowly than capsules
c. Tablets are manufactured more quickly than capsules
d. Soft gel capsules are manufactured much more quickly than tablets or hard gel capsules

A

c. Tablets are manufactured more quickly than capsules

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5
Q

Which of the following is NOT one of the body’s defense mechanisms against nasal delivery?

a. mucous
b. presence of cilia on the nasal epithelium
c. sense of smell
d. the sneeze reflex

A

c. sense of smell

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6
Q

Which of the following types of liquid formulations will allow for the fastest onset?

a. suspension
b. emulsion
c. solution
d. they will all be the same

A

c. solution

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7
Q

When ocular drugs are administered systemically, what is the approximately bioavailability in the eye?

a. 25%
b. 1%
c. 10%
d. 5%

A

b. 1%

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8
Q

A compounded medication has ____

a. an expiration date
b. a retest date
c. a beyond use date
d. all the above, they are equivalent terms

A

c. a beyond use date

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9
Q

The skin is the largest organ, is very accessible, and presents a large surface area, making it attractive for drug delivery. The differences between topical and transdermal delivery are:

a. topical delivery is local while transdermal delivery is systemic
b. topical delivery is systemic while transdermal delivery is local
c. both topical and transdermal delivery can be used for either local or systemic delivery
d. none of these

A

a. topical delivery is local while transdermal delivery is systemic

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10
Q

What is the hallmark of most ear diseases?

a. inflammation
b. tinnitus
c. infection
d. hearing loss

A

a. inflammation

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11
Q

What type of oral formulation is most commonly extemporaneously (quickly) compounded?

a. tablet
b. soft gel tablet
c. hard gel tablet
d. caplet

A

a. tablet

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12
Q

Traditional ocular formulations deliver the drug ___

a. to the anterior segment of the eye
b. systemically
c. to the posterior segment of the eye
d. all of the above

A

a. to the anterior segment of the eye

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13
Q

Which of the following is NOT important consideration when designing a topical formulation?

a. ability of drug to cross dermis
b. dosage uniformity
c. physical stability
d. aesthetic appeal

A

d. aesthetic appeal

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14
Q

Which of the following is an invasive route of administration?

a. subcutaneous injection
b. rectal
c. pulmonary
d. all of the above

A

a. subcutaneous injection

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15
Q

True/False: Ocular and otic drug delivery require many of the same considerations when designing a formulation

A

True

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16
Q

The biggest challenge to pediatric drug delivery is _____

a. finding drugs that are not toxic to children
b. taste making so children will be willing to swallow the medicine
c. convincing parents to administer the drug produces to their children
d. finding drugs that work in children

A

b. taste making so children will be willing to swallow the medicine

17
Q

“Ostwald’s rule” is that the LEAST stable polymorph:

a. tends to have the highest solubility in water
b. is usually preferred for pharmaceutical use
c. tends to crystalize first
d. tends to have smallest particle size

A

c. tends to crystalize first

18
Q

The most important test for generic drugs to show that they are equivalent to branded is _____

A

Answer: Bioequivalence

19
Q

Which of the following about PEGylated molecules is true?

a. because they are bigger, they are cleared more quickly
b. The FDA considers them equivalent to putting an approved molecule in a biodegradable depot
c. they are often less immunogenic
d. all of the above

A

c. they are often less immunogenic

20
Q

How are you most likely to increase the efficiency of drug delivery nasally?

A

Answer: increase viscosity

21
Q

The main reason you would lyophilize your drug produce is that:

a. you can manufacture more units more quickly than for other dosage forms
b. it is easy to do
c. it is cheaper than manufacturing a liquid dosage form
d. your API is unstable in an aqueous vehicle

A

d. your API is unstable in an aqueous vehicle

22
Q

What is the type of pulmonary delivery system that is able to deliver the largest range of doses?

A

Answer: Dry powder

23
Q

_____ can exchange the patent coverage

A

Answer: nasal delivery

24
Q

A drug substance has:

a. an expiration date
b. a reset date
c. a beyond use date
d. all the above, they are equivalent terms

A

b. a retest date

25
Q

The pKa of a drug is:

a. pH where drug is the most soluble
b. pH where drug is the most readily absorbed
c. pH where the concentration of an ionized drug molecules equal to the concentration of the unionized
d. All

A

IDK
c. pH where the concentration of an ionized drug molecules equal to the concentration of the unionized (this is for sure true but not sure if ALL)

26
Q

The Pure Food and Drug Act of 1906 was the result of ______

A

Answer: a book by Upton Sinclair

27
Q

What are the three main routes of administration for pharmaceutical products?

A

Answer: Parenteral, Enteral, Topical

28
Q

______ is a key step which enables a drug to be active in the human body

A

Answer: Dissolution

29
Q

An API can be used in the manufacturing of a drug product until:

a. the expiration date
b. the date specified by the retest interval, when it can continue to be used as long as the retest results meet specification
c. it is completely used up
d. the date specified by the retest interval, when it must be disposed

A

b. the date specified by the retest interval, when it can continue to be used as long as the retest results meet specification