Final 3 Flashcards

1
Q

When manufacturing a sterile dosage form, which of the following tests of typical liquid drug products must be performed on 100% of vials manufactured?

a. sterility
b. appearance
c. endotoxin
d. All of the above

A

b. appearance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

True/False: Suppositories are the only dosage form available for rectal and vaginal delivery

A

False

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

A pulmonary drug product MUST be sterile if:

a. a solid
b. all drugs administered via the pulmonary route must be sterile
c. a liquid

A

c. a liquid

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

What aspect of otic formulations is usually the most important for its effectiveness?

a. packaging
b. pH
c. viscosity
d. tonicity

A

c. viscosity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

TRUE/FALSE: Topical formulations are among the most complex dosage forms

A

False

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Which of the following statements is true?

a. local delivery uses chemical targeting strategies to maximize concentration of drug at desired site of action
b. systemic delivery means drug is delivered to the whole body by means of drug system, can only be achieved via injection
c. Most routes of administration can be used for either local or systemic delivery
d. none of these

A

c. Most routes of administration can be used for either local or systemic delivery

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

The easiest APIs to formulate are:

a. Class I
b. Class IV
c. Class II
d. Class III

A

a. Class I

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

The types of drugs that are most easily delivered systemically via the nasal route are:

a. hydrophobic
b. hydrophilic
c. both
d. systemic delivery via the nasal route isn’t possible for any drugs

A

b. hydrophilic

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

The major environmental factors which lead to a drug’s instability are:

a. pH and particle size
b. water and oxygen
c. light and heat
d. b and c

A

d. b and c

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

If you have a lipophilic drug and would like to design a suppository with a slow-release rate, the base you choose should be:

a. a PEG base
b. a hydrogenated vegetable oil base
c. neither, because both would yield a rapid release rate
d. either, because both would yield a slow-release rate

A

b. a hydrogenated vegetable oil base

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

To be pharmaceutically equivalent two products must have all but the same:

a. route of administration
b. strength
c. dosage form
d. packaging

A

d. packaging

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

The purpose of adding excipients into a dosage form is:

a. to make the drug product acceptable to the patient
b. for marketing and identification
c. to make manufacturing easier
d. it can be any of these

A

c. to make manufacturing easier

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What is the most common disease of the middle ear?

a. Meniere’s D
b. Swimmer’s Ear
c. Otitis externa
d. otitis media

A

d. otitis media

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

When a PLGA matrix containing drug is injected into a patient, three phases of drug release are observed. An initial fast release is followed by a period of constant release, and then finally a quick release rate is observed. Which of these three phases represents the desired drug release rate?

a. the initial burst
b. the final release of the remaining drug
c. the middle phase of constant release
d. all three are part of the desired release profile

A

c. the middle phase of constant release

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

If you were filling capsules, which of the following materials would be most desirable in terms of its physical characteristics?

a. granulated sugar
b. baking flour
c. powdered sugar
d. all are equal

A

a. granulated sugar

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

There are a large number of products which are applied directly to the skin to treat skin conditions, including “skin quality”. The desired route of administration for these products is:

a. transdermal
b. topical
c. both
d. neither

A

b. topical

17
Q

Which of the following regarding stability studies is FALSE?

a. accelerated stability studies can be used to predict the stability of a drug product, but cannot replace real-time studies at the intended storage condition
b. The max shelf-life allowed by the FDA is 5 years
c. Real-time stability data is needed to support the expiration date of the drug product
d. The real-time stability data of the drug product supports the shelf-life of the API

A

b. The max shelf-life allowed by the FDA is 5 years

18
Q

Which of the following statements regarding nasal delivery is true?

A

Nasal delivery can be used for lyophilize vaccinations