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Final 4 Flashcards

1
Q

What is the current estimate of the cost to bring a new drug to market?

A

$2.5 billion, more than doubled in the past 10 years

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2
Q

What types of drug products must meet USP standards?

a. Prescription drugs
b. OTC Drugs
c. Generic Drugs
d. All of the above

A

d. All of the above

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3
Q

What else should we mention regarding an ideal aerosol?

a. It is safe
b. Product should be inexpensive for the customer
c. Device is portable
d. Formulation is stable at ambient conditions

A
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4
Q

The scale is in _____

A

micrograms, grams, nanogram

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5
Q

The main reason the solution cools in a jet nebulizer is because of _____

A

Evaporation

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6
Q

In this specific example, what sentence describes the dry powder inhaler that is least efficient?

A

DiscHaler (lower FPF means higher loss) AND DiscHaler (Lower FPF means lower number of small particles)

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7
Q

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

A

False

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8
Q

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

A

A hydrogenated vegetable oil base

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9
Q

Which of the following is possible using nasal delivery?

a. Local delivery
b. Systemic delivery
c. Delivery to the CNS
d. All of the Above

A

d. All of the Above

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10
Q

By conjugating PEG to a protein, ______

a. The bigger size increases half-life
b. PEG may reduce immunogenicity of the protein
c. PEG may interfere with target binding
d. All of the above

A

d. All of the above

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11
Q

The largest number of topical products are formulated as _____

A

Creams

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12
Q

The most common method of enhancing penetration of an active molecule through skin is _____

A

Sorption promoting solvents

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13
Q

What does ICH stand for?

A

International Conference on Harmonization (of Technical Requirements for Registration of Pharmaceuticals for Human Use)

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14
Q

What is the product’s intended use containing the following excipients: croscarmellose sodium, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin?

A

Immediate release tablet

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15
Q

What is the purpose of the croscarmellose sodium in the formulation?

A

Disintegrant

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16
Q

Is the extended release tablet film coated?

A

No

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17
Q

What is the intended use for: ascrobic acid, flavor, carboxymethylcellulose sodium, anhydrous citric acid, glycerin, magnerisum aluminum silicate, orane oil, concentrate, polysorbate 40, purified water, no benzoate, sucrose, vanillin, FD&C yellow No.6?

A

Oral suspension

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18
Q

Which of the following is the US adopted name in lipitor (atorvastation calcium) tablets for oral administration?

A

Atorvastatin calcium

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19
Q

“Ostwald’s rule” is that the least stable crystal polymorph?

A

Tend to crystalize first

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20
Q

Which of the following are not considered part of pharmaceutical product SISPQ?

A

Preparation

SISPQ = Safety-Integrity-Strength-Purity-Quality

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21
Q

Roughly how many routes of administration are described by the FDA?

A

120

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22
Q

Which of the following routes of administration can be used for systemic drug delivery?

a. IV
b. Rectal
c. Nasal
d. Pulmonary
e. All of the above

A

e. All of the above

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23
Q

Which of the following is an invasive route of administration?

A

IV

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24
Q

Which of the following would NOT be considered an invasive type of delivery?

A

Rectal suppository

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25
Noninvasive routes of administration ALWAYS _____
Require the drug to pass across a mucosal or cellular barrier
26
What is the most important stability category and determines the expiration period?
Each is equally important and contributes to determining product shelf-life
27
True/False: Color changes can indicate chemical instability
True
28
True/False: Two agencies that regulate are the FDA and USP
False
29
True/False: Product shelf-life stability is determined by accelerated stability testing
False
30
Which of the following statements are true about lyophilization? a. Properly executed lyophilization cycles result in minimal product reconstitution times b. injectable products and fast dissolving oral tablets are available as freeze dried products c. The pharmacist must properly store, reconstitute and label lyophilized injectable products d. All of the above
d. All of the above
31
Which of the following is a surfactant?
Sodium lauryl sulfate
32
. The higher number capsule sizes (I.e. 0 -> 1 -> 2...) are desired because: a. “they get larger and therefore easier to pick up” b. “better for lower density, higher volume powders” c. “harder to swallow” d. None of the above
d. None of the above
33
A size 1 capsule (0.5 cc volume) can hold what amount of powder having a tamped powder density of 0.5 g/cc?
250 mg
34
Capsules are banded because _____
Prevents tampering/adulteration
35
True/False: Impurities are likely a critical attribute for release testing of a new batch of capsules
True | Critical attribute for release testing = AAIDI Assay, Appearance, Identity, Dissolution, Impurities
36
True/False: Sterility is a likely critical attribute for release testing of a new batch of capsules
False | Critical attribute for release testing = AAIDI Assay, Appearance, Identity, Dissolution, Impurities
37
Dissolution is a likely critical attribute for release testing of a new batch of capsules
True | Critical attribute for release testing = AAIDI Assay, Appearance, Identity, Dissolution, Impurities
38
Taste is a likely critical attribute for release testing of a new batch of capsules
False | Critical attribute for release testing = AAIDI Assay, Appearance, Identity, Dissolution, Impurities
39
True/False: Identity is a likely critical attribute for release testing of a new batch of capsules
True | Critical attribute for release testing = AAIDI Assay, Appearance, Identity, Dissolution, Impurities
40
True/False: Powder particle size and flow are likely critical attribute for release testing of a new batch of capsules
False | Critical attribute for release testing = AAIDI Assay, Appearance, Identity, Dissolution, Impurities
41
True/False: Appearance is a likely critical attribute for release testing of a new batch of capsules
True | Critical attribute for release testing = AAIDI Assay, Appearance, Identity, Dissolution, Impurities
42
True/False: Tamper resistance is a likely critical attribute for release testing of a new batch of capsules
False | Critical attribute for release testing = AAIDI Assay, Appearance, Identity, Dissolution, Impurities
43
True/False: Assay is a likely critical attribute for release testing of a new batch of capsules
True | Critical attribute for release testing = AAIDI Assay, Appearance, Identity, Dissolution, Impurities
44
True/False: One year stability results are a likely critical attribute for release testing of a new batch of capsules
False | Critical attribute for release testing = AAIDI Assay, Appearance, Identity, Dissolution, Impurities
45
Functional tablet coatings are not to be split because _____
The function of the coating is lost
46
In general, the main purpose of tablet formulations is to: a. Make the material more compressible b. Assure weight uniformity across tablets c. Assure active drug uniformity across tablets d. Assurance that tablets readily disintegrate and dissolve as intended e. All of the above
e. All of the above
47
The purpose of a tablet lubricant is to ______
Minimize friction during tablet ejection from the die hole
48
If a tablet is too soft, then to make harder tablets _______
a. Increase the compression force b. Engage pre-compression roller to double up on compressions per unit c. Increase compression dwell time by slowing down the process d. Alter formulation to be more compressible e. All of the above
49
Which of the following critical quality attributes should be included in stability testing to assure no change during the shelf life of the tablet?
Weight variation and/or content uniformity
50
What is the primary source of contamination during compounding?
Personnel
51
CQAs help ensure: a. Patient safety b. Efficacy of the drug product c. Quality of the drug product d. All of the above
d. All of the above CQA = Critical Quality Attribute
52
Controlling CQA for a drug product is ____
a. A FDA requirement b. An EMA (European Medicines Agency) requirement c. A health Canada requirement d. A PMDA L(Japan’s pharmaceuticals and Medical Devices Agency) requirement
53
During aseptic preparation of sterile dosage forms it is OK to: a. pick up items off the floor during compounding b. handle products with torn gloves/gown c. leave room and return to compounding without changing gloves or gowning d. ignore good aseptic technique e. none of the above
e. none of the above
54
For drug products confirmed to not have passed sterility testing you should _____
a. Perform an investigation to determine the root cause | b. Recall the lot of drug product that failed sterility testing
55
When you receive a warning Letter from the FDA: a. Ignore it b. Provide a formal written response back to the FDA within a specific time frame c. You can be personally found guilty of criminal charges d. Risk having the facility shut down e. B, C, and D
56
How does bioavailability affect dosage form and concentration?
Most topical eye drops are lost to tears making the absorbed component quite small
57
Ocular drugs can be administered systemically. What is the bioavailability in the eye for most drugs?
1%
58
Which is currently a common ocular delivery system, which is the basis for the largest selling ocular drugs for 2017? What is the indication?
Intravitreal injection for macular degeneration
59
True/False: Suppositories are the only dosage form available for rectal and vaginal delivery
False
60
True/False: From a clinical pharmacology perspective, pediatric patients can be thought of as “small adults”.
False
61
Children are often unable to swallow pills or capsules until age:
6-7
62
When a new pediatric formulation is developed for use in children, bioavailability studies should be conducted in pediatric patients
False
63
True/False: When a new pediatric formulation is developed for use in children, bioavailability studies should be conducted in pediatric patients
False
64
The largest number of topical products are formulated as _____
Creams
65
The most common method of enhancing penetration of an active molecule through skin is _____
Sorption promoting solvents
66
What biodegradable polymer have we discussed before?
PLGA
67
True/False: PLGA is used frequently because it has ideal release characteristics
False
68
By conjugating PEG to a protein _____ a. The bigger size increases half-life b. PEG may reduce immunogenicity of the protein c. PEG may interfere with target binding d. All of the above
d. All of the above

Dosage Forms (5 decks)

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