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Dosage Forms > Poll Ev > Flashcards

Poll Ev 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
OTC Drugs
Generic Drugs
*all of the above

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3
Q

What else should we mention regarding an ideal aerosol?

A
  • It is safe
  • Product should be inexpensive for the customer
  • Device is portable
  • Formulation is stable at ambient conditions
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4
Q

The scale is in:

A

in mg so NOT ounces, micrograms, grams, nanograms

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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 menas lower number of small particles)

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7
Q

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 vegatable oil base

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9
Q

Which of the following is NOT possible using nasal delivery?

A

Answer: all of these are possible
Local delivery
Systemic delivery
Delivery to the CNS

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10
Q

By conjugating PEG to a protein:

A
  • The bigger size increases half-life
  • PEG may reduce immunogenicity of the protein
  • PEG may interfere with target binding
  • all true
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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

Extended release tablet

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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

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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
Rectal
Nasal
Pulmonary

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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
Q

Noninvasive routes of administration ALWAYS:

A

Require the drug to pass across a mucosal or cellular barrier

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26
Q

What is the most important stability category and determines the expiration period?

A

Each is equally important and contributes to determining product shelf-life

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27
Q

Color changes can indicate chemical instability

A

True

28
Q

Two agencies that regulate are the FDA and USP

A

False

29
Q

Product shelf-life stability is determined by accelerated stability testing

A

False

30
Q

Which of the following statements are true about lyophilization?

A
  • Properly executed lyophilization cycles result in minimal product reconstitution times
  • Injectable products and fast dissolving oral tablets are available as freeze dried products
  • The pharmacist must properly store, reconstitute and label lyophilized injectable products
31
Q

Which of the following is a surfactant?

A

Sodium lauryl sulfate

32
Q

The higher number capsule sizes (I.e. 0 -> 1 -> 2…) are desired because:

A

answer: none of the above
NOT “they get larger and therefore easier to pick up”
NOT “better for lowe density, higher volume powders”
NOT “harder to swallow”

33
Q

A size 1 capsule (0.5 cc volume) can hold what amount of powder having a tamped powder density of 0.5 g/cc?

A

250 mg

34
Q

Capsules are banded because:

A

Prevents tampering/adulteration

35
Q

Impurities are likely a critical attribute for release testing of a new batch of capsules

A

True

36
Q

Sterility is a likely critical attribute for release testing of a new batch of capsules

A

False

37
Q

Dissolution is a likely critical attribute for release testing of a new batch of capsules

A

True

38
Q

Taste is a likely critical attribute for release testing of a new batch of capsules

A

False

39
Q

Identity is a likely critical attribute for release testing of a new batch of capsules

A

True

40
Q

Powder particle size and flow are likely critical attribute for release testing of a new batch of capsules

A

False

41
Q

Appearance is a likely critical attribute for release testing of a new batch of capsules

A

True

42
Q

Tamper resistance is a likely critical attribute for release testing of a new batch of capsules

A

False

43
Q

Assay is a likely critical attribute for release testing of a new batch of capsules

A

True

44
Q

One year stability results are a likely critical attribute for release testing of a new batch of capsules

A

False

45
Q

Functional tablet coatings are not to be split because

A

The function of the coating is lost

46
Q

In general, the main purpose of tablet formulations is to:

A

answer-all of the above

  • Make the material more compressible
  • Assure weight uniformity across tablets
  • Assure active drug uniformity across tablets
  • Assurance that tablets readily disintegrate and dissolve as intended
47
Q

The purpose of a tablet lubricant is to:

A

Minimize friction during tablet ejection from the die hole

48
Q

If a tablet is too soft, then to make harder tablets:

A

answer: any one of combination of the above
- Increase the compression force
- Engage pre-compression roller to double up on compressions per unit
- Increase compression dwell time by slowing down the process
- Alter formulation to be more compressible

49
Q

Which of the following critical quality attributes should be included in stability testing to assure no change during the shelf life of the tablet?

A

Weight variation and/or content uniformity

50
Q

What is the primary source of contamination during compounding?

A

Personnel

51
Q

CQAs help ensure:

A

answer: all of the above
- Patient safety
- Efficacy of the drug product
- Quality of the drug product

52
Q

Controlling CQA for a drug product is:

A

all of the above
A FDA requirement
An EMA (European Medicines Agency) requirement
A health canada requirement
A PMDA L(Japan’s pharmaceuticals and Medical Devices Agency) requirement

53
Q

During aseptic preparation of sterile dosage forms it is OK to:

A

answer: none of the above
NOT pick up items off the floor during compounding
NOT handle products with torn gloves/gown
NOT leave room and return to compounding without changing gloves or gowning
NOT ignore good aseptic technique

54
Q

For drug products confirmed to not have passed sterility testing you should:

A
  • Perform an investigation to determine the root cause

- Recall the lot of drug product that failed sterility testing

55
Q

When you receive a warning letter from the FDA:

A
  • Provide a formal written response back to the FDA within a specific time frame
  • You personally could be found guilty of criminal charges
  • Risk having the facility shut down
56
Q

How does bioavailability affect dosage form and concentration?

A

Most topical eye drops are lost to tears making the absorbed component quite small

57
Q

Ocular drugs can be administered systemically. What is the bioavailability in the eye for most drugs?

A

1%

58
Q

Which is currently a common ocular delivery system, which is the basis for the largest selling ocular drugs for 2017? What is the indication?

A

Intravitreal injection for macular degeneration

59
Q

What is the mechanism by which macular degeneration affects (occludes) your vision?

A

Blood vessels grow across retina into vitreous

60
Q

Suppositories are the only dosage form available for rectal and vaginal delivery

A

False

61
Q

From a clinical pharmacology perspective, pediatric patients can be thought of as “small adults”.

A

False

62
Q

Children are often unable to swallow pills or capsules until age:

A

6-7

63
Q

When a new pediatric formulation is developed for use in children, bioavailability studies should be conducted in pediatric patients

A

False

64
Q

What biodegradable polymer have we discussed before?

A

PLGA

65
Q

PLGA is used frequently because it has ideal release characteristics

A

False

Dosage Forms (18 decks)

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