Poll Ev Flashcards by Kaitlyn Coronel

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

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

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What types of drug products must meet USP standards?

Prescription drugs
OTC Drugs
Generic Drugs
*all of the above

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What else should we mention regarding an ideal aerosol?

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

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The scale is in:

in mg so NOT ounces, micrograms, grams, nanograms

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

evaporation

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

DiscHaler (lower FPF means higher loss) AND

- DiscHaler (Lower FPF menas lower number of small particles)

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

False

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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 hydrogenated vegatable oil base

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Which of the following is NOT possible using nasal delivery?

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

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By conjugating PEG to a protein:

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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The largest number of topical products are formulated as:

Creams

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

Sorption promoting solvents

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What does ICH stand for?

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

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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?

Immediate release tablet

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

Extended release tablet

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Is the extended release tablet film coated?

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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?

Oral suspension

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

Atorvastatin calcium

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

Tend to crystalize first

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

Preparation

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

120

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

IV
Rectal
Nasal
Pulmonary

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Which of the following is an invasive route of administration?

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

Rectal suppository

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Noninvasive routes of administration ALWAYS:

Require the drug to pass across a mucosal or cellular barrier

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

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

Color changes can indicate chemical instability

True

Two agencies that regulate are the FDA and USP

False

Product shelf-life stability is determined by accelerated stability testing

False

Which of the following statements are true about lyophilization?

- 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

Which of the following is a surfactant?

Sodium lauryl sulfate

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

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”

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

Capsules are banded because:

Prevents tampering/adulteration

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

True

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

False

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

True

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

False

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

True

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

False

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

True

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

False

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

True

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

False

Functional tablet coatings are not to be split because

The function of the coating is lost

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

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

The purpose of a tablet lubricant is to:

Minimize friction during tablet ejection from the die hole

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

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

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

What is the primary source of contamination during compounding?

Personnel

CQAs help ensure:

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

Controlling CQA for a drug product is:

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

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

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

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

- Perform an investigation to determine the root cause | - Recall the lot of drug product that failed sterility testing

When you receive a warning letter from the FDA:

- 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

How does bioavailability affect dosage form and concentration?

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

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

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

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

Blood vessels grow across retina into vitreous

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

False

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

False

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

6-7

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

False

What biodegradable polymer have we discussed before?

PLGA

PLGA is used frequently because it has ideal release characteristics

False