Pharmaceutics II Final PollEV Questions

Which of the following is the US Adopted Name (USAN) in Lipitor (atorvastatin Calcium) tablets for oral admin?

atorvastation Calcium

"Ostwald's rule" is that the least stable crystal polymorph...

tends to crystalize first

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

Preparation (SISPQ = Safety, Integrity, Potency, Quality)

Preformulation activities

Span discovery and development stages, support formulation development, identify potential liabilities of drug candidates with respect to target dosage forms.

The maximum absorbable dose (MAD) is:

a simple model that uses API properties (solubility and absorption rate constant) and average small intestine physiology to predict the highest dose that will be fully absorbed.

Biopharmaceutics Classification system (BCS)

is used to classify drugs based on solubility and permeability, & is intended to reduce generic drug maker costs for BCS-1 immediate release drugs.

Acid & Base Drug molecules:

are often made into salts to overcome poor aqueous solubility of their free forms

When attempting to discover / confirm the most thermodynamically stable crystal form of an API:

it is best to slurry the API in solvents providing high solubility, typically at least 8mM.

What does ICH stand for?

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

Can you select excipients for a formulation to provide immediate release followed by controlled release of the API?

yes

Why does an excipient come in different grades?

NOT taste, It is 1. Manufacturing process, 2. Type of release (intended use), 3. Natural or synthetic

Excipients must continually undergo strict safety testing.

True

Can the same excipient be used in solid dose, liquid/suspension and IV formulations?

yes and no but a different grade

Excipients must be listed in the Compendia (i.e US Pharmacopeia) to be used in a fomulation.

False, Like flavors/colors aren't in there.

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

~120

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

All:

Rectal

Nasal

IV

Pulmonary

Which of the following is considered an invasive route?

IV, not nasal or rectal

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

Rectal suppository, (IV admin, Sub Q inj, IM inj are all invasive)

Noninvasive routes of admin ALWAYS:

Require the drug to pass across a mucosal or cellular barrier.

Which is the most important stability category & determines the expiration period?

Chemical, Physical and microbiological are equally important and contributes to determining the product shelf life

Color changes can indicate chemical stability

True

2 agencies that regulate are FDA and USP ?

False: USP only sets the guidelines, FDA regulates

Is product shelf- life stability determined by accelerated stability testing?

No, its determined by the actual long term storage conditions

Which of the following statements about lyophilization is false?

A. The Process removes frozen water by desorption as a means to improve product stability to hydrolysis reaction.

B. Properly executed lyophilization cycles result in minimal product reconstitution times

C. Injectable products and fast dissolving oral tablets are available as freeze- dried products

D. The pharmacists must properly store, reconstitute and label lyophilized injectable products.

A. The process removes frozen water by desorption as a means to improve product stability to hydrolysis reaction.

Critical Quality Attributes (CQAs) help secure:

Patient Safety, Efficacy of the drug product, & Quality of the drug product

Controlling CQAs for a drug product is:

regulated by all regions (FDA, Canada, Japan) but they aren't all the same.

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

none of these: Pick up items off the floor during compounding, Handle products with torn gloves/gown, Leave room and return to compounding without changing gloves or gowning, ignore good aseptic techniques

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

A. Ignore the data and not perform an investigation

B. Perform an investigation to determine the root cause

C. Recall the lot of the drug product that failed sterility testing

D. Retest the lot to try to get a passing result

B & C

B. Perform an investigation to determine the root cause

C. Recall the lot of the drug product that failed sterility testing

When you receive a warning letter from the FDA:

A. Ignore it

B. Provide a formal written response back to the FDA with a specific plan

C. You could be found guilty of criminal charges

D. Risk having the facility shut down

E. B, C, D are correct

B, C, D are correct

B. Provide a formal written response back to the FDA with a specific plan

C. You could be found guilty of criminal charges

D. Risk having the facility shut down

which of the following is a surfactant ? (not on final)

Sodium Lauryl Sulfate

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

A. they get larger and therefore easier to pick up

B. They are better for low density, higher volume powders

C. They are harder to swallow

D. All

E. None

E. none

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

0.25 g or 250 mg

Capsules are banded because:

prevents tampering/adulteration.

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

true

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

False

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

true

Powder particle size and flow are likely critical attributes for release testing of finished, banded capsules?

false

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

false

Functional tablet coating (e.g. enteric coated) are not to be split because:

the function of the coating is lost

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

ALL of these:

1. Make the material more compressible

2. Assure weight uniformity across tablets

3. Assure active drug uniformity across tablets

4. Assure that tablets readily disintegrate and dissolve as intended

The purpose of the tablet lubricant is to:

minimize friction during tablet ejection from the die hole

compressible index

lower number= better flow

higher number = poorer flow

size of capsules

lower number= bigger capsule

higher number = smaller capsule

adhesion

something sticks to something different from itself

cohesion

when something sticks to itself

tablet picking

a problem when the adhesion > cohesion forces

Fixed by : increase compression force, slow down press, alter formulation

friability

% weight loss in tablets after testing

disintegration

time for dosage unit to pass through 10 mesh screen

disintegration limit ~ 5 mins

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

Any one or combo of these:

1. Increase the compress force

2. Engage pre-compression roller to double up on compressions per unit

3. Increase compression dwell time by slowing down the press

4. Alter the formulation to be compressible

In general, a harder tablet:

NONE of these:

1. will have a shorter disintegration time

2. will dissolve faster

3. will have the same bioavailability or Cmax as a tablet with lower hardness

4. will be more difficult to swallow

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

assay along with impurities

What is the primary source of contamination during compounding?

Personnel

What is the first ( most outer, exposed to the air) physical barrier in the ear?

tympanic membrane

What part of the inner ear sense balance?

vestibular system

Whats the most common disease of the middle ear?

Otitis media

What is a common feature of many inner ear disorders?

inflammation

Otic medicine is generally external (outside of a skin layer and exposed to air). Do otic drug products need to be sterile?

yes

Which of the following are important about tonicity in otic drug formulations?

a. There is some flexibility (0.6 -2% NaCl) in tonicity of otic formulation

b. otic formulations are required to be isoosmotic (0.9% NaCl)

c. Controls permeation of the drug into ear tissue

A and C

a. There is some flexibility (0.6 -2% NaCl) in tonicity of otic formulation

c. Controls permeation of the drug into ear tissue

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

Viscosity (You want to have a good residence time thats sufficient to get drug into the tissue)

Systemic absorption of drug from the eye is possible. Why?

Both

1. Drug is absorbed into the blood stream through the many compartments of the eye

2. Drug is mostly in tears, some of which can be reabsorbed

How does the bioavailability affect dosage from 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?

1%

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

Intravitreal injection for macular degeneration

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

Macula degenerates over time

The largest number of topical products are formulated as:

creams

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

sorption promoting solvents

At what age is a child typically able to swallow pills/capsules?

6-8 years old

Should we do a bioequivalence study in adults or pediatric study?

Adult

Does PLGA have ideal release characteristics?

No