Final 2 Flashcards
Key step which enables a drug to be active in human body
Dissolution
An API can be used in the manufacturing of a drug product until:
a. the expiration date
b. the date specified by the retest interval, when it can continue to be used
as long as retest results meet specifications
c. it is completely used up
d. the date specified by the retest interval, when it must be dispose
b. the date specified by the retest interval, when it can continue to be used
as long as retest results meet specifications
The predominant route of administration to treat back of eye disorder is ____
Intravitreal
The most stable crystal form of an API:
a. Has the highest solubility of all crystal forms of the API
b. Has the lowest solubility of all crystal forms of the API
a. Has the highest solubility of all crystal forms of the API
When a drug is delivered using a DUROS implant, constant drug release can be achieved for a year. The mechanism of release used in this system is:
Osmotic Pump
The percentage of drugs dispensed generically in the US is:
90%
Often, the most critical excipient for a pediatric formulation is:
Flavoring
Often, the most critical excipient for a pediatric formulation is:
Flavoring
An ANDA for a generic drug must contain:
Bioequivalence data
Otic medicine is generally applied externally. Are otic drug products required to be sterile?
Yes
The most common source of microbial contamination in the clean room environment is:
Personnel environmental contact
Which of the following factors are important to consider with developing an ophthalmic formulation?
a. sterility
b. tonicity
c. pH
d. All of the above
d. All of the above
True/False: The approval process in the US is the same for generic biotechnology-derived drugs as for traditional small drugs
False
The salt form of a drug substance:
a. Always the preferred form
b. Often used to increase aqueous solubility of drug substance
b. Often used to increase aqueous solubility of drug substance
Drugs administered nasally can be used for:
a. CNS delivery
b. Systemic
c. Local
d. All of the above
d. All of the above
True/False: Appearance of the drug product should be included on the specification at release AND on stability
True
True/False: All prescription drugs are FDA regulated
True
The current thinking is that children must be protected:
Through clinical research
Which of the following is NOT a method used for terminal sterilization of sterile solutions?
a. In-process filtration with aseptic processing
b. moist heat
c. UV light
d. dry heat
a. In-process filtration with aseptic processing
I think this is incorrect; verify
The primary type of excipient used in lyophilization is:
a. a lubricant
b. a colorant
c. a bulking agent
d. a preservative
c. a bulking agent
When engineering your powder formulation for pulmonary delivery, your ideal formulation would contain
a. uniform particle size
b. wide range of particle sizes
c. particles can’t be used, only liquid
a. uniform particle size
Noninvasive routes of administration ALWAYS:
a. have improved patient compliance
b. require the drug to pass across a mucosal or cellular barrier
c. have a slower onset of action
d. all
b. require the drug to pass across a mucosal or cellular barrier
Lipophilic drugs more easily permeate cells via:
a. transcellular transport
b. paracellular
c. either type
d. neither type
a. transcellular transport
Amorphous solids are sometimes produced for use in the final dosage form because:
a. they have higher solubility than crystalline
b. they are more chemically stable than crystalline
c. they can convert to the crystalline form
d. they are more physically stable than the crystalline form
a. they have higher solubility than crystalline
Excipients are also referred to as:
Inactive ingredients
PLGA can NOT be used to make:
a. gels
b. implantable rods
c. microspheres
d. All of it can be used
d. All of it can be used
A drug that exhibits polymorphism:
a. can exist in more than one crystal form
b. requires sterilization
c. is amorphous
d. can not be made into suitable drug product
a. can exist in more than one crystal form
In a drug product, “API” is a synonym for:
a. the excipient
b. the crystal form
c. the dosage form
d. the drug substance
d. the drug substance
TRUE/FALSE: PLGA has ideal release characteristics
FALSE
It not great for release but it’s good enough
APIs can NOT be:
Complex mixtures
