PHARM 124 EXAM QUESTIONS AND CORRECT ANSWERS
Define Pharmaceutics - ANSWER -study of chemical, physical and biological factors of
drug forms to determine the most effective and stable product
The study of how various drug forms influence the way in which the drug affects the bod
what is a drug - ANSWER an agent used for the diagnosis, treatment, reduction,
prevention, or curing of an illness
dosage form vs drug delivery system - ANSWER dosage form: preparation and way drug
is presented to person
dosage form can be drug delivery system: it is microscopic carrier eg nanoparticle that
encapsulates and targets drug to specific location
general dosage forms and examples - ANSWER 1) solids: capsules, tablets, powder
2)liquid: solutions and some dispersions
3) semi-solid: cream, ointment, gel, suppository
what is a drug product? generic vs brand name - ANSWER formulation of a drug
specifying the drug itself, excipients, dosage form, and method of preparation
Brand name/ Innovator:
rationale for different dosage forms and factors that influence the form chosen -
ANSWER Rationale:
-same and convenient means to deliver an accurate dose
-protect the drug from degradation from either GI tract or environment
-hide any unpleasant tastes
-ensure or control the release of the drug into the body and to achieve a predictable
therapeutic response
,Factors/considerations:
biopharmaceutic considerations: factors affecting bioavailability- factors affecting
absorption of drug from different routes of administration Drug factors: physical and
chemical properties of the drug itself
Therapeutic considerations: disease and patient factors
What are drug factors in terms of dosage form - ANSWER physical and chemical
properties of the drug itself. Includes:
-structural properites
-polymorphism
-dissolution
-particle size, solubility, partitioning
-stability
-organoleptic properties
-mechanism of decomposition
-interactions with other excipients
what are the therapeutic considerations in dosage form design - ANSWER Therapeutic:
nature of illness, disease, indication determines whether we need:
-systemic or local delivery
-targeted delivery
-required duration of action
-dose (amount given)
-dose regimen: drug, dose amount, interval between doses, duration of therapy
-fast or sustained or controlled release
-patient characteristics
-age, emergency conditions
, what are the biopharmaceutic considerations of dosage form design - ANSWER ADME
priniciple:
Absorption, Distribution, metabolism, elimination
-forms that avoid first-pass metabolism require less dose and has faster onset
types of effects a drug can have and what are the administration routes? what affects
this - ANSWER local vs systemic
Local: topical, transdermal, otic, opthalamic, conjunctival, nasal, inhalation etc
Systemic:
-enteral: oral, sublingual, buccal, rectal (can also be local)
-parenteral: intravenous, intramuscular, subcutaneous, intraosseous etc
What affects it:
disease or condition being treated
condition of patient
age
physical and chemical stability of drug
Innovator vs generic drug - ANSWER Innovator: product developed with new active
ingredient.
-it is patented for 20 years and takes 1.3B and 10-15 years to create
generic: brand name is reverse engineered to create a product that has same
bioavailability as brand name.
is same as brand name in terms of drug, dosage form, safety, strength, route of
administration, quality, performance, intended use
takes 3-6 years and 4M to develop
steps of innovator drug development process - ANSWER 1- drug is discovered and