packet 2 - rocca

Question 0

the study of physical and chemical properties of drugs and their proper dosage as related to the onset, duration, and intensity of the drug action (the biological effect they produce)

Answer 0

biopharmaceutics

Question 1

the study of physical and chemical properties of drugs and their dosage forms

Answer 1

physical pharmacy

Question 2

involves investigation of the factors that influence the absorption, distribution, excretion, and metabolism of drugs, and the mathematical description of these processes

Answer 2

pharmacokinetics

Question 3

reasons for discontinuing clinical development

Answer 3

miscellaneous - 5%
commercial reason - 5%
adverse effects in man - 10%
animal toxicity - 10%
lack of efficacy - 30%
pharmacokinetics - 40%

Question 4

the extent and rate of absorption from a dosage form reflected by a time-concentration curve in the systemic circulation

Answer 4

bioavailability

Question 5

pharmaceutical equivalent which, when administered to the SAME individuals in the SAME dosage regimen, will result in comparable bioavailability

Answer 5

biological equivalent (bioequivalent)

Question 6

pharmaceutical equivalent is not the same as ________

Answer 6

bioequivalent

Question 7

bioequivalent is the same as the ____________

Answer 7

therapeutic equivalent

Question 8

multiple source drug products which contain the SAME active ingredient, in IDENTICAL amounts, in IDENTICAL DOSAGE FORMS administered by the same route and meet existing standards in US pharmacopoeia —- the product may be different in color, flavor, shape, packaging, inert ingredient, and expiration

Answer 8

pharmaceutical equivalent

Question 9

pharmaceutical equivalent differs with bioequivalent, in that

Answer 9

pharmaceutical equivalent has the same moiety but when in-vivo the result are not the same. in bioequivalent, when tested gives you the same therapeutical result

Question 10

AUC

Answer 10

area under the curve - which is the amount of drug absorbed

Question 11

the peak in a graph is the same as the max concentration/tMax T/F

Answer 11

true

Question 12

characteristics of generics (5)

Answer 12

takes less time to develop
same active ingredient
therapeutically equivalent
different excipients
sometimes less variability and more robust

Question 13

1984 drug price competition and patent term restoration act

Answer 13

related to cost savings

FDA has authority to accept abbreviated new drug applications (ANDAs) for generic versions of post-1962 drugs

Question 14

what are the four main orange book classification

Answer 14

A
B
AA
AB

Question 15

orange book classification A

Answer 15

drugs therapeutically equivalent to pharmaceutical equivalent products

Question 16

pharmaceutical alternative

Answer 16

can have some active moiety but can be different salt

ex. erythromycin

Question 17

orange book classification B

Answer 17

drug not therapeutically equivalent to pharmaceutical equivalent products

Question 18

orange book classification AA

Answer 18

drugs with no bioequivalence problem

Question 19

orange book classification AB

Answer 19

products meeting bioequivalence requirements

Question 20

what are the the four classes/phases of biopharmaceutical classification system

Answer 20

Phase I: high solubility, high permeability
Phase II: low solubility, high permeability
Phase III: high solubility, low permeability
Phase IV: low solubility, low permeability

Question 21

an experimental model that measures permeability and solubility under prescribed conditions. purpose was to aid in the regulation of post-approval changes and generics, providing approval solely on in vitro data

Answer 21

BCS biopharmaceutical classification system

Question 22

flags drugs that should not be tested clinically unless appropriate formulation strategies are employed

Answer 22

Biopharmaceutical Classification System BCS

Question 23

a substance is considered “highly soluble” when the highest clinical dose strength is soluble at in ____ mL or less of aqueous media over a pH range of 1-7.5 at 37C

Answer 23

250ml

Question 24

an exemption granted by the FDA from conducting human bioequivalence studies when the ingredient meets certain solubility and permeability criteria in-vitro and when the dissolution profile of the dose form meets the requirements for an "immediate" (IR) release

Answer 24

biowaiver

Question 25

reason for dosage form development

Answer 25

to provide a safe and convenient delivery of accurate amount of a drug

Question 26

additional dosage forms are needed where: 4

Answer 26

drugs are susceptible to oxidation and hydration drugs are acid-labile drugs possess bitter, salty, offensive taste/odor placement of drug directly in bloodstream needed

Question 27

things considered when designing new dosage form

Answer 27

``` nature of illness therapeutic situation method of treatment (local/systemic) route of admin age anticipated condition of the patient ```

Question 28

advantages of oral drug delivery 5

Answer 28

decrease dosing frequency smooth initial delivery sustained consistent plasma drug levels within well defined therapeutic window increase patient compliance

Question 29

oral admin

Answer 29

most common ingestible - capsule, tablet, liquid neutral pH in mouth --- may stabilize drug

Question 30

rectal admin

Answer 30

used for local and systemic effect most commonly used as suppository and enema irregular/erratic absorption may bypass liver

Question 31

topical admin

Answer 31

``` 1.semisolid prep, ointments, creams applied to skin used for local or systemic effect 2.topical dermatology deliver drug into skin treats dermal disorders skin is target organ 3. transdermal - delivery of drug through skin for systemic effect, skin NOT target ```

Question 32

parenteral admin

Answer 32

intramuscular intravenous subcutaneous

Question 33

pulmonary admin

Answer 33

via inhalation drug administered as fine particles of liquid or solids or aerosol or spray local or systemic local: bronchodilator- general anesthetics, systemic, rapid absorption, difficult to get to target

Question 34

common routes of administration

Answer 34

``` oral topical pulmonary parenteral rectal/vaginal ```

Question 35

factors that affect bioavailability

Answer 35

physiological properties physiological factors and patient characteristics pharmaceutical ingredients and dosage form characteristics

Question 36

following oral administration, most drugs get absorbed in the ____ _____

Answer 36

small intestine

Question 37

for drug to reach circulation, it needs to:

Answer 37

cross intestinal wall and pass through liver | can be defined as barrier of absorption

Question 38

unmediated permeation of molecules in intestine occur in two ways

Answer 38

transcellular pathway - passive | paracellular pathway - active transport

Question 39

intra-arterial

Answer 39

drug administer through the arteries

Question 40

intrathecal

Answer 40

direct admin of drug to the cerebrospinal fluid -- pain management

Question 41

the majority of the absorption in the small intestine occurs where and in which order

Answer 41

duodenum jejunum ilium

Question 42

surface area of the small intestine is due to ____ and _____ allowing absorption

Answer 42

villi | microvilli

Question 43

highest surface area in the small intestine is found in the ____ and ____

Answer 43

jejunum | ileum

Question 44

the GI transit time for the duodenum with both liquid food and solid food is

Answer 44

less than 60 seconds

Question 45

for compounds to be effectively absorbed these two factors are vital

Answer 45

solubility and permeability

Question 46

in order for a drug to be absorbed, it must be dissolved in ______ at the absorption site

Answer 46

fluid

Question 47

if a drug does not have the right permeability, it will not be absorbed T/F

Answer 47

true

Question 48

________ drugs are not well absorbed

Answer 48

hydrophilic

Question 49

excessively _____-soluble drugs may not be soluble enough to cross water layer near membrane

Answer 49

lipid

Question 50

lipophilicity has been linked with substance that are

Answer 50

metabolized too quickly and cannot be properly absorbed into the body

Question 51

factors that affect drug dissolution

Answer 51

crystal and amorphous surface area salt form state of hydration

Question 52

components that determine stability

Answer 52

polymorphs solvates prodrug salts

Question 53

MTC

Answer 53

minimal toxic concentration

Question 54

MEC

Answer 54

minimum effective concentration

Question 55

in order to achieve an effect, you want your drug to be in between which two phases in a graph

Answer 55

MEC and MTC, anything above MTC is toxic, and anything below MEC does not produce an effect

Question 56

riboflavin study showed

Answer 56

increase in absorption with food

Question 57

metoclopramide

Answer 57

prokinetic drug used for gastro esophageal disease --- accelerates motility of the stomach

Question 58

propantheline

Answer 58

anti cholinergic/muscarinic so slows down gastric motility

Question 59

amoxicillin shows site-dependent absorption and no hepatic extraction, whereas testosterone has similar absorption from the same intestine or large intestine but high hepatic extraction. In this case we can say the testosterone is independent due to:

Answer 59

1st pass metabolism

Question 60

gamma scintigraphy

Answer 60

provides visual evidence of drug delivery | shows that the formulation is delivering the amount of drug in hte right place at right time

Question 61

bariatric surgery referred to as

Answer 61

referred to as weigh loss surgery

Question 62

bariatric surgery works in 3 ways

Answer 62

1. restrict amount of food the stomach can hold 2. prevents digestive system from absorbing all nutrients 3. a combination

Question 63

types of weight loss surgery

Answer 63

gastric banding (stapling) gastroplasty rouxen Y

Question 64

post operative adjustments after bariatric surgery

Answer 64

diet habits change drugs may need to be adjusted eating frequent small meals deficiency in supplements

Question 65

dumping syndrome

Answer 65

stomach contents move too rapidly through the small intestine

Question 66

enterion design

Answer 66

for all common dosage forms | allows us to tract and see how much is absorbed

Question 67

pharmacoscintigraphy

Answer 67

combination of gamma-scintigraphy with conventional pharmacokinetic testing examines effect of food with drug formulation

Question 68

magnetic labeling

Answer 68

allows for the visualization of GI performance of the dosage form

Question 69

magnetic marker monitoring allows us to obtain information on: 3

Answer 69

gastric residence intestinal transit localization of disentigration

Question 70

atenolol, a beta blocker is better absorbed in the ____ by passive diffusion

Answer 70

colon