Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

ceutics > packet 2 - rocca > Flashcards

packet 2 - rocca Flashcards

0
Q

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)

A

biopharmaceutics

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
1
Q

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

A

physical pharmacy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

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

A

pharmacokinetics

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

reasons for discontinuing clinical development

A 
miscellaneous - 5%
commercial reason - 5%
adverse effects in man - 10%
animal toxicity - 10%
lack of efficacy - 30%
pharmacokinetics - 40%
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

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

A

bioavailability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

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

A

biological equivalent (bioequivalent)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

pharmaceutical equivalent is not the same as ________

A

bioequivalent

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

bioequivalent is the same as the ____________

A

therapeutic equivalent

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

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

A

pharmaceutical equivalent

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

pharmaceutical equivalent differs with bioequivalent, in that

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

AUC

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

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

A

true

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

characteristics of generics (5)

A 
takes less time to develop
same active ingredient
therapeutically equivalent
different excipients
sometimes less variability and more robust
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

1984 drug price competition and patent term restoration act

A

related to cost savings

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

what are the four main orange book classification

A

A
B
AA
AB

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

orange book classification A

A

drugs therapeutically equivalent to pharmaceutical equivalent products

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

pharmaceutical alternative

A

can have some active moiety but can be different salt

ex. erythromycin

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

orange book classification B

A

drug not therapeutically equivalent to pharmaceutical equivalent products

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

orange book classification AA

A

drugs with no bioequivalence problem

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

orange book classification AB

A

products meeting bioequivalence requirements

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

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

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

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

A

BCS biopharmaceutical classification system

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

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

A

Biopharmaceutical Classification System BCS

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

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

A

250ml

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

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

A

biowaiver

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

reason for dosage form development

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

additional dosage forms are needed where: 4

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

things considered when designing new dosage form

A 
nature of illness
therapeutic situation
method of treatment (local/systemic)
route of admin
age
anticipated condition of the patient
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

advantages of oral drug delivery 5

A

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

29
Q

oral admin

A

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

30
Q

rectal admin

A

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

31
Q

topical admin

A 
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
32
Q

parenteral admin

A

intramuscular
intravenous
subcutaneous

33
Q

pulmonary admin

A

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

34
Q

common routes of administration

A 
oral
topical
pulmonary
parenteral
rectal/vaginal
35
Q

factors that affect bioavailability

A

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

36
Q

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

A

small intestine

37
Q

for drug to reach circulation, it needs to:

A

cross intestinal wall and pass through liver

can be defined as barrier of absorption

38
Q

unmediated permeation of molecules in intestine occur in two ways

A

transcellular pathway - passive

paracellular pathway - active transport

39
Q

intra-arterial

A

drug administer through the arteries

40
Q

intrathecal

A

direct admin of drug to the cerebrospinal fluid – pain management

41
Q

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

A

duodenum
jejunum
ilium

42
Q

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

A

villi

microvilli

43
Q

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

A

jejunum

ileum

44
Q

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

A

less than 60 seconds

45
Q

for compounds to be effectively absorbed these two factors are vital

A

solubility and permeability

46
Q

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

A

fluid

47
Q

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

A

true

48
Q

________ drugs are not well absorbed

A

hydrophilic

49
Q

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

A

lipid

50
Q

lipophilicity has been linked with substance that are

A

metabolized too quickly and cannot be properly absorbed into the body

51
Q

factors that affect drug dissolution

A

crystal and amorphous
surface area
salt form
state of hydration

52
Q

components that determine stability

A

polymorphs
solvates
prodrug
salts

53
Q

MTC

A

minimal toxic concentration

54
Q

MEC

A

minimum effective concentration

55
Q

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

A

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

56
Q

riboflavin study showed

A

increase in absorption with food

57
Q

metoclopramide

A

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

58
Q

propantheline

A

anti cholinergic/muscarinic so slows down gastric motility

59
Q

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:

A

1st pass metabolism

60
Q

gamma scintigraphy

A

provides visual evidence of drug delivery

shows that the formulation is delivering the amount of drug in hte right place at right time

61
Q

bariatric surgery referred to as

A

referred to as weigh loss surgery

62
Q

bariatric surgery works in 3 ways

A
  1. restrict amount of food the stomach can hold
  2. prevents digestive system from absorbing all nutrients
  3. a combination
63
Q

types of weight loss surgery

A

gastric banding (stapling)
gastroplasty
rouxen Y

64
Q

post operative adjustments after bariatric surgery

A

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

65
Q

dumping syndrome

A

stomach contents move too rapidly through the small intestine

66
Q

enterion design

A

for all common dosage forms

allows us to tract and see how much is absorbed

67
Q

pharmacoscintigraphy

A

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

68
Q

magnetic labeling

A

allows for the visualization of GI performance of the dosage form

69
Q

magnetic marker monitoring allows us to obtain information on: 3

A

gastric residence
intestinal transit
localization of disentigration

70
Q

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

A

colon

ceutics (2 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions