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Biopharmaceutics and Pharmacokinetics > Unit 1: Introduction > Flashcards

Unit 1: Introduction Flashcards

1
Q

release of drug from dosage form

A

drug product performance

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2
Q

substances intended for the use in diagnosis, cure, mitigation, treatment or prevention of disease

A

drug

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3
Q

refers to the active pharmaceutical ingredient (API)

A

drug

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4
Q

given in a variety of dosage forms or drug products for systematic or local therapeutic activity

A

drug

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5
Q

final dosage form

A

drug product

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6
Q

drug delivery systems that release and deliver drug to the site of action to produce the desired therapeutic effect and minimize adverse toxicity

A

drug product

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7
Q

should be designed to meet the patient’s INDIVIDUAL requirements (safety, efficacy, cost/convenience, compliance; if orally: palatability)

A

drug product

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8
Q

interrelationship of the physicochemical properties of the drug, the dosage form (drug product) in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption

A

biopharmaceutics

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9
Q

physical and chemical properties of a drug relate to: (4 answers)

A

bioavailability, pharmacokinetics, pharmacodynamics and toxicologic effects/toxicokinetics

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10
Q

represented by F

A

bioavailability

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11
Q

rate (time) & extent (amount) of systemic absorption of the therapeutically active drug

A

bioavailability

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12
Q

in which organ does absorption primarily occurs

A

small intestine

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13
Q

formulation parameter to predict the proportion [and frequency] of the dose that will be systemically absorbed in the patient when changing dosage forms of the same drug

A

bioavailability

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14
Q

a measure of systemic availability of a drug

A

bioavailability

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15
Q

biopharmaceutic classification system or BCS categorizes drugs based on: (2 answers)

A

absorption and permeability

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16
Q

route of delivery:
percentage of drug bioavailability when delivered thru IV

A

100%

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17
Q

route of delivery:
percentage of drug bioavailability when delivered orally

A

not 100%

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18
Q

are added to enhance the performance/efficacy of drug/AI

A

excipients

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19
Q

3 factors affecting bioavailability

A

nature of drug molecule, route of delivery, formulation of dosage form

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20
Q

bioavailability allows us to determine if the drug is: (3 answers)

A

therapeutically active, toxic, has no apparent effect

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21
Q

the time course of drug movement in the body during absorption, distribution, metabolism, & excretion (ADME)

A

pharmacokinetics

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22
Q

what the body does to the drug

A

pharmacokinetics

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23
Q

words of origin of pharmacokinetics

A

pharmakon + kinesis

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24
Q

pharmakon meaning

A

drug

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25
Q

kinesis meaning

A

movement

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26
Q

drug elimination involves which processes in the body

A

metabolism and excretion (ME in ADME)

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27
Q

drug disposition involves which processes/stages in the body

A

distribution, metabolism and excretion (DME)

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28
Q

goal of application of pharmacokinetics

A

assure patient safety:
“Assure maintenance of therapeutic drug concentration in the body while preventing danger of toxicity.”

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29
Q

relation of the drug concentration or amount at the site of action (receptor) & its pharmacologic response

A

pharmacodynamics

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30
Q

what the drug is doing to the body

A

pharmacodynamics

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31
Q

harmful or undesirable effects of the drug

A

toxicologic effects

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32
Q

result of a drug activating or inactivating receptors

A

pharmacologic response

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33
Q

includes biochemical and physiologic effects that influence the interaction of drug with the receptor

A

pharmacodynamics

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34
Q

is it possible for adverse effects to appear in therapeutic concentrations

A

yes; are unpredictable

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35
Q

component [in or at the surface] of a cell or organism that interacts with a drug and initiates the chain of events leading to the drug’s observed effects

A

receptor

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36
Q

agonist that elicits 100% effect upon receptor occupancy; maximum response upon drug administration

A

full agonists

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37
Q

agonist with subtherapeutic effect

A

partial agonist

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38
Q

agonist with opposite effect

A

opposite agonist

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39
Q

antagonist that competes for a receptor since they have affinity to the same receptor as the agonist

A

competitive antagonist

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40
Q

agonist that binds to an allosteric (non-agonist) site on the receptor to prevent activation of the receptor

A

non-competitive antagonist

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41
Q

antagonist that prevents receptor effect thru other means (ex. interacts directly with the drug being antagonized to remove it or to prevent it from binding to its target)

A

chemical antagonist

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42
Q

antagonist that occupies
another receptor that when activated, counteracts the effect of the other receptor

A

physiological antagonist

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43
Q

drugs that occupy receptors and activate them

A

agonist

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44
Q

drugs that occupy receptors but do not activate them; blocks the receptors

A

antagonist

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45
Q

refers to dose and various measures of acute or integrated drug concentrations in plasma and other biological fluid

A

drug exposure

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46
Q

refers to direct measure of the pharmacologic effect of the drug

A

drug response

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47
Q

includes endpoints or biomarkers from: remote, presumed mechanistic effect to a potential or accepted surrogate and to a full range short/long term clinical effect

A

drug response

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48
Q

which particles have better dissolution: smaller or bigger

A

smaller; they have greater surface area

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49
Q

is there great or limited absorption is the stomach

A

limited

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50
Q

biopharmaceutics involves factors that influence: (6 answers)

A

1) design of drug product
2) stability of drug within drug product
3) manufacture of drug product
4) release of drug from drug product
5) rate of dissolution/release of drug from absorption site
6) delivery of drug to site of action

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51
Q

drug which is altered by the presence of a precipitant drug

A

object drug

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52
Q

any component that may affect the drug (may be food, drug etc.)

A

precipitant drug

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53
Q

scope of biopharmaceutics:

all possible effects observed following the administration of the drug in its various dosage forms, including (3 answers)

A

therapeutic effect, adverse effect, drug-drug interaction

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54
Q

reflects the minimum concentration of drug needed at the receptors to produce the desired pharmacologic effect

A

minimum effective concentration (MEC)

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55
Q

represents the lowest drug concentration needed to just barely produce a toxic effect

A

minimum toxic concentration (MTC)

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56
Q

the concentration between MTC and MEC

A

therapeutic window

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57
Q

is it safer to have a wide or narrow therapeutic window

A

wide - safer

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58
Q

ratio between toxic and therapeutic dose; measurement of drug safety

A

therapeutic index

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59
Q

corresponds to the time required for the drug to reach the MEC

A

onset time

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60
Q

proportional to the number of drug receptors occupied, which is reflected in the observation that higher plasma drug concentrations produce a greater pharmacologic response, up to a maximum

A

intensity of pharmacologic effect

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61
Q

difference between the onset time and the time for the drug to decline back to the MEC

A

duration of drug

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62
Q

onset of minimal observable effect to normal physiologic respone

A

duration of drug

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63
Q

time of maximum drug concentration in the plasma and is a rough marker of average rate of drug absorption

A

time of peak plasma level/peak time

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64
Q

related to the dose, the rate constant for absorption, and the elimination constant of the drug

A

peak plasma level or maximum drug concentration

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65
Q

related to the amount of drug absorbed systemically in the body

A

AUC or area under the curve

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66
Q

scope of biopharmaceutics:

all possible effects of various dosage forms on biological response including:

A

onset of action and duration of action [and intensity]

66
Q

scope of biopharmaceutics:

all possible effects of various dosage forms on biological response including:

A

onset of action and duration of action [and intensity]

67
Q

scope of biopharmaceutics:

all possible physiological factors which may affect the drug contained in the dosage form, including (2 examples from ppt)

A

pH of the stomach & intestine, surface area of skin

68
Q

4 scopes of biopharmaceutics

A

1) all possible effects observed following the administration of the drug in its various dosage forms
2) all possible effects of various dosage forms on biological response
3) all possible physiological factors which may affect the drug contained in the dosage form
4) dosage form of the drug

69
Q

a drug that is bioavailable is [more or less] likely to cause an effect in the body

A

more

70
Q

breaking down into smaller particles

A

disintergation

71
Q

conversion from solid to liquid

A

dissolution

72
Q

most absorbable oral dosage form

A

solution

73
Q

a process of how the body deals with the drug

A

pharmacokinetics

74
Q

a process of how your drug deals with the body

A

pharmacodynamics

75
Q

individualized treatment/therapy; considers patient factors

A

clinical pharmacy

76
Q

application of pharmacokinetic models to drug therapy

A

clinical pharmacokinetics

77
Q

serves as basis of dosing regimens

A

drug disposition

78
Q

disease, age, gender and genetic and ethnic differences are factors that affect _______

A

drug disposition

78
Q

observation of drug manifestations on patient

A

therapeutic drug monitoring (TDM)

79
Q

used for very potent drugs ex. w/ narrow therapeutic range; optimize efficacy and prevent adverse toxicity

A

therapeutic drug monitoring (TDM)

80
Q

drug examples that require plasma drug concentration monitoring (4 answers from ppt)

A

theophylline, chemotherapeutic drugs, anticonvulsants, aminoglycosides

81
Q

monitor specific pharmacodynamic endpoint (1 example from ppt)

A

prothrombim clotting time - warfarin

82
Q

Goal in drug making – design a drug product that will deliver active drug in the most ________ form

A

bioavailable

83
Q

pharmaceutic factors affecting drug bioavailability (3 answers)

A

1) type of drug
2) nature of excipients in the drug
3) physicochemical properties of the drug molecule

84
Q

measurable characteristics

A

physicochemical characteristics

85
Q

determined by the number, kind, arrangement of atoms

A

physicochemical characteristics

86
Q

preferred expression of the properties that relate to biological action vs physical or chemical

A

physicochemical characteristics

87
Q

pH, solubility, H-bonding, partition coefficient, hydrophilicity, lipophilicity, BBB, placental barrier are examples of

A

physicochemical characteristics

88
Q

physicochemical factors that may alter bioavailability (6 answers)

A

1) particle size of drug in solid dosage form
2) particle size of dispersed phase in an emulsion
3) tablet disintegration
4) tablet and capsule adjuncts
5) tablet coating
6) crystalline drug properties

89
Q

solution to Griseofulvin being not very soluble

A

micronized Griseofulvin

90
Q

mixture of oil and liquid phase with each other

A

emulsion

91
Q

Griseofulvin has high affinity to ___

A

fats

92
Q

excipients that help with the equal distribution of both phases in an emulsion

A

emulsifying agent/surfactant

93
Q

break up of intact dosage form to its
component aggregates

A

tablet disintegration

94
Q

excipients that help break down tablets

A

disnintegrants

95
Q

“That state in which any residue of the tablet, except fragments of insoluble coating remaining on the screen of the test apparatus in the soft mass have no palpably firm core”

A

complete disintegration (USP)

96
Q

reference for quality control pharmacopoeial test

A

USP

97
Q

solid products exempted from disintegration test (2 answers)

A

troches and chewable tabs

98
Q

separate specs for (5 answers)

A

uncoated, buccal, enteric, plain coated, SL (sublingual) tabs

99
Q

added to form the dosage form; inert, inactive

A

excipients

100
Q

has no pharmacologic effect but has effect on physical and chemical characteristics of drug

A

excipients

101
Q

roles of tablet and capsule adjuncts

A

1) affect drug absorption
2) increase solubility
3) increase retention time of drug in GIT
4) act as carrier to increase drug diffusion across the intestinal wall

102
Q

increase viscosity of drug vehicle, resulting to changes in drug dissolution

A

suspending agents

103
Q

promote suspension throughout the formulation

A

suspending agent

104
Q

prevent the sticking of fill material to the punches and dies to produce tablets having a sheen

A

lubricant

105
Q

enhance the flow of the tableting material in the tablet dies, minimize wear of punches and dies

A

glidant

106
Q

prevent adhesion; aka non sticking agent; enhance adhesion properties

A

anti-adherents

107
Q

magnesium stearate

A

hydrophobic lubricant

108
Q

talc

A

glidant

109
Q

Talc, hydrogenated vegetable oil, magnesium stearate

A

lubricants, glidants, anti-adherents

110
Q

excessive use of lubricants, glidants and anti-adherents will result to

A

repel water and reduce dissolution

111
Q

increase bulk or mass of the dosage form

A

diluent/filler

112
Q

excess use will retard dissolution

A

diluent/filler

113
Q

lactose

A

diluent/filler

114
Q

dibasic calcium phosphate

A

diluent/filler

115
Q

starch

A

tablet disintegrant, diluent/filler

116
Q

explotab

A

tablet disintegrant

117
Q

avicel

A

tablet disintegrants

118
Q

sodium starch glycolate

A

tablet disintegrant

119
Q

microcrystalline cellulose

A

tablet disintegrant, diluent/filler

120
Q

makes diluent adhere to the tablet to form a compact mass

A

binder

121
Q

excessive use will retard disintegration and dissolution

A

binder

122
Q

acacia

A

binder

123
Q

amount of force required to break the tablet

A

tablet hardness/breaking force

124
Q

can tablet hardness/breaking force be found in pharmacopoeia

A

non pharmacopoeial

125
Q

added when drug is easily degraded

A

tablet coating

126
Q

thickness will affect drug release

A

tablet coating

127
Q

uneven release or not released at all

A

tablet coating

128
Q

protection against gastric acid

A

enteric coated

129
Q

cellulose acetate phthalate

A

enteric coated

130
Q

aspirin EC is an example of what type of coating

A

enteric coated

131
Q

protection against light, moisture & air during storage

A

film coated

132
Q

hydroxypropylmethyl cellulose

A

film coated

133
Q

to conceal or mask bitter taste

A

sugar coated

134
Q

sucrose

A

sugar coated

135
Q

glucose

A

sugar coated

136
Q

use of aspirin EC

A

anti-inflammatory, antipyretic

137
Q

adverse effect of aspirin EC

A

reye’s syndrome

138
Q

adverse effects of paracetamol

A

hepatoxicity and jaundice

139
Q

which has slower dissolution time/rate
amorphous or crystalline

A

crystalline

140
Q

which is less thermodynamically stable
amorphous or crystalline

A

amorphous

141
Q

which is more rigid
amorphous or crystalline

A

crystalline

142
Q

drug + water

A

hydrates (crystal)

143
Q

T/F
hydrates and anhydrous have same solubility

A

false

144
Q

which has faster dissolution
erythromycin dihydrate or monohydrate/anhydrous in phosphate buffer

A

dihydrate

145
Q

which has faster dissolution
anhydrous ampicillin or ampicillin trihydrate

A

anhydrous ampicillin

146
Q

different crystal forms, same chemical structure, different physical properties

A

polymorphs

147
Q

are the following physical or chemical properties:

solubility, density, hardness, compression characteristics

A

physical

148
Q

arrangement of drug in various crystal forms

A

polymorphism

149
Q

has several polymorphs, ß polymorph is used for suspension

A

chloramphenicol

150
Q

how soluble and absorbable is a ß polymorph when used for suspension

A

more soluble and better absorbed

151
Q

rank chloramphenicol A, B and C based on stability, the first being the most stable

A

A > B > C

152
Q

chloramphenicol used for suspension and is metastable

A

B

153
Q

erythromycin coating

A

enteric coated

154
Q

stability of erythromycin in acidic, neutral and alkaline medium

A

acid = unstable
neutral and alkaline = stable

155
Q

enalapril is an example of

A

prodrug

156
Q

therapeutic form of enalapril

A

enalaprilate

157
Q

L DOPA

A

prodrug

158
Q

diazepam

A

active drug with active metabolite

159
Q

active metabolite of diazepam

A

temazepam

160
Q

acetaminophen/paracetamol

A

active drug with toxic metabolite

161
Q

acetaminophen/paracetamol toxic metabolite

A

n-acetyl-p-benzoquinone imine (NAPQI)

162
Q

needed for very potent drugs like digoxin

A

therapeutic drug monitoring

Biopharmaceutics and Pharmacokinetics (5 decks)

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