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Pharmaceutics > Test 1 > Flashcards

Test 1 Flashcards

1
Q

drug

A

a chemical substance that interacts with a part of the body to alter an existing physiological or biochemical process

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2
Q

Food, Drug and Cosmetic act of 1938 a drug is

A

a natural or synthetic substance which affects its functioning structure, and is used in the diagnosis, mitigation, treatment or prevention of a disease or relief of discomfort

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3
Q

where do drugs come from

A

plants, animals, minerals or can be synthetic

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4
Q

synthetic drugs

A

are preferred bc of quality control , ease of preparation and they are not dependent on certain resources

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5
Q

dosage formulation

A

drug delivery system; final formulation of the drug in combination with one or more non medicinal agents

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6
Q

dosage formulations

A

important for accuracy, protection of a drug substance outside of the body, protection of a drug substance inside the body, optimization of delivery to its site of action or convenience

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7
Q

pharmacology

A

a drugs mechanism of action

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8
Q

toxicology

A

possible harmful side effects

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9
Q

medicinal chemistry

A

chemical structure and properties

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10
Q

pharmacotherapy

A

medicinal treatment by means of drugs

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11
Q

pharmacokinetics

A

what the body does to the drug

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12
Q

pharmacodynamics

A

what the drug does to the body

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13
Q

pharmaceutics is

A

all things related to drug formulations

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14
Q

the first pharmacists

A

were tribal people, sick ppl were those punished for their sins, evil spirts were tied to disease; v symbolic

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15
Q

hippocates

A

4 humors, rationalization of the source of illness; Hippocratic oath; father of medicine

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16
Q

dioscorides

A

1st century greek philosopher; wrote Materia Metica; developed the first pharmacopeia

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17
Q

Galen

A

2nd century greek philosopher; first cold creme; father of compounding

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18
Q

who split physicians and pharmacists why??

A

Frederick 2 of Germany; enforce ethics; too much knowledge for 1 person to know

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19
Q

Friedrich Wilhelm Adam serturner

A

specialized in removal of alkaloids and is credited with the discovery of morphine

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20
Q

Carl Wilhelm Scheele

A

discovery of oxygen; extracted and isolated chemicals

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21
Q

what is the USP

A

United States Pharmacopeia

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22
Q

what is the NF

A

National formulary

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23
Q

what is the timeline of USP and NF

A

USP originally run by physicians and only drugs of “therapeutic merit”; NF made their own with pharmacists; both were recognized by the pure food and drug act of 1906; USP became controlled by pharmacists; then USP bought NF

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24
Q

Pure Food and Drug Act of 1906

A

regulated drug production; standards for purity, strength, and quality

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25
Q

Sherley Amendment of 1912

A

regulated therapeutic benefit; and prohibited false claims

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26
Q

Food Drug and Cosmetic act of 1938

A

prohibit distribution of any drug without prior filing of a new drug application and approval by the FDA; ensured safety

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27
Q

Kefauver-Harris Amendment of 1962

A

added efficacy requirements

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28
Q

what are the 3 types of drug discoveries

A

serendipity; high throughput screening; molecular modeling

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29
Q

serendipity

A

good fortune

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30
Q

high throughput screening

A

a library of candidate compound is examined quickly using an applicable biologic assay to identify a lead compound that can be further tested

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31
Q

molecular modeling

A

computer aided evaluation of a target site receptor and design of a drug that can be synthesized to fit that target site

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32
Q

role of FDA in approval of dosage form

A

sponsor of a new drug must file and IND application with the FDA; institutional review board then evaluates the plan for safety; after 30 days human trials begin; three phrases of testing demonstrate drug safety and therapeutic effectiveness

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33
Q

Investigational New Drug

A

IND; identifications of phase, investigational plan with rationale for the study; brief summary of previous human experience, preclinical and clinical summary; protocol for each planned study

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34
Q

New Drug Application

A

NDA; names of drugs, statement as Rx; technical sections or human pharmacokinetics and bioavailability, clinical data, statistical methods, samples of the drug substance, drug product proposed for marketing; clinical case report forms

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35
Q

phase 1 of clinical trials

A

20-100; lasts several months, assess safety

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36
Q

phase 2 of clinical trials

A

up to several hundred patients with the condition; months - 2 years;

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37
Q

phase 3 of clinical trials

A

several hundred to several thousand patients with the condition for which the drug is intended; last 1- 4years

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38
Q

phase 4 of clinical trials

A

continued clinical study; drugs MOA, possible new therapeutic uses for drugs; dosage strengths, check for adverse rxn, side effects

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39
Q

what are functional groups & why are they important

A

a group of atoms responsible for the characteristic reactions of a particular compound; provide specific properties and behaviors that allow drug molecules to exert their desired pharmacokinetic and pharmacodynamic effects

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40
Q

solubility

A

the ability for a given substance to dissolve in another substance

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41
Q

saturation

A

when the max amount of solute is dissolved in the solvent

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42
Q

hydrophilicity

A

drugs ability to be dissolve in water

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43
Q

lipophilicity

A

drugs affinity to dissolve in lipids or other non polar solvents

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44
Q

intrinsic aqueous solubility

A

how inherently soluble a drug is in water; measured by the partition coefficient of the drug; determined after equilibrium is reached

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45
Q

P

A

the partition coefficient; equal to the partition solvent concentration divided by the concentration of dissolved water; solvent conc./conc. in H2O

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46
Q

the larger value of log P,

A

the more lipophilic the drug molecule is

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47
Q

polarity

A

used to describe the presence of a dipole moment

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48
Q

polar molecules

A

possess a dipole moment; meaning there is a partial charge separation between atoms due to the electronegativity of the atoms; dissolve in water

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49
Q

nonpolar molecules

A

do not possess a dipole moment; dissolve in lipid solvents due to van der wals forces

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50
Q

hydrogen bonding

A

a special kind of dipole dipole attraction that occurs between molecules with specific structural features

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51
Q

dielectric constant

A

a measure of the ability of a molecule or solvent to separate charges

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52
Q

what type of functional groups increase partition coefficient

A

carbons; halogens,

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53
Q

what type of functional groups decrease the partition coefficient

A

anything that has oxygen or nitrogen

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54
Q

general trends for increasing water solubility of drug molecules

A

1) introduction of a polar functional group 2) branching of alkyl groups 3) decrease molecular weight

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55
Q

electrolyte

A

a compound that ionizes in solution; can conduct electricity

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56
Q

strong electrolytes

A

ionize completely

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57
Q

weak electrolytes

A

ionizable but only dissociate partially

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58
Q

non-electrolyte

A

does not ionize in water; remains neutral and uncharge

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59
Q

ionization

A

allows for more water solubility due to the formation of ion-dipole bonds

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60
Q

the pH scale

A

is a logarithmic quantification of the concentration of H+

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61
Q

a change in 1 number on the pH scale

A

represents a tenfold change in [H+]

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62
Q

as the pH decrease

A

[H+] increases

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63
Q

acids

A

donate or lose a hydrogen

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64
Q

bases

A

accept or gain a hydrogen

65
Q

the strength of the acid

A

can be quantified by the acid dissociation constant; Ka

66
Q

Ka

A

is the ratio of products to reactant

67
Q

pka =

A

-logKa

68
Q

strong acids have a ___ pka

A

lower

69
Q

2 key features of an acidic functional group

A

1) presence of a liable proton 2) ability of the remaining atoms to delocalize the resulting negative charge via resonance

70
Q

key structural feature of a basic functional group is

A

the presence of an atom with a lone pair of electrons

71
Q

distribution coefficient

A

log D values for acidic and basic drugs will vary depending on the pH of the molecules environment; values for drugs without acidic or basic functional groups will remain constant

72
Q

salt

A

an ionic compound that is formed when an acid reacts with a base; dissociate in water; salts of drugs are typically more stable and more water soluble

73
Q

inorganic salts

A

the result of the reaction between a drug molecule and an inorganic acid or base

74
Q

inorganic salts acidic

A

typically made with NaOH, KOH, Ca(OH)2

75
Q

inorganic salts basic

A

typically made with HCl, HBr, H2SO4, H3PO4

76
Q

organic salts

A

the result of the reaction between a drug molecule and an organic acid or base

77
Q

processes for solid dosage form

A
  1. disintegration 2. dissolution 3. absorption
78
Q

process for semi-solid dosage

A
  1. release 2. dissolution 3. absorption
79
Q

process for liquid

A
  1. dissolution 2. absorption
80
Q

solubility

A

the capacity of a solute to dissolve in a solvent

81
Q

dissolution

A

the rate act which the dissolving occurs

82
Q

dissolution is defined by the ____ equation

A

Noyes-Whitney

83
Q

D =

A

diffusion coefficient; not easily manipulated

84
Q

A =

A

surface area of a drug, greater SA = faster dissolution

85
Q

S =

A

drug solubility, not easily manipulated

86
Q

C

A

concentration of a drug in solvent

87
Q

H

A

thickness of diffusion layer; thinner layer = faster

88
Q

ficks law

A

flux = K * S * D (C1 - C2) / h

89
Q

diffusion equation

A

dm/ dt = D * A(S-C) / h

90
Q

transcellular

A

take molecules in one side of the cell and out the other

91
Q

paracellular transport

A

occurs when a small molecule is able to pass between cells through tight junctions

92
Q

pH =

A

pka + base / acid

93
Q

OAT

A

organic anion transporter; influx transporters

94
Q

OCT

A

organic cation transporter; influx but bidirectional

95
Q

stomach

A

primary site for oral drug disintegration and dissolution, v acidic, little SA

96
Q

small intestine

A

less mucous than stomach, rich blood supply, less acidic, large SA

97
Q

a symporter is also called a

A

cotransporter

98
Q

antiporter AKA

A

exchangers

99
Q

efflux transporters

A

ABC (ATPase binding cassette) aka P-gp (P-glycoprotien) aka (multidrug resistant type 1); into the gut, urine, bile; out of brain, and other organs

100
Q

influx tranporters

A

OATP (organic anion transporter polypeptide) mediates transport of organic anions expressed in BBB, liver, intestines, kidneys, absorptive membrane surfaces; OCT (organic cation transporter) mediates transport of organic cations, expressed in the BBB, liver, intestines, and kidneys

101
Q

the first pass effect

A

describes hepatic metabolism of a drug when it is absorbed from the gut and delivered to the liver via the hepatic portal vein where some amount of the drug undergoes metabolism before entering into systemic circulation

102
Q

IV administration

A

plasma concentration starts at its highest level and steadily decreases

103
Q

other routes

A

plasma concentration starts at zero increase to a maximum then begins to decrease

104
Q

bioavailability

A

the fraction of an administered dose of a drug or other substance that reaches systemic circulation an is available to reach the site of action

105
Q

absolute bioavailability

A

compares bioavailability of a dosage form to that of intravenous administration

106
Q

relative bioavailability

A

compares the bioavailability of a dosage form to another dosage form is specifically uses when an intravenous form of the drug does not exist or cannot be used

107
Q

bioavailability

A

(area under curve for dosage form) / (area under curve for IV administration) then mult. by 100

108
Q

extemporaneous pharmacy compounding

A

the preparation, mixing, assembling, packaging, or labeling of a drug or device as a default of a practitioners prescription drug order initiated based of the triad course of professional practice or for the purpose of research, testing, chemical analysis and not for resale or dispensing

109
Q

compounding is regulated by

A

the state board of pharmacy; adhering to good practices set forth by USP 795 ad 797

110
Q

USP 795

A

NON-STERILE COMPOUNDING includes regulations for the environment, stability,, ingredient, strength, quality and pretty, process, records, quality control counseling

111
Q

USP 797

A

STERILE COMPOUDING; describes conditions and practice to prevent harm, including death to patients that could result from contamination, endotoxins, variability, contaminants, inappropriate quality

112
Q

manufacturing is regulated by

A

food and drug administration

113
Q

cGMP

A

current good manufacturing processes

114
Q

failure to meet cGMPs usually result in

A

voluntary recall of the drug

115
Q

API

A

active pharmaceutical ingredient; furnishes pharmacologic activity

116
Q

batch

A

specific quantity of drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture

117
Q

lot

A

a beach or any portion of a batch having uniform quality and a distinctive identifying lot number

118
Q

lot number

A

combination of letters which completed history of the manufacturer, processing, packaging, holding and distribution of a batch or lot of a drug product

119
Q

drug product

A

a finished form that contains an active drug and inactive ingredients

120
Q

compliance

A

determination through inspection of the extent to which a manufacturer s acting in accordance with prescribed regulations, standards, and practices

121
Q

master record

A

record containing the formulation, specifications, manufacturing procedures, quality assurance requirements, and labeling of a finished product

122
Q

validation

A

documented evidence that a system does what is should do

123
Q

added substances

A

inactive ingredients

124
Q

beyond use date

A

the date after which a compounded preparation should not be used

125
Q

component

A

any ingredient necessary for the compounding of a preparation

126
Q

compounded

A

a professional authorized by the appropriate jurisdiction to perform compounding

127
Q

compounding

A

the preparation, mixing, assembling, altering, packaging, and labeling of a drug or drug delivery device in accordance wit a a licensed practitioners prescription within the triad relationship

128
Q

hazardous drug

A

any drug that can cause cancer, reproductive toxicity, organ toxicity or gentoxicity

129
Q

preparation

A

a compound drug dosage form which ac compounder has introduced a drug

130
Q

3 categories of compounding by USP

A

simple, moderate, complex

131
Q

simple

A

using a recipe that lists specific components, compounding procedure and equipment, and stability data from a manufacturer or peer reviewed journal

132
Q

moderate

A

making a preparation that requires special calculations or procedures or making a preparation for which stability data is not available

133
Q

complex

A

making a preparation that requires special training, facilities, equipment, and procedures to ensure appropriate therapeutic outcomes

134
Q

responsibilities of a compounder

A

addresses the following areas of concern: appropriate ingredients, packing and beyond use dating, training of compounders, patient counseling

135
Q

formulation record

A

recipe; step by step instructions

136
Q

compounding record

A

what actually happened; specific to patient

137
Q

SOPs

A

standard operation procedures; maintaining consistency

138
Q

Materials safety data sheets

A

documentation of the chemical and physical properties of a chemical as well as safety information

139
Q

aqueous for oral use

A

no later than 14 days

140
Q

aqueous for topical use

A

no later than 30 days

141
Q

non aqueous formulation

A

not later than the time remaining until the earlier expiration date of any API or 6 months

142
Q

employee compounding procedure

A

the pharmacist demonstrates then employee does it; they will be monitored and be responsible for the finished preparation

143
Q

patient counseling

A

proper use, storage, handling, disposal, physical changes, adverse event

144
Q

micromeritics

A

field of science devoted to the study of the behavior and characteristics of small particles

145
Q

why is micromeritics important

A

influences a large number of parameters in research development, manufacturing of dosage forms such as amount of water needed, uniformity, efficacy

146
Q

powder

A

a solid consisting of v small particles; can refer to pharmaceutical ingredients or dosage formulation

147
Q

desirable qualities of powders

A

ability to flow, higher degree of circularity, larger particle size low angle of repose

148
Q

granules

A

specifically agglomerations of powders with desirable properties

149
Q

utility of formatting drugs into pharmaceutical powders and granules

A

fast acting, easier administration of doses involving large portions of drugs, easier administration of doses to patient populations that have difficulty swallowing

150
Q

most powders and granules are through what route

A

oral, topical, inhalation, and vaginal

151
Q

ingredients needed to make a pharmaceutical powder and granule

A

drug API to treat disease, diluent, lubricants, anti adherents, miscellaneous ingredients (to make powders easier to work with)

152
Q

general preparation of compounding pharmaceutical powders involves 2 processes:

A

reduction of particle size and blending of components

153
Q

___ has the slowest onset of actions

A

tablets

154
Q

which are faster granules or powders

A

powders

155
Q

advantages for using pharmaceutical powders / granules

A

more stable, more convient, faster onset of action, good for patients who have difficulty swallowing

156
Q

disadvantages for using pharmaceutical powders / granules

A

less convient to carry around than a small container of tablets, not good for drugs with unpleasant tastes, difficult to measure accurate doses, hygroscopic

157
Q

the more round the powder,

A

the better it will flow

158
Q

granules are preferred to powders due to the following

A

better flow, more stable, wetted better, better content uniformity

Pharmaceutics (1 decks)

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