Test 1 Flashcards
(158 cards)
1
Q
drug
A
a chemical substance that interacts with a part of the body to alter an existing physiological or biochemical process
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
3
Q
where do drugs come from
A
plants, animals, minerals or can be synthetic
4
Q
synthetic drugs
A
are preferred bc of quality control , ease of preparation and they are not dependent on certain resources
5
Q
dosage formulation
A
drug delivery system; final formulation of the drug in combination with one or more non medicinal agents
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
7
Q
pharmacology
A
a drugs mechanism of action
8
Q
toxicology
A
possible harmful side effects
9
Q
medicinal chemistry
A
chemical structure and properties
10
Q
pharmacotherapy
A
medicinal treatment by means of drugs
11
Q
pharmacokinetics
A
what the body does to the drug
12
Q
pharmacodynamics
A
what the drug does to the body
13
Q
pharmaceutics is
A
all things related to drug formulations
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
15
Q
hippocates
A
4 humors, rationalization of the source of illness; Hippocratic oath; father of medicine
16
Q
dioscorides
A
1st century greek philosopher; wrote Materia Metica; developed the first pharmacopeia
17
Q
Galen
A
2nd century greek philosopher; first cold creme; father of compounding
18
Q
who split physicians and pharmacists why??
A
Frederick 2 of Germany; enforce ethics; too much knowledge for 1 person to know
19
Q
Friedrich Wilhelm Adam serturner
A
specialized in removal of alkaloids and is credited with the discovery of morphine
20
Q
Carl Wilhelm Scheele
A
discovery of oxygen; extracted and isolated chemicals
21
Q
what is the USP
A
United States Pharmacopeia
22
Q
what is the NF
A
National formulary
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
24
Q
Pure Food and Drug Act of 1906
A
regulated drug production; standards for purity, strength, and quality
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Sherley Amendment of 1912
regulated therapeutic benefit; and prohibited false claims
26
Food Drug and Cosmetic act of 1938
prohibit distribution of any drug without prior filing of a new drug application and approval by the FDA; ensured safety
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Kefauver-Harris Amendment of 1962
added efficacy requirements
28
what are the 3 types of drug discoveries
serendipity; high throughput screening; molecular modeling
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serendipity
good fortune
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high throughput screening
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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molecular modeling
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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role of FDA in approval of dosage form
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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Investigational New Drug
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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New Drug Application
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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phase 1 of clinical trials
20-100; lasts several months, assess safety
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phase 2 of clinical trials
up to several hundred patients with the condition; months - 2 years;
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phase 3 of clinical trials
several hundred to several thousand patients with the condition for which the drug is intended; last 1- 4years
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phase 4 of clinical trials
continued clinical study; drugs MOA, possible new therapeutic uses for drugs; dosage strengths, check for adverse rxn, side effects
39
what are functional groups & why are they important
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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solubility
the ability for a given substance to dissolve in another substance
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saturation
when the max amount of solute is dissolved in the solvent
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hydrophilicity
drugs ability to be dissolve in water
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lipophilicity
drugs affinity to dissolve in lipids or other non polar solvents
44
intrinsic aqueous solubility
how inherently soluble a drug is in water; measured by the partition coefficient of the drug; determined after equilibrium is reached
45
P
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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the larger value of log P,
the more lipophilic the drug molecule is
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polarity
used to describe the presence of a dipole moment
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polar molecules
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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nonpolar molecules
do not possess a dipole moment; dissolve in lipid solvents due to van der wals forces
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hydrogen bonding
a special kind of dipole dipole attraction that occurs between molecules with specific structural features
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dielectric constant
a measure of the ability of a molecule or solvent to separate charges
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what type of functional groups increase partition coefficient
carbons; halogens,
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what type of functional groups decrease the partition coefficient
anything that has oxygen or nitrogen
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general trends for increasing water solubility of drug molecules
1) introduction of a polar functional group 2) branching of alkyl groups 3) decrease molecular weight
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electrolyte
a compound that ionizes in solution; can conduct electricity
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strong electrolytes
ionize completely
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weak electrolytes
ionizable but only dissociate partially
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non-electrolyte
does not ionize in water; remains neutral and uncharge
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ionization
allows for more water solubility due to the formation of ion-dipole bonds
60
the pH scale
is a logarithmic quantification of the concentration of H+
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a change in 1 number on the pH scale
represents a tenfold change in [H+]
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as the pH decrease
[H+] increases
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acids
donate or lose a hydrogen
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bases
accept or gain a hydrogen
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the strength of the acid
can be quantified by the acid dissociation constant; Ka
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Ka
is the ratio of products to reactant
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pka =
-logKa
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strong acids have a ___ pka
lower
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2 key features of an acidic functional group
1) presence of a liable proton 2) ability of the remaining atoms to delocalize the resulting negative charge via resonance
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key structural feature of a basic functional group is
the presence of an atom with a lone pair of electrons
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distribution coefficient
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
salt
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
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inorganic salts
the result of the reaction between a drug molecule and an inorganic acid or base
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inorganic salts acidic
typically made with NaOH, KOH, Ca(OH)2
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inorganic salts basic
typically made with HCl, HBr, H2SO4, H3PO4
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organic salts
the result of the reaction between a drug molecule and an organic acid or base
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processes for solid dosage form
1. disintegration 2. dissolution 3. absorption
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process for semi-solid dosage
1. release 2. dissolution 3. absorption
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process for liquid
1. dissolution 2. absorption
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solubility
the capacity of a solute to dissolve in a solvent
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dissolution
the rate act which the dissolving occurs
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dissolution is defined by the ____ equation
Noyes-Whitney
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D =
diffusion coefficient; not easily manipulated
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A =
surface area of a drug, greater SA = faster dissolution
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S =
drug solubility, not easily manipulated
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C
concentration of a drug in solvent
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H
thickness of diffusion layer; thinner layer = faster
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ficks law
flux = K * S * D (C1 - C2) / h
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diffusion equation
dm/ dt = D * A(S-C) / h
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transcellular
take molecules in one side of the cell and out the other
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paracellular transport
occurs when a small molecule is able to pass between cells through tight junctions
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pH =
pka + base / acid
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OAT
organic anion transporter; influx transporters
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OCT
organic cation transporter; influx but bidirectional
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stomach
primary site for oral drug disintegration and dissolution, v acidic, little SA
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small intestine
less mucous than stomach, rich blood supply, less acidic, large SA
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a symporter is also called a
cotransporter
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antiporter AKA
exchangers
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efflux transporters
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
influx tranporters
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
the first pass effect
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
IV administration
plasma concentration starts at its highest level and steadily decreases
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other routes
plasma concentration starts at zero increase to a maximum then begins to decrease
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bioavailability
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
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absolute bioavailability
compares bioavailability of a dosage form to that of intravenous administration
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relative bioavailability
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
bioavailability
(area under curve for dosage form) / (area under curve for IV administration) then mult. by 100
108
extemporaneous pharmacy compounding
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
compounding is regulated by
the state board of pharmacy; adhering to good practices set forth by USP 795 ad 797
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USP 795
NON-STERILE COMPOUNDING includes regulations for the environment, stability,, ingredient, strength, quality and pretty, process, records, quality control counseling
111
USP 797
STERILE COMPOUDING; describes conditions and practice to prevent harm, including death to patients that could result from contamination, endotoxins, variability, contaminants, inappropriate quality
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manufacturing is regulated by
food and drug administration
113
cGMP
current good manufacturing processes
114
failure to meet cGMPs usually result in
voluntary recall of the drug
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API
active pharmaceutical ingredient; furnishes pharmacologic activity
116
batch
specific quantity of drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture
117
lot
a beach or any portion of a batch having uniform quality and a distinctive identifying lot number
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lot number
combination of letters which completed history of the manufacturer, processing, packaging, holding and distribution of a batch or lot of a drug product
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drug product
a finished form that contains an active drug and inactive ingredients
120
compliance
determination through inspection of the extent to which a manufacturer s acting in accordance with prescribed regulations, standards, and practices
121
master record
record containing the formulation, specifications, manufacturing procedures, quality assurance requirements, and labeling of a finished product
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validation
documented evidence that a system does what is should do
123
added substances
inactive ingredients
124
beyond use date
the date after which a compounded preparation should not be used
125
component
any ingredient necessary for the compounding of a preparation
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compounded
a professional authorized by the appropriate jurisdiction to perform compounding
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compounding
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
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hazardous drug
any drug that can cause cancer, reproductive toxicity, organ toxicity or gentoxicity
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preparation
a compound drug dosage form which ac compounder has introduced a drug
130
3 categories of compounding by USP
simple, moderate, complex
131
simple
using a recipe that lists specific components, compounding procedure and equipment, and stability data from a manufacturer or peer reviewed journal
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moderate
making a preparation that requires special calculations or procedures or making a preparation for which stability data is not available
133
complex
making a preparation that requires special training, facilities, equipment, and procedures to ensure appropriate therapeutic outcomes
134
responsibilities of a compounder
addresses the following areas of concern: appropriate ingredients, packing and beyond use dating, training of compounders, patient counseling
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formulation record
recipe; step by step instructions
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compounding record
what actually happened; specific to patient
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SOPs
standard operation procedures; maintaining consistency
138
Materials safety data sheets
documentation of the chemical and physical properties of a chemical as well as safety information
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aqueous for oral use
no later than 14 days
140
aqueous for topical use
no later than 30 days
141
non aqueous formulation
not later than the time remaining until the earlier expiration date of any API or 6 months
142
employee compounding procedure
the pharmacist demonstrates then employee does it; they will be monitored and be responsible for the finished preparation
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patient counseling
proper use, storage, handling, disposal, physical changes, adverse event
144
micromeritics
field of science devoted to the study of the behavior and characteristics of small particles
145
why is micromeritics important
influences a large number of parameters in research development, manufacturing of dosage forms such as amount of water needed, uniformity, efficacy
146
powder
a solid consisting of v small particles; can refer to pharmaceutical ingredients or dosage formulation
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desirable qualities of powders
ability to flow, higher degree of circularity, larger particle size low angle of repose
148
granules
specifically agglomerations of powders with desirable properties
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utility of formatting drugs into pharmaceutical powders and granules
fast acting, easier administration of doses involving large portions of drugs, easier administration of doses to patient populations that have difficulty swallowing
150
most powders and granules are through what route
oral, topical, inhalation, and vaginal
151
ingredients needed to make a pharmaceutical powder and granule
drug API to treat disease, diluent, lubricants, anti adherents, miscellaneous ingredients (to make powders easier to work with)
152
general preparation of compounding pharmaceutical powders involves 2 processes:
reduction of particle size and blending of components
153
___ has the slowest onset of actions
tablets
154
which are faster granules or powders
powders
155
advantages for using pharmaceutical powders / granules
more stable, more convient, faster onset of action, good for patients who have difficulty swallowing
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disadvantages for using pharmaceutical powders / granules
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
the more round the powder,
the better it will flow
158
granules are preferred to powders due to the following
better flow, more stable, wetted better, better content uniformity
