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Hippocrates
Greek physician who is credited with the introduction of scientific pharmacy and medicine
Father of Medicine
proposed Theory of humoral pathology
Pedanius Dioscorides
Greek who was the first to deal with botany as an applied science of pharmacy
created De Materia Medica
Father of Pharmacology
Cladius Galen
first to associate galenicals, and originator of of cold cream
Philipus Aureolus Theophrastus Bombastus von Hohenheim
Swiss the introduced chemical science from traditional botanical science
replaces 4 body fluids ( Sulfur, Mercury, Salt)
Karl Wilhelm Scheele
Swedish that discovered acids; Lactic, Tartaric, Oxalic, Arsenic
discovered oxygen 1 year before Priestley
Friedrich Serturner
German that isolated morphine from opium
Pierre Robiquet
he independently isolated codeine from opium
Joseph Caventou, Joseph Pelletier
they isolated quinine/Cinchonine in cinchona
discovered Strychinine/Brucine
Pierre Robiquet, Joseph Pelletier
both isolated caffeine
Decemeber 15 1820
date that the first USP is published English and Latin
272 pg and 217 drugs listed
1864
year invented British Pharmacopeia
Lilitz Pharmacopeia
first American Pharmacopeia, 1778,
32 page with 84 internal, 16 external drug preparations
Dr Lyman Spalding
father of USP
Pharmacopeia
these present the Official standard of Purity, Strength, Quality and Analysis
Raufwolfia serpentina
source of Reserpine, used for hypotensive tranquilizer
Vincristine, Vinblastin
vinca alkaloids used for treating cancer (Acute Leukemia)
Pacific Yew tree
source of Paclitaxel
Draculin
this is found in Vampire bat salive used to treat MI and strokes
In Vitro test
bioassay that takes place outside the organismm applied to artifcial environment
In Vivo Test
bioassay by the use of biological experiment/technique carried out within the organism
Pre clinical testing
this the Laboratory and Animal studies, that assess safety and biological activity of the molecule
Phase 1
this is where the molecule is being determined its safety and dosage; bioavailability
with the use of 20-80 heatlhy volunteers
Phase 2
molecule being evaluated for its effectiveness, and its side effects
with the use of 100-300 patient volunteers
Phase 3
verification of effectiveness, monitor ADR
with the use of 1000-3000 patient volunteers
Phase 4
this is the Post Marketing studies and manufacturing that takes place
Scale up- increase batch size”
open label studies
study to which the patient is aware of the agents identities, to be admin to them
Double blinded studies
neither patient/clinician is aware of the agent being admin
abbreviated new drug application
this is submitted for the purpose of generic copies by competing companies
supplemental new drug application
this is submitted for the purpose of changes in synthesis, formulation, and analytical standards
lead compound
prototype chemical with desired activity
prodrug
drugs that require metabolic transformations, to produce effect
new drug
combination of two or more old drugs, changes in a previous formulation or proposed new use
dosage form
finished formulation designed to contain
stability
this is the measure of capability of particular formation in specific container/closure system to remain its specifications
Expiration date
limits of time during the drug is dispensed or used
shelf life
refers to duration of time which is how the drug will retain its specifications
Actual
a study to which conducted under normal conditions and may use different climatic zones
long duration
temperate
zone 1
subtropical
zone 2
hot and dry
zone 3
hot and humid
zone 4
Accelerated
Studies designated to increase the rate of chemical or physical degradation of a drug substance or product by using exaggerated storage conditions.
epinephrine
do not use if its brown/precipitate
isoproterenol
do not use if its pink to brown/precipitate
paraldehyde
this is subjected to oxidation to form acetic acid
Active ingredient
Any component that is intended to furnish pharmacologic activity or other effect
excipient
component other than the active ingredient in a drug product that is used as a carrier for the active ingredients
can also aid process
adsorbent
hold the molecules into the surface
aerosol propellant
buffering agent
colorant
clarifying agent
emulsifier
humectant
levigating agent
surfactant
essential components
those that impart satisfactory characteristics
-diluent, binders, disintegrants
glidants, lubricants, antiadherants
compression aids examples
sweet
flavor compounds with -OH
bitter
flavor compounds with N
blending, overshadowing
2 methods for flavorants
Saccharin
300× sweetness, and is Approved by FDA 1958
-E954
Cyclamate
30× sweetness and is banned by FDA 1969
causes cancer to rats
Aspartame
160-200 x sweetness and is approved to FDA 1981
but is discouraged to px with Phenylketonuria
Sucralose
600× sweetness and is approved to FDA 1998
E955
Acesulfame K
130 x sweet as sucralose and more stable than aspartame
similar structure to saccharin
Stevia rebaudiana bertoni
source of Stevia
30x as sweet as sucrose
Lakes
Pigments added to liquid dyes. Commonly, they are in the form of fine dispersions or suspensions.
Tartrazine
FDC Yellow 5
cause allergy to humans
marachino cherries
FDC red 4
used in cosmetics
amaranth
FDC red 2
a dye that causes cancer in rats
Cochineal, Anattenes
examples of natural dyes
William Henry Perkin
he discovered Mauve the first synthetic dye
contains chromophore
Benzoic, Sodium benzoate
preservatives with a conc of 0.1-0.2 %
Phenol, Cresol, Chlorobutanol
preservatives with a conc of 0.1-0.5%
0.002 to 0.01%
Concentration of Phenylmercuric nitrate and acetate as a preservative
can also include Benzalkonium chloride