P1 Cuetics 2

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1. The first college of Pharmacy in the US was located in

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Philadelphia

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2. Official monographs on recognized, therapeutically active drug substances appear in the

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USP (United States Pharmacopeia)

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3. The NDA is

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The final step a developer takes in seeking FDA approval for a new drug.

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4. The IND:

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Requires a proposed new drug to be relatively safe and potentially useful.

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6. The first Federal Law in the US designed to regulate the purity of drug products manufactured domestically was

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B. The Food and Drug Act of 1906

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7. The Kefauver-Harris Amendment to the Federal Food, Drug and Cosmetic Act of 1938

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A. Became law in 1962
B. Implemented the IND process
C. Required proof of both safety and efficacy

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8. The clinical phase of the FDA approval process for a new drug takes approximately

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5 years

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9. The dosage form most cited, but almost never used in drug therapy is the

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Pill

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requirements of a drug dosage form

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F. The therapeutic and non-therapeutic ingredients must be compatible
G. The dosage form must lend itself to efficient administration
H. The container must be clearly labeled

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12. Schedule 1 drugs have

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D. No accepted medical use and high potential for abuse

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1. A thermodynamic study can give the following type of information on a reaction

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B. The energy that may be released or consumed by the reaction

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3. A reaction that is spontaneous at all temperatures is ... enthalpy and entropy wise

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B. A decrease in enthalpy and an increase in entropy

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The first federal law in the US to regulate drug products manufactured domestically?

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Food and drug act 1906

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Drug approval process consists of?

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manufacturing standards
cant be introduced until FDA approved
adequate clinical studies
demonstrate efficacy

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Supercritical fluid

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when temperature and pressure of liquid goes beyond crit. point, polar and nonpolar are completly miscible

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Boyles law of Pressure

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PV=nRT
P=atm
V=litres
R-0.082
T=temp in kalvin
n-moles

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Eutectics

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minimum temp. at which two components of mixture will melt at certain compostion

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Solvate vs. Hydrate

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solvate is crystals
if solvent is water then its a hydrate

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Lyotropic vs Thermotropic crystal formation

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lyo: caused by water
thermo: caused by heat

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surface tension

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force pulling molecules of interface together, results contractions of liquid surface

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Amorphous Solids are?

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supercooled liquids
glass, plastics
like crystals but random

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Extensive vs. Intensive Properties

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extensive additive
intensive not

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Physical vs. Chemical change

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P: identity does not change
C: identity does change

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3 main bond types

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Ionic
Covalent
Hydrogen- FON

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Melting point and solubility relationship?

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higher melting point less solubility

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Van Der Walls Forces are?

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Debye (dipole induced)
London (both induced)
Keesom- Dipole (polarity)

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Iodine (I2) is dissolved in aqueous solution of potassium iodide (KI). What types of intermolecular forces are involved before and after the dissolution?

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a

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Solid state,
solution state
diffusion
exothermic
process feasibility

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read it somewhere else

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Open system, closed, isolated

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everything exchanged
energy
nothing

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Isothermal
Adiabatic

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process carried out w/o change in temp.
process carried out w/o change in heat content

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Federal food and drug act 1906

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required drugs marketed interstate to comply with their claimed standards of strength and quality

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Federal food , drug, and cosmetic act 1938

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prohibits the distribution and use of any new drug/drug product w/o the proir filing of NDA

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Kefauver/ Harris amendments 1962

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requires IND (investivational new drug application) filing w/ FDA before drug clinically tested on humans
only after safety and efficacy proved can file NDA

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Durham-Humphrey Amendment 1951

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RX's for legend drugs may not be refilled, w/o consent of prescriber, created 'legend' drugs and OTC drugs

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Comprehensive Drug abuse Preevention and control act

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1970 created 5 schedules for the classification and control of drugs with abuse potential

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CFR vs. FR

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FR is federal register where regulations first published for public comment.
once finalized go into CFR (code of federal regulations)

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Title 21 CFR req.s?

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8 volumes with regs. issued under FDA.
Federal Register issued each workday by superintendent of docs., GPO, contains proposed and final legal notices issued by federal agencies

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Main drug discovery resources

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Natural Resources
Synthetic
Semi-Synthetic

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Methods of drug discovery? Random

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Random-tests numerous compounds or natural substances for bio activity

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Methods of drug discovery? NonRandom

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Bioassays-test agents against controls for effects
Disease spec. animal models-bioassays invivo, great and expensive
High Throughput screening- a system able to examine 15000 compounds a week using 10-20 bioassays (shit ton)

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Methods of drug discovery? Molecular mod

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chemical alteration of a known and previously characterised chemical compound for the purpose of enhancing its usfulness as a drug

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Methods of drug discovery? Mechanism Based

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molecular mod to design drug that interferes with specific biochemical path of disease process

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Methods of drug discovery? Molecular Graphics

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Use of computer graphics to represent / manipulate to fit simulated structure of receptor

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Methods of drug discovery? Pharmocogenisis

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study of effect of genes, how genes effect if you get screwed by drugs or they actually help

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Drug Nomenclatures? 4

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Empirical Formula--> dont know this go home
Systematic chem name-->bullshit long as chemical name
nonproprietary name--> generic, aka ampicillin
code number assigned by USAN councel--> code assigned before nonproprietory name, prefix(sponsor) numbers after ie. SQ 14225 (captoprol) by squib

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Responsibility of pharacuetics

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characterized bio activity, evaluate chem properties to ensure stable and useful pharm. product

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info in IND?

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Safety eval-animals
clinical data
drug id and manufacturing instructions
outline of proposed clinical studies
routes of admin
approximate num. patients
estimate length of treatment
environmental impact? no one cares

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Steps of drug approval

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Bioequivalents

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pharmaceutically equivalent when administered to same individuals w/ same dosage regimen--> comparable bioavailiblilty

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Bioavailability

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extent and rate of absorbtion from a dosage form refected by a time concentration curve of the administered drug in systemic circulation

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therapeutic equivalent

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Pharmceutical equivalent provides same therapeutic effect as measured by control of a disease or disease symptom

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MEC

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minimum effective concentration
avaerage blood serum conc. representing the minumum conc. that can produce the drugs desired effect

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MTC

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minimum toxic concentration
serum conc. above level expected to produce dose related toxic effects

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MED

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median effective dose
amount that will produce desired intensity of effect in 50% of induvuduals tested

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MTD

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median toxic dose
amount that will produce a toxic effect in 50% ppl tested

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generic vs. reference drug product

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generic less time develop
G uses same active excipient
G bioequivalent to reference
G contain different crap excipients (dont matter)

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Orange Book
A and B

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A- drugs therapeutically equivalent to pharmaceutically equivalent product
B- not therapeutically equivalent to pharmaceutically equivalent product

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Orange Book
AA and AB

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AA- drugs not presenting bioequivalence problems
AB- products meet necessary bioequivilence reqs.

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Pharmacuetical reasons for dosage design

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safe and convient delivery of amount

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Considerations for dosage design

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nature of illness
therapuetic situation
method of treatment
route of admin
age
anticipated condition of patient

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Oral route perks? cons?

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P-natural, uncomplicated, convenient, safe
C- slow response, chance irreg. aborb, possible destruction by acid/enzyme

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Rectal perks? cons?

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perfered for drug destroyed by stomach or intestines
patients that are vomiting or coma
half drug miss first pass metab.
C: inconvieent, irregular absorb,

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Parentral routes
SQ, IM, IV , ID

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P: rapid absorb
blood levels predictable
small dose
good for uncouncious patients
C: sterility req.
costly to admin.
not reversible, easy overdose

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Epicutaneous route

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P:prolonged local action with minimal absorption,
C:creams ointments pastes, messy and shit, iritation to skin

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Ocular, Oral(great), Nasal

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P: local drug treament, sterile form created with comfort in mind
C: preparations can be adsorbed systemically

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Factors influence bioavailibility

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physiological factors and patient characteristics
drug substance , physiochemical properties
pharmaceutical ingredients and dosage form characteristics

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Differences in 4 types absorption

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Passive
Filtration
Specialized trans
Facilitated

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factors of drug dissolution

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drugs acid base or salt forms may result in differences in dissolution rate

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factors of drug dissolution

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crystal, amaphorous
surface area and state of hydration

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factors of drug stability

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oxidative decomp
hydrolysis
temp.
relative humidity (tolerable levels)
evironment of light and air
packaging

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factors effect drug absorption

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drug solubility
physical form
dissolution itself
particle size and surface area

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recognize the different conditions of GI tract

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pH
enzymes
that kinda shit
membrane perm.

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Exothermic
Endothermic
delta H's?
what about

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exo:H less than zero (losing heat)
endo: H greater than 0
all at constant T of course

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Strong electrolyte groups?

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Inorganic acids
inorganic bases
most salts

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Weak electrolytes groups?

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organic acids and bases
inorganic compounds
some salts
complex ions ex. Cu(NH3)4 2+

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Molarity
Normality
Molality
Mole Fraction

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g/L
N--> gram EQUIVALENT / L
m--> g / 1000g
X--> ratio of solute to, solute and solvent mix

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ppm
ppb

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(mass A/ all the shit together) 10 to the 6
for ppb same only 10 to the 9

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Atomic Number
Atomic Weight

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did you really even answer that? Go home

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Normality

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(Mw/valence) / L

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Add 20 gram of NaCl into 80 gram of water. What will be the molefraction of each?

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figure it out

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Ideal solution
Non-ideal solution

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Ideal solutions are formed by mixing substances with similar properties
gas: absence of attractive forces
solution: uniformity of forces

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What is the partial pressure of propellants 11 and 12 in the 50:50 weight mixture and what is the total vapor pressure of this mixture?
P11o(137.4 g/mol) at 21 oC = 13.4 psi
P12o(120.9 g/mol) at 21 oC = 84.9 psi

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6.27
45.17
51.44

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solution pressure laws
Henrys
Raoults

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Henry’s law -solute
psolute= ksolute Xsolute
Raoult’s law- solvent
psolvent= psolventoXsolvent

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Colligative properties

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Vapor pressure depression
boiling point elevation
freezing point depression
osmotic pressure

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Vapor Pressure Depression depends on

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mole fraction of solute
(p1o -p1)/ p1o= Δp/ p10= X2= n2/(n1+ n2)
delta p is lowering of vapor pressure

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Boiling point elevation

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ΔT = K x m
m molality
K constant
T in celcius

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The molal elevation constant of a drug is 0.5 oC kg mole -1. What will be the boiling point elevation of a 0.30 m aqueous solution of that drug?

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0.15

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Freezing point depression

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ΔT = i x K x m
i = Van't Hoff factor --> 1 for nonelectrolytes, for strong electrolyes i is ions in solute formula
K = constant
m is molality

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Van't Hoff Equation!
electrolyte vs. non

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i is the number of particles per unit molecule of a solute which are released into solution
Electrolyte
HCl= 2
H2SO4 =3
H3PO4 =4
CaCl2 =3

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Ethylene glycol [C2H5(OH)2] is used as antifreeze. Knowing that the normal freezing point of water is 0 oC and the cryoscopic constant of water is 1.86 oC kg mole-1, calculate the freezing point depression of a 35 wt/wt% EG in water?

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-16.1 C

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Tonicity
Hyper
Iso
Hypo

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Hyper water out
Iso same
Hypo water in

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Osmotic pressure is?

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pressure created to equilibrate solutions through semipermeable membrane

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Osmotic pressure formula?

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pi = m RT
Morse equation
R= 0.082 L atm/mol deg
T= absolute temp, aka kalvin
m = moles
note: pi should be for 1 L

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A solution containing 10.0 g of sucrose dissolved in 100 g of water has a boiling point of 100.149 oC. What is the molecular weight of sucrose? Kbfor water is about 0.51 oC m-1

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342

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Vapor pressure lowering

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Δp = 0.018 p1o m

in aq
0.018 p1o = 0.43 @ 25 oC
= 0.083 @ 0 oC

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Degree of dissociation variable? formula?

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alpha
alpha = (i -1)/(v-1)
can also be simplified but i dont have those symbols

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Activity and Activity Coefficient

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A: effective conc. of ions
A. co: effective stoichiometric ion conc.
AC<1 interionic interactions
AC>1 more water molecule for interaction

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Ionic Strength

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u= 1/2 (c1 z1(squared) + c2 z2(squared) ...)
c is conc. of ion
z is valence

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A buffer contains 0.3 mole of K2HPO4and 0.1 mole of KH2PO4per liter of solution. What is the ionic strength of the solution?

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1

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Debye-Huckel Theory

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to do with activity and valence and ionic strength
factor A is 0.51

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What is the milliosmolalityof a 0.120 msolution of potassium bromide? What is osmotic pressure in atmosphere?

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223 cuz 1.86 not 2

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Brownsted Lowry Theory
Lewis Acid and Bases

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Proton donor and acceptor
L: acid electron pair acceptor, bases is pair donor

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Amphoter

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can act as acid and base

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pH of a Weak Acid

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x = √(KaCa) = [H3O+]
Ca= original acid concentration
x = concentration of the Ac-or H3O+at equilibrium

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Acidity of a Weak Acid

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Ka= x2/Ca

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Buffer Capacity

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Buffer Capacity=number of moles of OH-or H3O+ added//////
(pH change) ×(volume of buffer in L)

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Approximate Buffer Capacity

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β= ΔB/ΔpH
ΔB=increment of base added
other is prolly change in pH morons

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Buffer Capacity Equation

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β= 2.3 C Ka[H3O+]/(Ka+ [H3O+])2
C is total acid and salt conc.

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Prepare a buffer solution of pH 5.00 having a capacity of 0.02.
acetic acid with pKa of 4.76 would be ideal

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β= 2.3 C Ka[H3O+]/(Ka+ [H3O+])2

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Acidic buffers
Basic Buffers

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pH = pKa + log ([salt]/[acid])
pH = pKw-pKb+ log ([base]/[salt])

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Change in entropy

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ΔS= Q/T
Q amount of heat added to sys.
T- temp kalvin

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When entropy gen. most heat?

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low temp.

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Gibbs Free Energy

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ΔG = ΔH -T ΔS

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Free Energy, Temperature

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If ΔS and ΔH have opposite signs, spontaneity is not temperature dependent, happens or not If ΔS and ΔH have similar signs, the spontaneity will be temperature dependent

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Internal Energy, Heat and Work

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Internal Energy: Total energy of a system
Heat: Transfer of energy due to the change in temperature
Work: Transfer of energy due to the other factors

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1stLaw thermodynamics

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ΔU = Q -W
change in energy = heat added - work done

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Iso-volumetric system

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Volume of the system remains same before and after the process
ΔU = Q

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Isobaric/ Adiabatic systems

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Pressure of the system remains same before and after the process
ΔU = Q –(P ×ΔV)
ΔU = -W in adiabatic