Card Set Information
Combination of two official compendia-
United States Pharmacopeia-National Formulary
Contains standards for medicine,dosage form, drug substances, excipients, medical devices and dietary supplements.
Uniform Standards to ensure quality of drugs and product.
Who publishes International Pharmacopeia?
World Health Organization (WHO)
Homeopathic Pharmacopeia of United States
"like cures like"
United States Pharmacopeia-Drug Information.
Publication and computer database with info on pharmaceutical products
: indications, pharmacology, side effects, dosage help for health care professionals.
Food and Drug Administration;
Responsible for drug regulation and control.
Safety and Effectiveness
Elixir prepared with diethylene glycol (toxic agent in antifreeze)
Sedative and Tranquilizer during pregnancy caused phocomelia (short/missing limbs)
Now treats leprosy
Investigational New Drug Application.
Permission to test on Humans.
FDA 30 days to evaluate drug.
Sponsor proposes protocol-"plan of study"
Over the Counter
safe enough for use by the layman for self treatment; no presciption required.
Too dangerous for self medication and useful only after expert diagnosis; "caution
: federal prohibits dispensing without presciption."
Drugs known to be subject to public abuse.
Regulated by DEA Drug Enforcement Administration.
: schedule 1: no medical use
Product must include
: DEA symbol "C"
: may be habit forming"
How are new drugs discovered?
Many years of tireless pursuit
: -targeted screening
-mechinism-based drug design
Sources of New Drugs
Hormones, Serum, vaccines, tissue cultures
: synthetic/semi synthetic
-recombinant DNA-humulin insulin
-gene therapy-stem cells
Full theraputic efficacy and no side effects.
Dose not exist!
with a fundamental desired pharmcological biologic activity.
Can be modified.
: penicilin---Librium (antianxiety)
Inactive substance requiring
to become pharmacologically active.
Designed for solubility, absorption, biostability, prolonged release.
FDA's definition of NEW DRUG?
new chemical entity
new use, even if established drug
new dosage schedule/regimen
new route of administration
new dosage form
change in formulation
change in proportion of each drug
number if atoms and their relationship
relative location of each atom (chemical name)
given by USAN-united states adopted name
given to manufacturers
First 4 numbers?
Next 4 numbers?
Last 2 numbers?
National Drug Code. number assigned permanently to a drug product by the FDA.
1)indicates manufacturer (Labeler Code)
2)indicates drug formulation (Product Code)
3)indicates package size and type (Package Code)
5 Steps for New Drug Approval Process (FDA)
of drug-pharmacology, metabolism, toxicology
-dosage form design
-reviewed and approved to test on humans-clinical investigation:3phases
-review clinical trials
Post marketing surviellance
-Medwatch "phase 4"
Components in Drug Development?
Word done in diverse fields
Disease process research
toxic side effect
safe dosage range
if too toxic, abandoned
Institutional Review Board
responsible to review and monitor biomedical research
A drug for rare disorders with no known cure.
When may foreign studies be used?
if well designed
Ethical principles applied
clinical trials should include?
: age, gender,disease state
Phase 1 clinical trials
up to 100 healthy people
how drug absorbed, processed and excreted
effects on organ and tissue
initial side effects observed
how much drug recieved
how often drug should be recieved
13-14 out of 20 pass
Phase 2 clinical trials
up to several hundred people with disease
clearer picture of side effects/risks
Phase 3 clinical trials
Up to several thousand patients with disease of different levels
Long term studiy 3-6 years
Final safety and efficacy
find less common side effects
5-6 out of 20 pass
New Drug Application
Behavior in Body
Results of all testing
Current Good Manufacturing Practice
established by FDA
Domestic and Foreign
Provide for systems that assure proper design, monitoring and control of manufacturing processes and facilities.
Current Good Compounding Practice
All drug products distributed in US must meet labeling requirement.
How long must records be maintainted for?
Maintained 1 year following expiration date of product batch...needed if recalled.
National Association of Boards of Pharmacy
The good compounding practices applicable to state licensed pharmacist.
excipeint or inactive ingredient
What is the reason for dosage forms?
administration by different routes
protection of drug
age of patient
liquid products of substances that are insoluble or unstable in desired vehicle
rate controlled drug action
mixture of two solides=melt
crystal and amorphous
How can you attain solubility?
Dissolution:rate limiting step in absorption
Membrane permeability-passive, active, facilitated
Partition coefficient-ratio of lipid/water solubility
PKa dissociation constant-degree of ionization
What are destructive processes?
mixing drugs with other chemicals to help dissolve/ protect degradation of first pass ex: metals
reduce particle size
How can you reduce Hydrolysis?
waterproof protective coating
use substitute of liquid
: glycerin, alcohol, veggie oil
preparation of suspension:non aqueous vehicle
dry powder for reconsitution
pH control-buffering agent
How can you reduce oxidization?
Air replacement of airspace within container-adding nitrogen gas (inert)
chelating agents:complexation of trace metals
light resistant (opaque) container
what percent can drug potency decrease by USDA?
rate reaction: zero order
drug loss independent of the concentration
rate reaction: first order
drug loss directly proportional to concentration remaining with respect to time
shelf life estimation
to assign expiration date of product
pharmaceutic ingredients importance?
establish primary features of product
: contribute to physical form
taste-palatability=flavoring, sweetening agents,coloring agents, preservatives (glycerin)
study of the time course of drug concentration in the blood and tissues
Study rate and extent of absorption and excretion
: tablet to granule
: granule to fine particle
: fine particle get wet in body fluid
: The rate limiting step fine particles diffuse into liquid
1st pass effect
first pass metabolism
phenomenon of drug metabolism wherby the concentration of a drug is greatly reduced before it reaches the systemic circulation.
Factors affecting rate of dissolution
: inversely proportional to particle size
crytal vs. amorphous form (dissolve faster) exception penicillin crytal form more stable and chloremphenical most active in crystal form.
state of hydration
GI tract pH
ficks first law
driven by concentration gradient
difference in drug concentration on both sides of the membrane
measurement of solubility of lipid/water solubility
against concentration gradient
similar to active but driven by concentration gradient
rate and extent of absorption and availability of drug at the site of action
comparison of bioavailabilities
Brand vs. Generic
original product compared to new one must work in same manner
rate and extent of absorption do not show significant differnece from that of the pioneer drug.
cross over design study
Tablet to liquid
apporved drug products with therapeutic equivalence evaluations, published and updates by FDA.
maximum drug concentration in blood
time of maximum concentration
area under the curve (blood/serum concentration time)
minimal toxic concentration
minimal effective concentration
Main routes of Drug Administration?
: IV, IM, SC, ID, etc
Intraocular, intranasal, intra-aural
Rectal, Vaginal, urethral
free to leave the circulation for tissues and cellular sites
Factors influencing metabolism
termination of drugs activity and presence in the body
Kidney #1 organ to get rid of drugs
time required for a drugs blood concentration to decrease by half
Help determine dosage regimen
removal of drug from body
total body clearance