Transcript Generic drug

Drug Forms.
Development of Drug.
Original drug (Brand name drug) – a drug on
the market that contains medication not known
before. It is protected several years by patent,
since a company spent money on research,
marketing and promotion.
Generic drug – is a drug without patent
protection. Needs to be bioequivalent to the
brand
name
drug
with
respect
to
pharmacokinetic
and
pharmacodynamic
properties.
Ways of administration
Way of administration is the way through which drug
reaches organism. Way of adinistration depends on drug
form, physical and chemical properties of the drug and
psysical and mental state of the patient. Ways of
administration are divided to local (topic) and systemic.
Systemic administration can be enteral or parenteral.
local
Administration
enteral
systemic
parenteral
Druf forms can be divided according to
consistency to liquid, solid, semisolid and
gaseous.
Drug forms can also be set for internal or external
use.
Solid drug forms
–
–
–
–
–
–
–
tablets
coated tablets
tablet or capsule with retarded drug release
capsules
powders
granulationes
species
Semisolid drug forms
–
–
–
–
–
ointment
cream
paste
suppository
patch
Liquid drug forms
–
–
–
enteral
– peroral administration
» solution
» syrup
» drops (eye drops can´t be opened more than
one month)
– rectal administration
» clysma
parenteral
– injections
– infusion
– transfusions
local
– solutions
– emulsions
– suspensions
– foams
Gaseous drug forms
–
Aerodispersions
Drug development
• synthesis of novel chemical compounds
• preclinical testing (cell cultures, isolated cells,
isolated organs  animals)
• clinical trials phase I (healthy people)
• clinical trials phase II (selected patients)
• clinical trials phase III (large group of patients, the
drug is compared to conventional treatments, e.g.
“double-blind“ study)
• registration of the drug (a national regulatory
body)
• clinical trials phase IV (surveillance after licence)