International non properietary name Glance_master.pdf
HamadAlshabi
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Sep 15, 2024
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About This Presentation
International non properietary name program by world health organization
Size: 398.63 KB
Language: en
Added: Sep 15, 2024
Slides: 20 pages
Slide Content
School of INN
INN at glance
INN at glanceINN at glance
School of INN
INN at glance
Nomenclature of medical substances
Nomenclature of medicines refers to
systematic naming of medical substances. It
has many implications, regarding: •
Prescribing
•
Dispensing
•
Acceptance of alternatives
•
Safety
•
Cost
•
Access to medicines
School of INN
INN at glance
Identification of medicinal products
• Chemical name (such as acetyl-para-
aminophenol or APAP)
• Brand name (like “Tylenol”, “Panadol” and
many others)
• National nonproprietary names (as
paracetamol in Europe vs acetaminophen in
the US)
• Often, one active substance is sold under
different brand names
• This can lead to confusion, and cause
medication errors
School of INN
INN at glance
What is an INN?
• INN -An International Nonproprietary
Name
• Single, unique name
• Distinctive in sound and spelling
• Not liable to confusion with other names
(such as trademarks)
• Globally recognized
• In the public domain
Also known as a
generic name
School of INN
INN at glance
Why are INN needed?
• INN facilitate the communication between
health care professionals, researchers,
regulators, and users around the world,
ensuring that everyone can easily identify a
given substance
School of INN
INN at glance
Where are INN used?
• Prescribing and dispensing of
pharmaceutical substances
• Labeling
• Drug regulation
• Scientific literature
• Communication between health
professionals
• Pharmacopoeias
• Advertising
School of INN
INN at glance
INN languages
• Latin
• English
• French
• Spanish
• Arabic
• Chinese
• Russian
School of INN
INN at glance
How are INN constructed?
• INN are usually constructed of stems and affixes
• Pharmacologically-related substances demonstrate
their relationship by using a common stem
• This common stem allows grouping of substances,
which may share similar pharmacological activity
• The affix (usually a prefix) is meant to distinguish
between the different substances, allowing to
create a unique name
• It is composed of random syllables, without
meaning
School of INN
INN at glance
INN structure -Example
The stem-cillinis designated for antibiotics, 6-
aminopenicillanic acid derivatives
The prefix distinguishes between the different members of the
pharmacological group, creating a unique name for each of
them •amoxicillin
•ampicillin
•cloxacillin
•nafcillin
•oxacillin
•penicillin
•piperacillin
•ticarcillin
School of INN
INN at glance
INN structure -Example
The stem -cillinis designated for antibiotics, 6-
aminopenicillanic acid derivatives
The prefix distinguishes between the different members of the
pharmacological group, creating a unique name for each of
them •amoxicillin
•ampicillin
•cloxacillin
•nafcillin
•oxacillin
•penicillin
•piperacillin
•ticarcillin
School of INN
INN at glance
INN structure -Example
The stem-cillinis designated for antibiotics, 6-
aminopenicillanic acid derivatives
The prefix distinguishes between the different members of the
pharmacological group, creating a unique name for each of
them •amoxicillin
•ampicillin
•cloxacillin
•nafcillin
•oxacillin
•penicillin
•piperacillin
•ticarcillin
School of INN
INN at glance
The stem
• The stem usually appears at the end of the
INN
For example: -pred,prednisone and
prednisolone derivatives
oxisopred
• But, it can also appear as a prefix
prednisolone
• Or as an infix
chloroprednisone
School of INN
INN at glance
Substems
• Sometimes, a sub-stem is added, in order to
further distinguish a pharmacological group
•Stem
vir, antivirals
•Substems
-amivir, neuraminidase inhibitors: oseltamivir,
zanamivir
-navir, HIV protease inhibitors: amprenavir,
ritonavir
School of INN
INN at glance
Modified INN (INNM)
• INN are selected only for the active part of
the molecule, which is usually the base,
acid or alcohol
• As a general rule, names for simple salts
and esters should be devised from the INN
• Names for different salts or esters of the
same substance should differ only with
regard to the inactive moiety
School of INN
INN at glance
INNM -Example
INN amlodipine
amlodipine
INNM amlodipine maleate
amlodipine besylate
School of INN
INN at glance
INNM (continued)
• Some INN were published for salts before
the acceptance of this rule. In such cases,
INNM may be used for the description of
the base or the acid INN INNM levothyroxine sodium
levothyroxine
School of INN
INN at glance
Two‐words INN
• INNM
• Glycosylated monoclonal antibodies and
proteins (as adalimumab beta)
• Conjugated proteins (as trastuzumab
emtansine)
• Substances containing PEG and other
polymers (as certolizumabpegol)
• Insulin derivatives (as insulin aspart, insulin
degludec)
• Others (as cell or gene therapy products)
School of INN
INN at glance
What does “nonproprietary” stand for?
• INN are placed in the public domain
• Therefore, they can be used without any
restriction
• For example, INN can be used for
dispensing interchangeable
pharmaceutical products
• INN are protected in trademark scope:
trademarks should not be derived from an
INN or contain common stems used in INN
School of INN
INN at glance
The selection of INN
• INN are selected in a broad consultation
process, according to a strict procedure
• Names are selected by the INN Expert
Group, in close collaboration with: •
Regulatory authorities
•
National authorities (such as the United States Adopted Names Council)
•
Pharmacopoeial commissions
•
Academics
•
Pharmaceutical companies
School of INN
INN at glance
INN –Linguistics
• INN are screened for linguistic problems
and unsuitable connotations in the major
languages spoken in the world
• Special consideration is given to
pronunciation in different languages, and
therefore: •
The letter f should be used instead of ph
•
t instead of th
•
e instead of ae or oe
•
i instead of y
•
The letters h and k should be avoided