Introduction To Various
Official Books
Physical
Pharmacy
B)
Introduction To Various Official Books
qIntroduction & Classification
qVarious Official Books
ØInternational
Pharmacopoeia (Ph.Int.)
ØEuropean
Pharmacopoeia (Ph. Eur.)
ØNational
Pharmacopoeia
ØExtra
Pharmacopoeia (Martindale)
ØNational
Formulary (NF)
ØSome other
official books
Introduction
ØBooks containing the standards for drugs and other
related substances are known as pharmacopoeias and formularies.
ØFORMULARY
vIt is a “List of medicines” approved
for use by a particular hospital or government
ØPHARMACOPOEIA
vIt is
derived from Greek word pharmakon means “drug”
and poieo
means “make” Hence “ drug-making”.
vIt is a list
of medicinal substances and formulae for making preparations from them.
vIt is a
legal and official book issued by recognized authorities usually appointed by
Government of each country.
ØThese books contain list of drugs
and related substances with information on their source, description, tests, formulas
for preparation, actions, uses, doses, storage conditions etc.
Pharmacopoeias
+ Formularies = DRUG COMPENDIA
ØCLASSIFICATION
Drug Compendia may be:
a)
Official Compendia
b)
Non-official Compendia
Classification
a) Official Compendia
Official
compendia are the compilations of drugs and other related substances which are
recognized as legal standards of
purity, quality and strength by a government
agency of respective countries of their origin. e.g. British Pharmacopoeia (BP)
British
Pharmaceutical Codex (BPC)
International
Pharmacopoeia (Ph.Int.)
United
States Pharmacopoeia (USP)
National
Formulary (NF)
Pharmacopoeias
of other countries
Classification
b) Non-official Compendia
The book
other than official drug compendia which are used as secondary reference sources for drugs and other related substances
are known as nonofficial drug compendia. e.g. Merck Index
United
States Dispensatory
Various
Official Books
Pharmacopoeias
v Pharmacopoeias are official
standards for purity, quality, strength and analysis of drugs
vPharmacopoeias are issued or
authorized by government or international agencies and are regularly updated
vPharmacopoeial standards are compliance requirements; that is, they
provide the means for an independent judgement as to the overall quality of a
substance, and apply throughout the shelf-life (length of time that a commodity may be stored without becoming unfit
for use, consumption, or sale) of a product.
Various
Official Books
Ø The International Pharmacopoeia
v The
International Pharmacopoeia is published by the World Health Organization(WHO) and is particularly used in
developing countries.
v Objective:
To provide a uniform list which would avoid the confusion caused by different
national standards, strengths and names.
Ø European
Pharmacopoeia
v The European Pharmacopoeia Commission is
responsible for the publication of the Ph. Eur.
v The UK is a
member of the EP Commission and is involved at all stages of Ph. Eur. monograph
development. v
Various Official Books
ØNational Pharmacopoeias
vThese
pharmacopoeias are generally prepared under
the authority of the government of the respective countries
vExample of
some national pharmacopoeias are as follows:-
ü
vThe drugs
used may vary from nation to nation so, the respective pharmacopoeia includes
those drugs or dosage forms which are frequently used in that very country at
that time.
vThe national pharmacopoeia is recognized as
the reference book by the legislative authority (by law) of the respective
country, whenever a conflict arises regarding drugs these books will be
referred.
Various Official Books
Ø British Pharmacopoeia (BP)
v1964: First edition of BP
vBritish pharmacopoeia is the source
of official collection of standards for
medicine in the United Kingdom
vAuthorized by government of
United Kingdom
vPublished annually
vEach edition is comprised of number
of volumes (e.g. I, II, III, IV, V, Veterinary)
ØA monograph includes the name of
the ingredient or preparation; the definition; packaging, storage, and labeling
requirements; and the specification (specification consists of a series of
tests, procedures for
the tests, and acceptance criteria.
) 4) appendices & supplementary
chapters (providing additional
• The BP
includes: guidance)
1)
Various Official Books
ØBritish Pharmaceutical Codex (BPC)
vIt was in 1903 that the decided to prepare a
reference book for the use of medical practitioners and dispensing pharmacists.
vThe first
edition of BPC was published in 1907.
BY council of Pharmaceutical Society of Great Britain vThe BPC
differs from BP in that:
• a) It contains many more drugs and preparations some may be included in advance to the
pharmacopoeia while other drugs may have been included in the former editions
of pharmacopoeia but now they are retained in the Codex because they are still
commonly used.
• b) It provides information on the actions and uses of drugs, their undesirable
effects, precautions and the treatment of poisoning.
• c) It contains formulae, method of
preparation, container and storage conditions of most of the preparations that
are still extemporaneously prepared in
the pharmacy.
Various
Official Books
ØUnited States Pharmacopoeia (USP)
vThe USP was
originally published in 1820 under
the authority of United States Pharmacopoeial Convention. The National
Formulary (NF) was published in 1888 under
the guidance of American Pharmaceutical Association.
vIn 1974 the NF was purchased by the United
States Pharmacopoeial Convention and from 1980
onwards only one official book of drug standards was published under the
heading The United States Pharmacopoeia and The National Formulary (USP-NF).
vUnited States Pharmacopeia 39th Edition National
Formulary 34, Latest
Edition
Various Official Books
vOfficial pharmacopoeia of United
States
vUSP–NF is a combination of two compendia, the United
States Pharmacopeia (USP) and the
National Formulary
(NF), two separate titles published
in 1 volume
vIncludes drugs and excipients
vDeveloped and accepted by US
Pharmacopoeal Convention
(it has pharmacists, physicians and
other health care community members)
vUSP contains monographs on drugs
and other substances with therapeutic uses
vNF includes monographs for excipients
and nontherapeutic agents in pharmaceuticals
Various Official Books
ØExtra Pharmacopoeia (Martindale: The Complete Drug Reference )
vMartindale
is a comprehensive source of information
on drugs and other substances of interest to pharmacists, academics, and
medical practitioners throughout the world.
v It includes
human and veterinary drugs, diagnostic agents, nutritional agents,
pharmaceutical excipients, drugs of abuse, pesticides, and toxic substances
vThe Extra
Pharmacopoeia was first produced in 1883 by William Martindale and is still
known as ‘Martindale’.
vPublished
by The Royal Pharmaceutical Society of Great Britain, every 3 years
vContains information
not only on official preparations but
also proprietary (brand) products and
preparations in foreign pharmacopoeias
Various Official Books
ØWHO Model Formulary
o
-1st in 2002, latest edition in 2008 o -2010 (for
children) o
It was considered that such a WHO Model
Formulary.
National Formularies
ØBritish National Formulary
o -By Royal Pharmaceutical Society of
Great Britain
ØBNF for children
(cBNF)
ØNational
Formulary of Pakistan
ØCompiled by Ministry of Health & Social Welfare, Pakistan.
Ø“The Federal Government shall compile and
publish in the official Gazette Pakistan National Formulary comprising all
drugs allowed to be imported, manufactured or sold and such Formulary may be
reviewed and modified from time to time”- SECTION 8, Drug Act, 1976.
ØIt comprises
of all drugs allowed to be imported, manufactured or sold in Pakistan
ØMedicines
are classified on the basis of pharmacological
class (e.g. antipyretic, analgesic, antibiotic, anti-allergic etc.),
containing information i.e. Generic name, dose and dosage form.
Comments
Post a Comment