PHARMACEUTICAL
LITERATURE
Syllabus: Development of Pharmacopoeias
History
and development of Indian Pharmacopoeia.
Various
official publications related to pharmacy profession in India.
 |
PHARMACOPOEIA /
FORMULARIES / COMPENDIA
The books
containing the standards for drugs and other related substances are known as pharmacopoeia
and formularies - collectively these books are known as the drug
compendia.
The
pharmacopoeias or formularies contain a list of drugs and other related
substances regarding their source, descriptions, standards, tests, formulae for preparing the
same, action and uses, doses, storage conditions etc.
These books are
prepared under the authority of the Government of the respective countries. The
word “pharmacopoeia” is derived from the Greek words ‘pharmacon’ meaning ‘drug’ and ‘poieo’
means ‘make’. Literally it means that it is a list of medicinal substances,
crude drugs and formulae for making preparations from them.
These books are
revised from time to time so as to introduce the latest information available
as early as possible after they become established. In order to keep the size
of book within reasonable limit it becomes necessary to omit certain less
frequently used drugs and pharmaceutical adjuvants from each new edition of the
book. Therefore, in each new edition of these books certain new monographs are
added while the older ones are deleted.
For the
preparation of these books the expert opinion of medical practitioners,
teachers and pharmaceutical manufacturers are obtained.
CLASSIFICATION
The
drug-compendia are classified as:
(i)
Official compendia
(ii)
Non-official compendia
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)
Indian Pharmacopoeia (IP)
United States Pharmacopoeia (USP)
National Formulary (NF)
The
State Pharmacopoeia of USSR and
Pharmacopoeias
of other countries
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 non-official drug compendia.
e.g. Merck Index
Extra
Pharmacopoeia (Martindale)
United States
Dispensatory etc.
INDIAN PHARMACOPOEIA
History
The historical
developments of Pharmacopoeia in India traces back to 1563 and the credit goes
to Garcia da Orta a Portugese physician-cum-teacher.
The idea of
indigeneous Indian Pharmacopoeia was concieved in 1837 which bore fruits in
1841 in the shape of Bengal
Pharmacopoeia and Conspectus of
Drugs.
The hindustani
version in Bengali and Hindi of London
Pharmacopoeia was made available in India from 1901 onwards.
The Indian Pharmacopoeial List, published
in 1946 formed the seeding for the true Official
Indian Pharmacopoeia published in 1955.
The first
edition of Indian Pharmacopoeia was published in 1955, but actually the process
was started as early as 1944. In 1944 Government of India asked the Drugs
Technical Advisory Board to prepare the list of drugs used, in India, having
sufficient medicinal value to justify their inclusion in official
pharmacopoeia.
The Indian Pharmacopoeial List, 1946.
The list of
drugs both included and not included in the British Pharmacopoeia along with
standards to secure their usefulness, tests for identity and purity was
prepared by the committee and was published by the Government of India under
the name ‘The Indian Pharmacopoeial List
1946’.
The committee
constituted under the chairmanship of Col. Sir R.N.Chopra along with other nine
members, prepared the list of drugs with the following details:
Substances included in the British Pharmacopoeia for
crude drugs, chemicals and their preparations.
Substances not included in the British pharmacopoeia
a)
Drugs of plant origin
b)
Drugs of animal origin
c)
Biological products
d)
Insecticides
e)
Colouring agents
f)
Synthetics
g)
Miscellaneous
h)
Drugs for veterinary use.
The Indian Pharmacopoeial List
1946 was prepared by Department of Health, Govt. of India in 1946.
The history of development of Indian Pharmacopoeia:
|
Year
|
Events
|
|
1946
1948
1955
1960*
1966*
1975
1978
1985
1989
1991
1996*
|
The Govt. of India published
the Indian Pharmacopoeial List.
The Govt. of India constituted
a permanent Indian Pharmacopoeia Committee. This committee was assigned the
task of preparing Indian Pharmacopoeia and to keep it up-to-date.
The first edition of Indian
Pharmacopoeia (IP) was published.
Supplement of IP 1955 was
published.
N.B. The work of revision of the Indian
Pharmacopoeia as well as compilation of new edition was taken up
simultaneously under the chairmanship of Dr. B.N.Ghosh, who died in 1958.
After Dr. B.N.Ghosh, Dr. B.Mukherjee, the Director of Central Drug Research
Institute was appointed as the chairman of Indian Pharmacopoeia committee.
The second edition of IP was published.
A supplement of IP 1966 was
published.
The Indian Pharmacopoeia
Committee was reconstituted by the Govt. of India, Ministry of Health and
Family Welfare, under the chairmanship of Dr. Nitya Nand, Director, Central
Drug Research Institute, Lucknow.
The third edition of IP was published in two volumes, Volume-I and
Volume-II by the Controller of Publications, on behalf of Govt. of India,
Ministry of Health and Family Welfare.
Volume-I contains:
Legal Notices, Preface,
Acknowledgments, Introduction, General Notices, and Monographs from A to P.
Volume-II contains:
Monographs from Q to Z,
Appendices, Contents of Appendices and Index.
Addendum (I) to IP 1985 was
published.
Addendum (II) to IP 1985 was
published.
The fourth edition of IP was published.
|
For the
preparation of Pharmacopoeia of India, the pharmacopoeias of other countries,
like British, Europe, United States, USSR, Japan, the National Formulary (USA)
and Merck Index were consulted. The persons working in pharmaceutical industry,
drug control laboratories, research and teaching institutions also actively
participated.
Under the Drugs
and Cosmetics Act 1940, the Indian Pharmacopoeia is an official book which
contains the standards for drugs and other related substances included in the
pharmacopoeia. The drugs and other related substances prepared by
pharmaceutical manufacturers must comply with these standards.
VARIOUS OFFICIAL PUBLICATIONS
RELATED TO PHARMACY PROFESSION IN INDIA
1. NATIONAL FORMULARY OF INDIA
For the guidance
of medical practitioners, medical students and pharmacists in hospitals
and in sales departments National Formulary of India has been formulated.
1960 First edition was published by Govt. of
India, Ministry of Health.
1966 Second edition was published.
1979 Third edition was published.
It contains information about
drug interaction, resistance, cumulative effects, drug dependence, prescription
writing etc.
2. THE INDIAN PHARMACOPOEIA
Under the Drugs
and Cosmetics Act 1940, the Indian Pharmacopoeia is an official book which
contains the standards for drugs and other related substances included in the
Pharmacopoeia. The drugs and other related substances prepared by
pharmaceutical manufacturers must comply with these standards.
1946 Indian Pharmacopoeial List was published by
Govt. of India.
1955 First edition of Indian Pharmacopoeia was
published.
1960 Supplement of IP 1955 was published.
1966 Second edition of IP was published.
1975 Supplement of IP 1966 was published.
1985 Third edition of IP was published.
1989 Addendum-I to IP 1985 was published.
1991 Addendum-II to IP 1985 was published.
1996 Fourth edition of IP was published.
Under each monograph chemical
structures, molecular weight, physical description, solubility, identification
tests, standards, assay method, storage etc. are given. Indian Pharmacopoeia is
published by the Controller of Publications, Delhi on behalf of Govt. of India,
Ministry of Health and Family Welfare.
3. THE BRITISH PHARMACOPOEIA (BP)
Under the
Medical Act 1858 the General Council of Medical Education and Registration was
empowered to alter, amend and republish the British Pharmacopoeia (BP) as often
as necessary. The first BP was published in 1964.
1864 The first
BP was published.
1926 Committee of Civil Research
recommended that a Pharmacopoeia Commission be formed and it should be
entrusted the work of new editions of BP and also recommended that BP be
revised and reissued at an interval of ten years.
1932 New edition of BP was
published according to the above recommendation.
1968 Medicines Act 1968 gave the
responsibility of preparing the BP to the Medicines Commission. Medicines Commission
reconstituted the British Pharmacopoeia Commission and gave the responsibility
to British Pharmacopoeia Committee.
1980 The thirteenth edition of BP was [published.
1988 The 14th edition of BP was
published.
1993 The 15th edition of BP was
published.
BP 1988 contains two volumes with
2100 monographs:
Vol-I
contains monographs on medicinal and
pharmaceutical substances along with Infra-red (IR) reference spectra.
Vol-II
contains formulated preparations, blood
products, immunological products, radio-pharmaceutical preparations, surgical
materials and appendices.
BP is the source of standards of
drugs in United Kingdom and other parts of Common Wealth Countries.
4. BRITISH PHARMACEUTICAL CODEX (BPC)
It was in 1903
that the council of Pharmaceutical Society of Great Britain decided to prepare
a reference book for the use of medical practitioners and dispensing
pharmacists. The first edition of BPC was published in 1907.
On the request
of British Pharmacopoeia Commission, the Council of the Pharmaceutical Society
agreed in 1959 for the publication of Codex to coincide with that of the BP, so
that BP and BPC should come into effect on the same date.
The 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 which are still extemporaneously prepared in the
pharmacy.
5. THE UNITED STATES PHARMACOPOEIA (USP)
The 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.
In 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).
6. EXTRA PHARMACOPOEIA
The Extra
Pharmacopoeia was first produced in 1883 by William Martindale and is still
known as ‘Martindale’. This is an
authorized reference book on drugs and is used throughout the world. It
provides all sorts of latest information on drugs and medicines. It is
published by the direction of the Council of the Royal Pharmaceutical Society
of Great Britain and prepared in the Society’s Department of Pharmaceutical
Sciences.
7. THE MERCK INDEX
It is an
encyclopaedia of chemicals, drugs and biologicals. The first edition was
published in 1989 and the eleventh edition was published in 1989 by Merck &
Co., Inc. Rahway, New Jersy, USA.
8. THE INTERNATIONAL PHARMACOPOEIA
The
International Pharmacopoeia is published by the World Health Organization and
is particularly used in developing countries. The first edition was published
in 1951 (Volume-I) and in 1955 (Volume-II).
The object of
this was to provide a uniform list which would avoid the confusion caused by
different national standards, strengths and names especially for the use of travelers
who might need to use the same prescription in different countries.
QUESTIONS:
Q1. What do you know about the IP. [91,94,95(2nd)] 4
Q2. Short Note on Pharmacopoeia.
[93,94] 4
Ans: See page 1; From
Pharmacopoeia/Formularies/Compendia
upto classification.
Q3. Short note on Indian Pharmacopoeial List (IPL 1946) [94] 5
Ans:- page 2
Q4. What is meant by National Pharmacopoeia? [91] 4
Ans:- Pharmacopoeias are
generally prepared under the authority of the government of the respective
countries - these pharmacopoeias are known as national pharmacopoeias.
Example of some national
pharmacopoeias are as follows:-
Indian Pharmacopoeia, British
Pharmacopoeia, united States Pharmacopoeia etc.
The 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.
The 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.
Q5. What are the points discussed in the Monograph of an official
drug? [94(2nd)] 6
Ans:- The word ‘Monograph’ means the written study of a
subject. The pharmacopoeial monographs (for example in IP) give the following
information about the drugs and pharmaceutical aids:-
1.
Main title: The main name of the substance.
2.
Synonym: The common name(s), if any, of the
substance.
3.
Chemical formula and Molecular Weight of the
substance: If necessary , its I.U.P.A.C.
chemical name and/or its chemical structure is also given.
4.
Category: Indicates the use of the drug in
medicine and pharmaceutical practices. e.g.
Antibacterial, antimalarial, diuretic, emetic, expectorant etc.
5.
Doses: Represents the average range of
quantities suitable for adults.
6.
Description: This includes the general physical
properties, i.e. whether the substance
is a solid or liquid, colourless or coloured, crystalline or amorphous, its taste etc.
7.
Solubility: According to IP the solubilities of
the substances are mentioned in terms of descriptive phrases as follows:
|
Descriptive
phrase
|
Volume of
solvent for dissolving 1 part of solute.
|
|
Very soluble
Freely soluble
Soluble
\Sparingly
soluble
Slightly
soluble
Very slightly
soluble
Practically
insoluble / insoluble
|
Less than 1
part
1 to 10parts
10 to 30 parts
30 to 100 parts
100 to 1000
parts
1000 to 10,000
parts
more than
10,000 parts
|
8.Standards:
Prescribes the standards of purity and strength e.g. Sodium bicarbonate IP contains not less than 99.0 % and not
more than 100.5 % of NaHCO3.
9.Identification:
This includes some specific and some non-specific tests for identity of
substance.
10. Tests of
purity: These tests include melting point, boiling point, weight per ml,
limit tests for chloride, sulfates, iron, heavy metals, lead and arsenic,
specific optical rotation, sulfated ash, loss on drying, pH of solution, etc.
as may be applicable for the substance.
11.Method of
Assay: The term ‘Assay’ is used in pharmacopoeias for quantitative determination
of principal ingredients of the official substances and of their preparations.
12.Storage:
Prescribes some conditions for the storage of some official substances which
are likely to deteriorate if not properly stored.
Q6. What are the various official publications
related to pharmacy profession of India.? [95] 12
Ans:- See page
3-5. Write in brief with following points for each pharmacopoeia.
a)
Publishing authority
b)
Year of 1st publication
c)
Any special features
d)
Other information
Q7. Discuss
briefly the importance of pharmacopoeia to drug industry and administration.
[94] 12
Ans:- The
importance of Pharmacopoeia can be discussed from the following three angles:
(i)
Drug industry
(ii) Administration
(iii)Academic
From the point
of view of drug industries
To market a new drug molecule stupendous amount of
money is required for the research and development. Very few companies can bear
this cost , especially the drug industries in developing countries (like India)
are unable to bear the expenditure. In that case the drugs of products
mentioned in the pharmacopoeias can be marketed without any further research on
it, because only the tested, safe and efficacious drugs and pharmaceuticals are
included in the pharmacopoeias.
Drugs and pharmaceuticals products are prepared from
some raw materials, the standards of which should rigorously be met with that
of pharmacopoeia. Though there are several other sources of information about
the standard of drugs and pharmaceuticals, the pharmacopoeia is the most reliable
one.
Assay methods and identifications of drug of
pharmaceuticals are given very clearly in the pharmacopoeias so it becomes easy
for the drug industry to design the tests and follow the methods confidently
because the assay and identification methods are tested and approved by the
authority.
2. From the
point of view of drug-administration
In
every country there are drug industries with varied intentions - among which
the major one is ‘to make profit’. While making the profit some industries
ignore the quality of the drugs and pharmaceuticals. Since drugs are related to
the health of human beings and animals, this negligence is unpardonable. So
every nation made their own Drugs and Acts and Rules. Whenever a conflict
surfaces between a drug industry and Government the first reference book that
is consulted, regarding the quality if the product, is the pharmacopoeia.
3.From the
stand point of academicia
The
pharmacopoeias are mines of information regarding drugs and pharmaceuticals.
The researchers always consult it in first hand for developing an assay method
of certain drug, for testing the quality of a dosage form. The microbiological
and bioassays are given in details in the appendices with statistical quality
controls. The usage of the drug, the adverse reaction, if any, and many more
information are provided in the pharmacopoeias. The reason for the popularity
of pharmacopoeias among the students, researchers, teachers is for the
reliability of the information provided in it.