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.
