Transcript pharmacopoeias - Hindu College Of Pharmacy

PHARMACOPOEIA
Pharmacopoeia
The term Pharmacopoeia comes from the Greek word “Pharmakon” meaning
‘drug’ and ‘Poiein’ meaning ‘make’, and the combination means any recipe or formula or other
standard required to make or prepare a drug.
The term ‘Pharmacopoeia’ was first used in 1580 in a book on drug standards
printed in Bergamo, Italy. After that a number of national pharmacopoeias were published by
various European Pharmacopoeias- the London, the Edinburgh and the Dublin pharmacopoeia
were official throughout the kingdom. Each pharmacopoeia described different strength and
method of preparation for the same preparation. Hence there was a lot of confusion. To
overcome this difficulty, the first British Pharmacopoeia came into existence in 1864.
Indian Pharmacopoeia
In the United States, the first pharmacopoeia was published in December
1820 both in English and in Latin. Later on a National Formulary was also published in
addition to U.S.P. (United States Pharmacopoeia). The object of the U.S.P.ws to select from
substances the ones which possess medicinal power, converted them into preparation of
suitable composition in order to enhance their power to the maximum advantage.
The first International Pharmacopoeia was published by the World Health
Organization 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.
Indian Pharmacopoeia
List of Pharmacopeias:
a) Argentine b) Austrian c) Belgian d) Brazilian e) British
f) Chinese g) Egyptian h) European i) French j) German
k) Hungarian l) Indian m) International n) Italian o) Japanese
p) Yugoslavian q) Mexican r) Netherlands s) Nordic t) Polish
u) Portuguese v) Rumanian w) Russian x) Spanish y) Turkish
z) United state.
Indian Pharmacopoeia
HISTORY OF THE PHARMACOPOEIA OF INDIA
The Government of India through its letter No. 2338 H(C)/43 dated 26
January, 1944, directed the Drugs Technical Advisory Board list the drugs used in India, which
are not mentioned in British Pharmacopoeia and also recommend the standards to be
prescribed to maintain uniformity and the chemical tests to be used to establish identity and
purity. The Government of India published the Indian Pharmacopoeial List in 1946, as a
supplement to the British Pharmacopoeia. The term “List” in the title was “misleading” in that,
the book not only contained a list of drugs which were of substantial medicinal value but also
laid down standards.
Indian Pharmacopoeia
The Indian Pharmacopoeial List contained about 180 monographs and a
number of appendices prepared on the lines of the British Pharmacopoeia. Approximately 100
monographs were on vegetable drugs growing in India and on their galenicals. The drugs of
plant origin such as cannabis, rauwalfia, vasaka etc. were included in it. Similarly several oils
such as ajowan, cassia, neem and pudina were included in it.
The Pharmaceuticals and Drug Research Committee of the Council of
Scientific and Industrial Research decided in February 1947 to compile a “Brochure” to
highlight the information and clinical uses of the important indigenous drugs of India. Later on
it was decided to prepare a “Codex” instead of Brouchure.
Indian Pharmacopoeia
After the publication of the Indian Pharmacopoeial List, the Government of
India, constituted an eleven-member Indian Pharmacopoeial Committee in 1948, in their
notification No. F.1-1/48-DS dated 23rd November, 1948, for preparing the Pharmacopoeia of
India. The tenure extended by one year vide Government notification No. F.6-10/53-DS dated
the 21st November, 1953. In compiling the monographs of the first pharmacopoeia of India,
help was taken from all available established scientific data in the modern pharmacopoeia,
such as British Pharmacopoeia, the United States Pharmacopoeia, the International
Pharmacopoeia products. The first edition of Pharmacopoeia of India was compiled and then
published in 1955.
Indian Pharmacopoeia
Salient Features of the First Edition of Pharmacopoeia of India(1955)
1.The title of monographs have been given in Latin language. Abbreviated titles for use in
prescription have been given immediately below the Latin title.
2.The English title has also been given below the abbreviation title.
3.The weights and measures have been given in metric system.
4.All statements contained in the individual monographs have been considered as constitute
standards for the official substances.
5.Doses are expressed both in the metric system as well as in the English system.
6.A list of preparations has been given at the end of some of the monographs.
7.The temperature has been expressed in Celsius thermometric scale.
8.The descriptive terms (very soluble, freely soluble, sparingly soluble, slightly soluble, very
slightly soluble, practically insoluble) have been used where the exact solubility of a
pharmacopoeial substance is not known.
Indian Pharmacopoeia
The tenure of the first Indian Pharmacopoeial Committee expired in 1954, and the
Committee was reconstituted under the chairmanship of Dr. B.N. Ghosh, Professor of
Pharmacology, R. G. Kar Medical College Calcutta. The Committee compiled a supplement to
the first edition of the Indian Pharmacopoeia. The supplement was published in 1960. The
composition of the Committee entrusted with the compilation of the second edition of
Pharmacopoeia was as follows:
•Chairman
•Members – 11 in number
•Member – Secretary
•Assistant – Secretary
The committee appointed the following Subcommittees to assist it in the compilation work:
•Pharmacology & Bioassay Subcommittee
•Biological Products Subcommittee
•Antibiotics, Vitamins & Hormones Subcommittee
•Pharmacognosy Subcommittee
•Pharmacy Subcommittee
•Pharmaceutical Subcommittee
•General Chemistry Subcommittee
•Analytical Subcommittee
•Physical Standards, Weights, measures and Nomenclature Subcommittee
•Indian Medicinal Plants Subcommittee
Indian Pharmacopoeia
In order to expedite the compilation of the second edition of Pharmacopoeia, the Indian
Pharmacopoeia Committee constituted a “Working Group” to examine the comments received
on the draft monographs and then submitted suitable recommendations to the Committee in the
light of their comments. The second edition of the Pharmacopoeia of India was published in
1966 and later on its supplement was published in 1975.
Salient Features of the Second Edition of Pharmacopoeia of India (1966)
1.The titles of monographs have been changed from Latin to English.
2.The words of the title have been transposed to give the name of the drug first e.g. Injection of
Aminophylline has been changed to Aminophylline Injection.
3.Doses are expressed in the metric system only.
4.Solubility is expressed in parts of solvent per unit part of solute.
5.The preparations of a drug have been given immediately after the monograph on the parent
drug.
6.The test for sterility has been modified to provide for detection of fungi in addition to aerobic
and anaerobic bacteria.
7.New analytical techniques such as non-aqueous titrimetry, column chromography have been
included.
8.In the monographs of “Tablets” and “Injections”, a new sub-heading “Usual Strength” has
been given to represent the strength of the tablet or injection in which it should be generally
marketed.
Indian Pharmacopoeia
The Government of India, Ministry of Health and Family Welfare, vide their resolution
No.X19014/1/77-D & M.S., dated 30th June 1979, reconstituted the Indian Pharmacopoeia
Committee for a period of five years for the preparation of the third edition of Pharmacopoeia
Committee for a period of five years for the preparation of the third edition of Pharmacopoeia
of India. The composition of the committee was as follows:
•Chairman
•Members – 13 in number representing academic, research and industry
•Member – Secretary
•Assistant – Secretary
The committee appointed the following Subcommittees:
•Clinical Medicines & Pharmacology Subcommittee
•Biological Products & Bioassay Subcommittee
•Antibiotics Subcommittee
•Synthetic Drugs Subcommittee
•Medicinal Plants, Galenicals & Surgical-Dressings Subcommittee
•Chemicals & Pharmaceutical Aids Subcommittee
•Parenteral & Sterile Products Subcommittee
•Non parenteral Products Subcommittee
•Analytical Methods, Reagents, Diagnostic Aids & Containers Subcommittee
Nomenclature & Formulae Subcommittee
Indian Pharmacopoeia
The Indian Pharmacopoeia Committee also constituted a “Working Group”
for the purpose of preparing draft monographs and appendices, to examine the
comments received on these from various sources and then make suitable
recommendations to the Committee.
The monographs, Appendices and General Notes as prepared by the
“Working Group” and finalized by the committee were then published in the
form of third edition of the Pharmacopoeia of India in 1985 by the Government
of India.
Indian Pharmacopoeia
Salient Features of the Third Edition of Pharmacopoeia of India (1985)
1.The new analytical techniques such as Flame Photometry, Flurometry, Electrophoresis and
Photometric Haemoglobinometry have been introduced as official method for certain chemical
analysis.
2.Dissolution Test has been introduced in the case of certain tablets.
3.Disintegration Test has been amended by modifying the design of the apparatus and method
of testing.
4.A microbial limit test has been prescribed for certain pharmaceutical aids and oral liquid
preparations.
5.The Pyrogen Test has been revised to make the test less time-consuming than the previous
method.
6.Gas Liquid Chromatography has been recognized as an alternative method for the
determination of alcohol concentration in various preparations.
7.The test for determination of viscosity has been modified by the introduction of other methods
involving the use of Ostwald Viscometer.
8.The new appendix on “Water for Pharmaceutical Use” use been introduced to clearly indicate
the different official standard in respect of purified water, water for injection and sterile water
for injection.
9.Some of the drugs have been renamed in this edition e.g. “Acetylsalicylic Acid” has been
changed to “Aspirin”.
10.Many drugs have been omitted from the third edition and many new drugs have been
included in the third edition.
Indian Pharmacopoeia
The Government of India, Ministry of Health and Family Welfare vide their resolution No.
X19020/1/89-DMS and PFA dated 12th August 1991, reconstituted the Indian Pharmacopoeia
Committee for a period of five years for the preparation of the fourth edition of Pharmacopoeia
of India. The composition of the committee was as follows:
•
Chairman
•
Members – 18 in number representing academic, research and industry
•
Member – Secretary
•
Assistant – Secretary
The Committee appointed the subcommittees and working groups in order to expedite the
preparation of the new edition of the Indian Pharmacopoeia.
The Monographs, Appendices and General Notes as prepared by the “Working Group” and
finalized by the Committee were then published in the form of fourth edition of the
Pharmacopoeia of India in 1996 by the Government of India.
Indian Pharmacopoeia
Salient Features of the Fourth Edition of Pharmacopoeia of India(1996)
1.It contains 1149 monographs and 123 appendices and available in two volumes.
2.The computer-generated structural formulae have been introduced.
3.Some titles have been changed to include the more commonly accepted names of India. E.g.
Hyoscine Hydrobromide for Scopolamine Hydrobromide
4.Infra-red and ultra-red absorption spectrophotometric tests for identification of drug substance
have been introduced as alternative tests to the classical chemical tests. The infra-red reference
spectra of a number of drug substances has been included in an appendix.
5.The high performance liquid chromatography (HPLC) has been widely used as a method to
analyse many formulations which can otherwise be analysed only by more difficult and less
accurate method e.g. biological assay of Insulin has been replaced by HPLC.
6.The test for bacterial endotoxins as a more suitable substitute for the test for pyrogens has
been introduced for some articles.
7.A quantitative method for determining particulate matter in injectable preparations has been
replaced by the quantitative test of the previous edition. The test is applicable solutions that are
supplied in containers with 100 ml or more.
8.The specific biological assays and tests provided for a vaccines; hormones, blood products
and enzymes have been transferred from an appendix to the individual monographs.
9.In the monographs for Oral Rehydration Salts (ORS), ORS-Bicarbonate formula has been
dropped due to its stability problem, whereas ORS_Citrate formula recommended by WHO is
retained.
Indian Pharmacopoeia
After the publication of fourth edition of the Indian Pharmacopoeia in 1996, an addendum
was published in 2000. Addendum 2002 was published to incorporate the latest developments
made in pharmaceutical sciences. The numbering of pages in this Addendum is continuous with
that of Volume I and II of Indian Pharmacopoeia 1996 and Addendum 2000. The following
changes are made:1. A number of tests and standards in monographs have been amended and replaced with old
monographs.
2. The test on bacterial endotoxins replaces the pyrogen test.
3. A new appendix on ‘residual solvent’ has been incorporated to monitor the content of organic
volatile impurities that are used or produced in the manufacture of an active pharmaceutical
substance, excipient or medicinal products.
4. An appendix on HPLC has been replaced by a revised version covering ion chromatography.
5. Monographs of a number of antiretroviral activities and their formulations have been
introduced in this Addendum.
6. Monographs on vaccines for Hepatitis B and that for Rabies have been revised.
Government of India has constituted the Indian Pharmacopoeia Commission (IPC) on 22nd
March, 2005. The Commission has its headquarters at the Central Indian Pharmacopoeia
Laboratory (CIPL). Sector-23, Raj Nagar, Ghaziabad U.P. The Indian Pharmacopoeia
Commission has a Governing Body of 8-10 members and Scientific Body of 15-23 members
from different related scientific fields. Various expert committees were also made to prepare
various monographs.
Indian Pharmacopoeia
Salient Features of the Fifth Edition of Pharmacopoeia of India(2007)
1.The Indian Pharmacopoeia 2007 is presented in three volumes. Volume I contains the general
notes, preface, the structure of the IPC, Introduction and general chapters. Volume II deals with
the general monographs on drug substances, dosage forms and pharmaceutical aids. Volume III
contains monographs on drug substances, dosage forms, pharmaceutical aids, vaccines and
immunosera for human use, herbs and herbal products, blood and blood related products,
biotechnology products and veterinary products.
2.General chemical tests for identification have been almost eliminated and more specific
infrared and ultraviolet spectrophotometric tests have been given.
3.The test for pyrogens involving the use of animals has been virtually eliminated. The test for
bacterial endotoxins has been introduced.
4.The test for abnormal toxicity is now confined to certain vaccines.
5.The use of chromatographic methods has been extended in assays to large number of
pharmaceutical products.
Indian Pharmacopoeia
6. Labeling and storage are featured at the end of a monograph.
7. The general monographs for dosage forms of active pharmaceutical ingredients are
grouped together at the beginning of Volume II followed by the monographs for active
pharmaceutical ingredients, pharmaceuticals aids and individual dosage forms, all in
alphabetical order.
8. Monographs for other articles of a special nature such as vaccines and immunosera for
human use, herbs and herbal products, blood and blood related products, biotechnology
products and veterinary products are given in separate section in Volume III.
9. Limit of bacterial contamination has been introduced for controlling the microbial quality
of all medicinal products.
10. Analytical methods are in general in harmony with those adopted internationally for
monitoring the quality of drugs.