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PHARMACEUTICS- I
Unit- I
Akanksha Patel,
Asst. Prof.
UNIT-I
Historical background and development of profession of pharmacy: History of profession
of Pharmacy in India in relation to pharmacy education, industry and organization, Pharmacy
as a career, Pharmacopoeias: Introduction to IP, BP, USP and Extra Pharmacopoeia.
Dosage forms: Introduction to dosage forms, classification and definitions
Prescription: Definition, Parts of prescription, Handling of Prescription, Errors in
prescription.
Posology: Definition, Factors affecting posology, Pediatric dose Calculations based on age,
body weight and body surface area.
Pharmacy
The word Pharmacy was coined from the Greek word “Pharmakon” meaning “medicine”
or ‘drug’.
Definition: “Pharmacy is the art and science of preparing and dispensing medication, the
provision of drug information, interpretation of prescription orders, the compounding, labeling,
drug product selection and drug utilization reviews, patient monitoring and intervention.”
Or
‘The art, practice, or profession of preparing, preserving, compounding, and dispensing
medical drugs’.
Pharmacist- ‘Pharmacist is a trained person who is certified to make, sell, distribute medicine
and medicinal compounds.’
Or
a health-care professional licensed to engage in pharmacy with duties including dispensing
prescription drugs, monitoring drug interactions, administering vaccines, and counseling
patients regarding the effects and proper usage of drugs and dietary supplements.
SYMBOL OF PHARMACY-
- ‘the bowl of Hygeia’ is a symbol of pharmacy.
- The bowl of Hygeia has roots traced to Greek mythology.
- It consists of a snake wrapped around a bowl. In this, the snake represents Aesculapius
(the God of Medicine) and the bowl represents Hygeia (his daughter & Helper).
PHARMACEUTICS- I
Unit- I
Akanksha Patel,
Asst. Prof.
HISTORY-
- The concept of Hospital was well developed and practiced in India (In BC 226), during
the period of great Ashoka. That time leaves, cold water, animal extracts etc are used in
the treatments.
- The allopathic system of medicine was introduced in India during the British rule. It was
mainly meant for the ruling class.
There are 5 classifications for era-
1. ANCIENT ERA (AD 1600)- in ancient time, leaves, cold water, and animal extracts
used in the treatment. There are no synthetic sources available in this era.
Three major advances in pharmacy occurred at this time:
1. The formulary – a continuation of the documentation of the knowledge of specific
drug information to be used by pharmacists.
2. Dosage form-drugs were no longer harvested from herb gardens. They were
incorporated into sweetened dosage forms, such as syrups, confections, and juleps,
mixed with sugar and honey.
3. pharmacy shop-first appeared in Baghdad in about AD 762.
2. EMPIRIC ERA (1600-1940)- in this era pharmacopoeia was introduced and become
primary tool for pharmacist.
- Benjamin Franklin started the first hospital in 1751. It had a pharmacy and the first
hospital pharmacist was Jonathan Roberts.
- Prof William Procter (The father of American Pharmacy) devoted his time and efforts
advancement of pharmacy.
3. INDUSTRIALIZATION ERA (1940-1970)- in this era development and
manufacturing of drugs started on industry level.
- Rapid mass production of medicine followed. Standardization, biologically prepared
products, complex chemical synthesis, and increased use of parenteral medications
were all part of this period.
4. PATIENT CARE ERA (1970-present)- in this era research and development of new
medicine started.
- New drugs were developed. Had a lot of adverse reactions to drugs so drug review
and monitoring resulted.
- Pharmacist started taking more responsibilities including dispensing medicine and
patient education.
5. BIOTECHNOLOGY AND GENETIC ENGINEERING ERA (future prospects)-
Medications are being produced through recombinant DNA technology.
- New therapies for cancer, anemia, and hepatitis are being introduced.
PHARMACEUTICS- I
Unit- I
Akanksha Patel,
Asst. Prof.
History of pharmacy in India- it can be divided into 2 parts: -
1. Before independence
2. After independence
Before independence-
1842- Pharmacy education started at certified level in GOA by Portuguese.
1870- Madras Medical college conducted first licentiate exam for chemist and druggist.
1881- Formal training of compounders started in Bengal.
1901- Establishment of Bengal chemical and pharmaceutical works, Calcutta by Acharya P.
C. Ray.
1903- a small factory at Parel (Bombay) by Prof. T. K. Gujjar.
1930- Government of India appointed a committee under the chairmanship of late Col. R. N.
Chopra to see pharmacy problems in India.
1935- United province pharmaceutical association was established which later converted into
‘Indian Pharmaceutical Association’.
1937- Introduction of 3 yrs. B. Pharm course by Prof. Mahadeva lal Schroff at Banaras
Hindu university.
1940- Establishment of IPCA (Indian Pharmaceutical Congress Association).
1945- Pharmacy bill introduced to manage the pharmacy education in India.
1946- Publication of ‘Indian pharmacopoeia list’.
After independence
1948- publication of pharmacy act 1948.
1948- Indian pharmacopoeia committee constituted under the chairmanship of late Dr. B. N.
Ghose.
1949- establishment of pharmacy council of India (PCI).
1953- first education regulation was framed and started D. Pharm.
1955- Publication of first edition of India Pharmacopoeia.
PHARMACEUTICS- I
Unit- I
Akanksha Patel,
Asst. Prof.
CAREER IN PHARMACY-
It is one of the best career across the world. Pharmacy is a part of health care services which
completely deals with the drugs. There are some options following-
PHARMACEUTICS- I
Unit- I
Akanksha Patel,
Asst. Prof.
PHARMACEUTICS- I
Unit- I
Akanksha Patel,
Asst. Prof.
PHARMACOPOEIA-
Derived from Greek word ‘Pharmakon’ means drug and ‘Poiea’ means to make.
 It can be defined as ‘a book of standards applicable to drug and their common dosage
forms and pharmaceutical aids published in a country under the authority of its own
government’.
- The book containing the standards for drug and other related substance are known as
pharmacopoeias and formularies. Collectively these books are known as drug compendia.
- It is a legal and official book issued by recognized authorities usually appointed by
Government of each country.
- It comprises list of pharmaceutical substances, formulae along with their description and
standards.
Classification- the drug compendia are classified as-
1. Official compendia.
2. Non official compendia.
1. Official compendia- official compendia are the compilation of drug and other related
substance which are recognized as legal standards of purity, quality, and strength, by govt
agency of respective countries of their origin.
Eg. 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.
2. Non official compendia- the book other than official drug compendia which are used as a
secondary reference sources for drug and other related substances are known as Non official
compendia.
Eg. Merck Index, Remington’s Pharmaceutical Sciences, the United State Dispensary,
Martindale.
Indian Pharmacopoeia- the development of IP was started with and aim to promote public
health by bringing out authoritative and officially accepted standard for quality of drugs
including API, excipients, dosage form, and medical devices for use by health professionals,
patients, consumer.
EDITION PUBLISHING
YEAR
VOLUMES ADDENDUM/
SUPPLEMENT
FEATURES
1st 1955 1  Chairmanship- Dr. B. N.
Ghose (IPC)
 986 monographs
 Official title of monograph is
written in Latin language.
 It includes crude drug, chemical,
biological and several formulae.

1960 
PHARMACEUTICS- I
Unit- I
Akanksha Patel,
Asst. Prof.
2nd 1966 1 Chairmanship- Dr. B.
Mukharji
890 monographs & 41
appendices
284 monograph are deleted from
first edition
Title of monographs in Latin
language to English language
Doses given in metric system and
usual strength has been given for
tablets and injections.

1975 126 new monographs were
included and 250 monograph of
2nd
edition have been added.
Analytical procedure and some
appendices have been added.
3rd 1985 2 Chairmanship- Dr. Nitya Nand
261 new monograph and 9
appendices.
IUPAC nomenclature has been
used.

1989 46 new monographs were added
and 126 monograph of 3rd
edition
were amended

1991 
4th 1996 2 Chairmanship- Dr. Nitya Nand
Color- blue
1149 monographs 123
appendices
Computer generated formulae
was used

2000  42 new monographs have been
added

2003  19 monographs have been added

Veterinary
supplement 1996
 208 monographs and 4
appendices
PHARMACEUTICS- I
Unit- I
Akanksha Patel,
Asst. Prof.

5th 2007 3  Chairmanship- Dr. Nitya
Nand
Color- blue
V1- general notes, preface,
structure of IPC
V2- general monographs on drug
substance, dosage form,
pharmaceutical aids
V3- monographs on drug
substances, immunno- sera,
vaccines, blood related products.

2008 
6th 2010 3  Chairmanship- Prof C.K.
Chandramauli
Color- blue
2000 monographs, 287 new
monographs, >600 monographs
are updated.
V1- general notes, structure of
IPC, acknowledgement,
introduction, general chapters.
V2- general notices, general
monographs on dosage form (A
to M), pharmaceutical aids.
V3- general monographs on
dosage form (N to Z)

2012 
7th 2014 4 Chairmanship- Prof Gulab
Nabi Azad
Color- Red
 2548 monographs,
radiopharmaceutical
monographs was added.
2015 
2016 
PHARMACEUTICS- I
Unit- I
Akanksha Patel,
Asst. Prof.
8th 2018 4 Chairmanship- Dr. C. K.
Mishra
Color- Orange
220 monographs are added, 366
monographs are revised, 7
monographs are omitted.
General chemical test and TLC
eliminated, UV, IR, HPLC, etc
are added.

2019 
9th 2022 Chairmanship- Dr. Mansukh
Mandaviya
Color- brick red
92 New monographs are added
with 12 general chapters,
Vit. Minerals, amino acids- 22
Biotechnological products- 8
Released on 1st
july 2022
Effective on 1st
dec 2022

British pharmacopoeia
 It is the national pharmacopoeia of the United Kingdom. It is an annually published
collection of quality standards for UK medicinal substances, which is used by individuals and
organizations involved in pharmaceutical research, development, manufacture and testing.
 It was first published by General Medicine Council and was later done by Pharmaceutical
Commission.
 Since then Pharmacopoeial commission is reconstituted from time to time and new editions of
British Pharmacopoeia are published.
 First edition Publication 1864- it has 2 parts-
 Part I- Materia Medica.
 Part II- preparation and compound.
 2nd
edition- 1867
 3rd
edition- 1885
 4th
edition- 1898
 5th
edition- 1914
 8th
edition- 1953: title of drugs and preparation were in English instead of Latin and matric
system
 BP 2004
 BP2007- monographs have been introduced for matrial specifically used in preparation of
traditional Chinese medicines.
PHARMACEUTICS- I
Unit- I
Akanksha Patel,
Asst. Prof.
 BP 2008- Approx. 3100 monographs
 BP2007-2009- there are 6 volumes
Vol 1 & 2- contains medicinal substances
Vol 3- contains formulated preparation, blood related products, immunological radiopharma -
ceutical preparations, surgical and homeopathic products.
Vol 4- supplementary chapters, IR spectra etc are included
Vol 5- veterinary
Vol 6- CD ROM version ( advance technology)
 Latest- BP 2023- 23 new monographs, 59 pharmaceutical European monographs.
British Pharmaceutical Codex (BPC)
 British Pharmaceutical Codex was prepared as a reference book to physicians and
dispensing pharmacists in 1907 as per the Council of Pharmaceutical Society.
 Since then subsequent revisions of these books are published.
 The decision of medicine commission stated that there should be only one book of
standards of medicine, so BPC was discontinued.
 Later BPC was published as “The Pharmaceutical Codex” and plans to be encyclopedia.
The BPC differs from BP in:
BPC BP British National
Formulary (BNF)
BPC contains more drugs
and preparations.
It contains additional
information on standard of
drugs, surgical dressing,
pharmaceutical preparations,
etc
Pharmacological
classification of drugs are
given. It includes
preparations as per
Pharmaceutical forms.
It provides action and uses of
drugs
It contains formula and
preparation methods of some
other formulations.
It provides information about
actions, uses, dosage &
adverse reactions.
PHARMACEUTICS- I
Unit- I
Akanksha Patel,
Asst. Prof.
European Pharmacopeia
 European pharmacopeia commission started working since 1964 to prepare EP Editions
 1st edition: published 1967
 2nd edition: published 1980
 3rd edition: published 1997
 4th edition: published 2001, valid from 1 January 2002
 5th edition: published 15 June 2004, valid from 1 January 2005
 6th edition: published 16 July 2007, valid from 1 January 2008
 7th edition: published June 2010, valid from 1 January 2011
 8th edition: published June 2013, valid from 1 January 2014
 The European Pharmacopoeia (Ph. Eur.) defines requirements for the qualitative and
quantitative composition of medicines, the tests to be carried out on medicines and on
substances and materials used in their production.
 It covers active substances, excipients and preparations of chemical, animal, human or herbal
origin, homoeopathic preparations and homoeopathic stocks, antibiotics, as well as dosage
forms and containers.
 It also includes texts on biologicals, blood and plasma derivatives, vaccines and
radiopharmaceutical preparations.
 The European Pharmacopoeia and its requirements are legally binding in the member states of
the European Pharmacopoeia Convention and the European Union.
 National Formulary (NF)
 First National Formulary of US was published in 1888 by American Pharmaceutical
Association.
 USP and NF was combined as a single book of drug standards as USP-NF.
 USP-NF represents 25th revision of USP & 20th revision of NF official on 2002. From then
USP-NF was published annually.
 NF covers over 3800 monographs for excipients and dietary supplements.
PHARMACEUTICS- I
Unit- I
Akanksha Patel,
Asst. Prof.
 United States Pharmacopoeia (USP)
 The United States Pharmacopoeia and the National Formulary (USP-NF) are recognized as the
official compendia and are used as reference books for determining the strength, quality, purity,
packaging and labeling of drugs and other related articles.
 First USP was published in 1820 by US Pharmaceutical Convention in English and Latin. It
consists of 272 drugs.
 USP contains over 3400 monographs for drug substances and products, together with over 160
general chapters that describe specific procedures to support monograph tests and other
information as well.
 USP also contains 16 monographs and 9 general chapters on nutritional supplements.
International Pharmacopoeia
 The International Pharmacopoeia is published by the WHO and is practically used in
developing countries.
 It was prepared to meet the international uniformity and standardization of drugs.
 International Pharmacopoeia was first published in 1951 in Multilanguage (English, French,
German, Japanese)
Japanese Pharmacopoeia (JP)
 JP is established and published to regulate the properties and quality of drugs by Ministry of
Health, Labor and Welfare of Japan.
 It consists of general notices, rules for crude drugs, rules for preparations, general tests,
processes, apparatus and official monographs.
 First published in 1886, JP has been revised many times.
PHARMACEUTICS- I
Unit- I
Akanksha Patel,
Asst. Prof.
Extra pharmacopoeia-
MARTINDALE
Martindale contains information on drug in clinical use worldwide, as well as selected
investigational and veterinary drugs. Herbal and complementary medicines, pharmaceutical
excipients, vitamins, and nutritional agents, vaccines, radiopharmaceuticals, contrast medica
and diagnostic agents, medicinal gases, drugs of abuse and recreational drugs, toxic substances,
disinfectants, pesticides.
 It is published by the royal pharmaceutical society of great Britain and was first
published in 1883 by William Martindale.
 It is an authoritative reference book on drug and medicines users.
 It aim to provide practicing pharmacists and physicians with up to date information on
all drug substances, official, unofficial and propriety that are currently used in
pharmacy.

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Historical background and development of profession of pharmacy

  • 1. PHARMACEUTICS- I Unit- I Akanksha Patel, Asst. Prof. UNIT-I Historical background and development of profession of pharmacy: History of profession of Pharmacy in India in relation to pharmacy education, industry and organization, Pharmacy as a career, Pharmacopoeias: Introduction to IP, BP, USP and Extra Pharmacopoeia. Dosage forms: Introduction to dosage forms, classification and definitions Prescription: Definition, Parts of prescription, Handling of Prescription, Errors in prescription. Posology: Definition, Factors affecting posology, Pediatric dose Calculations based on age, body weight and body surface area. Pharmacy The word Pharmacy was coined from the Greek word “Pharmakon” meaning “medicine” or ‘drug’. Definition: “Pharmacy is the art and science of preparing and dispensing medication, the provision of drug information, interpretation of prescription orders, the compounding, labeling, drug product selection and drug utilization reviews, patient monitoring and intervention.” Or ‘The art, practice, or profession of preparing, preserving, compounding, and dispensing medical drugs’. Pharmacist- ‘Pharmacist is a trained person who is certified to make, sell, distribute medicine and medicinal compounds.’ Or a health-care professional licensed to engage in pharmacy with duties including dispensing prescription drugs, monitoring drug interactions, administering vaccines, and counseling patients regarding the effects and proper usage of drugs and dietary supplements. SYMBOL OF PHARMACY- - ‘the bowl of Hygeia’ is a symbol of pharmacy. - The bowl of Hygeia has roots traced to Greek mythology. - It consists of a snake wrapped around a bowl. In this, the snake represents Aesculapius (the God of Medicine) and the bowl represents Hygeia (his daughter & Helper).
  • 2. PHARMACEUTICS- I Unit- I Akanksha Patel, Asst. Prof. HISTORY- - The concept of Hospital was well developed and practiced in India (In BC 226), during the period of great Ashoka. That time leaves, cold water, animal extracts etc are used in the treatments. - The allopathic system of medicine was introduced in India during the British rule. It was mainly meant for the ruling class. There are 5 classifications for era- 1. ANCIENT ERA (AD 1600)- in ancient time, leaves, cold water, and animal extracts used in the treatment. There are no synthetic sources available in this era. Three major advances in pharmacy occurred at this time: 1. The formulary – a continuation of the documentation of the knowledge of specific drug information to be used by pharmacists. 2. Dosage form-drugs were no longer harvested from herb gardens. They were incorporated into sweetened dosage forms, such as syrups, confections, and juleps, mixed with sugar and honey. 3. pharmacy shop-first appeared in Baghdad in about AD 762. 2. EMPIRIC ERA (1600-1940)- in this era pharmacopoeia was introduced and become primary tool for pharmacist. - Benjamin Franklin started the first hospital in 1751. It had a pharmacy and the first hospital pharmacist was Jonathan Roberts. - Prof William Procter (The father of American Pharmacy) devoted his time and efforts advancement of pharmacy. 3. INDUSTRIALIZATION ERA (1940-1970)- in this era development and manufacturing of drugs started on industry level. - Rapid mass production of medicine followed. Standardization, biologically prepared products, complex chemical synthesis, and increased use of parenteral medications were all part of this period. 4. PATIENT CARE ERA (1970-present)- in this era research and development of new medicine started. - New drugs were developed. Had a lot of adverse reactions to drugs so drug review and monitoring resulted. - Pharmacist started taking more responsibilities including dispensing medicine and patient education. 5. BIOTECHNOLOGY AND GENETIC ENGINEERING ERA (future prospects)- Medications are being produced through recombinant DNA technology. - New therapies for cancer, anemia, and hepatitis are being introduced.
  • 3. PHARMACEUTICS- I Unit- I Akanksha Patel, Asst. Prof. History of pharmacy in India- it can be divided into 2 parts: - 1. Before independence 2. After independence Before independence- 1842- Pharmacy education started at certified level in GOA by Portuguese. 1870- Madras Medical college conducted first licentiate exam for chemist and druggist. 1881- Formal training of compounders started in Bengal. 1901- Establishment of Bengal chemical and pharmaceutical works, Calcutta by Acharya P. C. Ray. 1903- a small factory at Parel (Bombay) by Prof. T. K. Gujjar. 1930- Government of India appointed a committee under the chairmanship of late Col. R. N. Chopra to see pharmacy problems in India. 1935- United province pharmaceutical association was established which later converted into ‘Indian Pharmaceutical Association’. 1937- Introduction of 3 yrs. B. Pharm course by Prof. Mahadeva lal Schroff at Banaras Hindu university. 1940- Establishment of IPCA (Indian Pharmaceutical Congress Association). 1945- Pharmacy bill introduced to manage the pharmacy education in India. 1946- Publication of ‘Indian pharmacopoeia list’. After independence 1948- publication of pharmacy act 1948. 1948- Indian pharmacopoeia committee constituted under the chairmanship of late Dr. B. N. Ghose. 1949- establishment of pharmacy council of India (PCI). 1953- first education regulation was framed and started D. Pharm. 1955- Publication of first edition of India Pharmacopoeia.
  • 4. PHARMACEUTICS- I Unit- I Akanksha Patel, Asst. Prof. CAREER IN PHARMACY- It is one of the best career across the world. Pharmacy is a part of health care services which completely deals with the drugs. There are some options following-
  • 6. PHARMACEUTICS- I Unit- I Akanksha Patel, Asst. Prof. PHARMACOPOEIA- Derived from Greek word ‘Pharmakon’ means drug and ‘Poiea’ means to make.  It can be defined as ‘a book of standards applicable to drug and their common dosage forms and pharmaceutical aids published in a country under the authority of its own government’. - The book containing the standards for drug and other related substance are known as pharmacopoeias and formularies. Collectively these books are known as drug compendia. - It is a legal and official book issued by recognized authorities usually appointed by Government of each country. - It comprises list of pharmaceutical substances, formulae along with their description and standards. Classification- the drug compendia are classified as- 1. Official compendia. 2. Non official compendia. 1. Official compendia- official compendia are the compilation of drug and other related substance which are recognized as legal standards of purity, quality, and strength, by govt agency of respective countries of their origin. Eg. 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. 2. Non official compendia- the book other than official drug compendia which are used as a secondary reference sources for drug and other related substances are known as Non official compendia. Eg. Merck Index, Remington’s Pharmaceutical Sciences, the United State Dispensary, Martindale. Indian Pharmacopoeia- the development of IP was started with and aim to promote public health by bringing out authoritative and officially accepted standard for quality of drugs including API, excipients, dosage form, and medical devices for use by health professionals, patients, consumer. EDITION PUBLISHING YEAR VOLUMES ADDENDUM/ SUPPLEMENT FEATURES 1st 1955 1  Chairmanship- Dr. B. N. Ghose (IPC)  986 monographs  Official title of monograph is written in Latin language.  It includes crude drug, chemical, biological and several formulae.  1960 
  • 7. PHARMACEUTICS- I Unit- I Akanksha Patel, Asst. Prof. 2nd 1966 1 Chairmanship- Dr. B. Mukharji 890 monographs & 41 appendices 284 monograph are deleted from first edition Title of monographs in Latin language to English language Doses given in metric system and usual strength has been given for tablets and injections.  1975 126 new monographs were included and 250 monograph of 2nd edition have been added. Analytical procedure and some appendices have been added. 3rd 1985 2 Chairmanship- Dr. Nitya Nand 261 new monograph and 9 appendices. IUPAC nomenclature has been used.  1989 46 new monographs were added and 126 monograph of 3rd edition were amended  1991  4th 1996 2 Chairmanship- Dr. Nitya Nand Color- blue 1149 monographs 123 appendices Computer generated formulae was used  2000  42 new monographs have been added  2003  19 monographs have been added  Veterinary supplement 1996  208 monographs and 4 appendices
  • 8. PHARMACEUTICS- I Unit- I Akanksha Patel, Asst. Prof.  5th 2007 3  Chairmanship- Dr. Nitya Nand Color- blue V1- general notes, preface, structure of IPC V2- general monographs on drug substance, dosage form, pharmaceutical aids V3- monographs on drug substances, immunno- sera, vaccines, blood related products.  2008  6th 2010 3  Chairmanship- Prof C.K. Chandramauli Color- blue 2000 monographs, 287 new monographs, >600 monographs are updated. V1- general notes, structure of IPC, acknowledgement, introduction, general chapters. V2- general notices, general monographs on dosage form (A to M), pharmaceutical aids. V3- general monographs on dosage form (N to Z)  2012  7th 2014 4 Chairmanship- Prof Gulab Nabi Azad Color- Red  2548 monographs, radiopharmaceutical monographs was added. 2015  2016 
  • 9. PHARMACEUTICS- I Unit- I Akanksha Patel, Asst. Prof. 8th 2018 4 Chairmanship- Dr. C. K. Mishra Color- Orange 220 monographs are added, 366 monographs are revised, 7 monographs are omitted. General chemical test and TLC eliminated, UV, IR, HPLC, etc are added.  2019  9th 2022 Chairmanship- Dr. Mansukh Mandaviya Color- brick red 92 New monographs are added with 12 general chapters, Vit. Minerals, amino acids- 22 Biotechnological products- 8 Released on 1st july 2022 Effective on 1st dec 2022  British pharmacopoeia  It is the national pharmacopoeia of the United Kingdom. It is an annually published collection of quality standards for UK medicinal substances, which is used by individuals and organizations involved in pharmaceutical research, development, manufacture and testing.  It was first published by General Medicine Council and was later done by Pharmaceutical Commission.  Since then Pharmacopoeial commission is reconstituted from time to time and new editions of British Pharmacopoeia are published.  First edition Publication 1864- it has 2 parts-  Part I- Materia Medica.  Part II- preparation and compound.  2nd edition- 1867  3rd edition- 1885  4th edition- 1898  5th edition- 1914  8th edition- 1953: title of drugs and preparation were in English instead of Latin and matric system  BP 2004  BP2007- monographs have been introduced for matrial specifically used in preparation of traditional Chinese medicines.
  • 10. PHARMACEUTICS- I Unit- I Akanksha Patel, Asst. Prof.  BP 2008- Approx. 3100 monographs  BP2007-2009- there are 6 volumes Vol 1 & 2- contains medicinal substances Vol 3- contains formulated preparation, blood related products, immunological radiopharma - ceutical preparations, surgical and homeopathic products. Vol 4- supplementary chapters, IR spectra etc are included Vol 5- veterinary Vol 6- CD ROM version ( advance technology)  Latest- BP 2023- 23 new monographs, 59 pharmaceutical European monographs. British Pharmaceutical Codex (BPC)  British Pharmaceutical Codex was prepared as a reference book to physicians and dispensing pharmacists in 1907 as per the Council of Pharmaceutical Society.  Since then subsequent revisions of these books are published.  The decision of medicine commission stated that there should be only one book of standards of medicine, so BPC was discontinued.  Later BPC was published as “The Pharmaceutical Codex” and plans to be encyclopedia. The BPC differs from BP in: BPC BP British National Formulary (BNF) BPC contains more drugs and preparations. It contains additional information on standard of drugs, surgical dressing, pharmaceutical preparations, etc Pharmacological classification of drugs are given. It includes preparations as per Pharmaceutical forms. It provides action and uses of drugs It contains formula and preparation methods of some other formulations. It provides information about actions, uses, dosage & adverse reactions.
  • 11. PHARMACEUTICS- I Unit- I Akanksha Patel, Asst. Prof. European Pharmacopeia  European pharmacopeia commission started working since 1964 to prepare EP Editions  1st edition: published 1967  2nd edition: published 1980  3rd edition: published 1997  4th edition: published 2001, valid from 1 January 2002  5th edition: published 15 June 2004, valid from 1 January 2005  6th edition: published 16 July 2007, valid from 1 January 2008  7th edition: published June 2010, valid from 1 January 2011  8th edition: published June 2013, valid from 1 January 2014  The European Pharmacopoeia (Ph. Eur.) defines requirements for the qualitative and quantitative composition of medicines, the tests to be carried out on medicines and on substances and materials used in their production.  It covers active substances, excipients and preparations of chemical, animal, human or herbal origin, homoeopathic preparations and homoeopathic stocks, antibiotics, as well as dosage forms and containers.  It also includes texts on biologicals, blood and plasma derivatives, vaccines and radiopharmaceutical preparations.  The European Pharmacopoeia and its requirements are legally binding in the member states of the European Pharmacopoeia Convention and the European Union.  National Formulary (NF)  First National Formulary of US was published in 1888 by American Pharmaceutical Association.  USP and NF was combined as a single book of drug standards as USP-NF.  USP-NF represents 25th revision of USP & 20th revision of NF official on 2002. From then USP-NF was published annually.  NF covers over 3800 monographs for excipients and dietary supplements.
  • 12. PHARMACEUTICS- I Unit- I Akanksha Patel, Asst. Prof.  United States Pharmacopoeia (USP)  The United States Pharmacopoeia and the National Formulary (USP-NF) are recognized as the official compendia and are used as reference books for determining the strength, quality, purity, packaging and labeling of drugs and other related articles.  First USP was published in 1820 by US Pharmaceutical Convention in English and Latin. It consists of 272 drugs.  USP contains over 3400 monographs for drug substances and products, together with over 160 general chapters that describe specific procedures to support monograph tests and other information as well.  USP also contains 16 monographs and 9 general chapters on nutritional supplements. International Pharmacopoeia  The International Pharmacopoeia is published by the WHO and is practically used in developing countries.  It was prepared to meet the international uniformity and standardization of drugs.  International Pharmacopoeia was first published in 1951 in Multilanguage (English, French, German, Japanese) Japanese Pharmacopoeia (JP)  JP is established and published to regulate the properties and quality of drugs by Ministry of Health, Labor and Welfare of Japan.  It consists of general notices, rules for crude drugs, rules for preparations, general tests, processes, apparatus and official monographs.  First published in 1886, JP has been revised many times.
  • 13. PHARMACEUTICS- I Unit- I Akanksha Patel, Asst. Prof. Extra pharmacopoeia- MARTINDALE Martindale contains information on drug in clinical use worldwide, as well as selected investigational and veterinary drugs. Herbal and complementary medicines, pharmaceutical excipients, vitamins, and nutritional agents, vaccines, radiopharmaceuticals, contrast medica and diagnostic agents, medicinal gases, drugs of abuse and recreational drugs, toxic substances, disinfectants, pesticides.  It is published by the royal pharmaceutical society of great Britain and was first published in 1883 by William Martindale.  It is an authoritative reference book on drug and medicines users.  It aim to provide practicing pharmacists and physicians with up to date information on all drug substances, official, unofficial and propriety that are currently used in pharmacy.