Pharmacopoeia - Pharmaceutical Inorganic Chemistry B. Pharma 1st Semester

Pharmacopoeia

Contents

• Drug compendia

• Pharmacopoeia

• Different edition of Indian Pharmacopoeia

• Indian Pharmacopoeia Commission

• Contents of pharmacopoeia

• Contents of monograph of a compound: API, Plant origin, Dosage forms, Vaccines and, Immuno sera

Learning Objectives

At the end of this lecture, the student will be able to:

• Define the drug compendia and classify it

• Define pharmacopoeia

• Classify pharmacopoeia

• List different edition of Indian Pharmacopoeia

• Recall about Indian Pharmacopoeia Commission

• Describe the various contents of pharmacopoeia

• Describe the various contents of monograph of a compound/API plant origin, dosage forms, vaccines and immuno sera

Drug Compendia

Pharmacopoeias and Formularies:

-Standards for drugs and other related substances

Collectively these books are known as Drug Compendia

Classification: The drug compendia are classified as:

• Official compendia

• Non-official compendia

Official compendia: include

a) Indian Pharmacopoeia

b) British Pharmacopoeia

c) British Pharmaceutical Codex

d) United State Pharmacopoeia

e) National Formulary

f) Pharmacopoeia of other countries

2) Non-official compendia: Include

a) Merck Index

b) Extra Pharmacopoeia (Martindale)

c) The United States Dispensary

INDIAN PHARMACOPOEIA

Definition

• Pharmacopoeia: The ancient Greek, φαρμακοποιΐα (pharmakopoiia),

• From φαρμακο- (pharmako-) ″drug″, ποι- (poi-) ″make″ and -ια (-ia).

• These three elements together can be rendered as ″drug making″ or ″to make a drug″.

• In its modern technical sense:

• It is a book containing directions for the identification of compound medicines and

• published by the authority of a government or a medical or pharmaceutical society

History of Indian Pharmacopoeia

• In 1833,a committee of the East Indian Company’s Dispensary recommended the Publication of Pharmacopoeia

• In 1844 Bengal Pharmacopoeia and General Conspectus of Medicinal Plants was published, which mainly listed most of the commonly used indigenous remedies

• In 1868 First official Pharmacopeia of India appeared which was edited by Edward John Waring

• In pre independence days, British Pharmacopeia was used in India

• The colonial addendum of BP 1898 was published in 1900, appeared as Government of India edition in 1901

• In 1946 “The Indian Pharmacopeial list” under chairmanship of Sir R. N. Chopra along with other nine members was released

• In 1948 Government of India appointed an Indian Pharmacopeia committee for preparing “Pharmacopeia of India”

• Indian Pharmacopeia committee under chairmanship of Dr. B. N. Ghosh Published first edition of IP in 1955

First Indian Pharmacopoeia

The actual process of publishing the first Pharmacopoeia started in the year 1944 under the chairmanship of Col. R. N. Chopra (Father of Pharmacology)

Contributions:

• Indian Pharmacopoeial List -1946 Published as supplement to British Pharmacopoeia

• The Indian Pharmacopoeia first edition- 1955

• The Pharmacy Act 1948

Indian Pharmacopoeia edition

• 1st edition I. P. 1955 was published in the official gazette. Dr. B. N. Ghosh, Chairman

– Supplement 1960

• 2nd edition I. P. 1966 Dr. B. Mukherji, Chairman

– Supplement 1975

• 3rd edition I. P. 1985 Dr. Nityanand, Chairman

– I Addendum/Supplement 1989

– II Addendum/Supplement 1991

• 4th edition I. P. 1996 Dr. Nityanand, Chairman

- Addendum/ Supplement 2000 for veterniary

- Addendum/ Supplement 2002

- Addendum/ Supplement 2005

• 5th edition I. P. 2007 Dr. Nityanand, Chairman

- Addendum/ Supplement 2008

• 6th edition I. P. 2010

- Addendum/ Supplement 2012

• 7th edition I. P. 2014 with DVD

- Addendum/ Supplement 2015

- Addendum/ Supplement 2016

• 8th edition I. P. 2018 with DVD

- Addendum/ Supplement 2019

- Addendum/ Supplement 2021

NATIONAL FORMULARY OF INDIA:

_The authoritative guide to prescribing, dispensing and administering medicines for all healthcare professionals.

-Information about drug interaction, resistance, cumulative effects, drug dependence, prescription writing etc

The National Formulary of India editions:

• 1960 – The first edition of NFI National Formulary of India

• 1966 – The Second edition of NFI National Formulary of India

• 1979 – The Third edition of NFI National Formulary of India

• 2011 – The Fourth edition of NFI National Formulary of India

• 2016 – The Fifth Edition of NFI National Formulary of India

• 2021 – The Sixth Edition of NFI National Formulary of India

The British Pharmacopoeia (B.P.)

• It was first published in 1864

• The new edition of British Pharmacopoeia is published at intervals of five years i.e. 1948, 1953, 1958, 1963, 1968, 1973

• After 1973 the new edition was published in 1980 and then in 1988,

1993, 1998, 2003, 2008

• After 2008 the new edition was published every year

• The addendums are also published from time to time in between two main editions

• The BP contains monographs, which set out the mandatory standards for active substances, excepients and formulated preparations, together with General Notices, Appendices (test methods, reagents, etc ) and Reference Spectra

British Pharmaceutical Codex

• The Council of Pharmaceutical Society of Great Britain decided to prepare a reference book for the use of medical practitioners and dispensing pharmacists in 1903

• The first edition of British Pharmaceutical Codex was published in 1907

• The subsequent revisions of this codex were published in 1911, 1923, 1934, 1949, 1954, 1959, 1963, 1968, and 1973

• The publication is still produced but since the Ninth edition, it is now called the Pharmaceutical Codex: Principles and Practice of Pharmaceutics

• The 12th edition was published in 1994

• The latest edition is also available

United State Pharmacopoeia- National Formulary

• An official public standards–setting authority for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States

• Standards for food ingredients and dietary supplements

• Originally published in 1820 under the authority of the United States Pharmacopoeial Convention

• The National Formulary was published in 1888 under the guidance of American Pharmaceutical Association

• In 1974 the National Formulary 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)

• The USP–NF is a three volume combination of two official compendia, the United States Pharmacopoeia (USP) and the National Formulary (NF)

• Monographs for drug substances and preparations are featured in the USP

• Monographs for dietary supplements and ingredients appear in a separate section of the USP

• Excepients of monographs are in the NF

EXTRA PHARMACOPOEIA (MARTINDALE)

• The Extra Pharmacopoeia was first produced in 1883 by William Martindale and is still known as ‘Martindale’ Published by The Royal Pharmaceutical Society of Great Britain

• The term “Extra” means in this instance “Outside”, because the book aimed to describe drugs that were outside the British Pharmacopoeia.

THE MERCK INDEX

• It is an encyclopedia of chemicals, drugs and biological

• The first edition was published in 1889 and the eleventh edition was published in 1989 by Merck & Co., Inc. Rahway, New Jersy, USA

• The Merck Index is the definitive reference work for scientists and professionals looking for authoritative information on chemicals, drugs and biological

Indian Pharmacopoeia Commission (IPC)

INDIAN PHARMACOPOEIA MONOGRAPH DEVELOPMENT

Indian Pharmacopoeia Commission (IPC):

• Formed in 1945 and

• 09th Dec. 2004: Autonomous institution of the Ministry of Health and Family Welfare, Government of India.

Location of IPC

• The Office of the Commission is located at the Central Indian Pharmacopoeia Laboratory Campus, Sector-23, Rajnagar, Ghaziabad-201 002, India

• It is an ultra-modern premise having state-of-the art infrastructure and excellent facilities

• www.ipc.gov.in

Mission:

• promote public health

• Standards for quality of drugs used by health professionals, patients and consumers

Role of IPC

1. To publish new edition and supplements of the Indian Pharmacopoeia

2. To accelerate the process of preparation, certification and distribution of IP Reference Substances

3. To establish working relations with other Pharmacopeial Bodies

Contents of the Pharmacopoeia

The technical part of the pharmacopoeia shall be broadly divided into the following sections:

• Introduction

• General Notices

• Monographs

• Test methods

• Reagents and Solutions

• General Texts

• Index

1. Introduction

• Written by IPC

• Background to the edition

• Salient features of the IP

• Deletions from previous edition

2. General Notices

• Basic guidelines to the interpretation

• Application of the standards, tests, assays and other specifications of the pharmacopoeia

3. Formats and Contents of Monographs:

IP Monograph:

• All the parameters of quality set out in a monograph are designed to determine the quality of a drug

Contents of Monographs: Include

• Active Pharmaceutical Ingredients (APIs) (Bulk Drug Substances) Chemical Excipients

• Inactive Ingredients other than Chemicals Drugs of Plant Origin

• Dosage Forms

• Vaccines, Immunosera and Products of Plant Origin

• General Monographs on Dosage Forms

A: Active Pharmaceutical Ingredients (APIs) (Bulk Drug)

• Title of the Monograph: Sodium Aminosalicylate, Sodium PAS

• Formula: Nacl

• Chemical name: Ethionamide is 2-ethylpyridine-4-carbothioamide.

• Carbamazepine is 5H-dibenz(b,f)azepine-5-carboxamide

• Statement of purity: Ethionamide contains not less than 98.5 per cent and not more than 101.0 per cent of C8H10N2S, calculated on the dried basis

• Description:  A white, crystalline powder or colourless, transparent crystals, efflorescent

• Identification: Instrumental, Physical, Chemical

• Solubility:

• Appearance of solution: Method of preparing the test solution to be given

• Other tests: pH, Specific optical rotation, Light-absorbing impurities, Related substances, Arsenic, Heavy metals, Iron, Chlorides, Sulphates, Non-volatile substances, Residual solvents, Microbial contamination, Bacterial endotoxins, Sterility, Pyrogens, Water, Loss on drying

• Assay: Different types of titration

• Storage: Store protected from moisture

• Labeling: Depending upon the physical, chemical property and dosage forms

B. Inactive Ingredients other than Chemicals: Drugs of Plant Origin

• Title of the Monograph

• Description, Identification and other tests, including Assay

• Relative density

• Weight per ml

• Refractive index

• Melting point

• Unsaponi-fiable matter

• Acetyl value, Hydroxyl value, Saponi-fication value,Iodine value

• Acidity

• Freezing point

• Viscosity

• Peroxide value, Acid value, Ester

• Foreign matter, Total ash, Ash insoluble in hydrochloric acid

• Storage

• Labelling

C. Dosage Forms

• Title of the Monograph

• Definition, Description

• Related substances

• Impurities

• Specific tests

• Disintegration Example Dissolution

• Assay

• Labelling

• Storage

D. Vaccines, Immunosera and Products of Plant Origin

• The texts of the monographs

• Production

• Identification

• Tests

E. General Monographs on Dosage Forms

The dosage forms for which General Monographs may be written are as follows:

• Capsules

• Ear preparations

• Eye preparations

• Granules

• Liquids for oral use

• Nasal Preparations

• Parenteral preparations

• Oral powders

• Preparations for inhalation

• Creams and Ointments

• Rectal and vaginal preparations

• Tablets

The General Monographs shall be generally in three sections:

1. General description or definition of the dosage form and its different types

2. Specific aspects of production that impact on the quality of the product

3. Tests to be done in addition to the ones set out in the individual monographs

4. Test Methods

Test Methods shall be broadly divided into the following sections:

a. Apparatus

b. Physical and physicochemical methods

c. Identification tests

d. Limit tests

e. Chemical assays

f. Biological tests

g. Pharmaceutical tests

5. Reagents and Solutions

• Details of the quality and of preparation of reagents and solutions that are to be used in the tests and assays of the pharmacopoeia

• Include information on Reference Substances that are required for specific tests

6. General Texts

• General information, not specific to any product, but pertaining to aspects of production

• Testing of pharmaceuticals impacting on quality such as sterilisation, the quality of water for pharmaceutical use, containers (including closures) for packing drugs and drug products etc

7. Index

The Index shall be in alphabetical order of:

• The titles of monographs

• Titles and sub-titles of test methods and of general texts  

• Reagents and special solutions mentioned in any of the pages of the Pharmacopoeia except the cover page

Summary:

• Drug Compendia:  Pharmacopoeia and Formularies-Standards of drugs and other related substances

• Pharmacopoeia means “to make a drug”

• Before independence India followed British Pharmacopoeia.

• The first pharmacopoeia was published in1955

• Col. R. N. Chopra, called as father of pharmacology, contributed pharmacopoeial list, first edition of IP and Pharmacy act

• I.P was first published in the year 1955, later on in the following years 1966, 1985, 1996, 2007, 2010, 2014, 2018

• Revision and publication of new I.P is done by IPC

• Contents of pharmacopoeia: Inclusion of new monographs, difference between previous and recent edition, salient features of I.P

• Monograph analysis of compound/ API: Name, synonym, chemical formula, standard, description, solubility, test for purity, limit tests, assay and storage  

• Monograph analysis of plant origin, dosage forms, vaccines and serum, general monograph procedure

• Preparing a known concentration of solutions and reagents

• General information like sterilization process, types of containers to be used for packing

• Index arranged in alphabetical order for monographs, reagents and solutions, various tests