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25
Historical Aspects of Indian Pharmacy
The British Pharmacopoeia (BP)
The British Pharmacopoeia (BP) is an official compendium of
quality standards for medicinal substances and pharmaceutical
products in the United Kingdom. It provides guidelines and
specifications for the identification, quality, and purity of drugs
that are used in healthcare. The BP is published by the British
Pharmacopoeia Commission, which is a part of the Medicines
and Healthcare products Regulatory Agency (MHRA).
The British Pharmacopoeia (BP) has undergone several
editions since its first publication in the 19th century. Here are
some key editions of the BP:
First edition (1864): This was the inaugural edition
of the BP, published by the British Pharmacopoeia
Commission. It laid the foundation for standardizing
the quality and purity of medicinal substances and
pre parations in the United Kingdom.
Subsequent editions: The BP has been regularly revised and
updated, with new editions published approxi mately every
ten years. Here are some notable editions:
Second Edition (1867)
Third Edition (1874)
Fourth Edition (1885)
Fifth Edition (1898)
Sixth Edition (1907)
Seventh Edition (1914)
Eighth Edition (1932)
Ninth Edition (1932)
Tenth Edition (1948)
Eleventh Edition (1953)
Twelfth Edition (1963)
Thirteenth Edition (1973)
Fourteenth Edition (1980)
Fifteenth Edition (1993)
Sixteenth Edition (2013)
Seventeenth Edition (2021)
British Pharmacopoeia (BP) and National Formulary (NF):
From 1948 to 1973, the BP and the National Formulary (NF)
were merged into a single publication known as the British
Introduction to Pharmaceutics
26
Pharmacopoeia and National Formulary (BP-NF). This
combined the standards for drug substances (BP) and practical
prescribing information (NF).
National Formulary of India
The National Formulary of India (NFI) is an official document
that provides standards for the quality and therapeutic use of
medicines in India. It is a reference book that contains a list of
formulations, their ingredients, dosages, and other relevant
information. The NFI is developed and published by the Indian
Pharmacopoeia Commission (IPC), which is responsible for
establishing and maintaining pharmacopoeial standards in the
country.
The primary objective of the NFI is to promote the rational
use of medicines and ensure their quality, safety, and efficacy.
It serves as a guide for healthcare professionals, including
physicians, pharmacists, and other healthcare providers, in
prescribing and dispensing medications. The NFI includes
a wide range of formulations, covering various therapeutic
categories, including but not limited to antibiotics, analgesics,
antidiabetics, cardiovascular drugs, and more.
The NFI provides detailed information about each
formulation, including its composition, dosage forms,
strengths, indications, contraindications, precautions, and side
effects. It also includes guidelines on the appropriate use of
medicines, such as dosage recommendations, administration
routes, and storage conditions. The NFI helps healthcare
professionals make informed decisions in selecting the
right medicines for their patients based on standardized
formulations and recommended dosages.
In year 1960, the first edition was published by Government
of India, Ministry of Health. Union Minister for Health
and Family Welfare, launched the sixth edition of National
Formulary of India (NFI) on October 25, 2021.
British Pharmaceutical Codex (BPC)
The British Pharmaceutical Codex (BPC) was first published
in 1907 as a reference book for medical practitioners and
27
Historical Aspects of Indian Pharmacy
dispensing pharmacists. It was created by the Council of the
Pharmaceutical Society of Great Britain. In 1959, the British
Pharmacopoeia Commission requested the publication of the
Codex to coincide with the British Pharmacopoeia (BP) so that
they would come into effect on the same date.
The BPC has some differences compared to the BP:
It includes a larger number of drugs and preparations. Some
of these may be included in advance of the pharmacopoeia,
while others may have been included in previous editions
of the pharmacopoeia but are now retained in the Codex
because they are still commonly used.
It provides information on the actions and uses of drugs,
their undesirable effects, precautions, and the treatment of
poisoning. This additional information helps healthcare pro-
fessionals understand the drugs better and use them safely.
It contains formulae, methods of preparation, container
and storage conditions for many preparations that are still
extemporaneously prepared in the pharmacy. This infor-
mation is valuable for pharmacists who need to prepare
medications on-site according to specific formulations.
Overall, the BPC complements the British Pharmacopoeia
by offering additional drug information, guidance on drug
actions and uses, and details on extemporaneous preparations
commonly performed in pharmacies.
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 Pharma-
copoeial 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 USPNF is a combination of two compendia, the
United States Pharmacopeia (USP) and the National Formulary
(NF). The current version, USP–NF 2023, Issue 1, was official
on May 1, 2023.
Introduction to Pharmaceutics
28
The Merck Index
It is an encyclopaedia of chemicals, drugs and biologicals.
The first edition was published in 1889 and the 15th and
latest edition was published in year 2013 by Royal Society of
Chemistry.
Some important key features about the Merck Index are:
Chemical and drug information: The Merck Index contains
detailed information about thousands of chemicals, drugs,
and substances. It provides data on their chemical structures,
physical properties, synthesis methods, therapeutic uses,
toxicity, and other relevant information.
Reference for researchers: Researchers often rely on the Merck
Index as a trusted source of information when studying or
working with specific chemicals or drugs. It helps them
understand the properties, characteristics, and potential
applications of these substances.
Drug identification: The Merck Index is valuable for
identifying unknown drugs or substances.
Safety and handling information: The index includes safety
and handling information for various chemicals and drugs.
Pharmaceutical development: The Merck Index is useful in
the pharmaceutical industry for drug development and
formulation.
Educational resource The Merck Index is also used as an edu-
cational resource in academic settings.
Updated editions: The Merck Index is regularly updated to
incorporate new compounds and discoveries.
2
UNIT
Packaging Materials
GENERAL INTRODUCTION
Packaging is the process by which the pharmaceuticals are
suitably packed so that they should retain their therapeutic
effectiveness from the time of their packaging till they are
consumed. Packaging may be defined as the art and science
which involves preparing the articles for transport, storage,
display and use. Different shapes and sizes of containers made
from different materials are used for packing different types of
formulations. Therefore, a careful consideration must be given
for the selection of packaging material. A package may consist
of:
Container: A container may be defined as a device in which
the drug is enclosed and is in direct contact with the drug.
A container which remains in contact with the drug at all
times is known as immediate container.
Closure: A closure is a device which seals the container to
exclude oxygen, carbon dioxide, moisture, micro-organisms
and prevent the loss of volatile substances. It also prevents
the loss of medicament during transport and handling. A
closure is considered as a part of container system. It does
not come in direct contact with the medicament.
Carton: Carton is the outer covering which gives secondary
protection against mechanical and other environmental
hazards. They are made from cardboard, moulded wood
pulp or expanded polystyrene.
Introduction to Pharmaceutics
30
Box: A box is a device which is generally used for packing
multiples of the product. It gives primary protection
against external hazards during transport and handling.
A box is usually made from thick cardboard, wood or any
other suitable material.
CHARACTERISTICS OF CONTAINERS AND CLOSURES
1. The container must be sufficiently strong to withstand
handl ing while empty, when filling, closing, sterilizing,
labelling, transport, storage and use by the consumer.
2. They should not allow any loss of product due to leakage,
spillage or penetration.
3. The material of the container from which they are prepared
must not react with the contents.
4. They must be able to withstand heat if process includes
sterilization by heat.
5. The surface of the container must be clear for easy
labelling.
6. The container must not absorb substances from the
preparation, e.g. absorption of water and oily substances
from ointments and creams by the cardboard boxes.
7. The container must not impart its own colour, taste and
odour to the preparation.
8. The container and closure must not react either with each
other or with the preparation.
9. The container should be able to protect light sensitive
preparations for which amber coloured glass containers
may be used.
10. The size of the container must be selected according to the
size of the preparation.
11. The closure must be easy to remove and replace.
12. The cost of container and closure is an integral part of
overall cost of the preparation, so it should not be high.
13. A container should facilitate the identification of a product,
i.e. whether meant for internal or external use.
14. Apart from all these characteristics a container and closure
should be attractive in appearance and must have sale
pro motional and marketing values.
31
Packaging Materials
TYPES OF CONTAINERS
Classification of Containers According to the
Method of Closure and Use
The containers are of following types:
Well-closed containers: A well-closed container is used to
protect the preparation from contamination by extraneous
solids, to prevent the loss of potency of active cunstituents
and to prevent the loss of contents during transport, storage
and handling.
Air-tight containers: Air-tight containers are used to protect
the containers from atmospheric contamination of liquids,
solids or vapours. They prevent the loss of drugs due to
efflorescence, deliquescence or evaporation.
Hermetically-sealed containers: Hennetically-sealed container
is that which does not allow the air and other gases to pass
through it. Generally these types of containers are used for
injectables. A glass ampoule sealed by fusion is the most
common example of these types of containers.
Light resistant containers: Light resistant containers are used
to protect the drugs which undergo decomposition in the
presence of light. Such drugs may be enclosed in light
resistant amber coloured or opaque containers.
Single dose containers: They are used to supply only one
dose of the medicament. They are sealed in such a way that
the contents cannot be removed without removing the seal,
the contents so removed are consumed immediately, e.g.
ampoules.
Multi-dose containers: A multi-dose container holds a number
of doses. It is sealed in such a way that successive doses can
be withdrawn easily without changing the strength, quality
or purity of the remaining contents, e.g. multidose vials.
Aerosol containers: Containers for aerosols must be strong
enough to withstand the pressure evolved inside the
container at the time of use of the preparation.
Classification of Containers According to their Shapes
Narrow mouth
Wide mouth
Introduction to Pharmaceutics
32
Dropper bottles
Collapsible tubes
Gallipots
Cardboard boxes
Ampoules
Vials
Polythene packets for intravenous fluids.
Polythene bottles for intravenous fluids.
Aerosol containers
Envelops, strips, cartons, boxes, drums, etc.
Liquid oral preparations intended to be swallowed like
mixtures, emulsions, linctuses, syrups, draughts, etc. are
required to be dispensed in narrow mouth bottles made from
glass or polythene.
Liquid preparations, which are not to be swallowed like
gargles, throat paints and mouth washes should be packed in
fluted or ribbed bottles so that from its characteristic feel the
patient may come to know that the preparation is not to be
swallowed.
Liquid preparations like liniments, lotions, paints, etc.
meant for external application to the skin should generally
be supplied in coloured fluted bottles in order to distinguish
them from preparations meant for internal use.
Eye drops, ear drops, nasal drops, etc. should be dispensed
in amber coloured glass bottles fitted with a dropper. Nowadays
manufacturers prefer a plastic squeeze bottle with a plastic cap
to which a dropper device is attached. This type of arrangement
has the advantage that whole of the medicament is not exposed
to atmospheric conditions when in use; the entire medicament
is not contaminated as a few drops are instilled into the cavity
while the dropper is still in its position; the chances of spillage
of liquid from the container are eliminated.
Semisolid preparations like ointments, creams, pastes,
etc. are dispensed in wide mouth containers or gallipots. On
manufacturing scale collapsible tubes made from metal or
plastic are preferred because:
Their narrow opening prevents the contamination of rest of
the contents because the material once removed from the
tube cannot re-enter it.
33
Packaging Materials
Wastage is reduced because patient will remove only the
required amount of medicament.
Nozzle type applicators may be attached to the tube to
facilitate introduction into the body cavities such as nose,
vagina or anus.
Individual powders are dispensed in paperboard or plastic
boxes or paperboard cartons. Bulk powders and granules for
internal use are usually packed in wide mouth screw capped
colourless glass jars but plastic containers and paper lined
aluminium containers may also be used.
Dusting powders and insufflations are dispensed in air
tight, wide mouthed, glass or plastic jars with instructions to
the patient to use the powder with a swab of clean cotton wool
or gauge. Proprietary dusting powders are packed in metal
sifter-top containers.
Solid dosage forms like tablets, lozenges, hard and soft
capsules are generally packed in strips made from cellophan
or tin foil. For bulk packing either amber coloured vials or
bottles are used which are closed with plastic or metal screw
caps that contain a suitable insert. Suppositories and pessaries
prepared by compression may be packed similar to that of
tablets or capsules but suppositories prepared by moulding
are wrapped individually in waxed paper or tin foil which
is then packed in shallow partitioned paperboard boxes.
Nowadays suppositories are prepared in a strip of· disposable
plastic moulds.
SELECTION CRITERIA OF PACKAGING MATERIAL
The selection of packaging material for pharmaceutical
products is crucial to ensure the integrity, safety, and efficacy
of the pre parations. Here are the characteristics that the
packaging materials should possess:
Environmental protection: The packaging material should
provide protection against environmental factors such as
moisture, light, oxygen, and temperature.
Non-reactivity: The packaging material should be non-
reactive with the pharmaceutical product to avoid any
chemical interactions or degradation of the formulation.
Introduction to Pharmaceutics
34
Taste and odor barrier: The packaging material should not
impart any taste or odor to the product, as it can affect the
sensory attributes and acceptability of the medication.
Non-toxicity: The packaging material should be non-toxic
and should not leach harmful substances into the product.
Regulatory approval: The packaging material should be
approved by regulatory authorities such as the FDA (Food
and Drug Administration) or other relevant agencies.
Tamper resistance: The packaging material should meet
applicable tamper-resistance requirements to prevent
unauthorized access or tampering with the product.
Compatibility with packaging equipment: The packaging
material should be compatible with commonly used high-
speed packaging equipment
Cost-effectiveness: The packaging material should have a
reasonable cost in relation to the overall cost of the product.
By considering these characteristics, pharmaceutical
manu facturers can select appropriate packaging materials
that ensure product integrity, safety, and patient satisfaction.
It is important to conduct compatibility studies and perform
appropriate testing to validate the suitability of the selected
packaging materials for specific pharmaceutical products.
Materials used for the Construction of Containers
The following materials are used for the construction of
containers. They are used either singly or sometimes in
combination with each other.
Glass
Plastics
Metals
Paper.
A. Glass
Glass is mostly produced by heating a mixture of silica
(SiO
2
), soda ash (Na
2
CO
3
) and lime stone (CaCO
3
) in a
furnace at about l400°C. The fused mass on rapid cooling
forms glass which is soft in nature and is used for making
bottles, light bulbs, etc. But if potassium carbonate is used