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IPS Academy College of Pharmacy, Indore (M.P.)
PHARMACEUTICS- I
UNIT-1
HISTORICAL BACKGROUND OF PHARMACY
DOSAGE FORM,PRESCRIPTION,POSOLOGY
By: POOJA TIWARI
ASSISTANT PROFESSOR
1
PHARMACY
2
HISTORICAL BACKGROUND OF
PHARMACY
3
INTRODUCTION
4
•The word pharmacy is derived from Greek word
pharmakon meaning medicine or drug. Galen is the
father of Pharmacy.. Prof. William Procter is the father
of American Pharmacy .
•Pharmacy is the art and science of preparing and
dispensing drugs and medicines.
•It is a health profession.
•A shop or hospital dispensary where medicinal drugs
are prepared or sold.
5
Galen
Prof. William Procter
INTRODUCTION
• Pharmacy as a profession and as a health care
discipline has gone through phenomenal changes and
development during the last few decades, at global as
well as regional levels.
• In the past, Pharmacists were known by names like
alchemists, apothecaries and compounders.
• Modern pharmacists are professionally qualified,
scientifically trained and technically competent health
care professionals knowing the secrets and facts of
drugs and medicines.
6
Pharmaceutics
Pharmaceutics is a branch of pharmacy which
includes the study of, formulation of drug in to a
dosage form. It is a systematic approach to get an
effective and stable formulation without disturbing its
quality. It is deal with technology involve in large
scale manufacturing.
Mahadeva Lal Schroff is considered as the father of
Pharmaceutics
7
HISTORY
Five Historical Periods
• Ancient Era: The beginning of time to 1600 AD
• Empiric Era: 1600 to 1940
• Industrialization Era: 1940 to 1970
• Patient Care Era: 1970 to present
• Biotechnology and genetic engineering: The new horizon
8
The Ancient Era
• Leaves, mud, and cool water were used to stop
bleeding and heal wounds
• Early man learned from watching injured animals’
behaviors
• Knowledge of materials with healing properties was
passed down through the tribes
• Medical information was documented on clay tablets
around 2600 BC
9
The Beginnings of Pharmacy
• The Ebers Papyrus, written around 1500 BC,
contained formulas for more than 800 remedies for
700 drugs.
• Herbs were the predominant form of curatives
10
The Greeks
• Hippocrates, the “father of medicine,” liberated
medicine from the belief that disease was caused by
spiritual reasons
• Theophrastus, the “father of botany,” classified plants
by their various parts
Mithridates studied the adverse effects of plants and
later became known as the “father of toxicology
11
The Romans
• The Romans organized medical and pharmaceutical
knowledge and converted theories into scientific rules
• The Romans, as well as the Greeks, were responsible
for preparing their own prescriptions
• The Romans initiated the first job titles of various
pharmacy-related personnel
12
Other Pioneers
• Dioscorides began the transition of the Greek system
of knowledge into the Roman system of science; he
is known as the “father of pharmacology”
• Galen, a Greek physician, wrote “On the Art of
Healing,” and was very critical of physicians who did
not prepare their own remedies
• Cosmos and Damien, the patron saints of pharmacy
and medicine, practiced both disciplines around 300
AD
13
Roman Pharmacy Titles
• Pharmacopeia — makers of remedies
• Pharmacotritae — drug grinders
• Unguentarii — makers of ointments
• Pigmentarii –— makers of cosmetics
• Pharmacopolae — sellers of drugs
• Aromatarii — dealers in spices
14
The Arabian Influence
• Formularies — continuation of documentation of
drug information
• Dosage forms — syrups
• Pharmacy shops — first appeared in Baghdad around
762 AD, and were privately owned
• Hospital pharmacies followed in Marrakech around
1190 AD
15
The Italian Influence
• Europe’s first university was established in Salerno,
and was responsible for major contributions to
pharmacy and medicine
• The Magna Carta of Pharmacy, separating pharmacy
from medicine, was issued by Emperor Frederick II
• Guilds of pharmacists were established
16
New Ideas
• A Swiss physician, Paracelsus, contradicted the
Galenic theories of botanical orientation to medicine
with his own theories based on chemicals
• Monasteries became host to their own pharmacies
• Germany became the first to governmentally regulate
its pharmacies
17
The Influence of Royalty
• Pharmacists who worked for royal families provided
specialized services, and were known as apothecaries
• New medicinal herbal substances, plants, trees, and
seeds began to be used
• Better documentation of this new knowledge began to
occur
18
The Renaissance
(Cultural rebirth that occurred in Europe)
• Pharmacy became separated from medicine
• Pharmacy regulation began
• University education of pharmacists was now
required
• Larger quantities of known and new drugs were
imported from the New World and the Orient
• New chemical medicines were introduced
19
The Empiric Era
• Pharmacopeias became the regulatory tools of
government, with standardized medicines listed
• Existing medications were questioned and tested as to
their actual effectiveness
• In the 18th century, pharmacy began to develop in the
colonies of the New World
• In 1751, Benjamin Franklin started the first hospital
in America .The first hospital pharmacist was
Jonathan Roberts
• William Proctor introduced control into the practice
of pharmacy in the New World
20
19TH CENTURY
• In 19th century, pharmacy began a transformation
from an art to a science.
• Scientists began exploring the structure of drugs,
linking it to the activity of compounds, and they
began to synthesis compounds with similar structures.
• The mass production of drug products had started in
industry.
• New standards and new knowledge meant new
opportunities for precision in prescribing
compounding and dosing
21
Drugs Discovered in the
19th Century
• Quinine
• Caffeine
• Morphine
• Codeine
• Niacin
• Adrenalin
• Penicillin
• Phenobarbital
• Testosterone
22
The Patient Care Era
• Increased concentration on rational, targeted research
through the use of computers
• Increased number of available medicines
• Well-coordinated teams of scientists with other
professions such as statisticians and financial
managers
• Multiple drug therapy, however, led to adverse
reactions, interactions, and therapeutic outcomes that
were greater or less than desired
23
The New Horizon
• Research into gene therapy and genetic defects has
greatly increased
• Recombinant DNA technology is producing new
medications based on the patient’s genetic make-up
• Some medications that come from natural sources,
such as insulin, are prone to producing allergies
• Genetic research is involved in the pursuit of cures
for major diseases, such as cancer
24
20TH CENTURY
• The 20th century will be forever remembered for its
remarkable advances in chemistry, medicine and
pharmacy.
• Countless new drugs were discovered and
manufacturers were literally at war to stay ahead with
new patents
25
EDUCATION
• Independent pharmacies were first established in Italy
and then countries like France and Germany.
• Pharmacy education at College/ University level
started in 1777 in France.
• Later in 1803 six schools of pharmacy were started in
France.
• Private pharmacy educational institutions arose in
Bavaria, the south east state in Germany in 1808.
• It was in 1821 the first American Pharmacy College –
Philadelphia College of Pharmacy admitted the first
batch of pharmacy students which was followed by
New York College of Pharmacy (1829). 26
Industry and Organization
It is a well-known fact that because of the British rule,
Pharmaceutical industry could not be develop
significantly in India. After independence, the
Government declared its industrial policy in the year
1950. The Government gave importance to the
development of the pharmaceutical industry During
1950, there were 65 domestic pharmaceutical units in
India,while foreign units were 28 in number. In 1952,
about 1,643 licenses were issued under the Drug Act.
In 1989, the number had increased to 12,000. Of these
27
continued..
only 1,554 were manufacturing units.In the year
2003-04, it had increased to over 24,000 units.In
1952, total investment in the pharmaceutical industry
was only Rs.24 crores which increased to Rs. 1,175
corers in 1984-85. Now, in 2004-05, it has reached
over Rs 15,000 crores. Due to development of the
pharmaceutical industry, the average life expectancy
of Indian increased from 32 years to 60 years. In fact,
India has also made adequate research in this field.
However, the multinationals have already entered the
Indian market. These companies are competing with
the Indian pharmaceutical companies.
28
continued..
In fact, India has also made adequate research in this
field. However,the multinationals have already entered
the Indian market. These companies are competing
with the Indian pharmaceutical companies. To give a
planned direction to all industries, the Republic of
India passed a bill known as the‘Industrial
Development Regulation Act’ in1951.
The Pharmaceutical industry is divided into two parts –
1.Bulk Drugs [fermentation, synthetic and plant
products]
29
continued..
2.Formulations- The whole pharmaceutical
manufacturing industry is divided into three
categories. Small scale, Medium scale, and Large
scale depending upon the amount of the investment.
Investments in the pharma industry were Rs.5,796
crores in the year 1994-95. The large-scale companies
are required to obtain industrial license from the
Director General of Technical Department.Presently,
the multinational companies operating in India are
keeping 40% of the shares with them and the rest
with the public.
30
continued..
All the pharmaceutical companies are governed by
the Drugs and Cosmetic Act, 1940 and the Rules of
1945 for the purpose of manufacturing, storage,
marketing, quality control, etc. Before starting the
manufacturing and marketing of the pharmaceutical
products, an industry is compelled to obtain license
from the Food and Drug Department. The food and
drug department is located in every part of the
country. In every state, there is a Commissioner or a
Director appointed by the Government.
31
continued..
Their major task is to enforce the existing rules and
regulations as well as the Bills passed by the
Parliament and the State Assemblies, from time to
time. In ancient days, medicinal and mineral herbs
were in practice,systematic drugs production took
place only by the 20th century.The modern
pharmaceutical industry came into existence in the
20th century with the invention of many active
medicinal compounds that could be efficiently
manufactured on a large scale.
32
continued..
In the process of research, new inventions have
replaced the old time herbal medicines. Since the
invention of Aspirin in 1899, the Indian
Pharmaceutical Industry has done remarkable
research work on life saving drugs.
33
CONCLUSION
• The face of pharmacy may have changed over the
past 1000 years, but its traditional role remains the
same.
• Although the preparation and preservation of drug
products have moved from pharmacy to the
pharmaceutical industry, the pharmacist continues to
fulfill the prescriber's intentions, by not only
dispensing a medication but also by providing a
quality product, providing advice and information,
and monitoring drug therapy.
34
HISTORICAL BACKGROUND OF
PHARMACY SHOWN BY PICTURES.
35
1. Before the Dawn of History
From beginnings as remote and simple as these came the proud profession of
Pharmacy. Its development parallels that of man. Ancient man learned from instinct,
from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first
soothing application. By trial, he learned which served him best. Eventually, he
applied his knowledge for the benefit of others..
36
2. Pharmacy in Ancient China
Chinese Pharmacy, investigated the medicinal value of several hundred herbs and
Medicinal plants .
37
3. Days of the Papyrus Ebers
Though Egyptian medicine dates from about 2900 B.C., best known and most
important pharmaceutical record is the "Papyrus Ebers" (1500 B.C.), a collection of
800 prescriptions, mentioning 700 drugs.
38
4. Theophrastus–FatherofBotany
Theophrastus (about 300 B.C.), among the greatest early Greek philosophers and
natural scientists, is called the "father of botany.". He lectured to groups of
students.
39
5. Galen Experimenter in Drug Compounding
He was the originator of the formula for a cold cream, essentially similar to
that known today. Many procedures Galen originated have their counterparts
in today's modern compounding laboratories.
40
06. The First Apothecary Shops
The Arabs separated the arts of apothecary and physician, establishing in Bagdad late
in the eighth century the first privately owned drug stores.
41
07. Separation of Pharmacy
In the 17th century Emperor of Germany at his palace in Palermo, he presented
subject Pharmacists with the first European edict completely separating their
responsibilities from those of Medicine, and prescribing regulations for their
professional practice.
42
08. The First Official Pharmacopeia
The idea of a pharmacopoeia with official status, to be followed by all apothecaries,
originally written in Italian, was published and became the legal standard for the
city-state in 1498.
43
09. American Pharmacy Builds its Foundations
The Philadelphia College of Pharmacy; a school of pharmacy; first pharmaceutical
association in the United States; American Pharmacy's first educational institution.
44
10. The Pharmacopeia Comes of Age
The first "United States Pharmacopoeia" (1820) was the work of the medical
profession. It was the first book of drug standards .
45
11. The Standardization of Pharmaceuticals
Despite the professional skill and integrity of 19th-century pharmacists.
46
12. Pharmaceutical Manufacturing Comes of Age
Pharmaceutical manufacturing as an industry apart from retail Pharmacy had its
beginnings about 1600; really got under way in the middle 1700's. It developed
first in Germany, then in England and in France.
47
13. Pharmacy Today and Tomorrow
Pharmacy, great professions. Like Medicine, it has come through many revolutions,
has learned many things, has had to discard many of its older ways. Pharmacists are
among the community's finest educated people. When today's retail pharmacist fills
a prescription written by a physician, he provides a professional service
incorporating the benefits of the work of pharmacists in all branches of the
profession - education, research, development, standards, production, and
distribution. Pharmacy's professional will continue to grow in the future.
48
Pharmacy as a career
49
50
PHARMACY
Science of Medicines
Manufacuring, Distribution
of Medicines for Mankind
Treatment and Prevention of
Diseases
51
Injections
Capsule
Tablet
52
COSMETICS
OTC
(Over The
Counter)
53
Pillars of Pharmaceutical Sciences:
 Pharmaceutical Chemistry
 Pharmaceutics
 Pharmacology
 Pharmacognosy
 Pharmaceutical Analysis
54
Opportunity Horizons
JOB
(B.Pharm/M.Pharm)
•Government
Organizations
•Pharma Industries
•Hospital Pharmacists
•Research Institutes
•Food & Cosmetic
Industries
•Clinical Pharmacy
•Clinical research org.
•Community Pharmacy
•Pharma Marketing
•Academic jobs
(Teaching)
BUSINESS
(B.Pharm)
• Own Industry
• Own Distribution
Agency or Pharmacy
Shop
55
INDUSTRIAL PHARMACY
56
Pharma Industry
R & D Production Marketing
Formulation Tablet Sales Promotion
Quality Assurance Capsule Sales executive
Quality Control Injections Product development
Bioanalytical Manager
Biotechnology
Pharmacology
Drug Discovery
Technology Transfer
57
Key role as community pharmacist
Evaluates a patient's drug-related needs
● Determine whether the patient has any actual or potential
drug related problems.
● Works with the patient and other healthcare professionals
to design, implement and monitor a therapeutic plan that
will resolve/prevent the problem.
58
PHARMACIST IN GOVERNMENT SERVICE
Pharmacist in Army, Navy, Air force & Govt.
Hospitals
Drug Inspectors –Govt of INDIA and State level
Scientists- Food and Drugs
Govt.University Proffesors and HODs
Opportunity to be Selected in UPSC and State
Public Service Commissions.
Government Analysts and Forensic Scientists
Research on tropical diseases, Public health
 Govt.Certified Pharmacologist &Toxicologist
PHARMACIST IN GOVERNMENT SERVICE
59
 Govt. Approved Chemist
 Consultants ( Mental health,Addiction, family
planning, poisons, self-medication, immunization
PHARMACOPOEIA
60
Pharmacopoeia
• Derived from Greek word ‘Pharmakon’ means drug
and ‘Poiea’ means to make.
• 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.
61
Indian Pharmacopoeia
• It is written in English & official titles of monographs given in
Latin.
• Indian Pharmacopeia committee under chairmanship of Dr. B. N.
Ghosh Published first edition of IP in 1955.
• It covers 986 monographs
• Second edition of IP was published in 1966 under the
chairmanship of Dr. B. Mukkerji.
• Official titles of monographs given in English.
• Dose were expressed in Metric system.
• For Tablets and Injections “USUAL STRENGTH” have been
given.
• Formulations of the drugs were given immediately after the
monograph of drugs.
62
Continued…
63
•93 new monographs were added.
•Supplement to this edition was published in 1975.
•126 new monographs have been included & 250 monographs
have been amended.
•Third edition of IP was published in 1985 with two volumes
•261 new monographs have been added.
•450 monographs were deleted.
• Addendum I to IP was published in 1989 were 46 new
monographs added and 126 amended.
• Addendum II was published in 1991 were 62 new monographs
added and 110 amended
Continued…
64
•Fourth edition of IP was published in 1996 under the
chairmanship of Dr. Nityanand.
•It has been made effective from 1st December 1996.
• It covered 1149 monographs and 123 appendices.
• It includes 294 new monographs & 110 monographs have
been deleted.
•Addendum I has been made effective from 31st December 2000
were 42 new monographs have been added.
• Addendum II has been made effective from 30th June 2003
were 19 new monographs have been added.
•The veterinary supplement to IP 1996 contains 208 monographs
Continued…
65
•Fifth edition of IP was published in 2007 & addendum to this
edition was published in 2008.
•IP 2007 is presented in Three Volumes.
•Volume One contains general notices & general chapters.
• Volume Two & Three contains general monographs on drug
substances , dosage forms & Pharmaceutical aids.
• 6th edition of IP is published in 2010.
• The 6th edition of the Indian Pharmacopoeia 2010 is published by
the Indian Pharmacopoeia Commission (IPC) Ghaziabad
Continued…
66
•This edition would be effective from 1st September, 2010.
• The Indian Pharmacopoeia 2010 is presented in three volumes
•Volume I contains the Notices, Preface, the Structure of the
•IPC, Acknowledgements, Introduction, and the General Chapters.
•Volume II contains the General Notice, General Monographs
on Dosage Forms and Monographs on drug substances, dosage
forms and pharmaceutical aids (A to M).
•Volume III contains Monographs on drug substances,dosage
forms and pharmaceutical aids (N to Z). Followed by Monographs
on Vaccines and Immunosera for Human use, Herbs and Herbal
products, Blood and blood related products, Biotechnology
products and Veterinary products.
67
•The scope of the Pharmacopoeia has been extended to include
products of biotechnology, indigenous herbs and herbal products,
veterinary vaccines and additional antiretroviral drugs and
formulations, inclusive of commonly used fixed-dose
combinations. Standards for new drugs and drugs used under
National Health Programmes are added and the drugs as well as
their formulations not in use now a day are omitted from this
edition.
•The number of monographs of Excipients, Anticancer drugs,
Herbal products and antiretroviral drugs has been increased in
this edition.
Continued…
Continued…
68
•Monographs of Vaccines and Immunosera are also upgraded in
view of development of latest technology in the field.
•A new chapter on Liposomal products and a monograph of
Liposomal Amphotericin B injection is an added advantage in
view of latest technology adopted for drug delivery.
• A chapter on NMR is incorporated in Appendices.
•The chapter on microbial contamination is also updated to a
great extent to harmonise with prevailing international
requirements.
Continued…
69
•The seventh edition of the Indian Pharmacopoeia (IP 2014) is
published by the Indian Pharmacopoeia Commission (IPC) on
behalf of the Government of India, Ministry of Health & Family
Welfare.
• The Indian Pharmacopoeia 2014 is presented in four volumes.
The scope of the Pharmacopoeia has been extended to include
additional anticancer drugs & antiretroviral drugs and
formulations, products of biotechnology, indigenous herbs and
herbal products, veterinary vaccines.
• The IP 2014 incorporates 2550 monographs of drugs out of
which 577 are new monographs consisting of APIs, excipients,
dosage forms and herbal products etc.
Continued…
70
• list of 577 New Monographs not included in IP-2010 and its
Addendum-2012 but added in this edition containing 313 New
Monographs on drug substances, Dosage forms & Pharmaceutical
aids (A to Z), 43 New Drugs Substances Monographs, 10
Antibiotic Monographs, 31 Herbal Monographs, 05 Vaccines &
immunosera for human use, 06 Insulin Products, 07
Biotechnology Products etc. along with the 19 new General
Chapters.
• 19 New Radiopharmaceutical Monographs & 1 General chapter
is first time being included in this edition.
• This edition of Indian Pharmacopoeia-2014 is now under
printing and will be available to stakeholders probably in
Sept.2013, before three months of its effective date, i.e. 1st Jan.
2014.
IP 2018
71
The Eighth edition of Indian Pharmacopoeia (IP- 2018) is
published by the Indian Pharmacopoeia Commission (IPC) on
behalf of the Ministry of Health & Family Welfare, Government
of India.
Indian Pharmacopoeia 2018 Salient Features:
Incorporating with 4 volume
New Monographs : 220
170 New Chemical Monographs
49 API
64 Formulations
53 Fixed Dose Formulations
02 Excipients
02 Antibiotic
Continued..
72
15 New Herbs and Herbal Products Monographs
03 New Radiopharmaceutical Monographs
14 New Veterinary Non-Biological Monographs
18 New Biological Monographs :
02 Vaccines & Immunosera for Human Use
06 Biotechnology Derived Therapeutic Products
10 Blood and Blood Related Products
Continued..
73
Standards for New Drugs, Drugs under National Health
Programme & Drugs in National List of Essential Medicines have
been included.
For ease of access and to make Pharmacopoeia more user friendly
index has been incorporated in Volume 1 along with that already
existing in Volume IV of IP
Indian Pharmacopoeia
74
British Pharmacopoeia
• First edition of BP was published in 1864.
• It consist of two sections
• Part I:- Materia Medica & Part II:- Preparation & compounds.
• In this edition titles of drugs & preparations were in English
instead of Latin and metric system. Fourth edition of BP was
published in 1898.
• Fifth edition of BP was published in 1914.
• Eighth edition of BP was published in 1953.
• It has been published annually.
• In BP 2007 monographs has been introduced for material
specifically used in preparation of Traditional Chinese medicines
• BP 2008 contains approximately 3100 monographs for substances,
preparations and articles used in practice
75
British Pharmacopoeia
76
UNITED STATE PHHARMACOPEIA
77
• First edition of United state Pharmacopeia was
published on 15th December 1820 in both Latin &
English.
• From 1820 to 1942 it was published at Ten years
intervals.
• From 1942 to 2000 it was published at Five years
intervals.
• From 2002 it was published annually. First National
Formulary of the united state appeared in 1888.
UNITED STATE PHHARMACOPEIA
78
•USP21-NF16 have eight supplements.
•First appeared in January 1985 & last in November
1988.
•USP22-NF17, 1990 is the third revision that
consolidates USP & NF into a single volume.
• Electronic version of USP-NF on floppy disks was
introduced in 1992.
•USP23-NF18, was published in Mumbai as an Asian
edition at the end of 1994.
UNITED STATE PHHARMACOPEIA
79
•USP23 has ten supplements.
• First supplement was published in January 1995 & Last
in May 1999.
•USP24-NF19, appeared from first January 2000.
• USP30-NF25, appeared from May 2007.
• It contains Scientific standards for drugs, dietary
substances, biological products & Excipients used in
dosage forms.
•It contains 4,100 monographs and 200 general chapters.
• It has been printed in three volume set.
UNITED STATE PHHARMACOPEIA
80
• Volume I contains general chapters & Volume II & III
contains monographs.
•First supplement to USP30-NF25, appeared from
August 2007 & second supplement from November
2007 which will be considered official from May 2008.
•From 2006, Spanish edition of USP is also being
published.
•Current edition of USP 2014 is in process.
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
• 9th edition: published June 2017
81
European Pharmacopeia
82
DOSAGE FORM
83
Dosage form
• Dosage form. The administration form of the
completed pharmaceutical product : e.g., tablet,
capsule or solution
84
Internal
•Suppositories
•pessaries
1.Unit solid:-
•tablets
•capsules
2.Bulk dosage form:-
•powder
•Dusting powder
1.Monophasic liquid:-
2.Biphasic liquid:-
•emulsion
•suspension
External
Ointment
•Cream
•Paste
•jellies
85
86
87
continued..
88
Tablets:-
They are unit solid dosage forms
consisting of active ingredient and suitable
pharmaceutical excipients.
They may vary in size, shape, weight,
hardness, thickness, disintegration and
dissolution characteristics, and in other
aspects.
Capsules:-
• They are unit solid
dosage forms consisting
gelatin shell that breaks
open after the capsule
has been swallowed and
releasing the drug.
• Types-
• hard-shell gelatin capsule
• soft-shell gelatin capsule
89
continued..
1 . soft gelatin shell manufactured
in one piece with drug usually in
liquid form inside the shell, e.g.
fat-soluble vitamins A and E
2. hard shell manufactured in two
pieces that fit together and hold the
drug, either in powdered or
granular form.
90
continued..
Powder:-
• They are bulk solid
dosage forms consisting
two or more medicament
meant for internal or
external use.
• Size of the powder
determine the
effectiveness of
physiological properties.
91
92
Granules :The bitter, nauseous and
unpleasant powders cannot be given in the tablet form or
in a capsule because a large number of them are required
to be taken as a single dose.
Examples
Proergy - protein granules
Promer plus - vitamins granules
Promiz - mineral and hematinic granules
93
continued..
• Semisolids contain both liquids and solids .They are meant
for topical application.
1.External application:
• Creams: -
• Creams are viscous semi-solid emulsions, that is used for
external application that is mixtures of oil and water.
• They usually contain a water soluble base due to which they
can be easily removed.
• They are divided into two types-
• 1.O/W TYPE
• 2.W/O TYPE
94
95
Ointment : is a topical medication applied on the body
surfaces. In medical terms, an ointment is defines as a
homogeneous, viscous, semi-solid preparation with a high
viscosity, that is used for external application. An
ointment has medicated ingredients which serve a
protective, therapeutic, or prophylactic purpose when
applied on the skin or mucous membranes .
Pastes :a soft plastic mixture or composition; especially
an external medicament that has a stiffer consistency than
an ointment and is less greasy because of its higher
percentage of powdered ingredients.
96
Jellies: are transparent or translucent, non greasy, semi
solid preparations mainly used for the external
application to the skin.eg. Ephedrine sulphate jelly
Internal application
suppository: is a drug delivery system that is inserted
into the rectum (rectal suppository), vagina (vaginal
suppository) or urethra (urethral suppository), were it
97
dissolves or melts and is absorbed into the blood stream.
They are used to deliver both systemically and locally
acting medications.
Examples
Dulcolax - Bisacodyl suppositories
98
Monophasic liquid dosage form
99
•Monophasic dosage form refers to liquid preparation
containing two or more components in one phase
system, it is represent by true solution.
•A true solution is a clear homogenous mixture that is
prepared by dissolving solute in a suitable solvent
•The component of the solution which is present in a
large quantity is known as “SOLVENT” where as the
component present in small quantity is termed as
“SOLUTE”.
Liquids meant for internal
administrations
100
Syrup : Aqueous preparations of 60% to 85% sucrose
with or without flavoring agents and medicinal
substances. e.g. Chlorpheniramine maleate syrup, Chloral
hydrate .
•Elixirs : Clear, aromatic, sweetened hydro alcoholic
solutions with or without medicinal substances, intended
for oral use. Eg: Dexamethasone elixir .
•Linctuses : Viscous, liquid and oral preparations that are
generally prescribed for the relief of cough. Eg: Codeine
Linctus.(expactorant )
Liquids used in the mouth
101
Gargles :Aqueous solutions containing antiseptics or
antibiotics used to treat throat infections. Available in
concentrated form with direction for dilution with warm
water before use. eg: Povidone Iodine gargle.
• Mouthwash: Aqueous solution with a pleasant taste and
odor used to clean and deodorize the buccal cavity. Have
antiseptic and astringent activity.eg: Antiseptics-phenol
derivatives.
• Throat paints : Viscous liquid preparation used for
mouth and throat infections. Eg: Phenol glycerine,
Compound Iodine
Liquids instill into body cavity
102
•Eye drops: Sterile, aqueous/oily solutions intended for
instillation in eye. Eg: Timolol maleate eye drops.
• Nasal drops: Administered through the nose to obtain
local effect. Used during nasal congestion and upper-
respiratory tract problem. Eg: Oxymetazolin Hydrochloride
nasal drops.
• Enemas: Aqueous or oily solution that is introduced into
the rectum and colon via the anus for cleansing, therapeutic
or diagnostic purposes.
Liquid meant for skin
103
•Liniments : Oily liquid preparations, intended for
external application with rubbing action to the affected
area. Use to relief pain and stiffness, such as from
muscles spasm and arthritis.
•Lotions : Topical preparation with a low to medium
viscosity. Use to moisturize dry skin. Eg: Calamine
Lotion, baby lotion
•Paints : Solutions used to sterilize the skin. Eg.
Betadine antiseptic paint, Magenta paint
Biphasic liquid dosage form
104
The liquid which consist of two phases are known
as biphasic liquids e.g. emulsion and suspensions
Prescription
It’s written order, especially by a physician, for the
preparation and administration of a medicine or
other treatment.
105
Doctor
106
Pharmacy
Patient
Parts of prescription
1. Date
2. Name, Age, Sex and Address of the patient.
3. Superscription (Rx)
4. Inscription
5. Subscription
6. Signatura
7. Renewal Instructions
8. Name, Signature & Registration no. of registered
physician
107
Date
It helps the pharmacist to find out the date of prescribing and the date
of prescription for filling. It also helps
-To know when the medicines were last dispensed
-To prevent the misuse of the drug by the patients.
The prescription which prescribes narcotic or other habit forming
drugs must bear the date so as to avoid the misuse of the
prescription.
Name, age, sex and address of the patient
Name, age, sex and address of the patient must be written in the
prescription because it serves to identify the prescription. Age and
sex of the patient especially the children, help the pharmacist to
check the prescribed dose of the medicine.
108
Inscription
This is the main part of the prescription, contains the names and
quantities of the prescribed ingredients
The names of the ingredients are generally written in English but
common abbreviation used can be written both in English and Latin
language. Extreme care should be taken by the pharmacist during
interpreting the abbreviations otherwise can lead to serious errors.
Subscription Subscription provides the direction to the pharmacist for
the preparation of the prescription information and the quantity and
dosage form of the drug to be dispensed.
109
Sugnatura
This consists of the direction to be given to the patient
regarding the administration of the drugs.
The instruction may include
• The quantity to be taken or the amount to be used.
• The frequency and timing of drug administration
• The route of drug administration
• The special instruction such as dilution direction.
110
111
Renewal instruction
The prescriber indicates on every prescription,
whether it may be renewed and if so how many times.
It is particularly important for the prescriptions
containing the narcotic and other habit forming drugs
to prevent its misuse.
Name, signature, address & registration no. of the
prescriber
The prescription must bear the signature of the
prescriber along with the registration number and
address.
Prescription Formatting
• Heading
• Body
• Closing
112
Handling of Prescription
113
• Receiving
• Compounding
• Finishing
• Pricing
• Delivering
Receiving the Prescription
114
Pharmacist should himself receive the Prescription.
It includes:
1.Reading the prescription:-
Prescription should be completely and carefully read
from top to bottom.
2.Checking of prescription:-
Prescription should be checked for any
incompatibility
Compounding
115
The ingredients are compounded By accurate
method.
For weighing electrical machines should be used.
Finishing the prescription
116
It includes
Packaging
Labeling
Rechecking
Filling
Continued…
117
Packaging
After compounding packaging of prescription
should be done.
For packaging following containers are used
1.Round vials
2.Oval bottles
3.Wide mouth bottles
4.Colored bottles
4.Collapsible tubes
5.Paper wrappers
6.Dropper bottles
Continued…
118
Labeling:
The filled container should be suitably labeled.
The label should be affixed on smooth surface of
bottle.
Label information's
Type of prescription
Name, age & sex of patient
Date of dispensing
Storage condition
Name & address of pharmacy
In case of liquid preparation attachauxiliary label
Route of administration
Continued…
119
Rechecking
Each prescription should be rechecked After
labeling container should be thoroughly polished
to remove finger prints
Recording
A variety of prescription files are available
which serve to maintain and preserve original
prescription in numerical order
Pricing of Prescription
120
The prescription should be priced immediately
after receiving it & informed the patient about
it. This should be done before starting the
compounding to avoid any dispute
Delivering the prescription
121
Three types
Store Delivery
Home Delivery
Mail Delivery
Sources of errors in prescription
Following are the sources of errors which arise in
prescription:
1) Abbreviation: Abbreviation presents a problem in
understanding parts of the prescription order. Extreme
care should be taken by a pharmacist in interpreting the
abbreviation. Acromycin-Acro-Acrostatin
2) Name of the Drug: There are certain drugs whose
name look or sound like those of other drugs. Some of the
examples of such drugs are as under:
Examples of Drugs often Confused
Digitoxin- Digoxin
Prednisone -Prednisolone
Continued…
Name of the pharmaceutical products have been
changed on certain occasion due to the possible
confusion with the name of the other products, e.g., the
name of potassium supplement was changed from
Kalyum to Kolyum because of the possible confusion
of the former designation with valium.
3) Strength of the Preparation: The strength of the
preparation should be stated by the prescriber For
example, it will be a wrong decision on the part of a
pharmacist to dispense paracetamol tablet 500 mg
Continued…
when prescription for paracetamol tablet is received with
no specific strength.
4)Dosage Form of the Drug Prescribed: Many
medicines are available in more than one dosage form. For
example, liquid, tablet, capsule and suppository. The
pharmaceutical form of the product should be written on
the prescription in order to avoid ambiguity.
Continued…
5) Dose: Unusually high or low doses should be discussed
with the prescriber. For example, a prescription for
sustained release formulation to be administered after
every four hours should be thoroughly checked because
such dosage forms are usually administered only two or
three times a day.
6) Instructions for the Patient: The quantity of the drug
to be taken, the frequency and timing of administration,
and route of administration should be clearly given in the
prescription so as to avoid any confusion.
Continued…
126
7) Incompatibilities: It is essential to check that there are
no pharmaceutical or therapeutic incompatibilities in a
prescribed preparation and that different medicines
prescribed for the same patient do not interact with each
other to produce any harm to the patient.Certain Antibiotic
should not be given with meals since it is significantly
decrese the absorption of given drug.
POSOLOGY
127
Posology
128
The word posology is derived from the Greek word
posos means how much and logos means science.
So we can define posology as a branch of medical science
which deals with dose or quantity of the drug .
factors affecting posology
• These are many factors are:
• Age
• Body weight
• Gender
• Route of administration
• Time of administration
• Presence of diseases
129
Continued…
• Environmental factors
• Emotional factors
• Accumulation
• Synergism
• Antagonism
• Habituation
130
Continued…
• Addiction
• Idiossyncrasy
• Hypersensitivity
• Tolerance
• Tachyphylaxis
131
Continued…
132
1.AGE: The pharmacokinetics of many drugs changes with
age. So while determining the dose of a drug, the age of an
individual is of great significance. Children and old people
need lesser amount of drug than the normal adult dose,
because they are unable to excrete drugs to that extent as
adults. Children can tolerate relatively larger amounts of
belladonna, digitalis and ethanol whereas, elderly patients
are more sensitive to some Drug effects e.g. hypnotics and
tranquillizers which may produce confusion states in them.
Continued…
133
2.SEX: Women do not always respond to the action of
drugs in the same manner as it is done in men. Morphine
and barbiturates may produce more excitement before
sedation in women. Special care should be taken when
drugs are administered during menstruation, pregnancy
and lactation. The strong purgatives such as aloes should
be avoided during menstruation. Similarly the drugs which
may stimulate the uterine smooth muscle e.g. drastic
purgatives, antimalarial drugs and ergot alkaloids are
contra indicated during pregnancy
Continued…
134
There are certain drugs which on administration t the
mother are capable of crossing the placenta and affecting
the foetus e.g. alcohol, barbiturates, narcotic and non
narcotic analgesics etc. During lactation, the drugs like
antihistamines, morphine and tetracycline which are
excreted in milk should be avoided or given very
cautiously to the mothers who are breast feeding to the
babies.
3.BODY WEIGHT: The average dose is mentioned either
in terms of mg per Kg weight or as a total single dose for
an adult weighing between 50-100 Kg.
Continued…
135
However, the dose expressed in this fashion may not apply
in case of obese patients, children and malnourished
patients. It should be calculated according to Body Weight
4.ROUTE OF ADMINISTRATION: Intravenous doses of
drugs are usually smaller than the oral doses, because the
drugs administered intravenously enter the blood stream
directly. Due to this reason the onset of drug action is quick
with intravenous route and this might enhance the chances
of drug toxicity. The effectiveness controlled by the route of
administration.
Continued…
136
5.TIME OF ADMINISTRATION: The presence of food
in the stomach delays the absorption of drugs. The drugs
are more rapidy absorbed from the empty stomach. So the
amount of drug which is very effective when taken before
a meal may during or after meals. The irritating drugs are
better tolerated if administered after meals e.g. iron,
arsenic and cod-liver oil should always be given after
meals.
6.ENVIRONMENTAL FACTORS: Daylight is stimulant,
enhancing the effect of stimulating drugs and diminishing
the effect of hypnotics.
Continued…
137
Darkness is sedative. Hypnotics are more effective at night.
The amount of barbiturate required to produce sleep during
daytime is much higher than the dose required to produce
sleep at night. Alcohol is better tolerated in cold
environments than in summer.
7.EMOTIONAL FACTORS: The personality and
behaviour of a physician may influence the Effect of drug
especially the drugs which are intended for use in a
psychosomatic disorder. The females are more emotional
than males and requires less dose of certain drugs.
Continued…
138
Inert dosage forms called placebos which resemble the
actual medicament in the physical properties are known
to produce therapeutic benefit in diseases like angina
pectoris and bronchial asthma.
8.PRESENCE OF DISEASE: Drugs like barbiturates and
chlorpromazine may produce unusually prolonged effect
in patients having liver cirrhosis. Streptomycin is
excreted mainly by the kidney may prove toxic if the
kidney of the patient is not working properly. During
fever a patient can tolerate high doses of antipyretics than
a normal person.
Continued…
139
9.ACCUMULATION: The drugs which are slowly
excreted may built up a sufficient high concentration in the
body and produce toxic symptoms if it is repeatedly
administered for a long time e.g. digitalis, emetine and
heavy metals. This occurs due to accumulative effect of the
drug. The cumulative effects are usually produced by slow
excretion, degradation and rapid absorption of drugs.
Sometimes, a cumulative effect is desired in drugs like
phenobarbitone in the treatment of epilepsy.
Continued…
140
10.SYNERGISM:When two or more drugs are used in the
combination form, their action is increased. The
phenomena is called synergism. Synergism is very useful
when desired therapeutic result needed is difficult to
achieve with a single drug e.g. procaine and adrenaline
combination, increases the duration of action of procain.
11.ADDITIVE EFFECT: When the total pharmacological
action of two or more drugs administered together is
equivalent to sum of their individual pharmacological
action, the phenomena is called as an additive effect.
Continued…
141
For example, combination of ephedrine and aminophylline
in the treatment of bronchial asthma.
12.ANTAGONISM: When the action of one drug is
opposed by the other drug on the same physiological system
is known as drug antagonism. The use of antagonistic
responses to drugs is valuable in the treatment of poisoning
e.g. milk of magnesia is given in acid poisoning where
alkaline effect of milk of magnesia neutralize the effect of
acid poisoning. When adrenaline and acetylcholine are
given together they neutralise the effect of each other
Continued…
142
due to antagonism because adrenaline is vasoconstrictor and
acetylcholine is vasodilator.
13.IDIOSYNCRASY: An extraordinary response to a drug
which is different from its characteristic pharmacological
action is called idiosyncrasy. The word idiosyncrasy has
now been replaced by the term drug allergy. For example,
small quantity of aspirin may cause gastric haemorrhage and
a small dose of quinine may produce ringing in the ears.
Some persons are sensitive to penicillin and sulphonamide
because they produce severe toxic symptoms.
Continued…
143
14.TOLERANCE: When an unusually large dose of a drug
is required to elicit an effect ordinarily produced by the
normal therapeutic dose of the drug, the phenomena is
termed as drug tolerance. e.g., smokers can tolerate
nicotine, alcoholic can tolerate large quantity of alcohol.
The drug tolerance is of two types:-
(i) True tolerance, which is produced by oral and parentral
administration of the drug.
(ii) (ii) Pseudo tolerance, which is produced only to the
oral route of administration.
Continued…
144
15.TACHYPHYLAXIS: It has been observed that when
certain drugs are administered repeatedly at short
intervals, the cell receptors get blocked up and
pharmacological response to that particular drug is
decreased. The decreased response cannot be reversed by
increasing the dose. This phenomenon is known as
tachyphylaxis or acute tolerance. For example, ephedrine
when given in repeated doses at short intervals in the
treatment of bronchial asthma may produce very less
response due to tachyphylaxis. Similarly, drugs like
amphetamine, cocaine and nitrates behave in this way.
Continued…
145
16.METABOLIC DISTURBANCES: Changes in water
electrolyte balance and acid base balance, body temperature
and other physiological factor may modify the effects of
drugs. Salicylates reduce body temperature only in case an
individual has rise in body temperature. They have no
antipyretic effect if the body temperature is normal. The
absorption of iron from G.I.T. is maximum if the individual
has an iron deficiency anaemia.
CALCULATIONS OF DOSES
146
The doses are also calculated in proportionate to age,
body weight.
Continued…
147
1.DOSES PROPORTIONATE TO AGE
(i) YOUNG’S FORMULA:
Dose for the child= (Age in years/Age in years+12)x Adult
dose
The formula for calculating the doses for children under 12
years of age.
(ii) DILLING’S FORMULA: Dose for the child= (Age in
years/20)x Adult dose The formula is used for
calculating the doses for children in between 4 to 20
years of age.
Continued…
148
2.DOSES PROPORTIONATE TO BODY WEIGHT:
Clark’s formula is used to calculate the dose for the child
according to body weight.
CLARK’S FORMULA:
Dose for the child= (Child’s weight in Kg/70)x Adult
dose
Continued…
149
3.DOSES PROPORTIONATE TO SURFACE AREA: The
calculation of child dose according to surface area is
satisfactory and appropriate rather than the method based
on age. The method is more complicated than the method
based on age. The method is based on the following
formula:- Percentage of adult dose = (Surface area of
child/Surface area of adult)X 100
The body surface area is calculated from the height and
weight of the child. It is better to depend on a handy
reference book rather than on one’s memory while
prescribing a dose for a child.
Thank you
150

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Pharmaceutics I

  • 1. IPS Academy College of Pharmacy, Indore (M.P.) PHARMACEUTICS- I UNIT-1 HISTORICAL BACKGROUND OF PHARMACY DOSAGE FORM,PRESCRIPTION,POSOLOGY By: POOJA TIWARI ASSISTANT PROFESSOR 1
  • 4. INTRODUCTION 4 •The word pharmacy is derived from Greek word pharmakon meaning medicine or drug. Galen is the father of Pharmacy.. Prof. William Procter is the father of American Pharmacy . •Pharmacy is the art and science of preparing and dispensing drugs and medicines. •It is a health profession. •A shop or hospital dispensary where medicinal drugs are prepared or sold.
  • 6. INTRODUCTION • Pharmacy as a profession and as a health care discipline has gone through phenomenal changes and development during the last few decades, at global as well as regional levels. • In the past, Pharmacists were known by names like alchemists, apothecaries and compounders. • Modern pharmacists are professionally qualified, scientifically trained and technically competent health care professionals knowing the secrets and facts of drugs and medicines. 6
  • 7. Pharmaceutics Pharmaceutics is a branch of pharmacy which includes the study of, formulation of drug in to a dosage form. It is a systematic approach to get an effective and stable formulation without disturbing its quality. It is deal with technology involve in large scale manufacturing. Mahadeva Lal Schroff is considered as the father of Pharmaceutics 7
  • 8. HISTORY Five Historical Periods • Ancient Era: The beginning of time to 1600 AD • Empiric Era: 1600 to 1940 • Industrialization Era: 1940 to 1970 • Patient Care Era: 1970 to present • Biotechnology and genetic engineering: The new horizon 8
  • 9. The Ancient Era • Leaves, mud, and cool water were used to stop bleeding and heal wounds • Early man learned from watching injured animals’ behaviors • Knowledge of materials with healing properties was passed down through the tribes • Medical information was documented on clay tablets around 2600 BC 9
  • 10. The Beginnings of Pharmacy • The Ebers Papyrus, written around 1500 BC, contained formulas for more than 800 remedies for 700 drugs. • Herbs were the predominant form of curatives 10
  • 11. The Greeks • Hippocrates, the “father of medicine,” liberated medicine from the belief that disease was caused by spiritual reasons • Theophrastus, the “father of botany,” classified plants by their various parts Mithridates studied the adverse effects of plants and later became known as the “father of toxicology 11
  • 12. The Romans • The Romans organized medical and pharmaceutical knowledge and converted theories into scientific rules • The Romans, as well as the Greeks, were responsible for preparing their own prescriptions • The Romans initiated the first job titles of various pharmacy-related personnel 12
  • 13. Other Pioneers • Dioscorides began the transition of the Greek system of knowledge into the Roman system of science; he is known as the “father of pharmacology” • Galen, a Greek physician, wrote “On the Art of Healing,” and was very critical of physicians who did not prepare their own remedies • Cosmos and Damien, the patron saints of pharmacy and medicine, practiced both disciplines around 300 AD 13
  • 14. Roman Pharmacy Titles • Pharmacopeia — makers of remedies • Pharmacotritae — drug grinders • Unguentarii — makers of ointments • Pigmentarii –— makers of cosmetics • Pharmacopolae — sellers of drugs • Aromatarii — dealers in spices 14
  • 15. The Arabian Influence • Formularies — continuation of documentation of drug information • Dosage forms — syrups • Pharmacy shops — first appeared in Baghdad around 762 AD, and were privately owned • Hospital pharmacies followed in Marrakech around 1190 AD 15
  • 16. The Italian Influence • Europe’s first university was established in Salerno, and was responsible for major contributions to pharmacy and medicine • The Magna Carta of Pharmacy, separating pharmacy from medicine, was issued by Emperor Frederick II • Guilds of pharmacists were established 16
  • 17. New Ideas • A Swiss physician, Paracelsus, contradicted the Galenic theories of botanical orientation to medicine with his own theories based on chemicals • Monasteries became host to their own pharmacies • Germany became the first to governmentally regulate its pharmacies 17
  • 18. The Influence of Royalty • Pharmacists who worked for royal families provided specialized services, and were known as apothecaries • New medicinal herbal substances, plants, trees, and seeds began to be used • Better documentation of this new knowledge began to occur 18
  • 19. The Renaissance (Cultural rebirth that occurred in Europe) • Pharmacy became separated from medicine • Pharmacy regulation began • University education of pharmacists was now required • Larger quantities of known and new drugs were imported from the New World and the Orient • New chemical medicines were introduced 19
  • 20. The Empiric Era • Pharmacopeias became the regulatory tools of government, with standardized medicines listed • Existing medications were questioned and tested as to their actual effectiveness • In the 18th century, pharmacy began to develop in the colonies of the New World • In 1751, Benjamin Franklin started the first hospital in America .The first hospital pharmacist was Jonathan Roberts • William Proctor introduced control into the practice of pharmacy in the New World 20
  • 21. 19TH CENTURY • In 19th century, pharmacy began a transformation from an art to a science. • Scientists began exploring the structure of drugs, linking it to the activity of compounds, and they began to synthesis compounds with similar structures. • The mass production of drug products had started in industry. • New standards and new knowledge meant new opportunities for precision in prescribing compounding and dosing 21
  • 22. Drugs Discovered in the 19th Century • Quinine • Caffeine • Morphine • Codeine • Niacin • Adrenalin • Penicillin • Phenobarbital • Testosterone 22
  • 23. The Patient Care Era • Increased concentration on rational, targeted research through the use of computers • Increased number of available medicines • Well-coordinated teams of scientists with other professions such as statisticians and financial managers • Multiple drug therapy, however, led to adverse reactions, interactions, and therapeutic outcomes that were greater or less than desired 23
  • 24. The New Horizon • Research into gene therapy and genetic defects has greatly increased • Recombinant DNA technology is producing new medications based on the patient’s genetic make-up • Some medications that come from natural sources, such as insulin, are prone to producing allergies • Genetic research is involved in the pursuit of cures for major diseases, such as cancer 24
  • 25. 20TH CENTURY • The 20th century will be forever remembered for its remarkable advances in chemistry, medicine and pharmacy. • Countless new drugs were discovered and manufacturers were literally at war to stay ahead with new patents 25
  • 26. EDUCATION • Independent pharmacies were first established in Italy and then countries like France and Germany. • Pharmacy education at College/ University level started in 1777 in France. • Later in 1803 six schools of pharmacy were started in France. • Private pharmacy educational institutions arose in Bavaria, the south east state in Germany in 1808. • It was in 1821 the first American Pharmacy College – Philadelphia College of Pharmacy admitted the first batch of pharmacy students which was followed by New York College of Pharmacy (1829). 26
  • 27. Industry and Organization It is a well-known fact that because of the British rule, Pharmaceutical industry could not be develop significantly in India. After independence, the Government declared its industrial policy in the year 1950. The Government gave importance to the development of the pharmaceutical industry During 1950, there were 65 domestic pharmaceutical units in India,while foreign units were 28 in number. In 1952, about 1,643 licenses were issued under the Drug Act. In 1989, the number had increased to 12,000. Of these 27
  • 28. continued.. only 1,554 were manufacturing units.In the year 2003-04, it had increased to over 24,000 units.In 1952, total investment in the pharmaceutical industry was only Rs.24 crores which increased to Rs. 1,175 corers in 1984-85. Now, in 2004-05, it has reached over Rs 15,000 crores. Due to development of the pharmaceutical industry, the average life expectancy of Indian increased from 32 years to 60 years. In fact, India has also made adequate research in this field. However, the multinationals have already entered the Indian market. These companies are competing with the Indian pharmaceutical companies. 28
  • 29. continued.. In fact, India has also made adequate research in this field. However,the multinationals have already entered the Indian market. These companies are competing with the Indian pharmaceutical companies. To give a planned direction to all industries, the Republic of India passed a bill known as the‘Industrial Development Regulation Act’ in1951. The Pharmaceutical industry is divided into two parts – 1.Bulk Drugs [fermentation, synthetic and plant products] 29
  • 30. continued.. 2.Formulations- The whole pharmaceutical manufacturing industry is divided into three categories. Small scale, Medium scale, and Large scale depending upon the amount of the investment. Investments in the pharma industry were Rs.5,796 crores in the year 1994-95. The large-scale companies are required to obtain industrial license from the Director General of Technical Department.Presently, the multinational companies operating in India are keeping 40% of the shares with them and the rest with the public. 30
  • 31. continued.. All the pharmaceutical companies are governed by the Drugs and Cosmetic Act, 1940 and the Rules of 1945 for the purpose of manufacturing, storage, marketing, quality control, etc. Before starting the manufacturing and marketing of the pharmaceutical products, an industry is compelled to obtain license from the Food and Drug Department. The food and drug department is located in every part of the country. In every state, there is a Commissioner or a Director appointed by the Government. 31
  • 32. continued.. Their major task is to enforce the existing rules and regulations as well as the Bills passed by the Parliament and the State Assemblies, from time to time. In ancient days, medicinal and mineral herbs were in practice,systematic drugs production took place only by the 20th century.The modern pharmaceutical industry came into existence in the 20th century with the invention of many active medicinal compounds that could be efficiently manufactured on a large scale. 32
  • 33. continued.. In the process of research, new inventions have replaced the old time herbal medicines. Since the invention of Aspirin in 1899, the Indian Pharmaceutical Industry has done remarkable research work on life saving drugs. 33
  • 34. CONCLUSION • The face of pharmacy may have changed over the past 1000 years, but its traditional role remains the same. • Although the preparation and preservation of drug products have moved from pharmacy to the pharmaceutical industry, the pharmacist continues to fulfill the prescriber's intentions, by not only dispensing a medication but also by providing a quality product, providing advice and information, and monitoring drug therapy. 34
  • 35. HISTORICAL BACKGROUND OF PHARMACY SHOWN BY PICTURES. 35
  • 36. 1. Before the Dawn of History From beginnings as remote and simple as these came the proud profession of Pharmacy. Its development parallels that of man. Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first soothing application. By trial, he learned which served him best. Eventually, he applied his knowledge for the benefit of others.. 36
  • 37. 2. Pharmacy in Ancient China Chinese Pharmacy, investigated the medicinal value of several hundred herbs and Medicinal plants . 37
  • 38. 3. Days of the Papyrus Ebers Though Egyptian medicine dates from about 2900 B.C., best known and most important pharmaceutical record is the "Papyrus Ebers" (1500 B.C.), a collection of 800 prescriptions, mentioning 700 drugs. 38
  • 39. 4. Theophrastus–FatherofBotany Theophrastus (about 300 B.C.), among the greatest early Greek philosophers and natural scientists, is called the "father of botany.". He lectured to groups of students. 39
  • 40. 5. Galen Experimenter in Drug Compounding He was the originator of the formula for a cold cream, essentially similar to that known today. Many procedures Galen originated have their counterparts in today's modern compounding laboratories. 40
  • 41. 06. The First Apothecary Shops The Arabs separated the arts of apothecary and physician, establishing in Bagdad late in the eighth century the first privately owned drug stores. 41
  • 42. 07. Separation of Pharmacy In the 17th century Emperor of Germany at his palace in Palermo, he presented subject Pharmacists with the first European edict completely separating their responsibilities from those of Medicine, and prescribing regulations for their professional practice. 42
  • 43. 08. The First Official Pharmacopeia The idea of a pharmacopoeia with official status, to be followed by all apothecaries, originally written in Italian, was published and became the legal standard for the city-state in 1498. 43
  • 44. 09. American Pharmacy Builds its Foundations The Philadelphia College of Pharmacy; a school of pharmacy; first pharmaceutical association in the United States; American Pharmacy's first educational institution. 44
  • 45. 10. The Pharmacopeia Comes of Age The first "United States Pharmacopoeia" (1820) was the work of the medical profession. It was the first book of drug standards . 45
  • 46. 11. The Standardization of Pharmaceuticals Despite the professional skill and integrity of 19th-century pharmacists. 46
  • 47. 12. Pharmaceutical Manufacturing Comes of Age Pharmaceutical manufacturing as an industry apart from retail Pharmacy had its beginnings about 1600; really got under way in the middle 1700's. It developed first in Germany, then in England and in France. 47
  • 48. 13. Pharmacy Today and Tomorrow Pharmacy, great professions. Like Medicine, it has come through many revolutions, has learned many things, has had to discard many of its older ways. Pharmacists are among the community's finest educated people. When today's retail pharmacist fills a prescription written by a physician, he provides a professional service incorporating the benefits of the work of pharmacists in all branches of the profession - education, research, development, standards, production, and distribution. Pharmacy's professional will continue to grow in the future. 48
  • 49. Pharmacy as a career 49
  • 50. 50 PHARMACY Science of Medicines Manufacuring, Distribution of Medicines for Mankind Treatment and Prevention of Diseases
  • 53. 53 Pillars of Pharmaceutical Sciences:  Pharmaceutical Chemistry  Pharmaceutics  Pharmacology  Pharmacognosy  Pharmaceutical Analysis
  • 54. 54 Opportunity Horizons JOB (B.Pharm/M.Pharm) •Government Organizations •Pharma Industries •Hospital Pharmacists •Research Institutes •Food & Cosmetic Industries •Clinical Pharmacy •Clinical research org. •Community Pharmacy •Pharma Marketing •Academic jobs (Teaching) BUSINESS (B.Pharm) • Own Industry • Own Distribution Agency or Pharmacy Shop
  • 56. 56 Pharma Industry R & D Production Marketing Formulation Tablet Sales Promotion Quality Assurance Capsule Sales executive Quality Control Injections Product development Bioanalytical Manager Biotechnology Pharmacology Drug Discovery Technology Transfer
  • 57. 57 Key role as community pharmacist Evaluates a patient's drug-related needs ● Determine whether the patient has any actual or potential drug related problems. ● Works with the patient and other healthcare professionals to design, implement and monitor a therapeutic plan that will resolve/prevent the problem.
  • 58. 58 PHARMACIST IN GOVERNMENT SERVICE Pharmacist in Army, Navy, Air force & Govt. Hospitals Drug Inspectors –Govt of INDIA and State level Scientists- Food and Drugs Govt.University Proffesors and HODs Opportunity to be Selected in UPSC and State Public Service Commissions. Government Analysts and Forensic Scientists Research on tropical diseases, Public health  Govt.Certified Pharmacologist &Toxicologist
  • 59. PHARMACIST IN GOVERNMENT SERVICE 59  Govt. Approved Chemist  Consultants ( Mental health,Addiction, family planning, poisons, self-medication, immunization
  • 61. Pharmacopoeia • Derived from Greek word ‘Pharmakon’ means drug and ‘Poiea’ means to make. • 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. 61
  • 62. Indian Pharmacopoeia • It is written in English & official titles of monographs given in Latin. • Indian Pharmacopeia committee under chairmanship of Dr. B. N. Ghosh Published first edition of IP in 1955. • It covers 986 monographs • Second edition of IP was published in 1966 under the chairmanship of Dr. B. Mukkerji. • Official titles of monographs given in English. • Dose were expressed in Metric system. • For Tablets and Injections “USUAL STRENGTH” have been given. • Formulations of the drugs were given immediately after the monograph of drugs. 62
  • 63. Continued… 63 •93 new monographs were added. •Supplement to this edition was published in 1975. •126 new monographs have been included & 250 monographs have been amended. •Third edition of IP was published in 1985 with two volumes •261 new monographs have been added. •450 monographs were deleted. • Addendum I to IP was published in 1989 were 46 new monographs added and 126 amended. • Addendum II was published in 1991 were 62 new monographs added and 110 amended
  • 64. Continued… 64 •Fourth edition of IP was published in 1996 under the chairmanship of Dr. Nityanand. •It has been made effective from 1st December 1996. • It covered 1149 monographs and 123 appendices. • It includes 294 new monographs & 110 monographs have been deleted. •Addendum I has been made effective from 31st December 2000 were 42 new monographs have been added. • Addendum II has been made effective from 30th June 2003 were 19 new monographs have been added. •The veterinary supplement to IP 1996 contains 208 monographs
  • 65. Continued… 65 •Fifth edition of IP was published in 2007 & addendum to this edition was published in 2008. •IP 2007 is presented in Three Volumes. •Volume One contains general notices & general chapters. • Volume Two & Three contains general monographs on drug substances , dosage forms & Pharmaceutical aids. • 6th edition of IP is published in 2010. • The 6th edition of the Indian Pharmacopoeia 2010 is published by the Indian Pharmacopoeia Commission (IPC) Ghaziabad
  • 66. Continued… 66 •This edition would be effective from 1st September, 2010. • The Indian Pharmacopoeia 2010 is presented in three volumes •Volume I contains the Notices, Preface, the Structure of the •IPC, Acknowledgements, Introduction, and the General Chapters. •Volume II contains the General Notice, General Monographs on Dosage Forms and Monographs on drug substances, dosage forms and pharmaceutical aids (A to M). •Volume III contains Monographs on drug substances,dosage forms and pharmaceutical aids (N to Z). Followed by Monographs on Vaccines and Immunosera for Human use, Herbs and Herbal products, Blood and blood related products, Biotechnology products and Veterinary products.
  • 67. 67 •The scope of the Pharmacopoeia has been extended to include products of biotechnology, indigenous herbs and herbal products, veterinary vaccines and additional antiretroviral drugs and formulations, inclusive of commonly used fixed-dose combinations. Standards for new drugs and drugs used under National Health Programmes are added and the drugs as well as their formulations not in use now a day are omitted from this edition. •The number of monographs of Excipients, Anticancer drugs, Herbal products and antiretroviral drugs has been increased in this edition. Continued…
  • 68. Continued… 68 •Monographs of Vaccines and Immunosera are also upgraded in view of development of latest technology in the field. •A new chapter on Liposomal products and a monograph of Liposomal Amphotericin B injection is an added advantage in view of latest technology adopted for drug delivery. • A chapter on NMR is incorporated in Appendices. •The chapter on microbial contamination is also updated to a great extent to harmonise with prevailing international requirements.
  • 69. Continued… 69 •The seventh edition of the Indian Pharmacopoeia (IP 2014) is published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Government of India, Ministry of Health & Family Welfare. • The Indian Pharmacopoeia 2014 is presented in four volumes. The scope of the Pharmacopoeia has been extended to include additional anticancer drugs & antiretroviral drugs and formulations, products of biotechnology, indigenous herbs and herbal products, veterinary vaccines. • The IP 2014 incorporates 2550 monographs of drugs out of which 577 are new monographs consisting of APIs, excipients, dosage forms and herbal products etc.
  • 70. Continued… 70 • list of 577 New Monographs not included in IP-2010 and its Addendum-2012 but added in this edition containing 313 New Monographs on drug substances, Dosage forms & Pharmaceutical aids (A to Z), 43 New Drugs Substances Monographs, 10 Antibiotic Monographs, 31 Herbal Monographs, 05 Vaccines & immunosera for human use, 06 Insulin Products, 07 Biotechnology Products etc. along with the 19 new General Chapters. • 19 New Radiopharmaceutical Monographs & 1 General chapter is first time being included in this edition. • This edition of Indian Pharmacopoeia-2014 is now under printing and will be available to stakeholders probably in Sept.2013, before three months of its effective date, i.e. 1st Jan. 2014.
  • 71. IP 2018 71 The Eighth edition of Indian Pharmacopoeia (IP- 2018) is published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Ministry of Health & Family Welfare, Government of India. Indian Pharmacopoeia 2018 Salient Features: Incorporating with 4 volume New Monographs : 220 170 New Chemical Monographs 49 API 64 Formulations 53 Fixed Dose Formulations 02 Excipients 02 Antibiotic
  • 72. Continued.. 72 15 New Herbs and Herbal Products Monographs 03 New Radiopharmaceutical Monographs 14 New Veterinary Non-Biological Monographs 18 New Biological Monographs : 02 Vaccines & Immunosera for Human Use 06 Biotechnology Derived Therapeutic Products 10 Blood and Blood Related Products
  • 73. Continued.. 73 Standards for New Drugs, Drugs under National Health Programme & Drugs in National List of Essential Medicines have been included. For ease of access and to make Pharmacopoeia more user friendly index has been incorporated in Volume 1 along with that already existing in Volume IV of IP
  • 75. British Pharmacopoeia • First edition of BP was published in 1864. • It consist of two sections • Part I:- Materia Medica & Part II:- Preparation & compounds. • In this edition titles of drugs & preparations were in English instead of Latin and metric system. Fourth edition of BP was published in 1898. • Fifth edition of BP was published in 1914. • Eighth edition of BP was published in 1953. • It has been published annually. • In BP 2007 monographs has been introduced for material specifically used in preparation of Traditional Chinese medicines • BP 2008 contains approximately 3100 monographs for substances, preparations and articles used in practice 75
  • 77. UNITED STATE PHHARMACOPEIA 77 • First edition of United state Pharmacopeia was published on 15th December 1820 in both Latin & English. • From 1820 to 1942 it was published at Ten years intervals. • From 1942 to 2000 it was published at Five years intervals. • From 2002 it was published annually. First National Formulary of the united state appeared in 1888.
  • 78. UNITED STATE PHHARMACOPEIA 78 •USP21-NF16 have eight supplements. •First appeared in January 1985 & last in November 1988. •USP22-NF17, 1990 is the third revision that consolidates USP & NF into a single volume. • Electronic version of USP-NF on floppy disks was introduced in 1992. •USP23-NF18, was published in Mumbai as an Asian edition at the end of 1994.
  • 79. UNITED STATE PHHARMACOPEIA 79 •USP23 has ten supplements. • First supplement was published in January 1995 & Last in May 1999. •USP24-NF19, appeared from first January 2000. • USP30-NF25, appeared from May 2007. • It contains Scientific standards for drugs, dietary substances, biological products & Excipients used in dosage forms. •It contains 4,100 monographs and 200 general chapters. • It has been printed in three volume set.
  • 80. UNITED STATE PHHARMACOPEIA 80 • Volume I contains general chapters & Volume II & III contains monographs. •First supplement to USP30-NF25, appeared from August 2007 & second supplement from November 2007 which will be considered official from May 2008. •From 2006, Spanish edition of USP is also being published. •Current edition of USP 2014 is in process.
  • 81. 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 • 9th edition: published June 2017 81
  • 84. Dosage form • Dosage form. The administration form of the completed pharmaceutical product : e.g., tablet, capsule or solution 84
  • 85. Internal •Suppositories •pessaries 1.Unit solid:- •tablets •capsules 2.Bulk dosage form:- •powder •Dusting powder 1.Monophasic liquid:- 2.Biphasic liquid:- •emulsion •suspension External Ointment •Cream •Paste •jellies 85
  • 86. 86
  • 87. 87
  • 88. continued.. 88 Tablets:- They are unit solid dosage forms consisting of active ingredient and suitable pharmaceutical excipients. They may vary in size, shape, weight, hardness, thickness, disintegration and dissolution characteristics, and in other aspects.
  • 89. Capsules:- • They are unit solid dosage forms consisting gelatin shell that breaks open after the capsule has been swallowed and releasing the drug. • Types- • hard-shell gelatin capsule • soft-shell gelatin capsule 89
  • 90. continued.. 1 . soft gelatin shell manufactured in one piece with drug usually in liquid form inside the shell, e.g. fat-soluble vitamins A and E 2. hard shell manufactured in two pieces that fit together and hold the drug, either in powdered or granular form. 90
  • 91. continued.. Powder:- • They are bulk solid dosage forms consisting two or more medicament meant for internal or external use. • Size of the powder determine the effectiveness of physiological properties. 91
  • 92. 92 Granules :The bitter, nauseous and unpleasant powders cannot be given in the tablet form or in a capsule because a large number of them are required to be taken as a single dose. Examples Proergy - protein granules Promer plus - vitamins granules Promiz - mineral and hematinic granules
  • 93. 93
  • 94. continued.. • Semisolids contain both liquids and solids .They are meant for topical application. 1.External application: • Creams: - • Creams are viscous semi-solid emulsions, that is used for external application that is mixtures of oil and water. • They usually contain a water soluble base due to which they can be easily removed. • They are divided into two types- • 1.O/W TYPE • 2.W/O TYPE 94
  • 95. 95 Ointment : is a topical medication applied on the body surfaces. In medical terms, an ointment is defines as a homogeneous, viscous, semi-solid preparation with a high viscosity, that is used for external application. An ointment has medicated ingredients which serve a protective, therapeutic, or prophylactic purpose when applied on the skin or mucous membranes . Pastes :a soft plastic mixture or composition; especially an external medicament that has a stiffer consistency than an ointment and is less greasy because of its higher percentage of powdered ingredients.
  • 96. 96 Jellies: are transparent or translucent, non greasy, semi solid preparations mainly used for the external application to the skin.eg. Ephedrine sulphate jelly Internal application suppository: is a drug delivery system that is inserted into the rectum (rectal suppository), vagina (vaginal suppository) or urethra (urethral suppository), were it
  • 97. 97 dissolves or melts and is absorbed into the blood stream. They are used to deliver both systemically and locally acting medications. Examples Dulcolax - Bisacodyl suppositories
  • 98. 98
  • 99. Monophasic liquid dosage form 99 •Monophasic dosage form refers to liquid preparation containing two or more components in one phase system, it is represent by true solution. •A true solution is a clear homogenous mixture that is prepared by dissolving solute in a suitable solvent •The component of the solution which is present in a large quantity is known as “SOLVENT” where as the component present in small quantity is termed as “SOLUTE”.
  • 100. Liquids meant for internal administrations 100 Syrup : Aqueous preparations of 60% to 85% sucrose with or without flavoring agents and medicinal substances. e.g. Chlorpheniramine maleate syrup, Chloral hydrate . •Elixirs : Clear, aromatic, sweetened hydro alcoholic solutions with or without medicinal substances, intended for oral use. Eg: Dexamethasone elixir . •Linctuses : Viscous, liquid and oral preparations that are generally prescribed for the relief of cough. Eg: Codeine Linctus.(expactorant )
  • 101. Liquids used in the mouth 101 Gargles :Aqueous solutions containing antiseptics or antibiotics used to treat throat infections. Available in concentrated form with direction for dilution with warm water before use. eg: Povidone Iodine gargle. • Mouthwash: Aqueous solution with a pleasant taste and odor used to clean and deodorize the buccal cavity. Have antiseptic and astringent activity.eg: Antiseptics-phenol derivatives. • Throat paints : Viscous liquid preparation used for mouth and throat infections. Eg: Phenol glycerine, Compound Iodine
  • 102. Liquids instill into body cavity 102 •Eye drops: Sterile, aqueous/oily solutions intended for instillation in eye. Eg: Timolol maleate eye drops. • Nasal drops: Administered through the nose to obtain local effect. Used during nasal congestion and upper- respiratory tract problem. Eg: Oxymetazolin Hydrochloride nasal drops. • Enemas: Aqueous or oily solution that is introduced into the rectum and colon via the anus for cleansing, therapeutic or diagnostic purposes.
  • 103. Liquid meant for skin 103 •Liniments : Oily liquid preparations, intended for external application with rubbing action to the affected area. Use to relief pain and stiffness, such as from muscles spasm and arthritis. •Lotions : Topical preparation with a low to medium viscosity. Use to moisturize dry skin. Eg: Calamine Lotion, baby lotion •Paints : Solutions used to sterilize the skin. Eg. Betadine antiseptic paint, Magenta paint
  • 104. Biphasic liquid dosage form 104 The liquid which consist of two phases are known as biphasic liquids e.g. emulsion and suspensions
  • 105. Prescription It’s written order, especially by a physician, for the preparation and administration of a medicine or other treatment. 105
  • 107. Parts of prescription 1. Date 2. Name, Age, Sex and Address of the patient. 3. Superscription (Rx) 4. Inscription 5. Subscription 6. Signatura 7. Renewal Instructions 8. Name, Signature & Registration no. of registered physician 107
  • 108. Date It helps the pharmacist to find out the date of prescribing and the date of prescription for filling. It also helps -To know when the medicines were last dispensed -To prevent the misuse of the drug by the patients. The prescription which prescribes narcotic or other habit forming drugs must bear the date so as to avoid the misuse of the prescription. Name, age, sex and address of the patient Name, age, sex and address of the patient must be written in the prescription because it serves to identify the prescription. Age and sex of the patient especially the children, help the pharmacist to check the prescribed dose of the medicine. 108
  • 109. Inscription This is the main part of the prescription, contains the names and quantities of the prescribed ingredients The names of the ingredients are generally written in English but common abbreviation used can be written both in English and Latin language. Extreme care should be taken by the pharmacist during interpreting the abbreviations otherwise can lead to serious errors. Subscription Subscription provides the direction to the pharmacist for the preparation of the prescription information and the quantity and dosage form of the drug to be dispensed. 109
  • 110. Sugnatura This consists of the direction to be given to the patient regarding the administration of the drugs. The instruction may include • The quantity to be taken or the amount to be used. • The frequency and timing of drug administration • The route of drug administration • The special instruction such as dilution direction. 110
  • 111. 111 Renewal instruction The prescriber indicates on every prescription, whether it may be renewed and if so how many times. It is particularly important for the prescriptions containing the narcotic and other habit forming drugs to prevent its misuse. Name, signature, address & registration no. of the prescriber The prescription must bear the signature of the prescriber along with the registration number and address.
  • 113. Handling of Prescription 113 • Receiving • Compounding • Finishing • Pricing • Delivering
  • 114. Receiving the Prescription 114 Pharmacist should himself receive the Prescription. It includes: 1.Reading the prescription:- Prescription should be completely and carefully read from top to bottom. 2.Checking of prescription:- Prescription should be checked for any incompatibility
  • 115. Compounding 115 The ingredients are compounded By accurate method. For weighing electrical machines should be used.
  • 116. Finishing the prescription 116 It includes Packaging Labeling Rechecking Filling
  • 117. Continued… 117 Packaging After compounding packaging of prescription should be done. For packaging following containers are used 1.Round vials 2.Oval bottles 3.Wide mouth bottles 4.Colored bottles 4.Collapsible tubes 5.Paper wrappers 6.Dropper bottles
  • 118. Continued… 118 Labeling: The filled container should be suitably labeled. The label should be affixed on smooth surface of bottle. Label information's Type of prescription Name, age & sex of patient Date of dispensing Storage condition Name & address of pharmacy In case of liquid preparation attachauxiliary label Route of administration
  • 119. Continued… 119 Rechecking Each prescription should be rechecked After labeling container should be thoroughly polished to remove finger prints Recording A variety of prescription files are available which serve to maintain and preserve original prescription in numerical order
  • 120. Pricing of Prescription 120 The prescription should be priced immediately after receiving it & informed the patient about it. This should be done before starting the compounding to avoid any dispute
  • 121. Delivering the prescription 121 Three types Store Delivery Home Delivery Mail Delivery
  • 122. Sources of errors in prescription Following are the sources of errors which arise in prescription: 1) Abbreviation: Abbreviation presents a problem in understanding parts of the prescription order. Extreme care should be taken by a pharmacist in interpreting the abbreviation. Acromycin-Acro-Acrostatin 2) Name of the Drug: There are certain drugs whose name look or sound like those of other drugs. Some of the examples of such drugs are as under: Examples of Drugs often Confused Digitoxin- Digoxin Prednisone -Prednisolone
  • 123. Continued… Name of the pharmaceutical products have been changed on certain occasion due to the possible confusion with the name of the other products, e.g., the name of potassium supplement was changed from Kalyum to Kolyum because of the possible confusion of the former designation with valium. 3) Strength of the Preparation: The strength of the preparation should be stated by the prescriber For example, it will be a wrong decision on the part of a pharmacist to dispense paracetamol tablet 500 mg
  • 124. Continued… when prescription for paracetamol tablet is received with no specific strength. 4)Dosage Form of the Drug Prescribed: Many medicines are available in more than one dosage form. For example, liquid, tablet, capsule and suppository. The pharmaceutical form of the product should be written on the prescription in order to avoid ambiguity.
  • 125. Continued… 5) Dose: Unusually high or low doses should be discussed with the prescriber. For example, a prescription for sustained release formulation to be administered after every four hours should be thoroughly checked because such dosage forms are usually administered only two or three times a day. 6) Instructions for the Patient: The quantity of the drug to be taken, the frequency and timing of administration, and route of administration should be clearly given in the prescription so as to avoid any confusion.
  • 126. Continued… 126 7) Incompatibilities: It is essential to check that there are no pharmaceutical or therapeutic incompatibilities in a prescribed preparation and that different medicines prescribed for the same patient do not interact with each other to produce any harm to the patient.Certain Antibiotic should not be given with meals since it is significantly decrese the absorption of given drug.
  • 128. Posology 128 The word posology is derived from the Greek word posos means how much and logos means science. So we can define posology as a branch of medical science which deals with dose or quantity of the drug .
  • 129. factors affecting posology • These are many factors are: • Age • Body weight • Gender • Route of administration • Time of administration • Presence of diseases 129
  • 130. Continued… • Environmental factors • Emotional factors • Accumulation • Synergism • Antagonism • Habituation 130
  • 131. Continued… • Addiction • Idiossyncrasy • Hypersensitivity • Tolerance • Tachyphylaxis 131
  • 132. Continued… 132 1.AGE: The pharmacokinetics of many drugs changes with age. So while determining the dose of a drug, the age of an individual is of great significance. Children and old people need lesser amount of drug than the normal adult dose, because they are unable to excrete drugs to that extent as adults. Children can tolerate relatively larger amounts of belladonna, digitalis and ethanol whereas, elderly patients are more sensitive to some Drug effects e.g. hypnotics and tranquillizers which may produce confusion states in them.
  • 133. Continued… 133 2.SEX: Women do not always respond to the action of drugs in the same manner as it is done in men. Morphine and barbiturates may produce more excitement before sedation in women. Special care should be taken when drugs are administered during menstruation, pregnancy and lactation. The strong purgatives such as aloes should be avoided during menstruation. Similarly the drugs which may stimulate the uterine smooth muscle e.g. drastic purgatives, antimalarial drugs and ergot alkaloids are contra indicated during pregnancy
  • 134. Continued… 134 There are certain drugs which on administration t the mother are capable of crossing the placenta and affecting the foetus e.g. alcohol, barbiturates, narcotic and non narcotic analgesics etc. During lactation, the drugs like antihistamines, morphine and tetracycline which are excreted in milk should be avoided or given very cautiously to the mothers who are breast feeding to the babies. 3.BODY WEIGHT: The average dose is mentioned either in terms of mg per Kg weight or as a total single dose for an adult weighing between 50-100 Kg.
  • 135. Continued… 135 However, the dose expressed in this fashion may not apply in case of obese patients, children and malnourished patients. It should be calculated according to Body Weight 4.ROUTE OF ADMINISTRATION: Intravenous doses of drugs are usually smaller than the oral doses, because the drugs administered intravenously enter the blood stream directly. Due to this reason the onset of drug action is quick with intravenous route and this might enhance the chances of drug toxicity. The effectiveness controlled by the route of administration.
  • 136. Continued… 136 5.TIME OF ADMINISTRATION: The presence of food in the stomach delays the absorption of drugs. The drugs are more rapidy absorbed from the empty stomach. So the amount of drug which is very effective when taken before a meal may during or after meals. The irritating drugs are better tolerated if administered after meals e.g. iron, arsenic and cod-liver oil should always be given after meals. 6.ENVIRONMENTAL FACTORS: Daylight is stimulant, enhancing the effect of stimulating drugs and diminishing the effect of hypnotics.
  • 137. Continued… 137 Darkness is sedative. Hypnotics are more effective at night. The amount of barbiturate required to produce sleep during daytime is much higher than the dose required to produce sleep at night. Alcohol is better tolerated in cold environments than in summer. 7.EMOTIONAL FACTORS: The personality and behaviour of a physician may influence the Effect of drug especially the drugs which are intended for use in a psychosomatic disorder. The females are more emotional than males and requires less dose of certain drugs.
  • 138. Continued… 138 Inert dosage forms called placebos which resemble the actual medicament in the physical properties are known to produce therapeutic benefit in diseases like angina pectoris and bronchial asthma. 8.PRESENCE OF DISEASE: Drugs like barbiturates and chlorpromazine may produce unusually prolonged effect in patients having liver cirrhosis. Streptomycin is excreted mainly by the kidney may prove toxic if the kidney of the patient is not working properly. During fever a patient can tolerate high doses of antipyretics than a normal person.
  • 139. Continued… 139 9.ACCUMULATION: The drugs which are slowly excreted may built up a sufficient high concentration in the body and produce toxic symptoms if it is repeatedly administered for a long time e.g. digitalis, emetine and heavy metals. This occurs due to accumulative effect of the drug. The cumulative effects are usually produced by slow excretion, degradation and rapid absorption of drugs. Sometimes, a cumulative effect is desired in drugs like phenobarbitone in the treatment of epilepsy.
  • 140. Continued… 140 10.SYNERGISM:When two or more drugs are used in the combination form, their action is increased. The phenomena is called synergism. Synergism is very useful when desired therapeutic result needed is difficult to achieve with a single drug e.g. procaine and adrenaline combination, increases the duration of action of procain. 11.ADDITIVE EFFECT: When the total pharmacological action of two or more drugs administered together is equivalent to sum of their individual pharmacological action, the phenomena is called as an additive effect.
  • 141. Continued… 141 For example, combination of ephedrine and aminophylline in the treatment of bronchial asthma. 12.ANTAGONISM: When the action of one drug is opposed by the other drug on the same physiological system is known as drug antagonism. The use of antagonistic responses to drugs is valuable in the treatment of poisoning e.g. milk of magnesia is given in acid poisoning where alkaline effect of milk of magnesia neutralize the effect of acid poisoning. When adrenaline and acetylcholine are given together they neutralise the effect of each other
  • 142. Continued… 142 due to antagonism because adrenaline is vasoconstrictor and acetylcholine is vasodilator. 13.IDIOSYNCRASY: An extraordinary response to a drug which is different from its characteristic pharmacological action is called idiosyncrasy. The word idiosyncrasy has now been replaced by the term drug allergy. For example, small quantity of aspirin may cause gastric haemorrhage and a small dose of quinine may produce ringing in the ears. Some persons are sensitive to penicillin and sulphonamide because they produce severe toxic symptoms.
  • 143. Continued… 143 14.TOLERANCE: When an unusually large dose of a drug is required to elicit an effect ordinarily produced by the normal therapeutic dose of the drug, the phenomena is termed as drug tolerance. e.g., smokers can tolerate nicotine, alcoholic can tolerate large quantity of alcohol. The drug tolerance is of two types:- (i) True tolerance, which is produced by oral and parentral administration of the drug. (ii) (ii) Pseudo tolerance, which is produced only to the oral route of administration.
  • 144. Continued… 144 15.TACHYPHYLAXIS: It has been observed that when certain drugs are administered repeatedly at short intervals, the cell receptors get blocked up and pharmacological response to that particular drug is decreased. The decreased response cannot be reversed by increasing the dose. This phenomenon is known as tachyphylaxis or acute tolerance. For example, ephedrine when given in repeated doses at short intervals in the treatment of bronchial asthma may produce very less response due to tachyphylaxis. Similarly, drugs like amphetamine, cocaine and nitrates behave in this way.
  • 145. Continued… 145 16.METABOLIC DISTURBANCES: Changes in water electrolyte balance and acid base balance, body temperature and other physiological factor may modify the effects of drugs. Salicylates reduce body temperature only in case an individual has rise in body temperature. They have no antipyretic effect if the body temperature is normal. The absorption of iron from G.I.T. is maximum if the individual has an iron deficiency anaemia.
  • 146. CALCULATIONS OF DOSES 146 The doses are also calculated in proportionate to age, body weight.
  • 147. Continued… 147 1.DOSES PROPORTIONATE TO AGE (i) YOUNG’S FORMULA: Dose for the child= (Age in years/Age in years+12)x Adult dose The formula for calculating the doses for children under 12 years of age. (ii) DILLING’S FORMULA: Dose for the child= (Age in years/20)x Adult dose The formula is used for calculating the doses for children in between 4 to 20 years of age.
  • 148. Continued… 148 2.DOSES PROPORTIONATE TO BODY WEIGHT: Clark’s formula is used to calculate the dose for the child according to body weight. CLARK’S FORMULA: Dose for the child= (Child’s weight in Kg/70)x Adult dose
  • 149. Continued… 149 3.DOSES PROPORTIONATE TO SURFACE AREA: The calculation of child dose according to surface area is satisfactory and appropriate rather than the method based on age. The method is more complicated than the method based on age. The method is based on the following formula:- Percentage of adult dose = (Surface area of child/Surface area of adult)X 100 The body surface area is calculated from the height and weight of the child. It is better to depend on a handy reference book rather than on one’s memory while prescribing a dose for a child.