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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5724_Библиотеки_им_академика_М_И_Перельмана.pdf
Preface to the Fifth Edition vii
Preface to the First Edition ix
Syllabus xvii
Unit 1: History of the Profession of Pharmacy in India in
Relation to Pharmacy Education, Industry, Pharmacy
Practice, and Various Professional Associations 1
• The History of the Profession of Pharmacy in India 2
• Pharmacy as a Career 7
• Pharmacopoeia 16
• National Pharmacopoeias 17
• Indian Pharmacopoeia 17
• Salient Features of IP 19
• History of Indian Pharmacopoeia 20
Unit 2: Packaging Materials 29
• General Introduction 29
• Characteristics of Containers and Closures 30
• Types of Containers 31
• Selection Criteria of Packaging Material 33
Glass 34
Plastics 38
Metals 41
Rubber 43
Unit 3: Pharmaceutical Aids 45
• Organoleptic Agents 46
Colouring Agents 46
Flavouring Agents 47
Sweetening Agents 48
• Preservatives 49
Unit 4: Unit Operations 51
Size Reduction 51
• Introduction 51
Ball mill 58
Hammer mill 59
Contents
Introduction to Pharmaceutics
xiv
Size Separation 61
• Definition 61
• Sieving/Sifting 61
• Grading of Powders 62
• Classification of Powders According to IP 63
• Cyclone Separator 64
• Sieves and Standards of Sieves 66
Mixing 67
• Definition 67
• Mixing Equipment 71
Double Cone Blender 71
• Turbine Mixer 72
• Triple Roller Mill 75
• Silverson Mixer-emulsifier 77
Filtration 77
• Definition 77
• Theory of Filtration 83
• Membrane Filters 85
Sintered Glass Filters 86
Drying 90
• Definition 90
Fluidised Bed Dryer 91
Freeze Drying 93
Extraction 95
• Definition 95
Extraction Processes 97
Unit 5: Dosage Forms 108
Tablet Dosage Forms 108
• Essential Qualities of a Good Tablet 109
• Types of Tablets 109
• Molded Tablets 110
Capsules 142
Hard Gelatin Capsules 144
Soft Gelatin Capsules 148
Liquid Oral Preparations 154
• Solubility 155
xv
Contents
• Syrups 158
• Elixirs 159
• Emulsions 160
• Suspensions 180
• Dry Powder for Reconstitution 189
Topical Preparations: Ointments, Creams, Pastes, Gels,
Liniments Lotions, Suppositories, and Pessaries 190
• Ointments 190
• Creams 206
• Pastes 207
• Gels 212
• Suppositories 212
• Liniments 214
• Lotions 216
Other Preparations 219
• Nasal Preparations 219
• Ear Preparations 219
Powders and Granules 224
• Insufflations 226
• Dusting Powders 226
• Effervescent Powders 227
• Effervescent Granules 229
Sterile Formulations 230
• Routes of Administration of Parenteral Products 230
• Types of Parenteral Preparations 233
• Formulation of Parenteral Products 234
• General Procedure of Preparation of Injections 237
• Precautions for Aseptic Work to Prevent Contamination 239
• Manufacturing of Parenteral Preparations 239
• Eye Drops and Eye Ointments 253
Immunological Products 256
• Immunity 257
• Forms of Vaccines 261
Unit 6: Basic Structure, Layout, Sections, and Activities of
Pharmaceutical Manufacturing Plants 277
• Design and Construction 277
• Layout 278
Introduction to Pharmaceutics
xvi
• Principle Areas of Premises 279
• Pharmaceutical Quality Assurance Premises—
Design and Construction 284
• Quality Control and Quality Assurance 285
• Current Good Manufacturing Practices 287
• Introduction to the Concept of Calibration and
Validation 290
Unit 7: Novel Drug Delivery Systems 295
• Introduction 295
• Classification of Novel Drug Delivery Systems 297
Important Questions 307
Index 317
Chapter Topics Hours
1 • History of the profession of Pharmacy in India in
relation to Pharmacy education, industry, pharmacy
practice, and various professional associations.
• Pharmacy as a career
• Pharmacopoeia: Introduction to IP, BP, USP, NF and
Extra Pharmacopoeia. Salient features of Indian
Pharmacopoeia
7
2 Packaging materials: Types, selection criteria, advan-
tages and disadvantages of glass, plastic, metal, rubber
as packaging materials
5
3 Pharmaceutical aids: Organoleptic (Colouring, flavour-
ing, and sweetening) agents
Preservatives: Definition, types with examples and uses
3
4 Unit operations: Definition, objectives/applications,
principles, construction, and workings of:
Size reduction: hammer mill and ball mill
Size separation: Classification of powders according to
IP, Cyclone separator, Sieves and standards of sieves
Mixing: Double cone blender, Turbine mixer, Triple
roller mill and Silverson mixer homogenizer
Filtration: Theory of filtration, membrane filter and
sintered glass filter
Drying: working of fluidized bed dryer and process of
freeze drying
Extraction: Definition, Classification, method, and
applications
9
5 Tablets: Coated and uncoated, various modified tablets
(sustained release, extended-release, fast dissolving,
multi-layered, etc.)
8
Capsules: Hard and soft gelatine capsules 4
Liquid oral preparations: Solution, syrup, elixir,
emulsion, suspension, dry powder for reconstitution
6
Topical preparations: Ointments, creams, pastes, gels,
liniments and lotions, suppositories, and pessaries
8
Contd...
Pharmaceutics – Theory
Course Code: ER20-11T
Syllabus
Introduction to Pharmaceutics
xviii
Chapter Topics Hours
Nasal preparations, Ear preparations 2
Powders and granules: Insufflations, dusting powders,
effervescent powders, and effervescent granules
3
Sterile formulations: Injectables, eye drops and eye
ointments
6
Immunological products: Sera, vaccines, toxoids, and
their manufacturing methods.
4
6 Basic structure, layout, sections, and activities of
pharmaceutical manufacturing plants
Quality control and quality assurance: Definition
and concepts of quality control and quality assurance,
current good manufacturing practice (cGMP),
Introduction to the concept of calibration and validation
5
7 Novel drug delivery systems: Introduction,
Classification with examples, advantages, and
challenges
5
1
UNIT
History of the Profession of Pharmacy in
India in Relation to Pharmacy Education,
Industry, Pharmacy Practice, and Various
Professional Associations
The history of pharmacy can be traced back thousands of years,
with its origins deeply intertwined with the development of
medicine and human civilization.
Ancient Times
Early civilizations in Mesopotamia, Egypt, and China, docu-
mented the use of various medicinal plants and herbs for
treating diseases and ailments. The Ebers Papyrus, an ancient
Egyptian medical text from around 1500 BCE, contains a
wealth of information on pharmaceutical preparations and
medicinal plants.
In India, the practice of Ayurveda, an ancient system of
medicine, included the use of herbal remedies and the com-
pounding of medicinal preparations.
Greek and Roman Period
The Greek physician Hippocrates, known as the ‘father of
Medicine’, emphasized the importance of observing patients
and using natural remedies for treatment. The Greek physician
Galen made significant contributions to the pharmacy by
developing pharmaceutical preparations and compounding
techniques.
The Roman Empire established a network of pharmacies
known as ‘tabernae,’ where drugs and medicinal preparations
were dispensed.
Introduction to Pharmaceutics
2
Middle Ages
The Middle Ages saw the decline of pharmacy and the domi-
nance of herbal medicine. Monasteries played a significant role
in preserving medical and pharmaceutical knowledge during
this period. Arab and Islamic civilizations made significant
contributions to the pharmacy, translating and expanding
upon Greek and Roman works.
Renaissance and Enlightenment
The Renaissance period marked a revival of scientific inquiry
and the study of medicine and pharmacy. Pharmacopoeias,
official books containing information on medicinal substances
and preparations, were published during this time. The Enligh-
tenment era brought about advancements in chemistry, leading
to a better understanding of the chemical properties of drugs.
19th Century
The 19th century witnessed the emergence of scientific
pharmacy and the development of professional organizations.
The estab lishment of the American Pharmaceutical Association
(1852) and the Pharmaceutical Society of Great Britain (1841)
marked the professionalization of pharmacy.
20th Century and Beyond
The 20th century brought significant advancements in pharma-
ceutical research, drug development, and manufacturing pro-
cesses. The discovery of antibiotics, vaccines, and other life-
saving medications revolutionized healthcare.
Regulatory bodies and laws governing the quality, safety,
and efficacy of drugs were established worldwide. Pharmacy
education and training programs expanded, leading to the
professionalization of the field.
THE HISTORY OF THE PROFESSION OF
PHARMACY IN INDIA
The history of the profession of pharmacy in India dates back
thousands of years. Here is a brief overview of the key periods
and developments:
3
Historical Aspects of Indian Pharmacy
Ancient India: The practice of pharmacy in ancient India
can be traced back to the Vedic period (1500–600 BCE).
Ayurveda, the traditional Indian system of medicine, played
a significant role in shaping the concepts and practices of
pharmacy. Medicinal herbs and plants were extensively
used, and knowledge of their properties and preparation
methods was documented in texts such as Charaka Samhita
and Sushruta Samhita.
Buddhist and Jain Periods: During the Buddhist and Jain
periods (6th century BCE to 5th century CE), the use of
medicinal plants continued to be prominent. Monasteries
and universities played a key role in preserving and
disseminating knowledge related to pharmacy.
Islamic Influence: With the arrival of Islamic rulers in India,
particularly during the Delhi Sultanate and Mughal Empire
(13th to 18th centuries), the Unani system of medicine
gained prominence. Unani medicine combined Greek,
Persian, and Indian knowledge and emphasized the use of
herbal remedies, minerals, and animal-derived substances.
The establishment of Unani hospitals and dispensaries
contributed to the growth of pharmacy practice.
Colonial Era: The arrival of European powers, especially
the Portuguese, Dutch, French, and British, in the 15th
century marked a new phase in the history of pharmacy in
India. The British East India Company established trading
posts and introduced Western medicine. Western-style
pharmacies were established, and indigenous practitioners
had to adapt to the changing landscape.
Pharmacy Education
Pharmacy education in India can be traced back to ancient
times when knowledge of medicinal plants and their
preparations was passed down through traditional systems
of medicine such as Ayurveda and Unani. Formal education
in pharmacy started in the early 20th century with the
establishment of the Banaras Hindu University College of
Pharmacy in 1932, followed by other colleges and universities
offering pharmacy programs. The Pharmacy Act of 1948 led
to the establishment of the Pharmacy Council of India (PCI),
Introduction to Pharmaceutics
4
which is responsible for regulating pharmacy education in
the country. The PCI sets standards for pharmacy curriculum,
approves pharmacy colleges, conducts inspections, and grants
licenses to pharmacists.
Over the years, the number of pharmacy colleges and the
scope of pharmacy education have expanded significantly.
Today, there are numerous diploma, undergraduate (B Pharm),
postgraduate (M Pharm), and doctoral (Pharm D) programs
offered by various institutions across India.
Pharmacy Organizations
Professional pharmacy associations started to emerge in
the early 20th century. The United Province Pharmaceutical
Association (later known as the Indian Pharmaceutical
Association) was established in 1937. The association played a
vital role in promoting the interests of the pharmacy profession
and addressing the challenges faced by pharmacists. The
Drugs Act of 1940 was a significant milestone in regulating the
import, manufacture, and sale of drugs in India. The act led to
the establishment of the Pharmacy Council of India (PCI) in
1948, which is responsible for regulating pharmacy education
and the practice of pharmacy in the country.
Pharmaceutical Industry
The pharmaceutical industry in India has a long history, dating
back to ancient times when indigenous systems of medicine
utilized herbal remedies and medicinal plants. With the advent
of colonial rule, the influence of European medicine and the
introduction of modern manufacturing techniques contributed
to the growth of the pharmaceutical industry.
After India gained independence in 1947, the pharmaceuti -
cal industry witnessed significant growth. The government
implemented policies to promote indigenous drug manufac-
turing, leading to the establishment of pharmaceutical com-
panies and the development of a robust pharmaceutical sector.
Professional Associations
Indian Pharmaceutical Association (IPA): The IPA, established
in 1937, is one of the oldest professional associations in the