Drug Chemistry and Technology Basics, Cleaner Production and Mega-Trends in Pharmaceutical Industry

Drug Chemistry and Technology Basics, Cleaner Production and Mega-Trends in Pharmaceutical Industry

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Description: The Most Common and Dangerous Diseases: - One new market in the U.S. and European economies is geriatrics People are becoming increasingly old, while at the same time healthcare spending is increasing with age. Thus, there are many new medicines under development that specifically aim at treating older people, targeting diseases such as diabetes, rheumatoid arthritis, Alzheimerís, Parkinsonís disease, depression, gastrointestinal disorders, osteoporosis, bladder/kidney disorders.

 
Author: Anastasya Sladkova PhD, Natalya Loginova PhD  | Visits: 310 | Page Views: 414
Domain:  Medicine Category: Biotech/Pharma 
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Contents:
LOGO
Drug Chemistry and Technology Basics,
Cleaner Production and Mega-Trends in Pharmaceutical Industry

Introduction

Dr. As. Prof. Anastasya Sladkova
Dr. Sci. Prof. Natalya Loginova

1

Literature Sources
1. An Introduction to Pharmaceutical Sciences. Production,
Chemistry, Techniques and Technology / J. Roy .  Woodhead
Publishing.  2011.  404 р.
2. Leading Pharmaceutical Innovation. Trends and Drivers for Growth
in the Pharmaceutical Industry (2 ed.) / O. Gassmann, G.
Reepmeyer, M. von Zedtwitz.  Springer-Verlag Berlin Heidelberg. 
2008.  186 р.
3. Pharmacy Management: Essentials for All Practice Settings (3 ed.)
/ S.P. Desselle, D.P. Zgarrick, G.L. Alston.  New York: McGraw-Hill
Medical.  2012.  736 р.
4. Essentials of Pharmaceutical Chemistry (4 ed.) / D. Cairns. 
Pharmaceutical Press. – 2012. – 320 p.
2

Literature Sources
(additional)
1. EUROPEAN PHARMACOPOEIA 8.0 /
https://www.edqm.eu/en/european-pharmacopoeia-8th-edition-1563.html.
2. The International Pharmacopoeia (Pharmacopoea internationalis) (5 ed.) (2015) /
http://apps.who.int/phint/en/p/docf/
3. World Medical Association Declaration of Helsinki. Ethical Principles for Medical
Research Involving Human Subjects. – WMA.  2004.

4. Pharmaceutical Analysis / D. C. Lee, M. Webb. ‒ UK: Bloomsbury Publishing PLC.
– 2003. – 384 p.
5. Pharmaceutical Process Development: Current Chemical and Engineering
Challenges / J. Blacker, M.T. Williams ed. ‒ RSC Publishing. – 2011. – 354 p.
6. Pharmaceutical Chemistry / D.G. Watson ed. ‒ Churchill Livingstone. – 2011. – 652
p.
7. Medicinal Chemistry: An Introduction (2 ed.) / G. Thomas ‒ Wiley-Interscience. –
3
2007. – 646 p.

LECTURES
1.

Introduction

2. Terminology of Drugs
3. Drug Design and Quality Standards
4. Falsification of Medicines
5. Quality Assurance in Medicines
6. Control by Pharmacopeias
7. *Trends in Pharmaceutical Industry
4

The Most Common and
Dangerous Diseases
• heart disease
• malignancy
• diabetes
• HIV/AIDS
• malaria
• tuberculosis
• lung disease
• viral hepatitis
• infectious diseases of the digestive system
• nervous system disease

• *rare (orphan) disease (any disease that affects a small percentage of the population,
most genetic, e.g. cystic fibrosis (mucoviscidosis), phenylketonuria)

5

The Most Common and
Dangerous Diseases
One new market in the U.S. and European economies is geriatrics
People are becoming increasingly old, while at the same time healthcare spending is
increasing with age. Thus, there are many new medicines under development that
specifically aim at treating older people, targeting diseases such as:



diabetes,



rheumatoid arthritis,



Alzheimer’s,



Parkinson’s disease,



depression,



gastrointestinal disorders,



osteoporosis,



bladder/kidney disorders

6

The Multidisciplinary Nature
Of Pharmaceutical Sciences

7

The Core Functionality
Of Pharmaceutical Sciences

8

Pharmaceutical Research
and Development (R&D)
The pharmaceutical industry is research-based
Since the first blockbuster pharmaceutical, cimetidine (antiulcer drug), was
launched by GlaxoSmithKline in the 1970s, both industry and regulators have
been convinced that the “blockbuster model” for the industry was the longterm way forward: drug discovery and development was known to be high risk,

expensive and time consuming, and that after patent expiry, generic
manufacture would dramatically reduce the price of novel pharmaceuticals.
However, new ‘blockbuster’ pharmaceuticals would continue to be invented at
regular intervals and the profits made during their patent life would be more than

sufficient to fund the necessary R&D for future products. Thus, the industry as a
whole would continue to deliver innovative pharmaceuticals which would be
available to all at low prices after a short patent life
Blockbuster drug  a drug that has made more than US$1 billion/year

9

Pharmaceutical Technology
Pharmaceutical Technology ‒ the application of scientific
knowledge or technology to pharmacy, pharmacology, and the

pharmaceutical industry
It includes methods, techniques, and instrumentation in the
manufacture,

preparation,

compounding,

dispensing,

packaging, and storing of drugs and other preparations used
in diagnostic and determinative procedures and in the

treatment of patients
10

Pharmaceutical Technology
The pharmaceutical industry uses different technologies, such as freeze
drying, spray drying, and sublimation, to formulate fast dissolving or
mouth dissolving tablets
There is a new dosage form under development called chronotherapeutic
technology, which would control drug release according to circadian
rhythms and the timing of the symptoms of certain diseases, such as
ulcers, asthma, and cardiovascular disease
Needleless injections are possible through technology, an engineering
process by which scientific needs are met
11

Needle-free Injection
Technology

Pharmaceutical Economics
Pharmaceutical economics, also known as pharmacoeconomics, deals
with supply and demand of pharmaceutical products, as well as the costbenefit evaluation of new and existing drugs
Primary concerns of the field include expanding drug accessibility, reducing
the price of drugs and improving the cost-effectiveness of new drug
therapies
The pharmaceutical industry is based on research, technology, investors,
and ethics, and is the most profitable industry in the world
The pharmaceutical R&D accounts for 10% of the total cost of overall healthcare costs in the

USA; other costs include the services of physicians, hospital care, and administration

13

Health Technology Assessment
(HTA) and Pharmacoeconomics
Health

technology

assessment

is

the

systematic

evaluation of the properties and effects of a health

technology, addressing the direct and intended effects of this
technology,

as

well

as

its

indirect

and

unintended

consequences, and aimed mainly at informing decision
making regarding health technologies

The Modern Market Of
Medicines

• Bayer (Germany)
• Teva (Israel)

• Takeda (Japan)
• Pfizer (USA)
• Merck & Co (USA)

• Sanofi-Aventis (France)

• Novartis (Switzerland)

• AstraZeneca (Britain, Sweden)

• Hoffmann-La Roche (Switzerland)

• GlaxoSmithKline (United Kingdom)

• Gedeon Richter (Hungary)
China, India, Brazil, Turkey 15

The Modern Market Of
Medicines

New Opportunities for Drug
Development in China
Chinese manufacturers are very
strong in their ability to copy foreign
drugs, sometimes selling them under
the foreign label
Almost 99 percent of the 3,000 pharmaceutical products
manufactured in China are copies of foreign products, either
legal generics or illegal counterfeits
It is important to note that R&D in China is a trend in the
beginning. Many more R&D collaborations and institutes will
be set up to make use of the vast gene pool in China (for
clinical trials)
17

Drug Discovery and
Development in India
Indian pharmaceutical companies’
entry into the drug discovery and
development field dates back to the
early 1990s when India announced
the signing of the World Trade
Organization (WTO) agreement
Over the past few years, Indian pharmaceutical companies
have been attempting to re-orientate their efforts toward
developing new innovative medicines. However, the transition
by Indian generic-drug makers will remain slow given the
high risk levels associated with drug discovery
18

In Belarus
The main features of the development of the Belarusian pharmaceutical
market:
I. expanding the range of manufactured drugs (mainly generics) for the treating
of population with standard medicines against major widespread diseases with
the aim of increasing the share of Belarusian medicines in the domestic
market
II. focus on modernization of pharmaceutical companies, the transition to the
constant and widespread use of international quality standards GMP (Good
Manufacturing Practice)
III. the high level of import drugs in the pharmaceutical market (Germany, India,
France, and others)
IV. Belarusian producers of drugs in general are focused on the domestic market,
the bulk of the export of pharmaceutical products is sent to the CIS countries
19

20

200 Years of Medicine

Antimicrobial Resistance

What is Drug
Drug (WHO)  Any substance or product
that is used or intended to be used to
modify or explore the physiological system
or pathological state for the benefit of the

recipient
Pharmaceutical drug (also a medication
or medicine)  chemical substance used

to treat, cure, prevent, or diagnose a
disease or to promote well-being

The Apothecary or
The Chemist by
Gabriël Metsu (c. 1651–67)

23

Classifications of Drugs
Drugs can be classified in different ways according to:
– their mode of action
– their indications
– their chemical structure etc.
Each classification system will have its advantages and

limitations and it usefulness will depend on the purpose, the
setting used and the user’s knowledge of the methodology
24

Classifications of Drugs
1. by therapeutic use ‒ nosological classification (e.g.,
antidepressants)
2. by pharmacologic profile (e.g., selective serotonin
reuptake inhibitors)
Most texts use a combination of therapeutic and pharmaceutical
classifications

3. by chemical structure
4. Anatomical Therapeutic Chemical (ATC) classification
Don’t confuse it with Anatomical Therapeutic (AT) classification
developed by European Pharmaceutical Market Research Association
(EPhMRA)
25

ATC Main Group
• A Alimentary tract and metabolism
• B Blood and blood forming organs
• C Cardiovascular system
• D Dermatologicals

• G Genito urinary system and sex
hormones

• L Antineoplastic and
immunomodulating agents
• M Musculo-skeletal system
• N Nervous system
• P Antiparasitic products,
insecticides and repellents
• R Respiratory system

• H Systemic hormonal preparations,
• S Sensory organs
excl. sex hormones and insulins
• J Antiinfectives for systemic use

• V Various
26

Structure of ATC Code
• A ALIMENTARY TRACT AND METABOLISM
(1st level, anatomical main group)
• A10 DRUGS USED IN DIABETES
(2nd level, therapeutic subgroup)
• A10B BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
(3rd level, pharmacological subgroup)
• A10BA BIGUANIDES
(4th level, chemical subgroup)
• A10BA02 METFORMIN
(5th level, chemical substance)
27

Classifications of Drugs
5. legal classifications of drugs (these classifications are
broken down based on their potential for abuse and if they
have a legitimate medical use) (Schedules I, II, III, IV, V of

FDA)
6. original drugs and generics (marketed after the expiry
date of the patent for original drugs)
7. allopathic (suppress symptoms) and homeopathic (cause
symptoms in a very small extent) drugs
28

Classifications of Drugs
8. Commercial production of medicinal product – a
finished dosage form of a pharmaceutical product that has
undergone all stages of manufacture, including packaging
in its final container and labelling
and
Extemporaneous compounding – constructed into a
drug individual chemical components that is usable by an
individual patient (made by pharmacists at the pharmacy)

29

Nomenclature of Drugs
Most of drugs are known under different names

The number of such synonyms can reach more than
100:
Aspirin ‒ 360
Paracetamol ‒ 413
Ascorbic acid ‒ more than 430

Why it is so?
30

Nomenclature of Drugs
Drug Names

Chemical
based on IUPAC
nomenclature

Nonroprietary
OR
Generic Name
OR
Approved Name
OR
Official Name

Proprietary
OR
Brand Name
OR
Trade Name
OR
Commercial
31

International Nonproprietary
Names
International Nonproprietary Names (INN)

identify

pharmaceutical substances or active pharmaceutical ingredients

Each INN is a unique name that is globally recognized and is
public property
A nonproprietary name is also known as a generic name
The INN system is managed by the World Health Organization
(WHO)
32

International Nonproprietary
Names
The INN is issued by the WHO for:


Active substance, NOT product



International, NOT country‐specific



Non‐proprietary, NOT company‐specific
The INN has important roles:

 Allows doctor and other healthcare professionals to identify an active
substance regardless of:
(i) which country(s) they currently practices and (ii) which company
manufactures the product for that country


Allows the global exchange of healthcare information
33

INN Lists
 New INNs are published in WHO Drug Information:
2 proposed and 2 recommended lists every year in English,

French, Spanish and Latin
 All INNs are published in a cumulative list with additionally
INNs in Arabic, Chinese and Russian
 About

8500

INNs

have

been

published

http://www.who.int/medicines/services/inn/publication/en/index.html

 On-line INN information: Mednet  INN Extranet
34

Comparison Of
Naming Standards
International Nonproprietary Name
(INN)

paracetamol (en)
paracetamolum (la)

British Approved Name (BAN)

paracetamol

United States Adopted Name (USAN)
United States Pharmacopeia (USP)

acetaminophen

Japanese Accepted Name (JAN)
Japanese Pharmacopoeia (JP)

acetaminophen

Other generic names

acetamol

Proprietary names

panadol

IUPAC name

N-(4-hydroxyphenyl)acetamide

ATC code

N02BE01
35

Sources for Drugs
1
Minerals


iron is used in treatment of iron

deficiency anemia


mercurial salts are used in syphilis



zinc oxide paste is used in wounds

and in eczema

36

Sources for Drugs
2
Tissues and organs of animals


insulin



thyroid hormones medications



enzyme preparations

Insulin manufacture in the 1920s. beef
pancreas is sorted and fed into a mincer

37

Sources for Drugs
3
Plants


cardiac glycosides (digitoxin etc.)



morphine



reserpine



atropine

38

Sources for Drugs
4-5
Microorganisms



antibiotics: penicillins,

cephalosporins, macrolides etc.


hormones (cortisone, prednisolone,

insulin)

Recombinant bacteria are bacteria
that have undergone genetic
engineering. This means their DNA
has been altered by the introduction
of new DNA. Such bacteria have
been of immense value in biological
research, and for industrial and
environmental uses.

39

Sources for Drugs
6
Chemical synthesis


sulfonamides



acetaminophen



acetylsalicylic acid

Drug Discovery Process, Drug Design

40

Sources of Drugs

LOGO

sladkova-an@yandex.ru