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pharmaceutical industry
Table of Contents: MainHistoryThe origin of medicinesMedicines of ancient
civilizationsPharmaceutical science in the 16th and 17th centuriesIsolation and synthesis of
compoundsThe development of anti-infective agentsDiscovery of antiseptics and
vaccinesImprovement in drug administrationDrug development in the 19th and 20th
centuriesNew classes of pharmaceuticalsTransitions in drug discoveryEstablishing the fight
against infectious diseaseEarly efforts in the development of anti-infective drugsDiscovery of
penicillinDiscovery and development of hormones and vitaminsIsolation of
insulinIdentification of vitaminsEmergence of modern diseases and
treatmentHypertensionEarly progress in cancer drug developmentPharmaceutical industry in
the modern eraDrug discovery and developmentDrug development processResearch and
discoveryContribution of scientific knowledge to drug discoveryDrug screeningSources of
compoundsLead chemical identificationLead compounds from natural productsTaxol and the
Pacific yewStrategies for drug design and productionStructure-activity relationshipComputer-
aided design of drugsCombinatorial chemistrySynthetic human proteinsDrug regulation and
approvalRegulation by government agenciesPublic influence on drug regulationObjectives
and organization of drug regulatory agenciesDrug approval processesDrug applicationsThe
Investigational New Drug applicationThe New Drug ApplicationSafety testing in
animalsToxicity testsTeratogenicity and mutagenicity testsBiopharmaceutical
studiesPharmacokinetic investigationDosage form developmentTabletsCapsulesOther solid
dosage formsLiquid dosage formsSemisolid dosage formsSpecialized dosage formsModified-
release dosage formsParenteral dosage formsRadiopharmaceuticalsObstacles in drug
developmentAdverse reactionsPostmarketing adverse drug eventsDrug interactionsDrug
- - Discovery of penicillin
patentsAdditional ReadingRelated Articles

 Main
 History
o The origin of medicines
 Medicines of ancient civilizations
 Pharmaceutical science in the 16th and 17th centuries
o Isolation and synthesis of compounds
o The development of anti-infective agents
 Discovery of antiseptics and vaccines
 Improvement in drug administration
o Drug development in the 19th and 20th centuries
 New classes of pharmaceuticals
 Transitions in drug discovery
o Establishing the fight against infectious disease
 Early efforts in the development of anti-infective drugs
 Discovery of penicillin
o Discovery and development of hormones and vitamins
 Isolation of insulin
 Identification of vitamins
o Emergence of modern diseases and treatment
 Hypertension
 Early progress in cancer drug development
 Pharmaceutical industry in the modern era
 Drug discovery and development
o Drug development process
 Research and discovery
  Contribution of scientific knowledge to drug discovery
o Drug screening
 Sources of compounds
 Lead chemical identification
 Lead compounds from natural products
 Taxol and the Pacific yew
o Strategies for drug design and production
 Structure-activity relationship
 Computer-aided design of drugs
 Combinatorial chemistry
 Synthetic human proteins
 Drug regulation and approval
o Regulation by government agencies
 Public influence on drug regulation
 Objectives and organization of drug regulatory agencies
o Drug approval processes
 Drug applications
 The Investigational New Drug application
 The New Drug Application
 Safety testing in animals
 Toxicity tests
 Teratogenicity and mutagenicity tests
 Biopharmaceutical studies
 Pharmacokinetic investigation
 Dosage form development
 Tablets
 Capsules
 Other solid dosage forms
 Liquid dosage forms
 Semisolid dosage forms
 Specialized dosage forms
 Modified-release dosage forms
 Parenteral dosage forms
 Radiopharmaceuticals
 Obstacles in drug development
o Adverse reactions
o Postmarketing adverse drug events
o Drug interactions
o Drug patents
 Additional Reading
 Related Articles
 Citations

 Document Info
 Media
 Related Topics
 Additional Content
 Widgets & Gadgets
 Dictionary
  VIDEO

 Archival footage of Alexander Fleming and the production of

penicillin.[Credits : Encyclopædia Britannica, Inc.]

 IMAGES

 Penicillium notatum, the source of penicillin.[Credits : Carlo

Bevilacqua—SCALA/Art Resource, New York]

 Flowchart of research and discovery processes used for drug

development.[Credits : Encyclopædia Britannica, Inc.]

 industry
 pharmaceutical

 PHARMACEUTICAL PUBLICATIONS. B to B, April 7, 2008

 Pharmaceutical Economics. Business Economics, July 2008
 pharmaceuticals &fine chemicals. Chemical Week, August 9, 2006
 pharmaceuticals &fine chemicals. Chemical Week, July 21, 2008
 PHARMACEUTICALS &FINE CHEMICALS. Chemical Week, March 9, 2009

Search Dictionary

Overview
Public and private organizations involved in the discovery, development, and manufacture of
drugs and medications.

Historically, medicines were prepared by physicians and later by apothecaries. Today, drug
development relies on the collaboration and effort of highly trained scientists at universities
and private companies. The modern era of drug discovery and development originated in the
19th century when scientists learned how to isolate and purify medicinal compounds and
developed large-scale manufacturing techniques. As understanding of biology and chemistry
improved in the 20th century, the occurrence and severity of such diseases as typhoid fever,
poliomyelitis, and syphilis were greatly reduced. While many drugs, such as quinine and
morphine, are extracted from plant substances, others are discovered and synthesized by
techniques including combinatorial chemistry and recombinant DNA technology. The
pharmaceutical industry has greatly aided medical progress, and many new drugs have been
discovered and produced in industrial laboratories. Identifying new drug targets, attaining
regulatory approval, and refining drug discovery processes are among the challenges that the
pharmaceutical industry faces in the continual advancement of control and elimination of
disease.

Main
the discovery, development, and manufacture of drugs and medications (pharmaceuticals) by
public and private organizations.

The modern era of the pharmaceutical industry—of isolation and purification of compounds,
chemical synthesis, and computer-aided drug design—is considered to have begun in the 19th
century, thousands of years after intuition and trial and error led humans to believe that
plants, animals, and minerals contained medicinal properties. The unification of research in
the 20th century in fields such as chemistry and physiology increased the understanding of
basic drug-discovery processes. Identifying new drug targets, attaining regulatory approval
from government agencies, and refining techniques in drug discovery and development are
among the challenges that face the pharmaceutical industry today. The continual evolution
and advancement of the pharmaceutical industry is fundamental in the control and
elimination of disease around the world.

The following sections provide a detailed explanation of the progression of drug discovery
and development throughout history, the process of drug development in the modern
pharmaceutical industry, and the procedures that are followed to ensure the production of safe
drugs. For further information about drugs, see drug. For a comprehensive description about
the practice of medicine and the role of drug research in the health care industry, see
medicine.

History
The origin of medicines

Medicines of ancient civilizations

The oldest records of medicinal preparations made from plants, animals, or minerals are those
of the early Chinese, Hindu, and Mediterranean civilizations. An herbal compendium, said to
have been written in the 28th century bc by the legendary emperor Shennong, described the
antifever capabilities of a substance known as chang shan (from the plant species Dichroa
febrifuga), which has since been shown to contain antimalarial alkaloids (alkaline organic
chemicals containing nitrogen). Workers at the school of alchemy that flourished in
Alexandria, Egypt, in the 2nd century bc prepared several relatively purified inorganic
chemicals, including lead carbonate, arsenic, and mercury. According to De materia medica,
written by the Greek physician Pedanius Dioscorides in the 1st century ad, verdigris (basic
cupric acetate) and cupric sulfate were prescribed as medicinal agents. While attempts were
made to use many of the mineral preparations as drugs, most proved to be too toxic to be
used in this manner.

Many plant-derived medications employed by the ancients are still in use today. Egyptians
treated constipation with senna pods and castor oil and indigestion with peppermint and
caraway. Various plants containing digitalis-like compounds (cardiac stimulants) were
employed to treat a number of ailments. Ancient Chinese physicians employed ma huang, a
plant containing ephedrine, for a variety of purposes. Today ephedrine is used in many
pharmaceutical preparations intended for the treatment of cold and allergy symptoms. The
Greek physician Galen (c. 130–c. 200 ad) included opium and squill among the drugs in his
apothecary shop (pharmacy). Today derivatives of opium alkaloids are widely employed for
pain relief, and, while squill was used for a time as a cardiac stimulant, it is better known as a
rat poison. Although many of the medicinal preparations used by Galen are obsolete, he made
many important conceptual contributions to modern medicine. For example, he was among
the first practitioners to insist on purity for drugs. He also recognized the importance of using
the right variety and age of botanical specimens to be used in making drugs.

Pharmaceutical science in the 16th and 17th centuries

Pharmaceutical science improved markedly in the 16th and 17th centuries. In 1546 the first
pharmacopoeia, or collected list of drugs and medicinal chemicals with directions for making
pharmaceutical preparations, appeared in Nürnberg, Ger. Previous to this time, medical
preparations had varied in concentration and even in constituents. Other pharmacopoeias
followed in Basel (1561), Augsburg (1564), and London (1618). The London Pharmacopoeia
became mandatory for the whole of England and thus became the first example of a national
pharmacopoeia. Another important advance was initiated by Paracelsus, a 16th-century Swiss
physician-chemist. He admonished his contemporaries not to use chemistry as it had widely
been employed prior to his time in the speculative science of alchemy and the making of
gold. Instead, Paracelsus advocated the use of chemistry to study the preparation of
medicines.

In London the Society of Apothecaries (pharmacists) was founded in 1617. This marked the
emergence of pharmacy as a distinct and separate entity. The separation of apothecaries from
grocers was authorized by King James I, who also mandated that only a member of the
society could keep an apothecary’s shop and make or sell pharmaceutical preparations. In
1841 the Pharmaceutical Society of Great Britain was founded. This society oversaw the
education and training of pharmacists to assure a scientific basis for the profession. Today
professional societies around the world play a prominent role in supervising the education
and practice of their members.

In 1783 the English physician and botanist William Withering published his famous
monograph on the use of digitalis (an extract from the flowering purple foxglove, Digitalis
purpurea). His book, An Account of the Foxglove and Some of Its Medicinal Uses: With
Practical Remarks on Dropsy and Other Diseases, described in detail the use of digitalis
preparations and included suggestions as to how their toxicity might be reduced. Plants
containing digitalis-like compounds had been employed by ancient Egyptians thousands of
years earlier, but their use had been erratic. Withering believed that the primary action of
digitalis was on the kidney, thereby preventing dropsy (edema). Later, when it was
discovered that water was transported in the circulation with blood, it was found that the
primary action of digitalis was to improve cardiac performance, with the reduction in edema
resulting from improved cardiovascular function. Nevertheless, the observations in
Withering’s monograph led to a more rational and scientifically based use of digitalis and
eventually other drugs.

Isolation and synthesis of compounds

In the 1800s many important compounds were isolated from plants for the first time. About
1804 the active ingredient, morphine, was isolated from opium. In 1820 quinine (malaria
treatment) was isolated from cinchona bark and colchicine (gout treatment) from autumn
crocus. In 1833 atropine (variety of uses) was purified from Atropa belladonna, and in 1860
cocaine (local anesthetic) was isolated from coca leaves. Isolation and purification of these
medicinal compounds was of tremendous importance for several reasons. First, accurate
doses of the drugs could be administered, something that had not been possible previously
because the plants contained unknown and variable amounts of the active drug. Second, toxic
effects due to impurities in the plant products could be eliminated if only the pure active
ingredients were used. Finally, knowledge of the chemical structure of pure drugs enabled
laboratory synthesis of many structurally related compounds and the development of valuable
drugs.

Pain relief has been an important goal of medicine development for millennia. Prior to the
mid-19th century, surgeons took great pride in the speed with which they could complete a
surgical procedure. Faster surgery meant that the patient would undergo the excruciating pain
for shorter periods of time. In 1842 ether was first employed as an anesthetic during surgery,
and chloroform followed soon after in 1847. These agents revolutionized the practice of
surgery. After their introduction, careful attention could be paid to prevention of tissue
damage, and longer and more-complex surgical procedures could be carried out more safely.
Although both ether and chloroform were employed in anesthesia for more than a century,
their current use is severely limited by their side effects; ether is very flammable and
explosive and chloroform may cause severe liver toxicity in some patients. However, because
pharmaceutical chemists knew the chemical structures of these two anesthetics, they were
able to synthesize newer anesthetics, which have many chemical similarities with ether and
chloroform but do not burn or cause liver toxicity.

The development of anti-infective agents

Discovery of antiseptics and vaccines

Prior to the development of anesthesia, many patients succumbed to the pain and stress of
surgery. Many other patients had their wounds become infected and died as a result of their
infection. In 1865 the British surgeon and medical scientist Joseph Lister initiated the era of
antiseptic surgery in England. While many of the innovations of the antiseptic era are
procedural (use of gloves and other sterile procedures), Lister also introduced the use of
phenol as an anti-infective agent.

In the prevention of infectious diseases, an even more important innovation took place near
the beginning of the 19th century with the introduction of smallpox vaccine. In the late 1790s
the English surgeon Edward Jenner observed that milkmaids who had been infected with the
relatively benign cowpox virus were protected against the much more deadly smallpox. After
this observation he developed an immunization procedure based on the use of crude material
from the cowpox lesions. This success was followed in 1885 by the development of rabies
vaccine by the French chemist and microbiologist Louis Pasteur. Widespread vaccination
programs have dramatically reduced the incidence of many infectious diseases that once were
common. Indeed, vaccination programs have eliminated smallpox infections. The virus no
longer exists in the wild, and, unless it is reintroduced from caches of smallpox virus held in
laboratories in the United States and Russia, smallpox will no longer occur in humans. A
similar effort is under way with widespread polio vaccinations; however, it remains unknown
whether the vaccines will eliminate polio as a human disease.

Improvement in drug administration

While it may seem obvious today, it was not always clearly understood that medications must
be delivered to the diseased tissue in order to be effective. Indeed, at times apothecaries made
pills that were designed to be swallowed, pass through the gastrointestinal tract, be retrieved
from the stool, and used again. While most drugs are effective and safe when taken orally,
some are not reliably absorbed into the body from the gastrointestinal tract and must be
delivered by other routes. In the middle of the 17th century, Richard Lower and Christopher
Wren, working at the University of Oxford, demonstrated that drugs could be injected into
the bloodstream of dogs using a hollow quill. In 1853 the French surgeon Charles Gabriel
Pravaz invented the hollow hypodermic needle, which was first used in the treatment of
disease in the same year by Scottish physician Alexander Wood. The hollow hypodermic
needle had a tremendous influence on drug administration. Because drugs could be injected
directly into the bloodstream, rapid and dependable drug action became more readily
producible. Development of the hollow hypodermic needle also led to an understanding that
drugs could be administered by multiple routes and was of great significance for the
development of the modern science of pharmaceutics, or dosage form development.

Drug development in the 19th and 20th centuries

New classes of pharmaceuticals

In the latter part of the 19th century a number of important new classes of pharmaceuticals
were developed. In 1869 chloral hydrate became the first synthetic sedative-hypnotic (sleep-
producing) drug. In 1879 it was discovered that organic nitrates such as nitroglycerin could
relax blood vessels, eventually leading to the use of these organic nitrates in the treatment of
heart problems. In 1875 several salts of salicylic acid were developed for their antipyretic
(fever-reducing) action. Salicylate-like preparations in the form of willow bark extracts
(which contain salicin) had been in use for at least 100 years prior to the identification and
synthesis of the purified compounds. In 1879 the artificial sweetener saccharin was
introduced. In 1886 acetanilide, the first analgesic-antipyretic drug (relieving pain and fever),
was introduced, but later, in 1887, it was replaced by the less toxic phenacetin. In 1899
aspirin (acetylsalicylic acid) became the most effective and popular anti-inflammatory,
analgesic-antipyretic drug for at least the next 60 years. Cocaine, derived from the coca leaf,
was the only known local anesthetic until about 1900, when the synthetic compound
benzocaine was introduced. Benzocaine was the first of many local anesthetics with similar
chemical structures and led to the synthesis and introduction of a variety of compounds with
more efficacy and less toxicity.

Transitions in drug discovery

In the late 19th and early 20th centuries, a number of social, cultural, and technical changes
of importance to pharmaceutical discovery, development, and manufacturing were taking
place. One of the most important changes occurred when universities began to encourage
their faculties to form a more coherent understanding of existing information. Some chemists
developed new and improved ways to separate chemicals from minerals, plants, and animals,
while others developed ways to synthesize novel compounds. Biologists did research to
improve understanding of the processes fundamental to life in species of microbes, plants,
and animals. Developments in science were happening at a greatly accelerated rate, and the
way in which pharmacists and physicians were educated changed. Prior to this transformation
the primary means of educating physicians and pharmacists had been through
apprenticeships. While apprenticeship teaching remained important to the education process
(in the form of clerkships, internships, and residencies), pharmacy and medical schools began
to create science departments and hire faculty to teach students the new information in basic
biology and chemistry. New faculty were expected to carry out research or scholarship of
their own. With the rapid advances in chemical separations and synthesis, single pharmacists
did not have the skills and resources to make the newer, chemically pure drugs. Instead, large
chemical and pharmaceutical companies began to appear and employed university-trained
scientists equipped with knowledge of the latest technologies and information in their fields.

As the 20th century progressed, the benefits of medical, chemical, and biological research
began to be appreciated by the general public and by politicians, prompting governments to
develop mechanisms to provide support for university research. In the United States, for
instance, the National Institutes of Health, the National Science Foundation, the Department
of Agriculture, and many other agencies undertook their own research or supported research
and discovery at universities that could then be used for pharmaceutical development.
Nonprofit organizations were also developed to support research, including the Australian
Heart Foundation, the American Heart Association, the Heart and Stroke Foundation of
Canada, and H.E.A.R.T UK. The symbiotic relationship between large public institutions
carrying out fundamental research and private companies making use of the new knowledge
to develop and produce new pharmaceutical products has contributed greatly to the
advancement of medicine.

Establishing the fight against infectious disease

Early efforts in the development of anti-infective drugs

For much of history, infectious diseases were the leading cause of death in most of the world.
The widespread use of vaccines and implementation of public health measures, such as
building reliable sewer systems and chlorinating water to assure safe supplies for drinking,
were of great benefit in decreasing the impact of infectious diseases in the industrialized
world. However, even with these measures, pharmaceutical treatments for infectious diseases
were needed. The first of these was arsphenamine, which was developed in 1910 by the
German medical scientist Paul Ehrlich for the treatment of syphilis. Arsphenamine was the
606th chemical studied by Ehrlich in his quest for an antisyphilitic drug. Its efficacy was first
demonstrated in mice with syphilis and then in humans. Arsphenamine was marketed with
the trade name of Salvarsan and was used to treat syphilis until the 1940s, when it was
replaced by penicillin. Ehrlich referred to his invention as chemotherapy, which is the use of
a specific chemical to combat a specific infectious organism. Arsphenamine was important
not only because it was the first synthetic compound to kill a specific invading
microorganism but also because of the approach Ehrlich used to find it. In essence, he
synthesized a large number of compounds and screened each one to find a chemical that
would be effective. Screening for efficacy became one of the most important means used by
the pharmaceutical industry to develop new drugs.

The next great advance in the development of drugs for treatment of infections came in the
1930s, when it was shown that certain azo dyes, which contained sulfonamide groups, were
effective in treating streptococcal infections in mice. One of the dyes, known as Prontosil,
was later found to be metabolized in the patient to sulfanilamide, which was the active
antibacterial molecule. In 1933 Prontosil was given to the first patient, an infant with a
systemic staphylococcal infection. The infant underwent a dramatic cure. In subsequent years
many derivatives of sulfonamides, or sulfa drugs, were synthesized and tested for
antibacterial and other activities.

Discovery of penicillin

The first description of penicillin was published in 1929 by

the Scottish bacteriologist Alexander Fleming. Fleming had been studying staphylococcal
bacteria in the laboratory at St. Mary’s Hospital in London. He noticed that a mold had
contaminated one of his cultures, causing the bacteria in its vicinity to undergo lysis
(membrane rupture) and die. Since the mold was from the genus Penicillium, Fleming named
the active antibacterial substance penicillin. At first the significance of Fleming’s discovery
was not widely recognized. It was more than 10 years later before British biochemist Ernst
Boris Chain and Australian pathologist Howard Florey, working at the University of Oxford,
showed that a crude penicillin preparation produced a dramatic curative effect when
administered to mice with streptococcal infections.

The production of large quantities of penicillin was difficult with the facilities available to the
investigators. However, by 1941 they had enough penicillin to carry out a clinical trial in
several patients with severe staphylococcal and streptococcal infections. The effects of
penicillin were remarkable, although there was not enough drug available to save the lives of
all the patients in the trial.

In an effort to develop large quantities of penicillin, the collaboration of scientists at the

United States Department of Agriculture’s Northern Regional Research Laboratories in
Peoria, Ill., was enlisted. The laboratories in Peoria had large fermentation vats that could be
used in an attempt to grow an abundance of the mold. In England the first penicillin had been
produced by growing the Penicillium notatum mold in small containers. However, P. notatum
would not grow well in the large fermentation vats available in Peoria, so scientists from the
laboratories searched for another strain of Penicillium. Eventually a strain of Penicillium
chrysogenum that had been isolated from an overripe cantaloupe was found to grow very well
in the deep culture vats. After the process of growing the penicillin-producing organisms was
developed, pharmaceutical firms were recruited to further develop and market the drug for
clinical use. The use of penicillin very quickly revolutionized the treatment of serious
bacterial infections. The discovery, development, and marketing of penicillin provides an
excellent example of the beneficial collaborative interaction of not-for-profit researchers and
the pharmaceutical industry.
Citations
MLA Style:

"pharmaceutical industry." Encyclopædia Britannica. 2009. Encyclopædia Britannica

Online. 04 Nov. 2009
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APA Style:

pharmaceutical industry. (2009). In Encyclopædia Britannica. Retrieved November 04,

2009, from Encyclopædia Britannica Online:
[Link]

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