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Developmental Drug Natalie Garza

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Page 1: Drug Development Project

Developmental

Drug

Natalie Garza

Page 2: Drug Development Project

Aspirin Source of Origin: Aspirin comes from the bark of a willow and spiraea.

History: There are scrolls that state that Hippocrates used to use a powder that was made from

the plants that make aspirin. In 1853 Charles Frederic Gerhardt was the first to prepare

acetylsalicylic acid. The drug has always been used in medicine as a painkiller. It works as an

anti clotting agent that reduces the risk of clotting disease.

Page 3: Drug Development Project

Beano

Source of Origin: Beano is made from wheat and uses the fungus, Aspergillus niger.

History: Beano was developed in 1990 by Alan Kligerman of AkPharma after research into gas-causing

vegetables that had begun in 1981. The idea for such a product was proposed at least as early as the

1780s in Benjamin Franklin's essay "A Letter To A Royal Academy”.

Use in Medicine: Beano has always been used to stop flatulence.

Page 4: Drug Development Project

Quinine Source of Origin: Quinine is from the ground bark of the cinchona trees.

History of Use: The Quechua Indians used it in South America and the Romans had been using it

since 1613. It is used for its anti-inflammatory properties. It can also be used as treatment for

malaria and can treat lupus and arthritis.

Use in Medicine: The cardiac effects of cinchona bark were noted in academic medicine at the

end of the 17th century. Quinine was used throughout the first half of the 18th century for

cardiac problems and arrhythmia and it became a standard of cardiac therapy in the second

half of the 19th century. In 1820 an alkaloid chemical in the bark which had an extremely high

antimalarial effect and named it quinine. In 1944 scientists were able to synthesize the quinine

alkaloid in the laboratory. This led to various synthesized and patented quinine drugs which

were manufactured by several pharmaceutical companies and which were of course, highly

profitable.

Natural quinine bark is still used in herbal medicine today around the world. In Brazil it is used

as malaria treatment as well as treatment for anemia, indigestion, digestive stimulant and

fever-reducer. In Europe the bark is considered antiprotozoal, antispasmodic, antimalarial and

a fever reducer. It’s used for appetite stimulant, for hair loss, liver, spleen, to treat irregular

heartbeat. In the U.S. it is used for digestive aid and to reduce heart palpitations, headaches

and for its astringent, bactericidal and anesthetic actions.

Page 5: Drug Development Project

Cocaine Source of Origin: Cocaine comes from the leaves of the coca plant.

History: It used to be that in the Andean Indian culture, the coca plant was linked to one of their goddess. The leaves of the coca plant were chewed or smoked to help these natives connect with spiritual beings, as well as provide magical protection and powers. When the Spanish invaded the Incas land, they tried to outlaw the chewing of coca leaves. But it soon became apparent that the Incas worked better when they were given leaves to chew. Coca leaves give the user a boost of energy, as well as prevents hunger. Cocaine was first extracted from the coca plant in the 1860s. At first it seemed to be a miracle drug that was useful in treating depression and morphine addiction, and it was prescribed by many physicians for various reasons.

Use in Medicine: Cocaine was first used in medicine to anesthetize the surface of the human

eye in 1884. It was a large breakthrough because they did not have true painkillers at the time.

It was described as a ‘miracle cure’ for everything. There were cocaine syrups, pastilles, wines,

tonics and elixirs. For example Reyno’s Hay Fever remedy was nearly a pure cocaine solution.

In 1900 it was one of the top five pharmaceutical products in the US. Now only synthetic

Page 6: Drug Development Project

versions of the chemicals in cocaine are used in medicine like Novocain and the chemicals that

go into epidurals.

Page 7: Drug Development Project

Marijuana Source of Origin: Comes from the cannabis plant, typical herbal form of cannabis consists of

the flowers and subtending leaves and stalks of mature pistillate female plants.

History: 3rd millennium BC, as indicated by charred cannabis seeds found in a ritual brazier at an ancient burial site in present day Romania. Cannabis leaf fragments and seeds was found next to a 2,500- to 2,800-year-old mummified shaman in the northwestern Xinjiang Uygur Autonomous Region of China. Cannabis is also known to have been used by the ancient Hindus thousands of years ago. Cannabis was also known to the ancient Assyrians. Cannabis has an ancient history of ritual use and is found in pharmacological cults around the world. Hemp seeds discovered at Pazyryk suggest early ceremonial practices like eating by the Scythians occurred during the 5th to 2nd century BC. Some believe that cannabis was even used for religious sacrament by ancient Jews and early Christians due to the similarity between the Hebrew word "qannabbos" ("cannabis") and the Hebrew phrase "qené bósem" ("aromatic cane"). It was used by Muslims in various Sufi orders as early as the Mamluk period, for example by the Qalandars.

How the Drug Has Been Used In Medicine:

Medical cannabis has established effects in the treatment of nausea, vomiting , unintentional weight loss, insomnia, and lack of appetite. Other "relatively well-confirmed" effects were in the treatment of spasticity, painful conditions, especially neurogenic pain, movement disorders, asthma, and glaucoma. Findings indicate that cannabis-based drugs could prove useful in treating inflammatory bowel disease, migraines, fibromyalgia, and related conditions. In America it is not a treatment that is suggested anymore because drug abuse runs wild with this drug and is said to be a gateway drug.

Page 8: Drug Development Project

Popular Antibiotics

Penicillin

Is derived from fungi. From ancient Greece and Indian people have thought using

molds were useful in treating infections. 1874 a scientist in England noticed that there

was not much bacterial growth if Penicillium glaucum was present. In 1875 John

Tyndall demonstrats to the Royal Society the antibacterial action of the Penicillium

fungus. Louis Pasteur and Jules Francois Joubert observed that cultures of the anthrax

bacilli, when contaminated with moulds, became inhibited in1877. Alexander Flemming

in 1928 concluded that the mould was releasing a substance that was inhibiting

bacterial growth. During the next twelve years, he grew and distributed the original

mould, unsuccessfully trying to get help from any chemist that had enough skill to make

a stable form of it for mass production. By 1943 Moyer, Coghill and Raper at

the USDA Northern Regional Research Laboratory (NRRL) developed methods for

industrialized penicillin production and isolated higher-yielding strains of

the Penicillium fungus.

Penicillin kills bacteria by interfering with the ability to synthesize cell

wall. The bacteria lengthen, but cannot divide. Eventually the weak

cell wall ruptures.

In this picture the bacteria are completely healthy, thick cell walls

and are dividing like normal.

The bacteria are exposed to penicillin.

Page 9: Drug Development Project

The bacteria lengths like normal but cannot synthesis the cell wall

properly, therefore putting pressure on existing wall.

The cell wall ruptures, meaning the bacteria is killed.

Page 10: Drug Development Project

Bacitracin

Is made from bacteria. It first isolated by John T. Goorley and was approved by the

FDA in 1948. Bacitracin was originally discovered in 1945. The first active strain of the

bacteria, Bacillus subtilis var Tracy--which is commonly found in soil--was found within

the body of a patient named "Tracy I." The bacteria was harvested from a severe

fracture of her tibia, a leg bone. and then was scientifically engineered into an

antibacterial agent. Since the bacteria strain was originally found in her body, the

antibacterial agent was named after her

It is generally found in the form of a topical ointment as it lacks effectiveness if

administered orally.

In this picture the bacteria are completely healthy, thick cell walls

and are dividing like normal.

The bacteria are exposed to penicillin.

The bacteria lengths like normal but cannot synthesis the cell wall

properly, therefore putting pressure on existing wall.

Page 11: Drug Development Project

The cell wall ruptures, meaning the bacteria is killed.

Page 12: Drug Development Project

Cephalosporins

Is derived from fungi. Was first isolated from cultures of cephalosphorium acremonium

from a sewer in Sardinia in 1948 by Giuseppe Brotzu. Cephalosporin compounds were

first isolated from cultures of Cephalosporium acremonium from a sewer in Sardinia in

1948 by Italian scientist Giuseppe Brotzu. He noticed that these cultures produced

substances that were effective against Salmonella typii, the cause of typhoid fever,

which had beta-lactamase. Guy Newton and Edward Abraham at the Sir William Dunn

School of Pathology at the University of Oxford isolated cephalosporin C. The

cephalosporin nucleus, 7-aminocephalosporanic acid (7-ACA), was derived from

cephalosporin C and proved to be analogous to the penicillin nucleus 6-

aminopenicillanic acid (6-APA), but it was not sufficiently potent for clinical use.

Modification of the 7-ACA side-chains resulted in the development of useful antibiotic

agents, and the first agent cefalotin (cephalothin) was launched by Eli Lilly and

Company.

Cephalosporins is useful because it is safe and prescribed for a wide range of

infections. Caphalosporins is also available in different forms for convenient

administration. It is seen as so safe and effective that most doctors prescribe it while

waiting for culture results. It can be used to treat everything from infections in the

bones, respiratory tract or urinary system.

Page 13: Drug Development Project

Genetically Modified Drug

ATryn

ATryn is an anticoagulant antithormbin. It is made from milk of goats that have been

genetically modified to produce human antithormbin, a plasma protein with anticoagulant

properties. The gene was chosen because it was the gene that controlled the ability to create

antithormbin. Microinjection was used to insert human antithrombin genes into the cell

nucleus of their embryos. One genetically modified goat can produce the same amount of

antithrombin in a year as 90,000 blood donations. Goats were chosen because they reproduce

faster than cows and produce more protein than rabbits and mice. Then seeing its ability as a

pharmaceutical it went through the appropriate clinical trials until the drug was approved by

the FDA to be effective and safe.

Page 14: Drug Development Project

The gene that controls the ability to create antithormbin was spliced out and inserted into the

nucleuses of goat embryos.

This modified embryo is then inserted into a female goat.

Then when the goat gets older milk is harvested and the protein can be taken out and used to

treat people who need anticoagulant.

Page 15: Drug Development Project
Page 16: Drug Development Project

Large Scale Bioreactor

The large tank is filled with the bacteria which are growing in a nutrient broth. The arrows at

the bottom symbolize the tube that is aerating the tank which is good for bacteria growth. The

arrows pointing out at the top represent air outlets, so that air being pumped into the tank can

easily escape without causing pressure issues. The red tubes are pipelines that lead to treated

water tanks. This is a good design because it allows the bacteria to be grown in a clean

environment without contaminates, and can grow a large amount so it can be used for

pharmaceuticals.

Page 17: Drug Development Project

Small Scale Bioreactor

This is my small scale bioreactor the bacteria is placed in the Erlenmeyer flask

(yellow arrow) along with a nutrient broth (light blue arrow), and a stopper with

holes for the three tubes (black arrow). The tube (purple arrow) is connected to a

air pump (pink arrow) which in turn aerates the broth. The red arrow displays the

tube that allows air to flow out of the Erlenmeyer flask so that the pressure

doesn’t build up in the flask. The tube pointed to by the dark blue arrow allows

the bacterium broth to be taken up in the syringe (green arrow) so that it can be

cultured.

Page 18: Drug Development Project

Developmental Drug

If I was going to create a drug I would work to create a cancer vaccine. I learned of this

possibility while on my internship that at M.D. Anderson they are working on creating cancer

vaccines from large amounts of plasma genetically altered. This medication would be

preventative because it would allow people with a high risk of developing cancer to lower their

chances and give them the chance to live a life without chemotherapy and all the challenges

alone with it. I believe this would work because it would work similar to common viral vaccines

in that it would strength the patient’s immune system to better recognize cancer cells early on

so that they can be killed before they multiply enough to create a tumor.

To create my product I would first have to acquire the latest in lab technology and host a

very large blood drive with disclaimers this blood would be used for research. These blood

drives would have to held at least every six months. Now with the blood I attained I would

have to strain out the plasma for each specimen. In the process of cleaning the samples genes

preferable identified to help better distinguish defective cells from healthy cells would need to

be spliced and ligated into bacteria plasmids. Then the plasmids would be inserted into the

healthy purified plasma cells and allowed to grow in a cell media. Then the plasmids would

need to be inserted into a test animal and therefore start animal testing. The next several steps

would be the tedious process of independent labs testing the product to be safe and effective

so in approximately 7 years or possibly more since it’s a new process it can be seen as a

revolutionary treatment and be approved by the FDA.

Page 19: Drug Development Project

There would be many obstacles in creating this vaccine because the technology alone is

very complex and will take years to decipher a basic version of this product. There is also the

problem of money, the materials and technology to create this product, coupled with the large

amount of time spent on it will cost lots of money no small feat to overcome. The last and

possibly largest obstacle will be social, the idea leads to a task that will be very complex and to

get the go ahead to proceed would be very difficult, also with the fact that the plasma needed

to make this product entails that a large amount of blood will be needed. Not everyone will like

this vaccination because it comes from blood and some religions do not agree with accepting

blood from any outside source.