Pharmaceutical engineering is a branch of

engineering Engineering is the use of scientific method, scientific principles to design and build machines, structures, and other items, including bridges, tunnels, roads, vehicles, and buildings. The discipline of engineering encompasses a broad rang ...

focused on discovering, formulating, and manufacturing

medication A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and re ...

, analytical and quality control processes, and on designing, building, and improving manufacturing sites that produce drugs. It utilizes the fields of

chemical engineering Chemical engineering is an engineering field which deals with the study of operation and design of chemical plants as well as methods of improving production. Chemical engineers develop economical commercial processes to convert raw materials int ...

biomedical engineering Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare purposes (e.g., diagnostic or therapeutic). BME is also traditionally logical sciences ...

pharmaceutical sciences Pharmacy is the science and practice of discovering, producing, preparing, dispensing, reviewing and monitoring medications, aiming to ensure the safe, effective, and affordable use of medicines. It is a miscellaneous science as it links healt ...

, and

industrial engineering Industrial engineering is an engineering profession that is concerned with the optimization of complex process (engineering), processes, systems, or organizations by developing, improving and implementing integrated systems of people, money, kno ...

History

Humans have a long history of using derivatives of natural resources, such as plants, as medication. However, it was not until the late 19th century when the technological advancements of chemical companies were combined with medical research that scientists began to manipulate and engineer new medications, drug delivery techniques, and methods of mass production.

Synthesizing new medications

One of the first prominent examples of an engineered, synthetic medication was made by Paul Erlich. Erlich had found that Atoxyl, an arsenic-containing compound which is harmful to humans, was very effective at killing

Treponema pallidum ''Treponema pallidum'', formerly known as ''Spirochaeta pallida'', is a spirochaete bacterium with various subspecies that cause the diseases syphilis, bejel (also known as endemic syphilis), and yaws. It is transmitted only among humans. It is ...

, the bacteria which causes

syphilis Syphilis () is a sexually transmitted infection caused by the bacterium ''Treponema pallidum'' subspecies ''pallidum''. The signs and symptoms of syphilis vary depending in which of the four stages it presents (primary, secondary, latent, an ...

. He hypothesized that if the structure of Atoxyl was altered, a “magic bullet” could potentially be identified which would kill the parasitic bacteria without having any adverse effects on human health. He developed many compounds stemming from the chemical structure of Atoxyl and eventually identified one compound which was the most effective against syphilis while being the least harmful to humans, which became known as

Salvarsan Arsphenamine, also known as Salvarsan or compound 606, is a drug that was introduced at the beginning of the 1910s as the first effective treatment for syphilis, relapsing fever, and African trypanosomiasis. This organoarsenic compound was the fi ...

. Salvarsan was widely used to treat syphilis within years of its discovery.

Beginning of mass production

Equipment used for making early forms of penicillin

In 1928,

Alexander Fleming Sir Alexander Fleming (6 August 1881 – 11 March 1955) was a Scottish physician and microbiologist, best known for discovering the world's first broadly effective antibiotic substance, which he named penicillin. His discovery in 1928 of w ...

discovered a mold named

Penicillium chrysogenum ''Penicillium chrysogenum'' (formerly known as ''Penicillium notatum'') is a species of fungus in the genus ''Penicillium''. It is common in temperate and subtropical regions and can be found on salted food products, but it is mostly found in in ...

which prevented many types of bacteria from growing. Scientists identified the potential of this mold to provide treatment in humans against bacteria which cause infections. During

World War II World War II or the Second World War, often abbreviated as WWII or WW2, was a world war that lasted from 1939 to 1945. It involved the vast majority of the world's countries—including all of the great powers—forming two opposin ...

, the United Kingdom and the United States worked together to find a method of mass producing

penicillin Penicillins (P, PCN or PEN) are a group of β-lactam antibiotics originally obtained from ''Penicillium'' moulds, principally '' P. chrysogenum'' and '' P. rubens''. Most penicillins in clinical use are synthesised by P. chrysogenum using ...

, a derivative of the Penicillium mold, which had the potential to save many lives during the war since it could treat infections common in injured soldiers. Although penicillin could be isolated from the mold in a laboratory setting, there was no known way to obtain the amount of medication needed to treat the quantity of people who needed it. Scientists with major chemical companies such as

Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...

were able to develop a deep-fermentation process which could produce a high yield of penicillin. In 1944, Pfizer opened the first penicillin factory, and its products were exported to aid the war efforts overseas.

Controlled drug release

Tablets for oral consumption of medication have been utilized since approximately 1500 B.C.; however, for a long time the only method of drug release was immediate release, meaning all of the medication is released in the body at once. In the 1950s, sustained release technology was developed. Through mechanisms such as

osmosis Osmosis (, ) is the spontaneous net movement or diffusion of solvent molecules through a selectively-permeable membrane from a region of high water potential (region of lower solute concentration) to a region of low water potential (region of ...

and diffusion, pills were designed that could release the medication over a 12-hour to 24-hour period.

Smith, Kline & French Smith, Kline & French (SKF) was an American pharmaceutical company. History In 1830, John K. Smith opened a drugstore in Philadelphia, and his younger brother, George, joined him in 1841 to form John K Smith & Co. In 1865, Mahlon Kline joined ...

developed one of the first major successful sustained release technologies. Their formulation consisted of a collection of small tablets taken at the same time, with varying amounts of wax coating that allowed some tablets to dissolve in the body faster than others. The result was a continuous release of the drug as it travelled through the intestinal tract. Although modern day research focuses on extending the controlled release timescale to the order of months, once-a-day and twice-a-day pills are still the most widely utilized controlled drug release method.

Formation of the ISPE

In 1980, the International Society for Pharmaceutical Engineering was formed to support and guide professionals in the pharmaceutical industry through all parts of the process of bringing new medications to the market. The ISPE writes standards and guidelines for individuals and companies to use and to model their practices after. The ISPE also hosts training sessions and conferences for professionals to attend, learn, and collaborate with others in the field.

References