ANTIBIOTICS PRODUCTION (other topics)
The production of a new antibiotic is lengthy and costly. First, the organism that makes the antibiotic must be identified and the antibiotic tested against a wide variety of bacterial species. Then the organism must be grown on a scale large enough to allow the purification and chemical analysis of the antibiotic and to demonstrate that it is unique. This is a complex procedure because there are several thousand compounds with antibiotic activity that have already been discovered, and these compounds are repeatedly rediscovered. After the antibiotic has been shown to be useful in the treatment of infections in animals, larger-scale preparation can be undertaken.
Commercial development requires a high yield and an economic method of purification. Extensive research may be needed to increase the yield by selecting improved strains of the organism or by changing the growth medium. The organism is then grown in large steel vats, in submerged cultures with forced aeration. The naturally fermented product may be modified chemically to produce a semisynthetic antibiotic. After purification, the effect of the antibiotic on the normal function of host tissues and organs (its pharmacology), as well as its possible toxic actions (toxicology), must be tested on a large number of animals of several species. In addition, the effective forms of administration must be determined. Antibiotics may be topical, applied to the surface of the skin, eye, or ear in the form of ointments or creams. They may be oral, or given by mouth, and either allowed to dissolve in the mouth or swallowed, in which case they are absorbed into the bloodstream through the intestines. Antibiotics may also be parenteral, or injected intramuscularly, intravenously, or subcutaneously; antibiotics are administered parenterally when fast absorption is required.
In the United States, once these steps have been completed, the manufacturer may file an Investigational New Drug Application with the Food and Drug Administration (FDA). If approved, the antibiotic can be tested on volunteers for toxicity, tolerance, absorption, and excretion. If subsequent tests on small numbers of patients are successful, the drug can be used on a larger group, usually in the hundreds. Finally a New Drug Application can be filed with the FDA, and, if this application is approved, the drug can be used generally in clinical medicine. These procedures, from the time the antibiotic is discovered in the laboratory until it undergoes clinical trial, usually extend over several years.
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