A drug (synonyms: drug , pharmaceutical agent , pharmaceutical agent ) is a substance in the manufacture of a medicament used as a medicinally effective ingredient. Usually the drug is processed into a drug in combination with one or more pharmaceutical excipients , but occasionally also without excipients.
The pharmacologically active substance ( active substance ) can be different from the active substance contained in the drug. So the pharmacologically active substance is sometimes z. B. incorporated into the drug in the form of its salt or a precursor substance (" prodrug ") used, which only becomes active after metabolism.
In addition to naturally occurring medicinal substances ( natural substances ), their partially synthetic derivatives and fully synthetic chemical medicinal substances are also used. Biotechnologically produced drugs are becoming increasingly important .
The term "medicinal substance" does not describe a special legal classification of a substance and therefore cannot form a negative distinction from other substances. Such substances can and may therefore also be placed on the market or used in other ways, unless this has been expressly prohibited (e.g. Drugs Act (AMG), BtMG ). There are many substances that, in addition to being used as active ingredients in pharmaceuticals, are also used as food, cosmetic or medical product components or as pharmaceutical excipients.
Natural substances are substances that are produced by living organisms such as plants, animals or microorganisms and can be obtained from them. The first pharmaceuticals consisted exclusively of natural substances, and pharmaceuticals with herbal ingredients ( phytopharmaceuticals ) are still very popular today , especially in self-medication .
Some natural substances are not extracted from biological material , but produced synthetically, semi-synthetically or biotechnologically , as this can be faster, safer and cheaper. In most cases, the complex structure of many natural substances prevents efficient total synthesis ( erythromycin , taxol , insulins, etc.). Natural substances are indispensable as key structures in pharmacology in many areas of application ( antibiotics , cytostatics , immunosuppressants ) .
Synthetically produced active ingredients - also known as synthetics - are the most widely used active ingredients in today's therapy. Increasing attention is being paid to the importance of the enantiomeric purity of synthetically produced substances, because molecular variants (enantiomers) of a chiral drug that are built up in mirror image to one another almost always have different effects. Only one of the two enantiomers usually has the desired pharmacological effect, whereas the other is ineffective or has undesired effects . In the past, this was often ignored due to a lack of knowledge of stereochemical relationships. While the majority of the newly approved chiral drugs on the market were introduced as racemates up to 2000 , more recently they have been almost exclusively pure enantiomers ( eutomers ). The entirety of all pharmaceuticals accessible by synthetic means is also referred to as chemical space .
Biotechnologically produced substances
Genetic engineering is an important branch of pharmaceutical biotechnology . Genetically engineered active ingredients are produced biotechnologically with the help of microorganisms (bacteria, yeast ) or mammalian cells in large fermenters . In new processes, active ingredients are also produced directly by mammals (e.g. in milk, e.g. antithrombin α ) or plants (e.g. in fruits). The first genetically engineered active ingredients were still nature-identical. In the meantime, the active ingredients are often genetically modified so that they have a particularly targeted effect. So acts z. B. the genetically modified erythropoietin (EPO) variant darbepoetin α is particularly specific against anemia . Currently, five percent of the approved active ingredients are of genetic engineering origin, although 15 to 25 percent of the active ingredients introduced each year are now of genetic engineering origin.
The traditional list of medicinal substances in use is the pharmacopoeia . It describes the specifications (qualitative and quantitative limit values) and the test methods for the individual medicinal products in detailed monographs.
The World Health Organization (WHO) publishes the recommended non-proprietary names ( International Nonproprietary Names , INN ) it has assigned for drugs in continuous lists . In Germany, the drug substance catalog (ASK) contains, as a synonym and reference register, the legally binding substance names for finished medicinal products in accordance with Paragraph 6, AMG .
The Pharmaceutical Substance List is an extensive collection of substances, which, based on data from the ABDA database, contains information on the characterization, substance classification and area of application of many medicinally and pharmaceutically relevant substances worldwide.
For systematic reasons, finished medicinal products are generally not recorded in the pharmacopoeia. In drug registers such as the Red List or the Yellow List , the composition of finished drugs is recorded including the amount of the drug contained, the area of application, the dosage, the manufacturer, the price and other details.
- Biogenic drugs
- Anatomical-therapeutic-chemical classification system
- Pharmaceutical residues in food and the environment
- Pharmaceutical Substances , Axel Kleemann , Jürgen Engel, Bernd Kutscher and Dieter Reichert, 4th edition (2000), Thieme-Verlag Stuttgart, ISBN 978-1-58890-031-9 .
- Pharmaceutical Synthesis , Hermann Josef Roth and Axel Kleemann, published by Thieme-Verlag Stuttgart (1982), ISBN 978-3-13-632901-6 .
- Drug Production , Axel Kleemann and Hermann Josef Roth, published by Thieme-Verlag Stuttgart (1983), ISBN 3-13-638501-2 .
- Organic-Chemical Drugs and Their Synonyms , Martin Negwer and Hans-Georg Scharnow, Wiley-VCH, Weinheim, (2007), ISBN 3-527-30247-6 .
- Drugs in the environment (UmweltWissen - Bavarian State Office for the Environment; PDF file; 416 kB)
- apisourcing.net : database of drug producers
- See also Franz-Christian Czygan : Possibilities for the production of medicinal substances through plant tissue cultures. In: Planta med. Supplement 1975, pp. 169-185.
- Hermann J. Roth, Christa E. Müller and Gerd Folkers: Stereochemie & Arzneimittel , Wissenschaftliche Verlagsgesellschaft Stuttgart, 1998 , ISBN 3-8047-1485-4 .
- EJ Ariëns: Stereochemistry, a basis for sophisticated nonsense in pharmacokinetics and clinical pharmacology , European Journal of Clinical Pharmacology 26 ( 1984 ) 663-668, doi : 10.1007 / BF00541922 .
- Hisamichi Murakami: From Racemates to Single Enantiomers - Chiral Synthetic Drugs over the last 20 Years , Topics in Current Chemistry 269 ( 2007 ) 273-299, doi : 10.1007 / 128_2006_072 .
- Association of Research-Based Pharmaceutical Manufacturers : Approved Genetic Drugs in Germany , November 8, 2010.
- For example in the European Pharmacopoeia, Deutscher Apotheker Verlag Stuttgart, 9th edition, basic work 2017 including 1st to 8th addendum 2019, ISBN 978-3-7692-7532-2 . Table of contents visible.
- Database information on ABDA drugs at DIMDI , accessed on April 9, 2020.