In this section of GMP-inspection.com, our translators provide definitions and explanations of various specialized terms from the pharmaceutical industry and GMP (Good Manufacturing Practice).
Pharmaceutical technology, also called pharmaceutics, is a subfield of pharmacy and deals with the technological processes and practical methods for the manufacture and testing of drugs. A subfield of pharmaceutical technology, on the other hand, is pharmaceutical formulation, i.e. the science of preparing active pharmaceutical ingredients in a specific form, such as capsules, ointments or injection solutions.
When an active pharmaceutical ingredient (API) is converted into a drug (British English: medicinal product), it is only then that a patient can apply and dose an API. In addition, the pharmaceutical formulation (German translation: Formulierung) must ensure the stability and dosing accuracy of the drug. Pharmaceutical technology covers all the steps involved in converting an active pharmaceutical ingredient into a dosage form and examines its physical properties, such as the disintegration time of a tablet.
As a rule, an active pharmaceutical ingredient (German: Wirkstoff) cannot simply be administered as such, but must first be formulated with certain excipients (German translation: Hilfsstoffe) to create a dosage form that can then be used on patients. For example, an antifungal API cannot simply be sprinkled onto the skin; it must first be formulated into a cream with a base and additives such as emulsifiers and preservatives before it can be used to treat a skin disease. In the case of peroral dosage forms, the drug must be individually dosed and sometimes enteric-coated (i.e. resistant to degradation in gastric acid), which requires a formulation. The pure active pharmaceutical ingredient usually cannot usually be pressed into a tablet. Moreover, a tablet must be easy to swallow and taste as good or as neutral as possible, which is why a coating is sometimes necessary. The chemical and physical properties of the respective API(s) must always be taken into account.
In addition to the development and design of dosage forms, pharmaceutical technology is concerned with the practical manufacture of drugs such as grinding or granulating powders, pressing tablets or preparing solutions, etc. Testing the manufactured dosage forms provides information about drug quality and is an essential step in drug manufacturing.
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