Glossary of pharmaceutical and GMP terms with explanations

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).

Excipients

Excipients are crucial for the development of effective, safe and high-quality drugs.

Excipients in pharmacy are all ingredients that are not active pharmaceutical ingredients and that are added to a dosage form in order to achieve or improve certain properties in the end product. These substances have no direct therapeutic effect, but play an important role for the manufacturing process, stability, safety and efficacy of the drug.

Examples of different classes of excipients (German translation: Hilfsstoffe):

  • Fillers (German: Füllstoffe): They are used to increase the volume of a drug, especially when the active pharmaceutical ingredient is required in very small quantities.
  • Binding agent: They bind the powders in tablets and help to retain shape of the tablet.
  • Disintegrants (German translation: Zerfallsbeschleuniger): Promote the disintegration of tablets or capsules after entering the gastrointestinal tract to ensure the release of the active pharmaceutical ingredients.
  • Film formers: They form a protective film around the tablet or granules, which can improve the taste, protect the drug from environmental influences or control the release of the active pharmaceutical ingredient.
  • Colorings and flavorings: Improve the appearance and taste of the drug and thus also patient compliance.
  • Preservatives (translation into German: Konservierungsmittel): They prevent the growth of microorganisms in products that contain water and extend their shelf life.
  • Emulsifiers and stabilizers: They help to maintain the homogeneity of the composition and stability of emulsions.

Excipients are crucial for the development of effective, safe and high-quality drugs. They ensure the right consistency, stability and bioavailability of active pharmaceutical ingredients and facilitate the manufacturing and packaging process. When selecting excipients and their quantities, pharmaceutical manufacturers must comply with strict legal regulations and quality standards in order to ensure drug safety and efficacy.

At GMP-inspection.com, we provide you with seasoned pharmaceutical interpreters and GMP translators who can support you during your GMP inspection in Russian or English. We also prepare specialist translations of your SOPs and other pharmaceutical documents.

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