Excipients are defined as substances other than the Active Pharmaceutical Ingredients (APIs) used in the formulation of a drug product for long-term stabilization. They play an integral role in the formulation of a stable medicinal drug and its administration. Ideally, an excipient does not demonstrate any medicinal property but facilitates the absorption of the drug.

Since excipients are an important part of the drug development process, it is necessary to choose the right excipient (or combination of excipients) for the drug in focus. There are following types of excipients that can be used individually as well as in combination:

  • Acidifying/alkalizing agent
  • Aerosol propellant
  • Antifoaming
  • Antimicrobial preservatives
  • Antioxidant
  • Binder
  • Buffering agent
  • Bulking agent (freeze-drying)
  • Chelating/sequestering agent
  • Coating agent
  • Coloring, flavour, perfume
  • Diluent
  • Disintegrant
  • Emulsifying/solubilizing/wetting agent
  • Glidant, anticaking agent
  • Humectant
  • Lubricant
  • Ointment/suppository base
  • Plasticizer
  • (Co)solvent
  • Stiffening agent
  • Suspending/viscosity-increasing agent
  • Sweetening agent
  • Tonicity agent
  • Vehicle
 

Role of Excipients

Though non-active excipients play important role in the formulation of a drug product, they are necessary for successful drug delivery. Some of the major roles that excipients have are:

  • Accelerating the process of drug delivery by aiding the manufacturing process
  • Enhancing and safeguarding the stability of the drug
  • Supporting the identification of the product while enhancing its safety
  • Enhancing the effectiveness and delivery of the drug
  • Maintaining the integrity of the drug product

Even though the excipients are inert substances in the drug product, they still may lead to adverse effects, if not used correctly. Therefore, identifying, analyzing and using the right excipient is necessary to ensure safe outcome of the drug. For assistance regarding excipients, reach out to Freyr at sales@freyrsolutions.com.