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Are Excipients used in Formulation Development Inert?

Are Excipients used in Formulation Development Inert?

We add spices to a meal for enhancing its taste and acceptance. Similarly, we have to add many additives in drug formulations to enhance their performance. These additives, also called excipients play a major role in the development of drug formulations. They hold together the components of the active drug substance and make it stable, palatable, and acceptable to the patients.

However, we often define the excipients as inert or inactive compounds which are added to the drug formulations. But, are they really inert?

To find an answer, let us see the effects of the excipients on active drug substances.

  • Excipients directly influence the dissolution rate and rate of absorption of the drug
  • They can facilitate or inhibit the penetration of the drug substance inside the tumour cell
  • Propylene glycol, a general solvent used in drug formulations has been linked to the toxic effects on the heart, liver, lungs, and brain.
  • Sucrose, used as a sweetening agent can cause dental caries in high concentrations.

With these pieces of evidence in hand, the excipients can no longer be considered as inert compounds. They further suggest that a wrong excipient at the wrong place or a wrong dose of the excipient can lead to serious health problems.

Therefore, formulation scientists should investigate the hazardous effects of excipients besides the active drug for a safe formulation development.

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