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Role of Excipients in Formulation Development

Role of Excipients in Formulation Development

An excipient, also known as the pharmaceutical inactive ingredient, is a substance that is formulated along with the active drug substance during the manufacture of the medicinal product. It is intended to act as a carrier of the active drug substance and contribute to its stability, pharmaceutical profile, appearance, and patient acceptability.

In other words, it’s rare to find a drug containing only the active drug substance.

The various functions performed by the excipient in drug formulation development are highlighted below.

  • Holds the ingredients of the drug together
  • Improves the solubility of the active ingredient
  • Enhances the stability of the formulated drug with respect to temperature, humidity etc.
  • Imparts weight, accuracy, and volume to the active drug substance
  • Modifies the drug release in a patient; slow or fast releasing
  • Increases the patient’s acceptance of the drug by making it palatable
  • Improves the appearance of the drug formulation
  • Facilitates designing of drug dosage
  • Facilitates active absorption of the drug in the patient’s digestive tract
  • Enhances the bioavailability of the drug i.e. what amount of the active ingredient will reach the systemic circulation or the target organ in patients

Thus, not only the active ingredient but also the excipient must be chosen wisely to avoid any adverse effects on the patient’s health.

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