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Pharmaceutical Excipients and Drug Formulation

Pharmaceutical excipients are substances that are included in a pharmaceutical dosage form not for their direct therapeutic action, but to aid the manufacturing process, to protect, support or enhance stability, or for bioavailability or patient acceptability.

Pharmaceutical excipients are no longer inert materials but it is effective and able to improve the characteristics of the products' quality, stability, functionality, safety, solubility and acceptance of patients. It can interact with the active ingredients and alter the medicament characteristics.

A successful pharmaceutical formulation development requires the combination of the active pharmaceutical ingredient (API) with inactive excipients. Excipients may be simple bulking agents, designed to aid control of the dose content uniformity. Increasingly, though, some excipients have a functional role in controlling drug release or ensuring the drug reaches the desired site of action. Here, compatibility between the selected excipient and the drug substance is critical in ensuring the correct dose is delivered within the required therapeutic window.


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