Essential elements influencing future of therapy

EXCIPIENTS are important parts of pharmaceutical formulations that are used to turn active pharmaceutical ingredients (APIs) into medicines that are safe, effective, and stable enough for patients to use.

- INDU RAGHUNATH

Excipients do not have any pharmacological effects, but they do affect many parts of a drug product's performance, such as how well it is made, how stable it is in dosage form, how quickly it is released, and how well it is accepted by patients. Their importance goes well beyond being simple fillers; they are carefully chosen materials whose properties and functions are essential to the success of both basic and advanced drug delivery systems.

Types and Functions of Excipients

Excipients are chemically diverse materials categorised according to their roles within a formulation. The main types include:

• Fillers (Diluents): Such as lactose and microcrystalline cellulose, these excipients increase the volume of a dosage form, enabling practical tablet or capsule sizes especially when the API concentration is low.

• Binders: Examples like povidone and starch provide cohesion within the powder blend, ensuring tablets possess adequate mechanical strength and do not disintegrate prematurely during handling.

• Disintegrants: Including croscarmellose sodium and sodium starch glycolate, these agents promote rapid tablet breakup upon contact with gastrointestinal fluids, facilitating the release of APIs for absorption. Without disintegrants, tablets risk passing through the digestive tract intact, reducing bioavailability.

• Lubricants: Magnesium stearate, commonly used as a lubricant, reduces friction between the formulation and manufacturing equipment, preventing adhesion and supporting smooth tablet compression and ejection.

• Glidants: Colloidal silicon dioxide enhances the flow properties of powder mixtures, contributing to weight uniformity and consistent filling of tablet dies.