- Excipients are inactive substances used alongside the active pharmaceutical ingredients (APIs) in drug formulations.
- They play a vital role in the stability, efficacy, and safety of the final dosage form.
- In liquid dosage forms, excipients can serve various functions, including solubilizing agents, preservatives, suspending agents, viscosity modifiers, emulsifying agents, and flavouring agents, among others.
Here’s a classification and explanation of excipients based on their function in liquid dosage forms:
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Solubilizing Agents
- Help dissolve poorly soluble APIs to improve bioavailability.
- Examples: Water, ethanol, propylene glycol, polysorbate 80, sodium lauryl sulfate.
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Preservatives
- Prevent microbial contamination and extend shelf life.
- Examples: Benzalkonium chloride, methylparaben, propylparaben, sodium benzoate.
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Suspending Agents
- Disperse insoluble APIs evenly, ensuring consistent dosing.
- Examples: Carboxymethyl cellulose, xanthan gum, hydroxyethyl cellulose.
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Viscosity Modifiers
- Adjust viscosity for better mouthfeel, stability, and administration.
- Examples: Hydroxypropyl methylcellulose, polyvinylpyrrolidone, polyvinyl alcohol.
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Emulsifying Agents
- Stabilize emulsions by reducing surface tension between immiscible liquids.
- Examples: Lecithin, glyceryl monostearate, sorbitan esters.
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Flavouring Agents
- Improve palatability, especially for pediatric formulations.
- Examples: Fruit extracts, vanillin, ethylvanillin.
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Sweetening Agents
- Mask bitter taste to enhance patient compliance.
- Examples: Sucrose, glucose, aspartame, saccharin, sucralose.
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Colouring Agents
- Add visual appeal and indicate strength or flavour.
- Examples: FD&C dyes, iron oxide pigments.
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Antioxidants
- Protect the formulation from oxidative degradation.
- Examples: BHA, BHT, ascorbic acid.
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Chelating Agents
- Sequester metal ions to prevent formulation degradation.
- Examples: Disodium EDTA, citric acid.
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