Pharmaceutical Excipients/Additives - All About Pharmaceutical Excipients
Pharmaceutical Excipients/Additives - All About Pharmaceutical Excipients
Pharmaceutical Excipients/Additives - Pharmaceutical excipients play a critical role in the creation of medicines, helping to preserve the efficacy, safety and stability of active pharmaceutical ingredients and ensuring that they delivered their promised benefits to patients. A careful choice of excipients is crucial for the development of effective and innovative pharmaceuticals.Excipients are an integral part of pharmaceutical product development to achieve the desired product profile (stability and efficacy).
Pharmaceutical additives or excipients are compounds that are added to the drug finished products to serve a specific function. They are added to increase bulk, aid manufacturing, improve stability, enhance drug delivery and targeting, and modify drug safety or pharmacokinetic profile.
The International Pharmaceutical Excipients Council (IPEC) defines “An excipient as any substance other than the active drug or prodrug that is included in the manufacturing process or is contained in a finished pharmaceutical dosage form.”
Role of Pharmaceutical Excipients
The role of excipients varies substantially depending on the individual dosage form.These include
- Ease of administration to the target patient population(s) by the intended route.
- Improves dosing compliance.
- Consistency and control of drug bioavailability.
- Modulates solubility and bioavailability of the product.
- Improved API stability including protection from degradation.
- To ensure a robust and reproducible physical product.
- Maintains the pH and osmolarity of liquid product.
- Helps the drug to maintain a suitable polymorphic form.
Criteria for the selection of excipient
The following key points should be considered in the selection of an excipient for any pharmaceutical products:- Influence of excipient on the overall quality, stability and effectiveness of drug product.
- Compatibility of excipient with drug and the packaging system.
- Compatibility of excipient with the manufacturing process.
- The amount or percentage of excipients that can be added to the drug product.
- Route of administration.
Classification of Pharmaceutical Excipients
Organoleptic compliance – Colour, Flavour, Sweetener.Stabilizers – Preservatives, Antioxidant, Emulsifier, Suspending agents.
Dose accuracy – Diluent, Bulking agents, Filler.
Process aids – Binder, Lubricant, Glidant, and Anti-adherent.
Drug release – Disintegrant, Penetration enhancer, Coating agent.
