Excipients are vitally important to optimal drug delivery
Prescription drugs are generally prescribed by a doctor and intended for use in the diagnosis, cure mitigation, treatment or prevention of various diseases. Usually purchased at a pharmacy, all drugs are made up of two core components – the active pharmaceutical ingredient or API and one or more excipients. The API is the central ingredient in the drug or the part of the drug that produces the intended effect. Pharmaceutical excipients are substances other than the API that have been appropriately evaluated for safety and are intentionally included in the drug delivery system, whether that is a tablet, a cream, a softgel or an injectable. Traditionally, excipients were often structurally simple, of natural origin and biologically inert. However, during the last few decades, many more novel and increasingly complex functional excipients have been developed as novel drug formulation delivery systems have evolved and emerged. These excipients are generally stable and reproducible, are pharmacologically inert and deliver the desired functionality. Within a particular formulation, excipients can have different roles. Some of the major ones can be:
- Aid in the processing of the drug delivery system during its manufacturing
- Protect, support, or enhance stability, bioavailability or patient acceptability/compliance
- Assist in the effectiveness and/or delivery of the drug in use
- Assist in maintaining the integrity of the drug product during storage.
The importance of quality
Croda understands the importance of excipient quality in pharmaceutical development. We know that producing stable and effective drug formulations is one of the main challenges faced by pharmaceutical formulators in general. This is why all of our excipients are designed and manufactured for pharmaceutical use, using Good Manufacturing Practice (GMP) standards, from start to finish, across all our platforms and manufacturing sites. We were one of the first excipient suppliers to receive EXCIPACT (or equivalent) certifications across all our global sites and we continue to pioneer new monograph approvals via our representation on global monograph industry forums. We believe that having the highest quality and purest grades of excipients helps our customers formulate seamlessly and drive products to market quickly and efficiently.
Offering the most highly purified excipients available, Croda’s Super Refined™ range of excipients are manufactured through proprietary processes that physically remove impurities without affecting the fundamental structure in any way. The removal of these impurities adds value to the formulated drug product by reducing negative API/excipient interactions and minimising the potential for oxidation, thereby maintaining the stability of the drug and the final formulation, increasing product shelf life. In addition, the removal of impurities can minimise cellular irritation, ideal for various drug administration routes as well as improve delivery of the API and minimise taste impact, highly valuable for oral drug formulators.
Driven by research and innovation
So if its self-emulsifying drug delivery excipients to solubilise a difficult API for a particular softgel application, or permeation enhancers and emulsifiers to enhance skin delivery of a cream or lotion, or high purity polysorbates to stabilise and solubilise complex biologics and parenteral formulations, we want to partner with you to provide solutions, solutions that drive growth and innovation that improve people’s lives.