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Reducing Risks

A pharmaceutical product’s ability to perform its purpose depends on its quality; the user expects the product to be safe, therapeutic and completely fit for function. To meet these criteria, it needs to be intrinsically stable, free of contamination and must reproducibly deliver the therapeutic benefit claimed on the label or in the product information leaflet to the consumer over the period of its shelf life. Such a product is said to deliver its quality through its design, hence the phrase ‘Quality by Design’ (QbD). QbD focuses on integrated product development, commencing at the concept stage (1). These principles have been adopted by the FDA for the discovery, development and manufacturing of drugs and have been developed further for biopharmaceutical products (2,3).

When a product is developed with raw material selection in mind, designing quality and removing formulationassociated risks are key considerations. To this end, using the best materials available is crucial to help manage these aspects of chemistry. Depending on how the drug is to be administered (topically, orally or parenterally), raw material choices and their attributes need to be deliberated, especially where key ‘natural’ materials are to be used. A control strategy needs to be developed for the entire process, including tight supervision on the excipients’ specifications, to ensure consistent quality and product stability over its shelf life.

As such, excipient selection plays a key role in determining the performance of a drug – not only in delivering the efficacy required, but also maintaining this over the product’s lifetime.

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Anthony Hubbard, Research and Technology Manager in Health Care at Croda Europe, has worked in product development for over 30 years. He has been involved in the innovation, development and testing of a variety of healthcare, cosmetic and toiletry formulations. In his position at Croda, Anthony’s current focus is on the development of drug delivery systems (parenteral, oral and topical) that enhance the stability and availability of APIs. He has a Bachelor of Science (Hons) and is a fellow of the Royal Society of Chemistry.
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