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Raising expectations of excipients 

FRED MONSUUR, JULIA PONCHER 

Excipients have never shared the limelight with active pharmaceutical ingredients (APIs), nor have they historically been given the credit that they deserve in drug development, manufacturing, and delivery. An excipient's role has traditionally been viewed as merely a filler or binder contributing to the stability of the end product.The full value that a formulation can bring to a final dosage form; or the real importance of ensuring an excipient's quality and performance; are often underestimated, overlooked, misunderstood, or disregarded. In reality, the functionality of the excipient can help determine whether or not a drug succeeds or fails.The possible consequences of not carefully choosing the best excipient for your formulation include manufacturing complications, compromised stability, poor bioavailability of the API, unintended side-effects, reduced shelf-life of the finished product, and even serious adverse reaction or death of the patient (1). This seems the ultimate irony when therapies and pharmaceuticals are intended to help patients and improve their well-being, not harm them. To avoid these undesirable outcomes, what can you do to select the right excipient for you ...



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