High functionality excipients are inactive ingredients that meet four criteria:
First, they are multifunctional. They contribute two or more functions to a formulation through a single ingredient. Second, they have high inherent functional performance, even at low use levels, allowing for increased batch sizes and higher drug loading. Third, they require no complex processing, making them ideal for cost effective direct compression processes. Lastly, they impart their high inherent functional performance to the overall formulation. This last criterion is critical since it separates high functionality excipients from other multi-functional excipients or conventional specialty grade excipients. High functionality excipients provide the means for simplifying formulation development, and improving overall operational costs while preserving the quality that is expected by the industry.
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