Increasingly, the pharmaceutical industry is focused on reducing operating costs while improving the output of manufacturing processes. One promising approach to meet this challenge is the use of direct compression1,2 (DC) as a viable alternative for wet granulation processes for immediate release (IR) tableting. However, broad application of DC technology offers challenges of its own: it requires that the blend of active pharmaceutical ingredient (API) and excipients delivers good flowability, compactability and low tendency of particle segregation.
Since many of the available traditional excipients do not meet these requirements, demand for novel DC excipients has grown over the past 20 years – culminating in the emergence of today’s ‘performance excipients’ or ‘co-processed excipients’ class.3-6
Co-processed excipients consist of two or more excipient materials combined into an engineered excipient product with the functionality desirable for a DC process. In addition to their value in DC, performance excipients also reduce some of the variables of complex pharmaceutical manufacturing processes,7 making them optimal in designing drug products under quality by design (QbD) principles.
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