CO-PROCESSED EXCIPIENTS – A REVIEW
Harsha Kathpalia*, Kishori Jogi
Abstract
Excipients are no more considered as inert ingredients of formulation,
but have a well-defined functional role. The shift in tableting toward
direct-compression and high-speed manufacturing has forced the
excipient industry to search for new excipients. The search for novel
excipient consumes time and investment. Co-processed excipients on
the other hand are the result of synergistic properties of existing
excipients. Co-processed excipients are a combination of two or more
excipients designed to physically modify their properties in a manner
not achievable by simple physical mixing and without significant
chemical change. These excipients have high functionalities as
compared to individual excipients like better flow property,
compressibility, reduced lubricant sensitivity. Marketed products such
as Ludipress, Ludiflash and Prosolv etc. have already proven their
worth in the market by reducing the cost of product and number of
excipients yet maintaining efficacy of formulation. Such excipients face some limitations due
to their quality assessment and reproducibility of results. Regulatory concern is also a prime
factor hindering the complete potential of co-processed excipients. International
Pharmaceutical Excipients Council (IPEC) is finding a way to get them into official
monographs either as mixtures or as single-bodied excipients.
Keywords: Co-processed, IPEC, Particle engineering, Spray drying, Regulatory concern
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