Abstract

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