Review on novel pharmaceutical co-processed excipients
Excipients play an important role in formulating a dosage form. In recent years drug formulation scientists have recognized that single component excipients do not always provide the requisite performance to allow certain active pharmaceutical ingredients to be formulated or manufacturing adequately. In addition to this the cost involved in development of new chemical excipients with improved properties is quite high. In response numbers of combination excipients introduced by excipient manufacturers into the commercial market.
New combinations of existing excipients are an interesting option for improving excipient functionality now-a-days. Particle engineering of individual excipients and excipient combinations using co-processing, by virtue of sub particle modifications, has provided an attractive tool for developing high functionality excipients that are suited to modern tablet manufacturing processes. Co-processed excipients are a combination of two or more excipients designed to physical mixing and without significant chemical change. These co-processed excipients have high functionalise compared to individual excipients such as better flow property, compressibility, reduced lubricant sensitivity.
All the developed co-processed excipients are enlisted highlighting their multi-functional and beneficial characteristics. Regulatory issues concerned with the development of new excipient as well as coprocessed excipients are also discussed. These excipients flow ability, compressibility, tablet manufacturing by spray drying, solvent evaporation, speronization, melt extrusion, granulation/agglomeration method. Marketed product such as ludipress, celactose and prosolv etc. have already proven their worth in the market by reducing the cost the product and number of excipients yet maintaining efficacy of formulation. Such excipients for some limitations due to their quality assessment and reproducibility of result.
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Article Information: S. B. Pawar, S. P. Ahirrao, S. J. Kshirsagar; Pharmaceutical Resonance, 2019.