Active pharmaceutical ingredient process optimization

These asymmetric bioreduction reactions give examples of practical applications of enzymes in the synthesis of optically active molecules. While some of these processes have been already implemented on industrial scale for the preparation of active pharmaceutical ingredients, many of these routes still require upscaling feasibility studies and process optimization in order to demonstrate their practical... 

This optimization method, which represents the mathematical techniques, is an extension of the classic method and was the first, to our knowledge, to be applied to a pharmaceutical formulation and processing problem. Fonner et al. [15] chose to apply this method to a tablet formulation and to consider two independent variables. The active ingredient, phenylpropanolamine HC1, was kept at a constant level, and the levels of disintegrant (corn starch) and lubricant (stearic acid) were selected as the independent variables, X and Xj. The dependent variables include tablet hardness, friability, volume, in vitro release rate, and urinary excretion rate in human subjects. 

First layers of a 10-pm thin monolithic sihca gel structure with 1- to 2- am macropores and 3- to 4-nm mesopores were manufactured by hydrolytic polycondensation of hquid alkoxysiloxane films coated on glass substrates. Separations were performed for steroids, pesticides, dyestuffs, amino acids, pharmaceutically active ingredients, phenols, and plasticizers [3,4]. Besides this commercially available monohthic UTLC product, which resulted from these studies and was used for several hyphenations to MS [5-10], the sol-gel synthesis process was further improved to provide a high homogeneity, reproducibihty, and mechanical stability of the layer material. Optimized synthesis is still used to build up monolithic stationary phases with new characteristics, and synthetic dyes and food dyes were separated on a 100-pm thin layer [11,12]. 

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