Abstract: An excipient for tableting of powder mixtures, e.g. pharmaceutical powder mixtures comprises particles of an inert solid material, said particles being of average particle size in the range from 50-1,000 .mu.m in diameter and having surface pores of at least 10 .mu.m in diameter. Preferred excipients comprising dendritic spherulites of sugars e.g. fructose, mannitol or lactose, are prepared by crystallization of sugars under conditions of high crystallization pressure; for instance on addition of crystallizing agents, e.g. ethanol, and/or seeding materials to saturated sugar solutions. The excipients are mixed with finely divided active ingredients e.g. micronized drug particles, and tableted to produce tableted products. The new excipients are suitable for use in direct compression tableting techniques and advantageously diminish problems of excipient/active ingredient segregation during handling of the excipient/active ingredient mixtures.
May 5, 1980
Date of Patent:
September 14, 1982
National Research Development Corporation