Method for dry blend compression of medicaments

Details Method for dry blend compression of medicaments Method for dry blend compression of medicaments

A - Human Necessities

61

K

A61K 31/56 (2006.01) A61K 9/20 (2006.01) A61K 31/565 (2006.01) A61K 31/57 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2176460

Disclosed is a method of dry blend compression of potent drugs with low solubility, such as steroidal medicaments using directly compressible agglomerated excipients that are not a conventional or spray dried polyalcohol or lactose. The agglomerated excipients include mannitol, maltodextrin or corn syrup solids which hold the medicaments (s) in the crevices of the agglomerates. Also disclosed are the critical ratios of the agglomerated excipients to steroidal agent, specifically estradiol, that is distributed uniformly throughout the dry blend and then compressed into tablets.

Procédé de compression d'un mélange sec de substances médicamenteuses puissantes présentant une faible solubilité, telles que des médicaments stéroïdiens, à l'aide d'excipients agglomérés pouvant être compressés directement, ces excipients n'étant pas un polyalcool ou un lactose classique ou séché par pulvérisation. Lesdits excipients agglomérés peuvent être du mannitol, de la malto-dextrine ou du sirop de maïs déshydraté, et servent à retenir le(s) médicament(s) dans les fissures des agglomérats. Cette invention décrit également les rapports critiques excipients agglomérés/agents stéroïdiens, notamment l'oestradil, qui est réparti uniformément dans le mélange sec puis compressé sous forme de comprimés.

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