ABRAMOWICZ, JAIME;SOUZA, FERNANDO RAFAEL DE;MARTINS, CARLOS AN;DIFFUCAP CHEMOBRAS QUIMICA E FARMACEUTICA LTDA
发明人:
ABRAMOWICZ, JAIME,SOUZA, FERNANDO RAFAEL DE,MARTINS, CARLOS ANTONIO
申请号：
BRBR2014/000214
公开号：
WO2015/027303A1
申请日:
2014.06.30
申请国别(地区):
BR
年份:
2015
代理人:
摘要：
Method for manufacturing a pharmaceutical combination containing an analgesic agent and an antispasmodic agent and pharmaceutical combination relates to a method for manufacturing a novel pharmaceutical combination containing an analgesic agent, Ketorolac tromethamine, and an antispasmodic agent, such as Hyoscine or Pargeverine； each of these active agents is manufactured in the form of microgranules, those related to Ketorolac being immediate release microgranules and those related to Hyoscine or Pargeverine being controlled release microgranules, coating polymers being added to the latter to obtain the appropriate release profile； the microgranules are incorporated in a capsule in different proportions； said method comprises the following steps: 1): Manufacturing the immediate release microgranules of the Ketorolac tromethamine analgesic by means of a total of ten substeps； 2) Manufacturing the controlled release microgranules of the Hyoscine or Pargeverine antispasmodic agent by means of a total of ten substeps； the composition of the contents of each capsule containing immediate release microgranules of the Ketorolac tromethamine analgesic and controlled release microgranules of the Hyoscine or Pargeverine antispasmodic agent is as follows: Ketorolac tromethamine: 2.5%-15% by weight, Hyoscine or Pargeverine: 2.5%-15% by weight, Povidone (PVP K30): 1%-5% by weight, white talcum: 5%-30% by weight, dyes (yellow + green): 0.03%-0.06% by weight, core (sugar and starch): 87.97%-29.94% by weight, coating polymers: 1%-5% by weight.L'invention concerne un procédé de fabrication d'une combinaison pharmaceutique contenant un agent analgésique et un agent anti-spasmodique et une combinaison pharmaceutique, et notamment un procédé de fabrication d'une nouvelle combinaison pharmaceutique contenant un agent analgésique, ou kétorolac de trométhamine, et un agent anti-spasmodique, du type hyoscine ou pargévérine, chacun de ces agents actifs étant fabriqué sous forme de microgran
