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    • 22. 发明公开
    • PHARMAZEUTISCHE FORMULIERUNG FÜR DIE HERSTELLUNG VON SCHNELL ZERFALLENDEN TABLETTEN
    • 药物制剂FOR FAST崩解片剂的制造
    • EP2164460A1
    • 2010-03-24
    • EP08760350.2
    • 2008-06-02
    • BASF SE
    • KOLTER, KarlSCHÖNHERR, MichaelGEBERT, SilkeMEYER-BÖHM, KathrinMASCHKE, Angelika
    • A61K9/00A61K9/20A61K47/26
    • A61K9/0056A61K9/2018A61K9/2027A61K9/2054
    • The invention relates to a pharmaceutical formulation in the form of compacts containing A) an agglomerated auxiliary agent fraction consisting of a1) 60 - 97 % by weight of sugar or sugar alcohols, a2) 1 - 25 % by weight of a disintegration agent selected from the group consisting of crospovidone, croscarmellose, sodium carboxymethyl starch and L-hydroxypropyl cellulose, a3) 1 - 15 % by weight of water insoluble film-forming polymers, a4) 0 - 15 % by weight of water-soluble polymers, and a5) 0 - 15 % by weight of additional conventional pharmaceutical adjuvants, the sum of the components a1) to a5) totalling 100 % by weight, B) at least one active ingredient, C) 0 to 10 % by weight, in relation to the total quantity and A) to D) of a lubricant or mould release agent, and D) optionally additional pharmaceutical auxiliary agents.
    • 在压坯包括a1的组成A)凝聚的赋形剂含量)为60〜97%(重量)的糖或糖醇的形式的药物制剂,A2)(重量)的崩解剂1-25%,选自交聚维酮中选出, 联羧甲基纤维素,羧甲基淀粉钠和L-羟丙基纤维素,a3)的(重量)的水不溶性成膜聚合物的A4)(重量)的水溶性聚合物的和a5)0-15%0-15%1-15%(重量)的另外的 药学惯用的赋形剂,总组分a1)至a5的)由100%是重量,B)至少一种活性成分,C)0至重量10%,基于A的总量)至D),的 润滑剂或脱模剂,和D),如果合适的话,另外的药物赋形剂。