BARI, Mohammad Mafruhul,CHHETTRY, Anil,CURRIE, Mark G.,DEDHIYA, Mahendra,SANGHVI, Ritesh,GRILL, Andreas,HASHASH, Ahmad,MILLER, Matthew,MO, Yun,FRETZEN, Angelika
申请号：
PE0008042016
公开号：
PE13732016A1
申请日:
2014.12.11
申请国别(地区):
PE
年份:
2016
代理人:
摘要：
Refers to a Pharmaceutical composition as a tablet or a delayed Release Capsule, comprising linaclotide or a pharmaceutically acceptable Salt.The controlled release Tablet comprising: a) linaclotide 1 UG 2 mg b) functional or Enteric Coating such as hydroxypropyl methylcellulose acetate succinate, Polyvinyl Acetate Phthalate, among others (c) Film or sub Coating also comprises a protective Polymer Poly Grouper, a Stabilizing amount of primary Amine and a Stabilizing amount of a cation.The controlled-release Capsule comprises: (a) to 300ug linaclotide 1ug (b) such as enteric coated hydroxypropyl methylcellulose acetate succinate, Polyvinyl Acetate Phthalate, among others histidine (c) and (d) polyvinyl alcohol. It also relates to a preparation method. Said composition is useful in the treatment of gastrointestinal disordersSe refiere a una composicion farmaceutica tal como una tableta o una capsula de liberacion retardada que comprende linaclotida o una sal farmaceuticamente aceptable. La tableta de liberacion controlada comprende: a) Linaclotida 1 ug a 2 mg b) revestimiento funcional o enterico tal como acetato succinato de hidroxipropil metilcelulosa, ftalato de acetato de polivinilo, entre otros c) pelicula o sub-revestimiento de polimero protector ademas, comprende un polimero, una cantidad estabilizante de amina primaria o una cantidad estabilizante de un cation. La capsula de liberacion controlada comprende: a) linaclotida 1ug a 300ug b) revestimiento enterico tal como acetato succinato de hidroxipropil metilcelulosa, ftalato de acetato de polivinilo, entre otros c) histidina y d) alcohol polivinilico. Tambien se refiere a un metodo de preparacion. Dicha composicion es util en el tratamiento de trastornos gastrointestinales
