EP 0857020 A1 19980812 - WET GRANULATION FORMULATION OF A GROWTH HORMONE SECRETAGOGUE
Title (en)
WET GRANULATION FORMULATION OF A GROWTH HORMONE SECRETAGOGUE
Title (de)
NASSGRANULATIONSFORMULIERUNG EINES WACHSTUMSHORMONSEKRETIONSFÖRDERERS
Title (fr)
FORMULATION DE SECRETAGOGUE STIMULANT LA SECRETION DE L'HORMONE DE CROISSANCE, DESTINEE A ETRE GRANULEE PAR VOIE HUMIDE
Publication
Application
Priority
- GB 9603238 A 19960216
- GB 9603834 A 19960223
- US 9617196 W 19961023
- US 589795 P 19951027
- US 590195 P 19951027
Abstract (en)
[origin: WO9715191A1] The present invention relates to a pharmaceutical composition and a process for the preparation of a tablet containing a growth hormone secretagogue as the active ingredient. The tablet is prepared by forming a powder blend of the active ingredient N-[1(R)-[(1,2-dihydro-1-methanesulfonyl-spiro[3H-indole-3,4'-piperdin]-1'-yl)carbonyl]-2-(phenylmethyl-oxy)ethyl]-2-amino-2-methyl-propanamide, or a pharmaceutically acceptable salt thereof, in particular the methanesulfonate salt, with a binder/diluent, a first diluent, a second diluent, a first portion of a disintegrant, and a lubricant; wet granulating the powder blend with a solution of ethanol/water to form granules; drying the granules to remove the ethanol/water; adding a second portion of a disintegrant; lubricating the granules; and compressing the dried granules into the desired tablet form. The present invention further relates to a novel amorphous form of the compound N-[1(R)-[(1,2-dihydro-1-methanesulfonyl-spiro[3H-indole-3,4'-piperdin]-1'-yl)carbonyl]-2-(phenylmethyl-oxy)ethyl]-2-amino-2-methylpropanamide methanesulfonate which is produced directly as a result of the process of tablet formulation.
IPC 1-7
IPC 8 full level
A61K 9/20 (2006.01); A61K 9/36 (2006.01); A61K 31/438 (2006.01); A61K 31/445 (2006.01); A61K 31/4465 (2006.01); A61K 31/4523 (2006.01); A61K 31/454 (2006.01); A61K 47/38 (2006.01); C07D 471/10 (2006.01)
CPC (source: EP)
A61K 9/2004 (2013.01); A61K 9/2077 (2013.01); A61K 31/438 (2013.01)
Designated contracting state (EPC)
AT BE CH DE DK ES FI FR GB GR IE IT LI LU NL PT SE
DOCDB simple family (publication)
WO 9715191 A1 19970501; AU 7522896 A 19970515; CA 2234817 A1 19970501; EP 0857020 A1 19980812; EP 0857020 A4 19990107; JP H11513989 A 19991130
DOCDB simple family (application)
US 9617196 W 19961023; AU 7522896 A 19961023; CA 2234817 A 19961023; EP 96937761 A 19961023; JP 51684197 A 19961023