Title of Invention

"A METHOD FOR PRODUCING PHARMACEUTICAL FORMULATIONS OR PRECURSORS THEREOF"

Abstract The present invention provides a method for producing pharmaceutical formulations or precursors thereof by means of extrusion, wherein the pharmaceutical formulation has an amorphous matrix whose essential properties are formed by extrusion and which comprises starch and/or derivatives of starch as an essential constituent, and at least one pharmaceutically active agent. The release of the active agent of the formulation is regulated by variation of the extrusion process parameters. The matrix formed is water-insoluble and a sustained release matrix. The pharmaceutically active agent may be present in the matrix in dissolved, solid or liquid form.
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We Claim:
1. A method for producing pharmaceutical formulations or precursors thereof by means of
extrusion, characterized in that the formulation has an amorphous matrix whose essential
properties are formed by extrusion and which comprises starch and/or derivatives of starch as
an essential constituent, and at least one pharmaceutically active agent, wherein the release of
the active agent of the formulation is regulated by variation of the extrusion process
parameters, and wherein the method comprises the following steps:
a) producing a dry formulation by mixing up to 50 weight percent based on the formulation, of at least one pharmaceutically active agent with starch and/or derivatives of starch, and
b) producing the matrix by extruding the formulation into a shaped body, wherein the temperature at the orifice of the extruder does not exceed 100 degree C under normal pressure.

2. The method as claimed in claim 1, wherein the matrix is water-insoluble.
3. The method as claimed in any one of the preceding claims, wherein the matrix is a sustained release matrix.
4. The method as claimed in any one of the preceding claims, wherein at least one
pharmaceutically active agent is present in the matrix in dissolved, solid or liquid form.S

Documents:

2170-delnp-2003-Abstract-(11-10-2012).pdf

2170-delnp-2003-Abstract.pdf

2170-delnp-2003-Claims-(11-10-2012).pdf

2170-delnp-2003-Claims.pdf

2170-delnp-2003-Correspondence-Others-(05-10-2012).pdf

2170-delnp-2003-Correspondence-Others-(11-10-2012).pdf

2170-delnp-2003-Correspondence-others.pdf

2170-delnp-2003-Correspondence-PO.pdf

2170-delnp-2003-Description (Complete).pdf

2170-delnp-2003-Drawings.pdf

2170-delnp-2003-Form-1-(11-10-2012).pdf

2170-delnp-2003-Form-1.pdf

2170-delnp-2003-Form-13.pdf

2170-delnp-2003-Form-18.pdf

2170-delnp-2003-Form-2-(11-10-2012).pdf

2170-delnp-2003-Form-2.pdf

2170-delnp-2003-Form-3.pdf

2170-delnp-2003-Form-5.pdf

2170-delnp-2003-GPA.pdf

2170-delnp-2003-Petition-137.pdf


Patent Number 255000
Indian Patent Application Number 2170/DELNP/2003
PG Journal Number 03/2013
Publication Date 18-Jan-2013
Grant Date 12-Jan-2013
Date of Filing 12-Dec-2003
Name of Patentee EURO-CELTIQUE S.A.,
Applicant Address 122, BOULEVARD DE LA PETRUSSE, L-2330, LUXEMBURG,
Inventors:
# Inventor's Name Inventor's Address
1 REIN, HUBERT D-35396 GIEßEN-WIESECK, EICHENRODER WEG 30
2 STEFFENS, KLAUS-JURGEN HOMMELSHEIMSTRASSE 9-11, D-53359 RHEIBACH
PCT International Classification Number A61K 9/20
PCT International Application Number PCT/EP2000/003612
PCT International Filing date 2000-04-20
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 19918325.2 1999-04-22 Germany