Method for the production of a form of administration of a medicament

Patent metadata

Field	Value
Publication number	US-10080724-B2
Application number	US-201414204216-A
Country	US
Kind code	B2
Filing date	Mar 11, 2014
Priority date	Jun 1, 2007
Publication date	Sep 25, 2018
Grant date	Sep 25, 2018

Abstract

The present invention relates to a method for producing a medicament dosage form which consists of at least one piece which in each case comprises at least one medicament and at least one additive, the medicament and the additive being mixed and extruded from a die as a strand and the strand being cut into pieces of precise weight. The invention additionally relates to a device.

First claim

The invention claimed is:

1. A method for producing a medicament dosage form which consists of one or more pieces which in each case comprises at least one medicament and at least one additive, said method comprising (i) mixing the at least one medicament and the at least one additive to form a pasty mixture, (ii) extruding an extrudate consisting of the pasty mixture from a die as a strand, (iii) calibrating a cross-section of the strand, and thereafter (iv) measuring the cross-section of the strand, (v) determining a cross-sectional area of the strand, (vi) calculating a length of the strand to be severed on a basis of a concentration of an active ingredient in the strand and the cross-sectional area determined after the calibrating of the cross-section of the strand, (vii) cutting the strand into one or more pieces of said length and, as a result, predetermined weight, and (viii) producing said medicament dosage form directly from said one or more pieces of said length without further steps being taken for compliance with the predetermined weight.

2. A method according to claim 1 , wherein the strand is cooled prior to cutting to length.

3. A method according to claim 1 , wherein the calibrating proceeds after cooling.

4. A method according to claim 1 , which further comprises, prior to cutting to length, drawing out the strand at a predetermined speed using a drawing device.

5. A method according to claim 4 , which further comprises buffering the strand prior to the drawing out.

6. A method according to claim 4 , which further comprises outputting a signal by the drawing device, determining the draw-out speed with said signal, and using said draw-out speed to control a cutting device with which the strand is cut to length.

7. A method according to claim 1 , wherein said cutting to length is effected by a rotating cutting device.

8. A method according to claim 7 , wherein a conveying speed regulates a rotational speed of the cutting device.

9. A method according to claim 1 , wherein the strand is guided during cutting to length.

10. A method according to claim 1 , which further comprises checking a diameter of the strand prior to cutting to length.

11. A method according to claim 1 , which further comprises singulating the pieces after cutting to length.

12. A method according to claim 1 , which further comprises adjusting a temperature of the strand once more after drawing out and before cutting to length.

13. A method for producing a medicament dosage form, said dosage form consisting of one or more pieces, said one or more pieces comprising at least one medicament and at least one additive, said method comprising (i) mixing the at least one medicament and the at least one additive to form a mixture, (ii) extruding the mixture from a die as a strand, (iii) buffering the strand between a first and a second drawing out means, (iv) calibrating a cross-section of the strand, and thereafter (v) measuring the cross-section of the strand, (vi) determining a cross-sectional area of the strand, (vii) calculating a length of the strand to be severed on a basis of a concentration of an active ingredient in the strand and the cross-sectional area determined after the calibrating of the cross-section of the strand, (viii) cutting the drawn out strand into one or more pieces of said length and, as a result, predetermined weight, and (ix) producing the medicament dosage form directly from said one or more pieces without further steps being taken for compliance with the predetermined weight.

14. A method according claim 1 , wherein said pasty mixture is homogeneous.

Assignees

• Gruenenthal Gmbh

Inventors

• Arkenau-Marić Elisabeth
• Bartholomäus Johannes
• Schateikis Dieter
• Ustorf Kai-Uwe

Classifications

• B29C48/90

  with calibration or sizing, i.e. combined with fixing or setting of the final dimensions of the extruded article · CPC title

• B29C2948/92438

  Conveying, transporting or storage of articles · CPC title

• B29C2948/92209

  Temperature · CPC title

• B29C48/0022

  combined with cutting · CPC title

• Y10T83/647

  With means to convey work relative to tool station · CPC title