Device and method for producing solid shape containing an active ingredient

• US 20030015814A1
• Filed: 06/13/2002
• Published: 01/23/2003
• Est. Priority Date: 12/15/1999
• Status: Active Grant

• Current Assignee: Abbvie Deutschland GmbH & Company KG (Abbvie Incorporated)
• Original Assignee: Knoll Atiengesellschaft
• Inventors: Buhrle, Hans, Breitenbach, Jorg, Rosenberg, Jorg, Hofmann, Jurgen, Klenz, Rainer, Krull, Harald
• Granted Patent: US 7,014,810 B2
• Time in Patent Office: Days
• US Class Current: 264/40.6
• CPC Class Codes: A61J 3/06 into the form of pills, lozenges or dragees
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00
• CPC Class Codes: B29C 2045/466 supplying the injection unit directly by a compounder
• CPC Class Codes: B29C 2045/545 alternately operating injection plungers
• CPC Class Codes: B29C 45/54 and plasticising screw B29C45/532 takes precedence
• CPC Class Codes: B29C 45/542 using an accumulator between plasticising and injection unit, e.g. for a continuously operating plasticising screw
• CPC Class Codes: B29K 2105/0035 Medical or pharmaceutical agents

Abstract

The present invention relates to an apparatus for producing solid active ingredient-containing forms from an active ingredient-containing formulation which comprises at least one polymeric binder. The apparatus according to the invention has at least one extruder 1 for continuous plastication of the formulation and at least two injection units 2 which are provided separate from one another, each of which is connected to the extruder 1, and through which the formulation can be injected into at least one mold 3. In the process according to the invention for producing solid active ingredient-containing forms from an active ingredient-containing formulation which comprises at least one binder, the active ingredient-containing formulation is continuously plasticated, the plasticated formulation is fed into an injection unit 2₁, and the formulation present in this injection unit 2₁ is injected into a mold 3, and plasticated formulation is fed into another injection molding unit 2₂, and the formulation present in the other injection molding unit 2₂ is injected into the mold 3 or another mold.

Claims

1. An apparatus for producing solid active ingredient-containing forms from an active ingredient-containing formulation which comprises at least one polymeric binder, having at least one extruder (1) for continuous plastication of the formulation, comprising at least two injection units (2) which are provided separate from one another, each of which is connected to the extruder (1) and through which the formulation can be injected into at least one mold (3).

2. An apparatus as claimed in claim 1, wherein at least one injection unit (2) is connected to a plurality of molds (3₁-3_n) which are arranged in parallel and into which the formulation can be injection simultaneously.

3. An apparatus as claimed in claim 1 or 2, wherein at least one injection unit (2) is connected to a plurality of molds (3₁-3_n) which can be coupled singly to the injection unit (2) and into which the formulation can be injected successively.

4. An apparatus as claimed in any of the preceding claims, wherein a plurality of injection units (2) can be coupled alternately to a mold (3).

5. An apparatus as claimed in any of the preceding claims, where in each case the volume of one cylinder of an injection unit (2) corresponds to the volume of the mold (3) or of the molds (3) into which the formulation can be injected by this injection unit (2).

6. An apparatus as claimed in any of the preceding claims, wherein an accumulator unit (4) is provided between the extruder (1) and the injection units (2) for temporary storage of the formulation continuously produced by the extruder (1) and for conveying the formulation to the discontinuously operated injection units (2).

7. An apparatus as claimed in any of the preceding claims, wherein there is provided between the extruder (1) and the injection units (2) a feed valve (5) into which the formulation plasticated by the extruder (1) can be fed and through which the formulation fed in can be distributed to the injection units (2).

8. An apparatus as claimed in any of the preceding claims, wherein the apparatus has a plurality of extruders (11, 12) for processing different compositions, where at least one composition comprises the active ingredient-containing formulation, and where the plurality of extruders (11, 12) are each connected to one or more injection units (2), and wherein a mold (3) is connected to at least two injection units (2) into which compositions can be fed from different extruders (11, 12).

9. An apparatus as claimed in claim 8, wherein the mold (3) has, as female mold for an active ingredient-containing form to be produced, the shape of a hemisphere with a cavity or of a hollow hemicylinder.

10. An apparatus as claimed in claim 9, wherein the compositions can be fed to the mold (3) by the injection units in such a way that the produced form can release the active ingredient only across the surface of the inner wall of the hollow sphere or of the hollow cylinder.

11. An apparatus as claimed in any of the preceding claims, wherein one or more injection unit(s) (2) and molds (3) are connected via temperature-controllable hot runner systems to heated injection runners (6) through which the injection compositions can be injected into molds (3).

12. An apparatus as claimed in claim 11, wherein the hot runner system has a fluid or an electrical heating with counter-cooling for controlling the temperature of the injection runners (6).

13. The use of the apparatus as claimed in any of claims 8 to 12 for producing active ingredient-containing forms with 0 order active ingredient release.

14. The use of the apparatus as claimed in any of claims 8 to 12 for producing active ingredient-containing forms with a multiphase release profile.

16. A process as claimed in claim 15, wherein the volume of formulation fed into one injection unit (2) corresponds to the volume injected into the mold (3).

17. A process as claimed in claim 15 or 16, wherein two sheets are placed in the mold (3) before the injection, between which the formulation is injected.

15. A process for producing solid active ingredient-containing forms from an active ingredient-containing formulation which comprises at least one polymeric binder, in which

the active ingredient-containing formulation is continuously plasticated,

the plasticated formulation is fed into an injection unit (2₁), and the formulation present in this injection unit (2₁) is injected into a mold (3), plasticated formulation is fed into another injection unit (2₂), and the formulation present in the other injection unit (2₂) is injected into the mold (3) or another mold.