Method of producing solid shape forms containing an active ingredient

• US 7,014,810 B2
• Filed: 12/15/2000
• Issued: 03/21/2006
• Est. Priority Date: 12/15/1999
• Status: Expired due to Term

• Current Assignee: Abbvie Deutschland GmbH & Company KG (Abbvie Incorporated)
• Original Assignee: Abbott GmbH & Company KG (Abbott Laboratories Incorporated)
• Inventors: Hofmann, Jürgen, Breitenbach, Jörg, Klenz, Rainer, Rosenberg, Jörg, Krull, Harald, Bührle, Hans
• Primary Examiner(s): Heitbrink, Tim
• Application Number:
  US10/149,762
• Publication Number:
  US 20030015814A1
• Time in Patent Office: 1,922 Days
• Field of Search: 425/557, 425/560, 425/567, 425/572, 425/559, 425/574, 425/812, 425/130, 425/549, 425/547, 425/548, 425/552, 264/266, 264/268, 264/328.14, 264/328.4
• US Class Current: 264/328.4
• 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. 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 temporarily stored and then

the plasticated formulation is fed into an injection unit (2₁), the formulation present in this injection (2₁) is injected into a mold (3) and, during this, 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

the temperature of the plasticated formulation is controlled by a hot runner system comprising injection runners, wherein the hot runner system has a fluid or an electrical heating with counter-cooling for controlling the temperature of the injection runners (6).

2. A process as claimed in claim 1, wherein the volume of formulation fed into one injection unit (2) corresponds to the volume injected into the mold (3).

3. A process as claimed in claim 1, wherein two sheets are placed in the mold (3) before the injection, between which the formulation is injected.

4. The process of claim 1 wherein the solid active ingredients are pharmaceuticals.