Process for producing coated solid dosage forms

• US 6,350,398 B1
• Filed: 08/30/1999
• Issued: 02/26/2002
• Est. Priority Date: 09/03/1998
• Status: Expired due to Term

• Current Assignee: Abbvie Deutschland GmbH & Company KG (Abbvie Incorporated)
• Original Assignee: BASF AG (BASF SE)
• Inventors: Kleinke, Andreas, Breitenbach, Jörg, Maier, Werner, Kothrade, Stephan, Lange, Armin
• Primary Examiner(s): Tentoni, Leo B.
• Application Number:
  US09/385,459
• Time in Patent Office: 911 Days
• Field of Search: 264/129, 264/134, 264/141, 264/148, 264/151, 427/2.14, 427/2.21, 427/2.22
• US Class Current: 264/129
• 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: A61K 9/2893 Tablet coating processes mechanical aspects A61J3/06

Abstract

The invention relates to a process for producing coated solid dosage forms by forming a plastic mixture from at least one thermoplastic physiologically tolerated polymeric binder and at least one active ingredient and extruding the plastic mixture, wherein the extrudate is subsequently treated with at least one liquid or vaporized coating agent, and the coated extrudate is shaped to the required dosage form.

Claims

1. A process for producing coated solid dosage forms by forming a plastic mixture comprising at least one thermoplastic physiologically tolerated polymeric binder and at least one active ingredient and extruding the plastic mixture, wherein the extrudate is subsequently treated with at least one liquid or vaporized coating agent, and the coated extrudate is shaped to the required dosage form wherein an excess of a liquid coating agent is applied to the extrudate, and the extrudate treated with the coating agent is passed through a calibrated die to strip off the excess of coating agent and thus to adjust the coating thickness and the coating shape, and the coated extrudate is shaped to the required dosage form.

2. A process as claimed in claim 1, wherein the coating of the extrudate with the coating agent takes place by dipping into or spraying with the coating agent.

3. A process as claimed in claim 1, wherein the coating agent is employed as melt, solution, dispersion, emulsion, suspension.

4. A process as claimed in claim 1, wherein a multilayer dosage form is shaped from the coated extrudate by a hot cut, cold cut, rounding off, pinching off or calendering using molding rolls.

5. A process as claimed in claim 1, wherein at least one of the coating agents employed comprises one or more active ingredients.

6. A process as claimed in claim 1, wherein the coating agent comprises as film-forming ingredient a cellulose derivative and/or a polyvinyl ester.

7. A process as claimed in claim 1, wherein the thermoplastic binder is selected from the group consisting of homo- and copolymers of N-vinyllactams, vinyl esters of saturated carboxylic acids, (meth)acrylic acids and (meth)acrylic esters.

8. A process as claimed in claim 1, wherein the thermoplastic binder has a Fikentscher K value>

45.

9. A process as claimed in claim 1, wherein the extrudate to be