Process for producing solid dosage forms

• US 6,423,256 B1
• Filed: 10/13/1999
• Issued: 07/23/2002
• Est. Priority Date: 10/15/1998
• Status: Expired due to Term

• Current Assignee: Abbvie Deutschland GmbH & Company KG (Abbvie Incorporated)
• Original Assignee: BASF AG (BASF SE)
• Inventors: Kessler, Thomas, Reinhold, Ulrich, Breitenbach, Jörg, Maier, Werner, Krull, Harald, Kothrade, Stephan, Lange, Armin
• Primary Examiner(s): Vargot, Mathieu D.
• Application Number:
  US09/417,070
• Time in Patent Office: 1,014 Days
• Field of Search: 264/109, 264/122, 264/141, 264/151, 264/210.2, 264/331.19, 264/211, 264/142, 264/211.23
• US Class Current: 264/122
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 9/2027 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• 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

Abstract

A process for producing solid dosage forms, in which (i) a plastic mixture of at least one pharmacologically acceptable polymeric binder with a K value of more than 75, at least one pharmaceutical active ingredient and, where appropriate, conventional pharmaceutical additives is prepared and (ii) the plastic mixture is shaped to the required dosage form, with step (i) being carried out under conditions of temperature and shear energy input such that the reduction in molecular weight of the polymeric binder, expressed as the difference in the K value, is less than 15 is described.

Claims

1. A process for producing solid dosage forms, in which

(i) a plastic mixture of at least one pharmacologically acceptable polymeric binder with a K value of more than 75, at least one pharmaceutical active ingredient and, where appropriate, pharmaceutical additive is prepared and

(ii) the plastic mixture is shaped to the required dosage form, with step (i) being carried out under conditions of temperature and shear energy input such that the reduction in molecular weight of the polymeric binder, expressed as the difference in the K value, is less than 15 wherein the polymeric binder is a homo- or copolymer.

2. A process as claimed in claim 1, wherein the polymeric binder is a homo- or copolymer of vinylpyrrolidone.

3. A process as claimed in claim 1, wherein the temperature in step (i) is not more than 250°

C.

4. A process as claimed in claim 1, wherein step (i) is carried out in a continuously operating kneader.

5. A process as claimed in claim 4, wherein the kneader has a shaft provided with a screw flight in a cylindrical housing, and the shaft executes an axial movement to and fro in addition to the rotational movement around its own axis.

6. A process as claimed in claim 5, wherein the screw flight has multiple interruptions, and the housing has fixed kneading cogs, with the kneading cogs passing through the interruptions during the movement to and fro of the shaft.

7. A process as claimed in claim 1, wherein the plastic mixture comprises at least one plasticizer.

8. A process as claimed in claim 1, wherein the plastic mixture comprises at least one antioxidant.