Solid medicaments obtained by extrusion of an isomalt-containing polymer-active substance melt

• US 6,187,342 B1
• Filed: 02/24/1998
• Issued: 02/13/2001
• Est. Priority Date: 09/29/1995
• Status: Expired due to Term

• Current Assignee: Abbvie Deutschland GmbH & Company KG (Abbvie Incorporated)
• Original Assignee: BASF AG (BASF SE)
• Inventors: Breitenbach, Jörg, Rosenberg, Joerg, Zeidler, Jürgen, Neumann, Jörg
• Primary Examiner(s): Webman, Edward J.
• Application Number:
  US09/029,362
• Time in Patent Office: 1,085 Days
• Field of Search: 424/486
• US Class Current: 424/486
• CPC Class Codes: A61K 31/277 having a ring, e.g. verapamil
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/2018 Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• 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

The invention relates to solid drug forms obtainable by extrusion with subsequent shaping of a solvent-free melt, comprising, besides one or more active ingredients,

A) 10-90% by weight of a melt-processable, water-soluble polymer,

B) 5-85% by weight of isomalt, and

C) 0-5% by weight of lecithin,

where the total of all the ingredients is to be equal to 100% by weight.

Claims

1. A solid drug form obtained by extrusion with subsequent shaping of a solvent-free melt, comprising, besides one or more active ingredients,

A) 2-90% by weight of a melt-processable, water-soluble polymer,

B) 5-89.9% by weight of isomalt, and

C) 0-5% by weight of lecithin,

where the total of all the ingredients is to be equal to 100% by weight.

2. A drug form as claimed in claim 1, comprising

A) 10-90% by weight of a melt-processable, water-soluble polymer,

B) 5-89.9% by weight of isomalt, and

C) 0-5% by weight of lecithin,

where the total of all the ingredients is to be equal to 100% by weight.

3. A solid drug form as claimed in claim 1, comprising as polymer A) a homo- or copolymer of an N-vinyllactam.

4. A solid drug form as claimed in claim 3, comprising a copolymer of N-vinylpyrrolidone and vinyl acetate.

5. A solid drug form as claimed in claim 1, comprising a hydroxypropylcellulose as polymer A).

6. A solid drug form as claimed in claim 1, comprising as active ingredient verapamil or its physiologically tolerated salts.

7. A solid drug form as claimed claim 1, comprising in addition pharmaceutical ancillary substances.

8. A process for producing drug forms as claimed claim 1, which comprises converting the components into a melt at from 50 to 180°

C.