Title:
経口ペプチド医薬投与形および製造方法
Document Type and Number:
Japanese Patent JP2004525123
Kind Code:
A
Abstract:
A pharmaceutical composition for oral delivery of a peptide is in the form of a lamination having at least two layers. The first layer of the lamination includes at least one pharmaceutically acceptable pH-lowering agent. The second layer includes a therapeutically effective amount of the peptide. The composition also includes at least one absorption enhancer effective to promote bioavailability of the peptide, which is preferably in the second layer, and an enteric coating surrounding the lamination. In a preferred dosage form of a tablet, a water-soluble coating is applied between the lamination and enteric coating which substantially prevents contact between the pH-lowering agent and the enteric coating. In a preferred embodiment, the peptide is salmon calcitonin, the pH-lowering agent is citric acid, and the absorption enhancer is lauroyl l-carnitine.
Inventors:
George Crotz
Isaac Gever-Ceracy
Ashles Chess
Isaac Gever-Ceracy
Ashles Chess
Application Number:
JP2002571034A
Publication Date:
August 19, 2004
Filing Date:
March 08, 2002
Export Citation:
Assignee:
Unigene Laboratories, Inc.
International Classes:
A61K9/20; A61K9/32; A61K9/36; A61K9/38; A61K38/23; A61K47/04; A61K47/12; A61K47/18; A61K47/24; A61K47/28; A61K47/36; A61K9/28; (IPC1-7): A61K38/23; A61K9/32; A61K47/04; A61K47/12; A61K47/18; A61K47/24; A61K47/28; A61K47/36
Domestic Patent References:
| JPH05294829A | 1993-11-09 | |||
| JPH08325145A | 1996-12-10 | |||
| JPS5944311A | 1984-03-12 | |||
| JPH11508606A | 1999-07-27 | |||
| JPH06511237A | 1994-12-15 | |||
| JP2000514051A | 2000-10-24 | |||
| JP2000336027A | 2000-12-05 | |||
| JP2001055322A | 2001-02-27 | |||
| JP2002529413A | 2002-09-10 | |||
| JP2001526213A | 2001-12-18 | |||
| JP2000503316A | 2000-03-21 |
Foreign References:
| WO1999038495A2 | 1999-08-05 | |||
| WO1999032093A1 | 1999-07-01 | |||
| WO2000027392A1 | 2000-05-18 |
Attorney, Agent or Firm:
Aoyama Aoi
Mitsutaka Iwasaki
Shoji Nakajima
Kazuaki Kojima
Mitsutaka Iwasaki
Shoji Nakajima
Kazuaki Kojima