Title:
最終容器中で電離放射線により滅菌されるプロトンポンプ阻害剤を含む非経口製剤
Document Type and Number:
Japanese Patent JP2009536195
Kind Code:
A
Abstract:
The present invention relates to a stable sterilized parenteral formulation comprising an acid susceptible proton pump inhibitor. The formulation, a solid formulation comprising the acid susceptible proton pump inhibitor and optionally pharmaceutically acceptable excipients, has been sterilized in its final container by ionizing radiation. The container may consist of several compartments and separately contains a suitable solvent, which is sterilized, i.e. radiated, at the same time as the solid formulation. Alternatively, the suitable solvent is sterilized separately or aseptically manufactured. The solid formulation is dissolved in a suitable solvent before being administered to the patient, i.e. being prepared ex tempore. The present invention also relates to the prepared sterilized parenteral formulation, the stable solid formulation, processes for obtaining said parenteral formulation and the solid formulation as well as to the therapeutic uses thereof.
Inventors:
Michael Bruhls
Johanna Carlson
Johanna Carlson
Application Number:
JP2009509484A
Publication Date:
October 08, 2009
Filing Date:
May 07, 2007
Export Citation:
Assignee:
ASTRAZENECA AKTIEBOLAG
International Classes:
A61K45/00; A61K9/08; A61K9/14; A61K31/4439; A61P1/08; A61P43/00
Domestic Patent References:
| JP2005200409A | 2005-07-28 | |||
| JP2006501936A | 2006-01-19 | |||
| JP2004525949A | 2004-08-26 |
Other References:
JPN6012034191; Ｒｅｉｄ ＢＤ．: 'Ｇａｍｍａ ｐｒｏｃｅｓｓｉｎｇ ｔｅｃｈｎｏｌｏｇｙ： ａｎ ａｌｔｅｒｎａｔｉｖｅ ｔｅｃｈｎｏｌｏｇｙ ｆｏｒ ｔｅｒｍｉｎａｌ ｓｔｅｒｉｌｉｚａｔｉｏｎ ｏｆ ｐａｒｅｎｔｅｒａｌｓ．' ＰＤＡ Ｊ Ｐｈａｒｍ Ｓｃｉ Ｔｅｃｈｎｏｌ． Ｖｏｌ．４９ Ｎｏ．２, 199504, ｐｐ．８３-８９
Attorney, Agent or Firm:
Junji Yuda
Shoji Miwa
Noriyuki Takebayashi
Chika Takagi
Shoji Miwa
Noriyuki Takebayashi
Chika Takagi