Details for Patent: 4,396,597

Summary for Patent: 4,396,597

Title:	Process for the preparation of a sterile injectable physiologically acceptable solution of an X-ray contrast agent and solutions of the X-ray contrast agent and a buffer
Abstract:	Sterile, injectable, physiologically acceptable solutions of an X-ray contrast agent are prepared by autoclaving a solution of a m-carboxamido-o-iodo-N-(.beta.-hydroxyalkyl)aniline X-ray contrast agent in the presence of a physiologically acceptable buffer system the pH of which decreases with increasing temperature. The presence of a temperature dependent buffer, preferably an amine, enables X-ray contrast agents to be sterilized by autoclaving without significant decomposition. Examples of the autoclaving processes are given and solutions for autoclaving containing a m-carboxamido-o-iodo-N-(.beta.-hydroxyalkyl)aniline X-ray contrast agent and a physiologically acceptable buffer system the pH of which decreases with increasing temperature are described and claimed.
Inventor(s):	Rakli; Fridtjov B. (Oslo, NO), Kelly; Michael J. (Oslo, NO)
Assignee:	Nyegaard & Co. A/S (NO)
Application Number:	06/233,137
Patent Claim Types: see list of patent claims	Formulation; Compound; Process;

Drugs Protected by US Patent 4,396,597

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 4,396,597

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	28764/78	Jul 4, 1978

International Family Members for US Patent 4,396,597

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	222337
Austria	371998
Austria	A464479
Australia	4861579
Australia	523295