Process for the preparation of a sterile injectable physiologica

Drug – bio-affecting and body treating compositions – Radionuclide or intended radionuclide containing; adjuvant... – Molecular bilayer structure

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A61K 4904

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active

043965970

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.

REFERENCES:
patent: 3910989 (1975-10-01), Felder et al.
patent: 4021481 (1977-05-01), Almen et al.
patent: 4101647 (1978-07-01), Clauss et al.
patent: 4132731 (1979-01-01), Klieger et al.
patent: 4250113 (1981-02-01), Nordal et al.
patent: 4256729 (1981-03-01), Lin

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