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

042786541

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: 3733397 (1973-05-01), Bjork et al.
patent: 3910989 (1975-10-01), Felder et al.
patent: 4132731 (1979-01-01), Klieger et al.
The Extra Pharmacopoeia, 26th ed., pp. 461, 466 and 467.

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