Sterilization of compositions of limited stability

Details Sterilization of compositions of limited stability Sterilization of compositions of limited stability

1987-02-05

1989-09-05

Waddell, Frederick E.

Drug, bio-affecting and body treating compositions

Radionuclide or intended radionuclide containing; adjuvant...

Molecular bilayer structure

424 4, A61K 4904

Patent

active

048637149

ABSTRACT:
Methods and compositions are provided for producing sterile drug formulations, where drugs are thermolabile and pH sensitive. The method provides formulating the drug with a physiologically acceptable inorganic or organic acidic buffer for buffering at a pH in excess of 6, reducing the pH below about 5 by adding carbon dioxide, and heat sterilizing the formulation in a gas permeable sealed container. The resulting formulation is substantially free of degraded drug and at the desired physiologically acceptable pH. Also, formulations are provided which do not cause clotting during administration.

REFERENCES:
patent: 4224440 (1980-09-01), Smith
patent: 4278654 (1981-07-01), Rakli et al.

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