Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Patent
1990-01-12
1990-10-16
Bell, Mark L.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
514970, 544357, A61K 31495
Patent
active
049635514
ABSTRACT:
The present invention is directed to a stable, rapidly soluble lyophilized injectable composition containing up to about 6% moisture and capable of being stored at room temperature comprising the hydrochloric or sulfate salt of a compound selected from the group consisting of (S)-(+)-bis-4,4'-(1-methyl-1,2-ethanediyl)2,6-piperazinedione and (R)-(-)-bis-4,4'-(1-methyl-1,2-ethanediyl)2,6-piperazinedione; wherein said lyophilized composition is prepared from a bulk solution comprising from about 25 mg/mL to about 40 mg/mL of said compound dissolved in a hydrochloric acid or sulfuric acid; wherein the pH of said bulk solution is from about 1.0 to about 2.0. The invention is further directed to an isotonic solution which is formed upon reconstitution of the lyophilizate of the invention with a pharmaceutically acceptable diluent.
REFERENCES:
patent: 3196153 (1965-07-01), Dazzi
patent: 4275063 (1981-06-01), Creighton
patent: 4764614 (1988-08-01), Miller
Repta et al., J. Pharm. Sci., 1976, 65(2), 238-42.
Martin Joyce W.
Palepu Nagesh R.
Bell Mark L.
Brunsman David M.
Erbamont Inc.
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