Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ester doai
Reexamination Certificate
2005-05-17
2011-11-01
Oh, Taylor Victor (Department: 1622)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Ester doai
C560S179000
Reexamination Certificate
active
08048919
ABSTRACT:
This invention is based upon the unexpected discovery that ethyl lactate can be used as an emulsifying/dispersing excipient for numerous biologically active compounds without destroying the pharmacological activity of the active ingredient. Ethyl lactate proves to be an extremely effective agent for solubilizing biologically active compounds that are difficult to solubilize in conventional excipients. The operability of this invention is predicated on the necessity for the ethyl lactate to be essentially free of peroxide compounds. Such pharmaceutical grade ethyl lactate can be made by reducing the level of peroxide compounds in high purity ethyl lactate by hydrogenation, reduction with a non-catalytic chemical reducing agent, absorption into activated carbon or alumina, or distillation. In any case, it has been determined to be critical for the level of peroxide compounds to be reduced to less than 10 ppm for the pharmaceutical grade ethyl lactate to be viable as an excipient for many biologically active ingredients. The present invention more specifically discloses a pharmaceutical composition which is comprised of a biologically active ingredient wherein said biologically active ingredient is dispersed in ethyl lactate and wherein said ethyl lactate contains no more than 10 ppm of peroxidic materials and maintains a Gardner 1 color rating throughout its shelf-life period.
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Gessner G. Hawley, the Condensed Chemical Dictionary, 8th ed.,1971, p. 522, 3 pages.
Colvin Howard A.
Muse, Jr. Joel
Archer Daniels Midland Company
Nilles Andrew F.
Oh Taylor Victor
LandOfFree
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