The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Nov. 01, 2011

Filed:

May. 17, 2005
Applicants:

Joel Muse, Jr., Annapolis, MD (US);

Howard A. Colvin, Decatur, IL (US);

Inventors:

Joel Muse, Jr., Annapolis, MD (US);

Howard A. Colvin, Decatur, IL (US);

Assignee:

Archer Daniels Midland Company, Decatur, IL (US);

Attorney:
Primary Examiner:
Int. Cl.
CPC ...
C07C 69/66 (2006.01); A61K 31/22 (2006.01);
U.S. Cl.
CPC ...
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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