Drug – bio-affecting and body treating compositions – Fermentate of unknown chemical structure
Reexamination Certificate
2003-03-10
2004-05-11
Tate, Christopher R. (Department: 1654)
Drug, bio-affecting and body treating compositions
Fermentate of unknown chemical structure
C424S078070, C424S404000, C424S246100, C424S522000, C514S887000
Reexamination Certificate
active
06733751
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to compositions and methods of use for the treatment of bacterial, fungal, and viral infections of the dermis and cuticle. More specifically, the present invention relates to compositions and methods of use of Emu Oil, and it various associated fractions, in combination with the appropriate medicaments, in the treatment of bacterial, fungal, and viral infections of the dermis and cuticle. The present invention also relates to the utilization of therapeutic compositions comprised of Emu Oil in combination with a probiotic, viable Bacillus bacteria, spores, and extracellular supernatant products, as well as the extracellular product of
Pseudomonas lindbergii
, as a topical agent for the prevention and/or control of infections caused by bacterium, fungi, yeast, and virus, and combinations thereof.
BACKGROUND OF THE INVENTION
1. Emu Oil
Emu Oil, is an animal-derived lipid composition, extracted from the Emu (Dromais Novae-Hollandiae), a flightless bird part of a group called ratites (which also includes the ostrich and the kiwi), indigenous to Australia and New Zealand.
Emu Oil is extracted from a thick fat-pad on the back of the bird which putatively functions to protect the animal from the extreme temperatures in its Australian homeland. The fat is carefully extracted to prevent the formation of trans-fatty acids, wherein approximately 100 pounds of fat produces approximately 50 to 90 pounds of unrefined, pale yellow oil. The chemical composition and characteristics of Emu Oil has been quantitatively ascertained and is set forth below in Table I.
TABLE I
Fatty Acid Composition:
C-14:0 (Myristic):
0.4%
C-16:0 (Palmitic):
21.5%
C-16:1 (Palmitoleic):
3.7%
C-18:0 (Stearic):
10.6%
C-18:1 (Oleic):
51.4%
C-18:2 (Linoleic):
12.7%
C-18:3 (Linolenic):
0.9%
Calculated Iodine Value:
69.7
Free Fatty Acid:
0.33%
Acid Value:
0.66%
Peroxide Value:
1.53%
Moisture:
0.03%
Refractive Index @ 40° C.:
1.4606%
As illustrated in Table I, when correctly extracted and processed, Emu Oil is comprised of approximately 50% to 70% monounsaturated fatty acids, with the rest being both saturated and polyunsaturated fatty acids (see e.g.,
American Emu Association News
, March 1995). Emu Oil is almost purely triglyceride in nature, which makes it an almost completely neutral lipid. In addition, the monounsaturated fatty acid, oleic acid, is the largest single fatty acid component of Emu Oil. Traditional beliefs of geographically widely-separated Australian Aboriginal communities agree on the beneficial properties of Emu Oil as a natural remedy. The oral history of the Australian Aborigines indicates their use of Emu Oil for over forty thousand years to reduce pain and stiffness in sore muscles and joints, to help expedite wound healing, as a dermal protectorate from the effects of wind and sun, and in the treatment of bruised subcutaneous tissue, burns and dry skin problems. Methods of administration are quire varied. For example, Aborigines have revealed methods of treatment which included hanging an Emu skin on a tree to collect the oil, and wrapping the affected area on the individual in a freshly-killed Emu skin. However, it is believed that in both of the aforementioned scenarios, the catalyst of the suns' heat was used to liquefy the Emu fat and enhance its absorption qualities.
Documented records of the utilization of Emu Oil may be antedated well over 100 years (see e.g., Whitehouse, et al., 1996. Concerning Emu Oil and its anti-arthritic activity.
Fifth Queensland Poultry Science Symposium
, Gatton College). The use of Emu Oil was among many natural remedies adopted by settlers from the original inhabitants of Australia. The first report known was published in the Australian Post regarding experiments by Dr. Peter Gosh (Raymond Purves Bone and Joint Research Laboratories, University of Sydney at the Royal North Shore Hospital) and Dr. Michael Whitehouse (Department of Pathology, University of Adelaide), wherein the Emu Oil was required to be massaged vigorously onto the sore muscle or joint and the process repeated as often as required, hence pressure, heat and duration of rubbing were all deemed to be relevant factors.
This, although Emu Oil has been previously described, the majority of its uses or properties/characteristics is anecdotal in nature. These uses and properties include (see e.g., DuBois, 1999
. Explore Issue
8:1-10): (i) its ability to act as a dermal penetrant and medicament carrier; (ii) its anti-inflammatory properties; (iii) its ability to act as an emollient/emulsifier; (iv) its bacteriostatic properties; (v) its low potential for irritation of the skin; (vi) its non-comedogenic properties (i.e., it does not clog up pores); and (vii) its moisturizing, wound-healing, general “anti-aging” properties. However, the quantitative information currently available almost exclusively relates to the benefits of Emu Oil as an anti-inflammatory agent for arthritis, its uses for cardiovascular health when ingested, which is similar to the use of Omega-3 fish oils to improve high-density lipoprotein (HDL) cholesterol, and its moisturizing and general “anti-aging” properties.
There is much anecdotal material available on the anti-inflammatory abilities of Emu Oil. It has been shown to reduce pain, swelling and stiffness in joints, to reduce recent bruising and muscle pain, and ease sports related muscle strains as well. Studies have shown that different Emu Oils (i.e., oils which were extracted by different methodologies, from different sources, and the like) possessed different levels of anti-inflammatory ability. The ability of Emu Oil to penetrate the stratum coneum dermal barrier and concomitantly act as a carrier, makes it highly valuable for use in therapeutic compounds in the prevention and/or treatment of a variety of conditions. This ability is believed to be primarily due to both its extremely high content of oleic acid and a total lack of indigenous phospholipids. Accordingly, Emu Oil could be combined with various medicinals or cosmetic materials to facilitate their ability to penetrate this layer of keritinized tissue in a more efficacious and cost-effective manner than the currently-utilized liposome- and iontophorisis-based technologies. For example, the ability of Emu Oil to act as a trans-dermal penetrant with respect to Ketoprofen, a well known non-steroidal, anti-inflammatory drug (NSAID) found in Actron™ and like products, was examined in a recent study performed at Auburn University. Ketoprofen is one of the proprionic acid derivative drugs, which have been utilized in numerous European countries for more than 15 years as an effective treatment for rheumatoid arthritis and osteoarthritis. Although it is available in more than 80 countries throughout the world, it did not receive approval for over-the-counter (OTC) use in the United States until 1996. Although Ketoprofen is readily absorbed, it frequently produces a number of adverse side-effects in the gastrointestinal tract when taken orally. Moreover, the oral administration of Ketoprofen has also been associated with such serious deleterious physiological side-effects as renal dysfunction, marked edema, and hepatic dysfunction (e.g., jaundice). The utilization of a topically-administered Ketoprofen composition to the dermis over the inflamed tissues or joints would perhaps mitigate some of the aforementioned side-effects and may also potentially result in the accumulation of the drug within associated synovial tissues, the site of the desired anti-inflammatory reaction. However, recent studies in which Ketoprofen was topically-administered without the utilization of dermal-penetrants (e.g., Emu Oil) demonstrated that this compound was adsorbed through viable, keritinized dermal tissue in a very limited concentration, if at all.
Conversely, the results demonstrated that the concomitant utilization of a dermal-penetrant produced markedly elevated adsorption of the compound. Specifically, an Emu Oil—propanol—Ketoprofen combination was shown to produce a 3-time
Flood Michele C.
Ganeden Biotech, Inc.
Mintz Levin Cohn Ferris Glovsky and Popeo P.C.
Tate Christopher R.
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