Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ester doai
Reexamination Certificate
1999-04-28
2002-07-09
Williamson, Michael A. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Ester doai
C424S448000
Reexamination Certificate
active
06417227
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to novel and advantageous methods of delivery of cetyl myristoleate. The delivery methods are useful in the treatment of several diseases affecting humans and animals.
Cetyl myristoleate (CM) is found in and isolated from mice, in particular, Swiss albino mice, sperm whales, and the anal glands of some species of male beavers. The compound can also be synthesized in the laboratory using cetyl alcohol and myristoleic acid. The methods of obtaining CM are described in U.S. Pat. No. 4,049,824, 4,113,881, and 5,569,676. These patents are incorporated herein in their entirety.
CM can be used to treat diseases in humans and animals. CM is useful in the treatment of diseases associated with the inflammation of tissues such as tendinitis, tenosynovitis, bursitis, chronic patellar tendinitis, Achilles tendinitis, fibrositis, inflammation of the spine, colitis, bronchitis, polymyalagia rheumatica, Crohn's disease, primary biliary cirrhosis, pericarditis, ulcerative colitis, and Sjogren's syndrome.
CM is also useful in the treatment of inflammatory conditions that affect joints such as arthritis, juvenile chronic arthritis, chronic arthritis, Behcet's disease, ankylosing spondylitis, mixed connective tissue disease, Reiter's syndrome, and synovitis. Diehl and May, (1994) J Pharm Sci 83(3):296-299.
Autoimmune diseases such as autoimmune Addison's disease, autoimmune hepatitis, Behcet's disease, lupus, antiphospholipid syndrome, multiple sclerosis, and essential mixed cryoglobulinemia can be treated with CM.
CM can also be used in the treatment of migraine, emphysema, asthma, myofascial pain, arteriosclerosis, joint sports injuries and sprains, insulin dependant diabetes, peripheral vascular disease, carpal tunnel syndrome, cardiomyopathy, chronic fatigue immune dysfunction syndrome, Churg-Strauss syndrome, and psoriasis.
CM can be delivered orally; however, absorption of waxy esters such as CM is low compared to other lipids and is therefore very poor. The administration of lipase digestive enzyme is presently recommended along with oral doses of CM to increase absorption. New methods of delivery are needed for CM that allow for the efficient absorption of CM.
SUMMARY OF THE INVENTION
It is an object of the invention to provide transdermal delivery devices, suppositories, enterically coated compositions, and microencapsulated compositions comprising cetyl myristoleate.
It is another object of the invention to provide methods of treatment of various diseases affecting humans and animals by providing cetyl myristoleate compositions a human or animal in need thereof.
These and other objects of the invention are provided by one or more of the embodiments described below.
One embodiment of the invention provides a transdermal delivery device for the delivery of cetyl myristoleate. The transdermal delivery device contains between 1 mg and 3000 mg of cetyl myristoleate.
Another embodiment of the invention provides for a transdermal delivery device comprising a backing layer and a matrix layer underlying the backing layer. The matrix layer of the transdermal delivery device comprises a mixture of cetyl myristoleate and a pressure sensitive adhesive.
Even another embodiment of the invention provides a transdermal delivery device wherein the matrix layer further comprises one or more of the components selected from the group consisting of glucosamine sulfate, chondroitin sulfate, sea cucumber extract, hydrolyzed shark cartilage, collagen II, and methylsulfonylmethane.
Still another embodiment of the invention provides a transdermal delivery device wherein the device is worn for between 5 and 10 days.
Yet another embodiment of the invention provides a transdermal delivery device wherein between 0.01 mg/kg/day and 10 mg/kg/day of cetyl myristoleate is delivered.
A further embodiment of the invention provides a method of treating a disease associated with the inflammation of tissues. A transdermal delivery device comprising cetyl myristoleate is affixed to the skin of an animal or human. The transdermal delivery device is useful in treating diseases selected from the group consisting of tendinitis, tenosynovitis, bursitis, chronic patellar tendinitis, Achilles tendinitis, fibrositis, inflammation of the spine, colitis, bronchitis, polymyalagia rheumatica, Crohn's disease, primary biliary cirrhosis, pericarditis, ulcerative colitis, and Sjogren's syndrome.
Another embodiment of the invention provides a method of treating a disease associated with an inflammatory condition that affects joints. A transdermal device comprising cetyl myristoleate is affixed to the skin of an animal or human. The disease to be treated is selected from the group consisting of arthritis, chronic arthritis, Behcet's disease, ankylosing spondylitis, mixed connective tissue disease, Reiter's syndrome and synovitis.
Even another embodiment of the invention provides a method of treating an autoimmune disease. A transdermal device comprising cetyl myristoleate is affixed to the skin of an animal or human. The disease to be treated is selected from the group consisting of autoimmune Addison's disease, autoimmune hepatitis, Behcet's disease, lupus, antiphospholipid syndrome, multiple sclerosis, and essential mixed cryoglobulinemia.
Still another embodiment of the invention provides an oral medicament comprising cetyl myristoleate and an enteric coating. The enteric coating is resistant to dissolution in the stomach but predisposed to dissolution in the intestine so as to prevent release of the cetyl myristoleate until the medicament is in the intestine.
Yet another embodiment of the invention provides for an oral medicament comprising cetyl myristoleate and an enteric coating. The enteric coating is resistant to dissolution in an environment having a pH less than 5.5.
A further embodiment of the invention provides for an oral medicament comprising cetyl myristoleate and an enteric coating. The oral medicament comprises between 0.1 g and 1 g of cetyl myristoleate.
Another embodiment of the invention provides an oral medicament comprising cetyl myristoleate and an enteric coating. The oral medicament further comprises one or more of the components selected from the group consisting of glucosamine sulfate, chondroitin sulfate, sea cucumber extract, hydrolyzed shark cartilage, collagen II, and methylsulfonylmethane.
Even another embodiment of the invention provides a method of treating a disease associated with the inflammation of tissues. An oral medicament comprising cetyl myristoleate and an enteric coating is administered to a human or animal. The disease to be treated is selected from the group consisting of tendinitis, tenosynovitis, bursitis, chronic patellar tendinitis, Achilles tendinitis, fibrositis, inflammation of the spine, colitis, bronchitis, polymyalagia rheumatica, Crohn's disease, primary biliary cirrhosis, pericarditis, ulcerative colitis, and Sjogren's syndrome.
Still another embodiment of the invention provides for a method of treating a disease associated with an inflammatory condition that affects joints. An oral medicament comprising cetyl myristoleate and an enteric coating is administered to a human or animal. The disease to be treated is selected from the group consisting of arthritis, chronic arthritis, Behcet's disease, ankylosing spondylitis, mixed connective tissue disease, Reiter's syndrome, and synovitis.
Yet another embodiment of the invention provides for a method of treating an autoimmune disease. An oral medicament comprising cetyl myristoleate and an enteric coating is administered to a human or animal. The disease to be treated is selected from the group consisting of autoimmune Addison's disease, autoimmune hepatitis, Behcet's disease, lupus, antiphospholipid syndrome, multiple sclerosis, and essential mixed cryoglobulinemia.
A further embodiment of the invention provides an oral medicament comprising microencapsulated cetyl myristoleate. The microencapsulatio
Lord Gary R.
Lytle Carol D.
Banner & Witcoff , Ltd.
CG and Associates
Williamson Michael A.
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