Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Separated animal oil or solidified form thereof derived from...
Reexamination Certificate
2000-10-23
2002-11-26
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Separated animal oil or solidified form thereof derived from...
C424S725000, C424S765000, C514S824000, C514S825000
Reexamination Certificate
active
06485752
ABSTRACT:
TECHNICAL FIELD
This invention relates to the use of a composition containing a rose hip extract and fish oil for the treatment of pain and stiffness in the joints, such as associated with osteoarthritis.
BACKGROUND
Various rose hip formulations are known. For example, in U.S. Pat. No. 6,024,960, commonly assigned with the present application, a rose hip formulation for use as an anti-inflammatory natural medicine is described.
Fish oil is also a known material that has some beneficial effects. In particular, the n−3 polyunsaturated fatty acids (n−3 PUFA) of dietary fish oil are known to reduce the level of triglycerides and very low density lipoprotein cholesterol. Dietary supplementation by, for example, 1.0 ml capsules of fish oil containing about 0.3 g of the primary n−3 PUFA, eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA), have been used, though other concentrations of the PUFA's in supplements are available, ranging for example from 20 to 50% by weight.
Osteoarthritis is characterized by an erosion of articulated cartilage which becomes soft, frayed and thinned with eburnation of subchcondral bone and outgrowths of marginal osteophytes. Pain and loss of function result. This is more common in older persons and is considered a degenerative joint disease which mainly affects the weight bearing joints such as the hips and knees.
While inflammation is one symptom of arthritis, the pain and stiffness of the joints is particularly debilitating as this physically inhibits activity and lessens the motivation for daily activities, as well as causing sleeplessness, and results in an overall negative impact on the general well being of an individual, as one susceptible to such pain and joint stiffening must generally refrain from normal daily activities such as walking, entering a vehicle, etc.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a formulation for the treatment of symptoms associated with joint disease.
It is a further object of the present invention to provide a formulation for the prophylaxis of joint disease.
It is a further object of the present invention to provide a formulation based on natural products to substantially avoid side effects associated with traditional drugs used to treat joint pain and stiffness.
It is yet another object to provide a method for treating and alleviating the symptoms of pain and joint stiffness associated with joint disease.
These and other objects of the present invention are achieved by a combination of a rose hip concentrate and fish oil, preferably in a physiologically acceptable carrier. Using the combination, a surprising improvement in pain relief and reduction in joint stiffness is achieved with a consequent improvement in overall well being.
DETAILED DESCRIPTION OF THE INVENTION
The present invention is directed to a formulation using natural ingredients in the treatment of the symptoms associated with joint disease, particularly joint pain and joint stiffness. The formulation includes two primary ingredients, a rose hip extract and fish oil containing n−3 PUFA's.
As these are natural substances, their exact composition may vary somewhat. The rose hip component may be an extract (also referred to herein as a “concentrate”) generally having a high vitamin C content, in the range of about 0.6 to 1.5 mg per g, as well as other vitamins and minerals. Preferably, a rose hip extract produced in accordance with the description in U.S. Pat. No. 6,024,960 is used as that extract is obtained by a process that substantially preserves the vitamin content. Of course, the quantities of the specific vitamins and minerals may vary by species or through use of different extraction/concentration methods. An exemplary rose hip extract in powder form is shown in Table I, though the invention is not limited thereto.
TABLE 1
Analysis (per 400 g)
Result
Vitamin A
<10
&mgr;g/100 g
Vitamin B1
<0.2
mg/100 g
Vitamin B2
0.99
mg/100 g
Vitamin B6
0.20
mg/100 g
Vitamin B12
<0.5
&mgr;g/100 g
Vitamin C
560
mg/100 g
Vitamin K1
63
&mgr;g/100 g
Vitamin E
4.6
mg/100 g
Niacin
0.96
mg/100 g
Calcium
630
mg/100 g
Phosphorus
160
mg/100 g
Magnesium
170
mg/100 g
Iron
1.9
mg/100 g
Potassium
0.97%
Sodium
0.018%
Sulphur
1000
mg/kg
Zinc
1.0
mg/100 g
Copper
10,900
&mgr;100 g
Manganese
3,900
&mgr;g/100 g
Silicon
85
mg/kg
Iodine
93
&mgr;g/100 g
Selenium total
<0.020
mg/kg
Chromium
<0.020
mg/kg
Molybdenum
0.21
mg/kg
Cobalt
<0.050
mg/kg
Nickel
0.79
mg/kg
Aluminum
8.7
mg/kg
Boron
15
mg/kg
Fluorine
2
mg(kg
Chloride
0.5
g/kg
Lithium
0.041
mg/kg
Preferably, the rose hip extract is in powdered form and can be pelletized or placed in capsules with a physiologically acceptable carrier for formulation into unit dosages. A unit dosage comprises a therapeutically effective daily amount of the rose hip which can be taken as a single daily administration or by multiple small doses taken over the course of a day. In either instance, the formulation can be manufactured into tablets, capsules, caplets, elixirs, enteral formulations or be incorporated into slow release carriers. Examples of physiologically acceptable carriers would include water, oil emulsions, alcohol, etc.
A unit dosage may vary based upon many factors such as age, condition and disease state of the individual and number of times the units may be taken in a single day. In any event, the entire daily dosage will be that which is physiologically acceptable and tolerable to an individual and which can be administered daily for a long period of time, as joint disease is a chronic illness.
A preferred unit dosage of the rose hip ingredient will be from about 0.02 to about 0.3 g/kg per day or about 1.5 to 30 g per day. About 2.5 to 15 g per day are preferred, and about 2.5 to 6.0 g are most preferred.
The fish oil ingredient, also as a natural substance, may vary in its concentration of n−3 PUFAX's. Thus, the amount constituting a unit dose may vary in relation to the concentration of the fatty acids. For example, fish oil may contain from 1 to 50% by weight of the n−3 PUFA's, particularly, eicosapentaenoic acid and docosahexanoic acid, typically measured as triglycerides. The lower the concentration of n−3 PUFA's, the higher unit daily dosage should be administered, i.e., five capsules at 10% would be equivalent to one capsule at 50%.
This can, of course, vary with the type of fish used to obtain the fish oil and the processing used to produce the fish oil component, which techniques are conventional in the art. For example, cod fish oil may have about 20% of the n−3 PUFA's while other species may have more or less and this amount may be further concentrated using appropriate conventional processing steps. The most common fish oil supplement is in the form of 1.0 ml capsules, containing about 0.3 g of PUFA's per capsule, though capsules containing up to 50% PUFA's are commercially available.
The fish oil may be obtained in a dry powdered form. For example, a dry powder containing 25% by weight of fish oil is commercially available, one such powder containing 25.7% n−3 18:22 fish oil, having from about 41.0 to 42.2 mg/g EPA as triglycerides and from about 27.0 to 28.8 mg/g DHA calculated as triglycerides. Such a material is well suited for use in accordance with the present invention.
A unit daily dose of fish oil in accordance with the present invention should be in the range of about 500-3600, more preferably 1300-2600 mg of the n−3 PUFA containing fish oil per day in either a single dose or in multiple smaller doses, so as to provide from about 0.1 to 1.8 g PUFA's per day, more preferably about 0.1 to 0.8 g PUFA's per day.
Of course, the ingredients can be preferably combined and formulated together, though separate administration is possible so as to distribute the consumption of these ingredients over the course of a day.
Another way to characterize the inventive formulation is by ratio. The ratio of rose-hip concentrate to fish oil may vary from about 20 to 1
Coleman Sudol Sapone P.C.
Hansen Otto Torbjorn
Sapone William J.
Srivastava Kailash C.
Tate Christopher R.
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