Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined...
Reexamination Certificate
1999-09-14
2002-02-12
Lilling, Herbert J. (Department: 1651)
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
C426S074000, C426S648000
Reexamination Certificate
active
06346275
ABSTRACT:
FIELD OF INVENTION
This invention relates to calcareous materials from natural organic sources and particularly compositions comprising residues of corallinaceae for example Lithothamnium corallioides for use in the therapeutic treatment of humans or animals. The invention also relates to the use of said materials in foodstuffs and processing of foodstuffs.
BACKGROUND OF INVENTION
Corallinaceae, for example Lithothamnium corallioides, are known seaweeds which are very abundant in certain cold and temperate seas. Once harvested the crude residual product consists primarily of mineral substances, particularly calcium carbonate and magnesium carbonate. The largest component is calcium carbonate, often about 34% by weight. This product is sometimes identified as Maërl though the term Maërl encompasses residues of coralline algae of various members of the order corallinales (Class Rhodophyceae) including members of corallinaceae for example members of the species Lithothamnium corallioides, Phymatolithon calcareum and Lithothamnium glaciate.
Crude corallinaceae (Lithothamnium corallioides) residues have been commercially available for use in the prevention of acidosis in intensively fed cows. In French patent FP2 201 040 there is disclosed the use of Maërl which appears to be in the crude form for animal feeds. Such products as have been available until the present time have tended to be relatively impure products frequently from contaminated sources. Usually they contain significant amounts of siliceous materials derived from the original product as dredged and other non-corallinaceae residues for example ground shells of sea-creatures.
The Institute of Oceanography in Paris produced a report on corallinaceae particularly Lithothamnium in 1989 describing the residual crude product (Maërl) and describing its use in treatment of soil and for animal feed as a dietary supplement and for treatment of water.
The subject invention provides further medical uses for compositions comprising residue of corallinaceae (Maërl) in highly purified form.
SUMMARY OF INVENTION
Corallinaceae particularly Lithothamnium corallioides are coralline algae. There are a number of sub-species of corallinaceae particularly Lithothamnium differentiated by morphological data but these data can vary depending on local sea bed and weather conditions. Other known “relatives” include Phymatolithon calcareum and in more northerly regions Lithothamnium glaciale. These plants lay down calcium carbonate in their cell walls which gives them a hard stony texture. The living corallinaceae for example Lithothamnium corallioides generally show a red colour due to the presence of a pigment phycoerythrin in their structure. When dead the colour is white or yellowish. Corallinaceae for example Lithothamnium corallioides occurs naturally in cold and temperate seas and has been reported in Norway, Canada, Scotland, Ireland and France.
Since compositions of the subject invention are to be used therapeutically it is of course important that the corallinaceae which is to be exploited in the invention is derived from a part of the world which does not suffer from heavy pollution. For this purpose corallinaceae particularly Lithothamnium corallioides harvested from stocks north of Lonehort Point, Castletownbere, County Cork in the Republic of Ireland have proved very satisfactory but there are also deposits off the West Coast of Galway.
In the concentrated and purified form of the invention the residue of corallinaceae has proved particularly effective for use in a composition for the manufacture of medicament for the treatment of disorders arising from immunoregulation problems. These problems are, for example, rheumatoid arthritis, osteo arthritis, gout, raised cholesterol levels, period pains, reduced body fluid pH levels, osteoporosis, incipient ulcerative conditions, and certain conditions sometimes described as “low energy” or chronic fatigue problems. Also the product is applicable to reduced calcium level problems and raised pH levels in the colon and certain indigestion problems.
Naturally occurring residues of Lithothamnium corallioides were harvested at the above site at Lonehort Point, purified, concentrated and formed into capsules containing 0.5 grammes of concentrate.
The raw material can be purified by initial extensive washing with sea and fresh water together with removal of extraneous sand, shells, and other debris particularly siliceous debris such as stones. This step usually reduces the material obtained by dredging from the sea bed to about 20% by weight.
The cleaned and separated product is then subjected to intensive cleaning by for example, bleaching and sterilising in hydrogen peroxide for from 8 to 24 hours, further washing in water, drying in a sterile fluid bed and final milling under bacterial controlled conditions.
The stringent washing conditions reduce sodium content of the raw product from amounts in the order of well in excess of 1,000 ppm for example amounts up to 5,200 ppm to sodium contents in the low hundreds, for example 300 ppm. Thus there is a reduction of about 10 fold in the sodium content as compared to raw material.
The silica content of this final material is normally not more than 0.5% by weight as compared to a silica content in previously available Maërl from a commercial source, of about 5% by weight.
The product is packaged by aseptic formation into capsules, tablets or emulsions.
A representative sample of this purified, concentrate contained the following elements in the following amounts
Calcium
34%
Magnesium
2.4%
Phosphorous
0.08%
Potassium
0.10%
Sulphur
0.45%
Iron
20
ppm
Boron
16.5
ppm
Sodium
300
ppm
Manganese
125
ppm
Cobalt
6
ppm
Copper
10
ppm
Zinc
37
ppm
Selenium
1
ppm
Molybdenum
<3
ppm
Iodine
160
ppm
Arsenic
<1
ppm
Lead
<1
ppm
Chromium
13
ppm
Cadmium
0.2
ppm
Mercury
<50
ppb
Aluminium
<1
ppm
One possible reason for the activity of this material is the availability of mineral elements. These serve the physiology of the body in various ways for example;
(a) constituents of skeletal structure;
(b) regulation of physical properties of colloidal systems (viscosity, diffusion, osmotic pressure);
(c) acid-base regulators; and
(d) components and activators of enzymes and other active biological systems.
Thus the calcium from the product of the invention may assist in:
(i) blood coagulation;
(ii) muscle irritability;
(iii) myocordial function;
(iv) control of acetylcholine (neuromuscular irritability); and
(v) enzyme activation
The magnesium content may be of benefit in relation to over 300 enzymatic reactions including carbohydrate utilisation, ATP metabolism, muscle contraction, nerve impulse conduction, transmembrane ion transport, enzyme activation particularly in relation to utilisation of vitamins B1, B2, B6, C and E, and synthesis of fat, protein and nucleic acids. The composition may assist in providing an Na/calcium balance and also may affect the potassium balance. In addition the content and availability of metals such as copper, iron, cobalt, zinc and other components in the product may have effects on physiological and biochemical systems in the body which would not have been anticipated from the mere analysis of the raw material. For example, the copper content may assist with connective tissue dysfunctions, bone fragility, cardiovascular disorders and defects in the lysyl oxidase function. The zinc content may assist with defects in the over 70 enzymatic systems in which zinc is a cofactor.
Rat feeding trials have been conducted with the concentrate to assess the safety of the product in humans. These trials were completely satisfactory.
Pharmaceutically effective amount of the corallinaceae residues can be used in the methods of the invention.
For example patients being treated with the concentrate can be dosed with from 0.5 grammes to 3 grammes of concentrate per day.
Compositions comprising effective amounts of the purified concentrate are useful inter alia for the treatment of conditions involving failure of immuno regulations and include rheumatoid
Aquacal Limited
Ladas and Parry
Lilling Herbert J.
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