Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Reexamination Certificate
1999-12-13
2001-05-01
Witz, Jean C. (Department: 1651)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
Reexamination Certificate
active
06224876
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to pharmacologically and biologically active compositions containing carotenoids, micro and macro nutrients, a process for their preparation from carrots and their use in formulations for health care and nutrition applications.
BACKGROUND OF THE INVENTION
Carotenoids are a class of naturally-occuring yellow, orange or red tetraterpenoids, found in traces in plant tissue, algae, bacteria and fungi. In particular they are found in vegetable sources such as carrots, spinach, tomatoes and fruits, such as, mango, peach, pumpkim, pappaya. The more commonly known carotenoids are, alpha-carotene, beta-carotene, lutein, zeaxanthin, lycopene and cryptoxanthin.
Carotenoids possess significant nutritional value, carotenes and cryptoxanthin being considered as a provitamin A precursor for the formation of retinal and Vitamin A in humans. Vitamin A, an essential vitamin, for life is not synthesized in the animal cell.
Because carotenoids occur naturally in only trace amounts, the carotenoids must be extracted in concentrated form in order to be useful. Further carotenoids are sensitive to oxygen, air, heat and light.
Nutritionists advocate the the daily use of carrots apart from other fresh vegetables and fruits in diet. Carrots are grown seasonally and good quality carrots are not available throughout the year at affordable prices. A little advertised fact about carrots is that only 20% of the total carotenes present are absorbed even when carrots are eaten in a finely grated form. The percentage of absorption from coarsely grated raw or cooked carrots is still less being around 5%.
The low absorption is attributed to the poor permeability of the cellulosic cell wall to carotenes even after cooking with the result that the major part remains enclosed within the cells. Hence as a source for deriving Vitamin A and use by themselves, carotenoid supplements free from cellulose are strongly recommended. Another advantage of using provitamin A carotenoids is that indiscriminate use of Vitamin A leads to serious toxic effects (Hypervitaminosis) whereas even in large doses carotenoids are harmless.
U.S. Pat. No. 2,567,362 describes fractional centrifugation process for the separation of colloidal dispersoids of active plant pigment units from the generated vegetable hydrosol.
U.S. Pat. No. 2,739,145 describes the separation of coagulated carotenoid-protein particles following heating of a suspension of the vegetable fibre-separated particles in vegetable serum.
U.K. patent 776,405 describes a carotene-concentrate used as a foodstuff for animals using calcium hydroxide and subsequent pH adjustment with phosphoric acid and then with formic acid.
U.S. Pat. No. 2,848,508 describes a process for recovery of carotene from carrots and provides a saturated solution of carotene in natural carrot oil from carrots.
WTO 86/04059 describes the use of a pectolytic enzyme followed by ultrafiltration for extracting and concentrating carotene.
U.S. Pat. No. 5,245,095 describes the use of calcium chloride, calcium hydroxide, calcium lactate or calcium gluconate to extract carotenoids from natural sources.
None of the above or any known processes provide a composition containing carotenoids in combination with micro and macro nutrients, the carotenoids being bound in moieties as in the natural source of carotenoids.
NATURE OF THE INVENTION
In recent times, carotenoids have been found in epidemiological observations to display protective activity as physiological antioxidants, thus reducing the risks of development of several chronic disorders such as heart diseases, cancer, cataract and other ailments. Holistic systems of medicine have, however, for centuries been advocating the synergistic value of dispensing not just pure but natural product ingredients. Use of pharmacologically or biologically active plant extracts is well-known.
Naturally occurring plant material contain a series of closely-related compounds produced naturally via biological and biochemical reactions. The plant is capable of producing a wide range of analogues at least one of which possesses the desired receptor compatibility. However, the related compounds appear to exercise a synergistic effect on the pharmacological or biological activity of the compatible compound and at the same time suppress toxic effects. Therefore the use of a composite set of nutrients as they are present in the natural source, is rapidly gaining supporters in modern medicine.
However, a major drawback in using plant material in its crude form or to use the plant material in its natural state, is that the dosages required of such material, to be therapeutically beneficial, are quite high. For example for receiving the therapeutic supply of carotenoids about one Kg of good quality carrots will have to be consumed every day. Such quantities cannot be conveniently converted into suitable dosage forms.
This invention, therefore, seeks to disclose a process for obtaining a pharmacologically or biologically active plant extract substantially as it occurs in its natural state suitable for converting in a convenient administrable dosage form. The process according to this invention, seeks to provide a concentrated plant extract, in which the plant extract comprises all pharmacologically or biologically active chemicals in the proportions as they exist in the original natural state without the use of organic solvents at any stage of its manufacture and avoiding the use of oils, enzymes, mineral acids, alkalis, metal salts and treatment by temperature in excess of 60 degrees celsius.
The advantage of naturally occurring series and analogues of compounds is achieved without compromising the overall effects of these compounds.
There is no report to date of a product which is standardised in respect of both the carotenoids content as well as the micro and macro nutrients with which the carotenoids are bound to and associated in its natural state occurring in vegetables, particularly carrots.
The present invention describes for the first time biologically or pharmacologically active material obtained from carrots, standardised with respect to its content of carotenoids, vitamins, proteins, lipids, carbohydrates, mineral and trace elements.
The present invention also describes a process to obtain the said material from carrots, which process comprises the addition of a carboxylic acid as herein defined to appropriately processed carrots, followed by the addition of a carbohydrate as herein defined, separation of a carotenoids-rich paste, and subsequent drying.
The present invention also describes the use of the biologically or pharmacologically active material in the preparation of formulations for health care and nutrition applications for use in as variety of prophylactic and therapeutic conditions.
SUMMARY OF THE INVENTION
According to this invention there is provided a pharmacologically and biologically active composition extracted from carrots, including 0.25-5% mass as a percentage of total mass of extract of active carotenoid fraction, absorbable by an animal or human body in a convenient dosage form, in combination with micro and macro nutrients aiding in the absorption, assimilation and supplementing the action of the carotenoid fraction.
Typically, the carotenoid fraction includes alpha-carotene, beta-carotene, lutein, zeaxanthin and lycopene.
Typically the micro nutrients are 0.01 to 1% vitamins, particularly the B complex vitamin, B
1
, B
2
, niacin and Vitamin C and 3 to 10% of minerals and trace elements, as a percentage of total mass of extract.
Typically, the macro nutrients are 20-40% lipids, 10-50% proteins and 1 to 25% carbohydrates as a percentage of total mass of extract.
The invention also provides a process for making a pharmacologically and biologically active composition extracted from carrots comprising the steps of
comminuting cleaned and washed carrots to obtain a homogeneous comminution;
separating the juice from the comminution by filtration;
treating the juice with a carboxylic acid to adjust the pH of the ju
Ann Nunes Priya
Harnarayan Gupta Sanjay
Kesharlal Biyani Milind
Milind Biyani Sushma
Pratap Simha Nanda
Bierman, Muserlian and Lucas
Witz Jean C.
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