COMPLETE AFTER PROVISIONAL
26 FORM 2 18 JAN 2002
The Patents Act, 1970
Complete Specification Section 10
"Carotenoids, Vitamins and Mineral Rich Formulation"
APPLICANT:
Ajanta Pharma Limited
An Indian Company, Registered under Companies Act, 1956 and having its Registered Office at: Ajanta House, 98 Govt. Industrial Area, Charkop, Kandivli (W), Mumbai - 400 067, Maharashtra, India
The inventors under Sec.28 are:
1. BIYANI Milind Kesharlal;
2. SIMHA Nanda Pratap
All being Indian nationals and working as Research Scientists
at Research Centre, Ajanta Pharma Limited, Ajanta House, 98 Govt. Industrial
Area, Charkop, Kandivli (W), Mumbai - 400 067, Maharashtra, India
The following specification particularly describes and ascertains the nature of this invention and the manner in which it is to be performed:

FIELD OF THE INVENTION:
The present invention relates to a natural carotenoids, vitamins and mineral rich formulation to meet specific requirement of menopausal and post-menopausal women. More particularly it relates to composition formulated for reducing the symptoms and health risks during menopause and post-menopause .
BACKGROUND OF THE INVENTION:
The term menopause refers to time in a woman's life between pre-menopause (the reproductive years) and post-menopause. The menopausal period is an age related factor generally occurring between 40-60 years of age characterized by rapid change in hormonal balance in woman. Such hormonal change is natural and caused by time dependant cessation of ovarian function clinically marked by termination of menses over a period of months.
Menopausal symptoms include hot flushes, mood swings, fatigue, night sweats, dizziness, anxiety, depression, headaches, bladder problems, poor libido, vaginal discomfort, breast tenderness, shortness of breath, insomnia and heart palpitation. Some of the other pathological symptoms may arise like fluid retention and imbalance. Apart from these symptomatic disorders the menopausal or post menopausal women is also at a greater risk of developing cardiovascular disease, osteoporosis, cancer, degenerative diseases and other health problems that increases as women age.
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One form of present therapy is to provide exogenous estrogen alone or hormone replacement therapy using estrogen and progesterone to provide certain symptomatic benefits. But these are found to be associated with potential health risks and side effects such as intolerance, tachyphylaxis, risk of cancer. Moreover due to some of its side effects it may not be suitable for women with a family history of breast cancer or at risk of thrombosis. Therefore eventually there is requirement for a more natural option, which is safe and effective.
Moreover it is found that during menopause the risk of nutritional disturbances, particularly vitamins and trace elements are on higher side. The consequences of these deficiencies were linked to increased sensitivity to estrogens, skin structure, bone metabolism, immune function and increased risk of degenerative pathology.
Further recent clinical evidence suggests that many of the
menopausal problems can be considerably reduced and in many
instances, resolved by optimizing the supplementation of
specific nutrients. At the same time, the real risk of
developing osteoporosis and cardiovascular disease after menopause can be greatly minimised through corrective nutritional therapy.
Besides, nutritional supplements can play an important role in chronic fatigue recovery. They help stimulate the immune system, glands and digestive tract, and they can help stabilize and relax mood. They also promote good circulation of blood
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and oxygen to the entire body, a necessity for high energy and vitality. Poor or inadequate nutrition plays a major role in causing fatigue.
However most women have difficulty getting their nutrient intakes up to the levels needed for optimal health benefits, using diet alone.
Thus considering the undesirable effect of HRT, and role of specific nutrients like vitamins and trace elements, nutritional supplements comprising of vitamin and minerals have been recommended to reduce certain symptoms associated with menopause.
At present, available dietary supplements comprising of vitamins, trace elements and vitamin A or carotenoids, predominantly comprise of beta-carotene or optionally other carotenoids. However the recent clinical studies involving postmenopausal women have shown the inadequacy of supplementation with beta-carotene or other carotenoids alone in reducing the health risks.
One study has shown a significant inverse association of risk of ovarian cancer, predominantly in postmenopausal women with intake of carotene. Food items most strongly related to decreased risk for ovarian cancer were raw carrots and tomato sauce Int. J Cancer 2001 Oct 1; 94(1): 128 -34.
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Still another study showed that serum levels of total carotenes and total carotenoids including beta-carotene, which reflects food intake of coloured vegetables and fruits and has a protective role for certain cancer, were significantly lower among breast cancer cases and hospital controls compared to healthy controls, especially in postmenopausal women, suggesting low intake of green-yellow vegetables rich in fiber and carotenoids J. Epidemiol 1999 Nov; 9(5): 306-14.
In yet another study carried out in Greece it was observed that inverse association of beta-carotene intake with breast cancer risk was weaker than the association previously observed with vegetable intake, suggesting that the observed beta-carotene effect is accounted for by another component of vegetables, Br. J. cancer 1999 Jan; 79 (1): 23-9.
Further Gey K F in Bibl-Nutr-Dieta. 1995(52): 75-91 has reported that epidemiological surveys provided abundant evidence that under steady-state conditions diets rich in antioxidants (from vegetables/fruits and suitable vegetable oils) reduce the relative risk of premature death from CVD and cancer. However the 'suboptimal' levels of any single antioxidant may increase the relative risk independently, also the antioxidant-related health benefits seem to depend on an adequacy of all antioxidants, and possibly of nanoantioxidant nutrients as well.
In view of the above findings and data it is evident that nutritional supplements containing beta-carotene or any other
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carotenes added in an isolated form would not be satisfactory in reducing health risks in postmenopausal women. Therefore to derive the maximum benefit from beta-carotene or other carotenes, they need to be incorporated in association with other constituents, in a composite form, as present in their natural state, in the original plant material.
Accordingly there has been provided by present invention a formulation comprising of carotenoids in association with micronutrients derived from carrots further supplemented with natural carotenoids for augmenting their effect along with vitamins and minerals to meet specific requirement of menopausal and post-menopausal women, for reducing the symptoms and health risks during menopause and post-menopause. The present invention formulation is novel with regard to having carotenoids and micronutrients of carrots obtained as per our Indian patent no. 183599 comprising of alpha-carotene, beta-carotene, Lutein, zeaxanthin, lycopene in association with micro and macro nutrients in proportions compatible with those originally found in the natural state occurring in carrots for providing proper health benefits, rather than including carotenes in isolated form unlike other supplements.
PRIOR ART:
US patent no. 586908 (February 9,1999) describes muti-vitamin and mineral supplements for administration to lactating, non-lactating, and menopausal women. A multi-vitamin and mineral supplement for menopausal women comprises of from about 320 -480 mg of elemental calcium; 320 - 480 I.U. Vitamin D; 250 -
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750 I.U. beta-carotene or 3600 - 5400 I.U. Vitamin A and mixture thereof; 20 - 30 mcg vitamin B12, 2.4 - 3.6 mg vitamin B6; 16 - 24 mg vitamin B3; 1.3 - 2.0 mg vitamin B2; 1.2 - 1.8 mg of vitamin Bl, 70 - 110 I.U. vitamin E, 7-11 mg elemental iron; 16 -24 mg elemental zinc; 40 - 60 mcg elemental molybdenum; 80 - 120 mcg elemental chromium.
The compositions of prior art supplement and present invention formulations are quite different from each other. Prior art supplements do not contain many of the ingredients found to be necessary in alleviating the symptoms of menopause or post menopause. Moreover the prior art supplement comprises of beta-carotene or vitamin A and combination of both, whereas the present invention formulation comprises of natural carotenoids and micronutrients of for providing optimal health benefits by way of their synergistic effect in reducing the health risks in menopausal or postmenopausal women.
US patent no. 6040333 (March 21, 2000) relates to dietary supplements containing low doses of phyto estrogens for supplementing the specific phytochemical dietary needs of premenopausal and menopausal women.
Present invention formulation is different from prior art dietary supplement as it does not contain phytoestrogen but comprises of vitamins, mineral along with natural carotenoids and micronutrients of carrots for providing synergistic effect in alleviating the symptoms and reducing the health risks in menopausal or postmenopausal women.
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Susan M. Lark, in "Vitamins, Minerals and herbs for chronic fatigue" excerpted from "The Menopause Self Help Book", Celestial Arts - Berkeley has described an optimal nutritional supplement for fatigue related to menopause. It has described the following composition:
Vitamins & Minerals Maximum Daily Dose
Beta carotene 5000 I.U.
Vitamin A 5000 I.U.
Vitamin D 400 I.U.
Vitamin E (d-alpha tocopheryl acetate) 800-2000I.U.
Vitamin C 1000-2000 mg
Bioflavonoids 800-2000 mg
Rutin 200 mg
Vitamin B 150 mg
Vitamin B 250 mg
Niacin (as niacinamide) 30 mg
Vitamin B6 30 mg
Vitamin Bl 250 mcg
Folic acid 400 mcg
Biotin 200 mcg
Pantothenic acid 50 mg
Choline 50 mg
Inositol 50 mg
PABA (para-aminobenzoic acid) 50 mg
Calcium (calcium citrate) 1200 mg
Magnesium 320 mg
Iodine 150 mcg
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Iron (ferrous fumarate) 27 mg
Copper 2 mg
Zinc 15 mg
Manganese 10 mg
Potassium(potassium aspartate)100 mg
Selenium 25 mcg
Chromium 100 mcg
Bromelain 100 mg
Papain 65 mg
Boron 3 mg
From the above it is obvious that the present invention formulation is substantially different from the prior art as it does not comprise of the ingredients such as Bioflavonoids, Rutin, Bromelain, Papain, instead the present invention formulation is much simpler and contains lesser ingredients. Moreover the prior art comprises of beta-carotene alone, however it has already been observed that single antioxidant may not provide sufficient biological activity, but on the contrary it can increase the relative risk independently. Further the antioxidant-related health benefits are seen to depend on an adequacy of all antioxidants, and possibly of antioxidant nutrients as originally present in the plant material. Therefore the present invention includes natural carotenoids and micronutrients of carrots comprising of alpha-carotene, beta-carotene, Lutein, zeaxanthin, lycopene in association with micro and macro nutrients in proportions compatible with those originally found in the natural state occurring in carrots rather than single isolated beta-carotene
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as in prior art to specifically address the health risks during menopause or postmenopause.
Thus from the foregoing it is evident that the present invention formulation comprising of carotenoids in association with micronutrients derived from carrots further supplemented with natural carotenoids for augmenting their effect along with vitamins and mineral to meet specific requirement of menopausal and post-menopausal women, for reducing the symptoms and health risks during menopause and post-menopause is different from earlier patented prior arts and publications. Furthermore, the composition has been formulated in tablet form and has been stabilized with proper coating of vitamins and separating the metallic content from vitamin and carotenoid content during processing by separate granulation procedures. The present invention formulation is unique in content and formulation, a procedure that has not been referred in any of the prior arts.
OBJECTS OF THE INVENTION:
Accordingly it is an object of the present invention to provide a formulation comprising natural carotenoids, vitamins and mineral to meet specific requirement of menopausal and post¬menopausal women and reduce the symptoms and health risks during menopause and post-menopause.
It is another object of the present invention to provide formulation unique in content with respect to natural carotenoids and micronutrients of carrots comprising of alpha-carotene, beta-carotene, lutein, zeaxanthin, lycopene in
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association with micro and macro nutrients for providing synergistic effect in alleviating the symptoms and reducing the health risks in menopausal or postmenopausal women.
It is yet another object of the present invention to provide formulation in suitable oral dosage forms such as tablet or capsule.
It is yet another object of the present invention to provide a process for preparation of formulation, which is specifically designed so as to provide stability to the formulation.
SUMMARY OF THE INVENTION:
The present invention relates to a natural carotenoids, vitamins and mineral rich formulation to meet specific requirement of menopausal and post-menopausal women and reducing the symptoms and health risks during menopause and post-menopause. The present invention formulations are prepared in tablet dosage form by a specifically designed process to provide stability to the formulation.
DETAILED DESCRIPTION OF INVENTION:
The present invention relates to a formulation comprising of natural carotenoids along with appropriate constituents of vitamins and mineral to meet specific requirement of menopausal and post-menopausal women, and reduce the symptoms and health risks during menopause and post-menopause.
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The present invention formulation comprises of carotenoids and micronutrients of carrots 50 - 250 mg; natural carotenoids 1 -50 mg; vitamin c 30 - 500 mg; vitamin e acetate 15 - 400 mg; elemental zinc 5-50 mg; elemental selenium 50 - 200 mcg; chromium 25 - 100 mcg; folic acid 200 to 1000 mcg; thiamin mononitrate 5-50 mg; pyridoxine hydrochloride 10 - 100 mg; cyanocobalamin 5 - 50 mcg; elemental copper 0.5 - 5 mg; elemental manganese 1 - 5 mg; elemental magnesium 50 - 200 mg; niacinamide 5 - 100 mg; biotin 15 - 50 meg; riboflavin 1 - 10 mg; elemental boron 0.1 - 5 mg; elemental iodine 200 -400 mcg; aminobenzoic acid 10 - 50 mg; calcium pantothenate
10 - 100 mg; vitamin d3 50 - 200; elemental iron 5.0 -25 mg and other pharmaceutically accepted inert and safe excipients in appropriate amounts.
Carotenoids and micronutrients of carrots and other natural carotenoids incorporated in the present invention formulation are antioxidants well known to fight the oxidative damage produced by free radicals. They defend tissue and cell membranes in body systems. They also help protect the circulatory system, which is important as estrogen declines during menopause. Their incorporation is therefore intended to reduce the health risks during menopause or postmenopause. Beta-carotene a provitamin A carotenoid is as important as retinol to which it gets converted in the body, for maintaining health.
Vitamin C is required for the synthesis of collagen; thus its intake would have beneficial effects in reducing bone loss in
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menopausal women. It is also useful in healing wounds, fighting infection, reducing inflammation, lowering cholesterol, reducing risks of heart diseases, and many other conditions. It also works as an antioxidant thereby providing additional health benefits.
Vitamin E acetate is a potent antioxidant. It is useful in relieving hot flushes, mystodynia, in fighting fibriocystic breast disease, reducing mammary tumors, and reducing risk of lung cancer and heart disease.
Zinc is an integral part of many enzymes. It is also important to enhance immune function and for proper formation of DNA, and RNA. It is also required for proper alcohol metabolism and digestion of proteins in GI tract. It improves muscle strains and endurance.
Selenium also is an antioxidant it acts synergistically with vitamin E. It helps in reducing the risk of coronary heart disease to which postmenopausal women are specially prone. It also supports liver function; the liver performs the important function of promoting hormonal balance by processing excess levels of hormones.
Chromium assists in the regulation of glucose metabolism. An imbalance of glucose can be associated with mood swings as are commonly experienced by menopausal women. It is also useful in synthesis of fatty acids and cholesterol.
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Folic acid is an essential component, which plays a role in production of red blood cells, hormones and synthesis of DNA.
Thiamine generally known as vitamin Bl is useful in keeping collagen-rich connective and mucous membranes healthy. It is also needed by the body for final metabolism of carbohydrates and amino acids.
Pyridoxine commonly referred to as vitamin B6 acts as coenzyme for many chemical reactions like those related to amino acid and protein metabolism, production of RNA and DNA, relieving water retention in women. It has been found to reduce fatigue and depression in women
Cyanocobalamin known as vitamin B12 plays an important role in overall metabolism and nervous system function. One of the major functions is promotion of RBC; therefore it is essential for preventing anemia.
Copper plays a vital role in providing elasticity to blood vessels. It is also required for formation of elastin and collagen. Copper has been found to be a strong anti-oxidant and is an essential mineral in many enzymes and hormones. It is also exceedingly important for a healthy immune system.
Manganese assists in regulation of production and release of insulin, it plays a role in metabolism of proteins and fats. It is also important in maintaining bone growth, and therefore in reducing risk of osteoporosis.
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Magnesium has been found to reduce emotional stress, anxiety and insomnia in women. It has been found to calm the mood and induce peaceful sleep. It is useful for proper bone health.
Niacin generally referred to as Vitamin B3 plays a role in production of hormones. It helps in lowering cholesterol levels and is beneficial in proper blood circulation and reducing bone loss.
Biotin plays a role in maintaining healthy skin. Biotin assists in energy production inside the cell and helps to convert folic acid into its biologically active form.
Riboflavin commonly known as vitamin B2 is useful for digestive functions. Its deficiency can cause headaches, mental depression and forgetfulness and therefore its supplementation is very vital in women suffering from menopausal symptoms.
Boron plays an important role in maintaining health of bones. It enhances absorption of calcium.
Iodine prevents fatigue caused by low thyroid functions. It has been found that it can reduce certain breast-related diseases, fatigue, excess weight, and constipation and metabolism problems.
Potassium is also important for energy and vitality and maintenance of body water balance.
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Calcium Pantothenate reduces stress by improving adrenaline function.
Para amino benzoic acid assists the body in its use of
pantothenic acid, which supports and enhances the formation of
red blood corpuscles and acts as a coenzyme in the breakdown and utilization of protein.
Calcium is very vital for bone formation. It is required for reducing fatigue, emotional irritability, muscular irritability and cramps and is useful in cases of osteoporosis, fatigue, and anxiety related problems. It has been found to help in regularizing blood pressure, nerve impulse and heartbeats and also reduction of cholesterol. It also helps in blood clotting.
Vitamin D3 facilitates absorption of calcium from intestine and reduces symptoms of osteoporosis seen with older women.
Iron has been found to reduce anemia.
The present invention formulation, has been appropriately designed by way of the role played by each of the above mentioned vitamins and minerals, individually as well in correlation with other nutrients. Further the present invention specifically comprises of carotenoids and micronutrients from carrots along with natural carotenoids for providing an overall synergistic effect with other ingredients in alleviating the symptoms and reducing the health risks in menopausal or postmenopausal women.
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Apart from the afore mentioned ingredients the composition also comprises of other pharmaceutically inert excipients like lubricants such as colloidal silicon dioxide, magnesium stearate, talc or the like and or the combination thereof in the range of 0.5 % to 10% by weight of the composition; disintegrant such as sodium starch glycolate, crospovidone, croscarmellose or the like and or the combination thereof in the range of 0.5 % to 10% by weight of the composition; or diluents such as microcrystalline cellulose, starch, dicalcium phosphate, tricalcium phosphate, calcium silicate, maltodextrin, or the like and or the combination thereof in the range of 5% to 60% by weight of the composition.
According to the present invention the formulations are prepared in suitable oral dosage forms such as tablet or capsule.
As per the present invention the formulations are prepared in accordance with and by the specifically designed process to provide the stability to the formulations by proper coating of vitamins and separating the metallic constituents from the vitamins and carotenoids by separate granulation procedures. The process for preparation of the tablet comprises of following steps:
I) Granulation of all minerals salts (metallic constituents): a. The mineral salts were sifted through 40 mesh sieve and blended with microcrystalline cellulose;
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b. selenium salt was dissolved in water and adsorbed on
microcrystalline cellulose and the blend passed through 40
BSS sieve;
c. chromium salt was dissolved in water or mixed dry by
geometric dilution with the microcrystalline cellulose and
the blend passed through 40 BSS sieve;
blends of (b) and (c) were mixed with the mineral salts blend of (a) and the resultant blend was granulated with starch paste by the process of wet granulation; the granules were dried at 60°C, to a loss on drying of between 3 to 5 % and sized to 20 mesh granules. II) Granulation of carotenoids and vitamins:
a. vitamin C and niacinamide were sifted separately through 20
mesh sieve, and mixed, to the blend liquid paraffin was
added;
b. thiamine mononitrate was sifted through 20 mesh sieve, to
which liquid paraffin was added;
c. other vitamins were sifted through 20 mesh sieve and blended
with vitamin blend of a and b.
d. carotenoids dispersion and vitamin E were adsorbed on
precipitated silica and resultant powder sifted through 40
mesh sieve.
e. carotenoids and vitamin powder was further blended with
microcrystalline cellulose.
f. the blends of step (c) and (e) were mixed together.
g. the blend obtained from (f) was granulated with non-aqueous
solution of povidone.
h. above resultant granules were dried in the fluid bed dryer at a temperature not exceeding 50 degree centigrade to a
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moisture content not less than 3 % and granules were sized
to a size of 20 mesh. III) The resultant granules of step I and II were mixed and lubricated with lubricants comprising of colloidal silicon dioxide, magnesium stearate, talc already passed through 40 mesh sieve and a disintegrant such as sodium starch glycolate, crospovidone or croscarmellose and compressed with appropriate punch, to pre-determined weight and thickness.
The tablet are coated with a non aqueous coating formula containing 2% w/w hydroxypropyl methylcellulose 15 cPs, 1% ethyl cellulose, 1% titanium dioxide, 0.5% ponceau 4 R and 0.5% each of propylene glycol and polyethylene glycol. The tablets were coated to a build up of 1.5 to 3.5% of the tablet weight.
During the entire process the process conditions were selected to ensure the stability of the carotenoids. Care was taken during the process to minimize exposure to air, heat and light to avoid the degradation of the carotenoids. All the steps of process were carried out in diffused light to avoid oxidation of light sensitive carotenoids
The tablets were strip packed with 40-micron aluminum foil to increase the stability of the formulation.
The following examples illustrate but do not limit the scope of invention. It is understood that various other modifications will be apparent to and can be really made by those skilled in
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the art without departing from the scope and spirit of the invention.
EXAMPLE:
Example 1:
The tablets were prepared as per the process described in the
description of the invention comprising of the following
composition.

INGREDIENT AMOUNT PER TABLET
Carotenoids and Micronutrients of carrots 100 mg
Natural Carotenoids 20 mg
Vitamin C IP 45 mg
Vitamin E Acetate IP 30 mg
Zinc sulphate monohydrate USP Equivalent to elemental Zinc 15 mg
Selenium dioxide monohydrate USP Equivalent to elemental Selenium 100 mcg
Chromic Chloride USP Equivalent to Chromium 50 mcg
Folic acid IP 400 mcg
Thiamine mononitrate IP 10 mg
Pyridoxine Hydrochloride IP 40 mg
Cyanocobalamin IP 9 mcg
Cupric Sulphate USP Equivalent to elemental Copper 1 mg
Manganese Sulphate USP
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Equivalent to elemental Manganese 2 mg
Magnesium Hydroxide IP Equivalent to elemental Magnesium 100 mg
Niacinamide IP 20 mg
Biotin USP 30 mcg
Riboflavin IP 5 mg
Sodium Borate BP
Equivalent to elemental Boron 2 mg
Potassium Iodide IP Equivalent to elemental Iodine 225 mcg
Aminobenzoic acid BP 30 mg
Calcium Pantothenate IP 30 mg
Vitamin D3 IP 100 IU
Ferrous Fumarate IP Equivalent to elemental Iron 12 mg
Example 2:
The tablets were prepared as per the process described in the
description of the invention comprising of the following
composition.

INGREDIENT AMOUNT PER TABLET
Carotenoids and Micronutrients of carrots 100 mg
Natural Carotenoids 20 mg
Vitamin C IP 45 mg
Vitamin E Acetate IP 30 mg
Zinc Sulphate monohydrate USP 15 mg
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Equivalent to elemental Zinc
Selenium dioxide monohydrate USP Equivalent to elemental Selenium 100 mcg
Chromic Chloride USP
Equivalent to elemental Chromium 50 mcg
Folic acid IP 400 mcg
Thiamine mononitrate IP 10 mg
Pyridoxine Hydrochloride IP 40 mg
Cupric Sulphate USP Equivalent to elemental Copper 1 mg
Manganese Sulphate USP Equivalent to elemental Manganese 2 mg
Magnesium Hydroxide IP Equivalent to elemental Magnesium 100 mg
Niacinamide IP 20 mg
Biotin USP 30 mcg
Riboflavin IP 5 mg
Sodium Borate BP
Equivalent to elemental Boron 2 mg
Potassium Iodide IP Equivalent to elemental Iodine 225 mcg
Aminobenzoic acid BP 30 mg
Calcium Pantothenate IP 30 mg
Vitamin D3 IP 100 IU
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CLAIMS:
We claim,
1. A natural carotenoids, vitamins and mineral rich formulation
for menopausal and postmenopausal women comprising of
carotenoids and micronutrients of carrots 50 - 250 mg;
natural carotenoids 1-50 mg; vitamin c 30 - 500 mg;
vitamin e acetate 15 - 400 mg; elemental zinc 5-50 mg;
elemental selenium 50 - 200 mcg; chromium 25 - 100 mcg;
folic acid 200 to 1000 mcg; thiamine mononitrate 5-50 mg;
pyridoxine hydrochloride 10 - 100 mg; cyanocobalamin 5-50
mcg; elemental copper 0.5-5 mg; elemental manganese 1 -
5 mg; elemental magnesium 50 - 200 mg; niacinamide 5 - 100
mg; biotin 15 - 50 meg; riboflavin 1-10 mg; elemental
boron 0.1 - 5 mg; elemental iodine 200 - 400 mcg; para
amino benzoic acid 10 - 50 mg; calcium pantothenate 10
- 100 mg; vitamin d3 50 - 200; elemental iron 5.0 - 25 mg and other pharmaceutically accepted inert and safe excipients in appropriate amounts.
2. A natural carotenoids, vitamins and mineral rich formulation
as claimed in claim 1, wherein the said carotenoids and
micronutrients of carrots obtained as per our Indian patent
no. 183599 comprising of alpha-carotene, beta-carotene,
Lutein, zeaxanthin, lycopene in association with micro and
macro nutrients in proportions compatible with those
originally found in the natural state occurring in carrots
for providing synergistic effect rather than including
carotenes in isolated form.
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3. A natural carotenoids, vitamins and mineral rich formulation as claimed in claim 1, wherein other pharmaceutically inert excipients included are lubricants such as colloidal silicon dioxide, magnesium stearate, talc or the like and or the combination thereof in the range of 0.5 % to 10% by weight of the composition; disintegrant such as sodium starch glycolate, crospovidone, croscarmellose or the like and or the combination thereof in the range of 0.5 % to 10% by weight of the composition; or diluents such as microcrystalline cellulose, starch, dicalcium phosphate, tricalcium phosphate, calcium silicate, maltodextrin, or the like and or the combination thereof in the range of 5% to 60% by weight of the composition.
4. A natural carotenoids, vitamins and mineral rich formulation as claimed in claim 1, wherein the said formulations are in the suitable oral dosage forms such as tablet or capsule.
5. A natural carotenoids, vitamins and mineral rich formulation as claimed in claim 1, wherein the said formulations are prepared in accordance with and by the specifically designed process by proper coating of vitamins and separating the metallic constituents from the vitamins and carotenoids by separate granulation procedures to provide the stability to the formulations.
6. A natural carotenoids, vitamins and mineral rich formulation as claimed in claim 1, wherein the said formulation is
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useful to reduce the symptoms and health risks during menopause and postmenopause.
Dated this 18th day of January 2002
For AJANTA PHRMA LIMITED

To:
The Controller of Patents Patent Office Branch, at Mumbai - 13


DR. BIYANI MILIND K.
Vice President - Scientific Affairs Ajanta Pharma Limited 98,Govt. Indl. Areas, Kandivli (W) , Mumbai67.