FORM 2
THE PATENT ACT 1970
(39 of 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule13)

1. TITLE OF THE INVENTION: "Medicinal Composition"
2. APPLICANT
(a) NAME: L'AMAR NATURAL PRODUCTS PRIVATE LIMITED
(b)NATIONALITY: Indian Company incorporated under the Indian
Companies ACT, 1956
(c) ADDRESS: 12, Gunbow Street, Fort,Mumbai - 400001 Maharashtra, India
3.PREAMBLE TO THE DESCRIPTION
The following specification particularly describes the invention and the manner
in which it is to be performed.
1 4 JUL 2006

Technical field:
The present invention relates to an energy boosting composition. It further also relates to the process of preparing the same.
Background and prior art:
Men who are in their midlife are standing on the threshold of a 'new youth'. It is also called as 'second adulthood'. What possibly comes in the way of enjoying the 'second adulthood' is the impact of modern lifestyle on the energy levels, stamina as well as drive. The causes and effects of modern lifestyles include stress factors and environmental pollution. Stress produces excess levels of hormone Cortisol in our bodies and can have a negative effect on memory and concentration. Since the beginning of man's recorded history, herbs have been used to enhance mood, pleasure and sexual response. There is an increasing scientific evidence to support historical lore regarding the use of herbs as energy boosters as well as aphrodisiacs.
US20060110478 Al describes delivery system and method for supporting and promoting healthy sexual function, prevention and treatment of sexual dysfunction. The compositions include one or more cGMP-specific PDE5 inhibitors and/or dopaminergic agonists and are administered in the form of a breath-care strip, mint or lozenge, or a food or beverage product. The cGMP-specific PDE5 inhibitor comprises an ingredient selected from the group consisting of sophoflavescenol, vardenafil, tadalafil, and sildenafil. The dopaminergic agonist comprises apomorphine. Vitex agnus-castus extract, and one or more of lipoic acid, L-Arginine, folic acid, trimethylglycine, policosanol, carnitine, biotin, and acetyl L-Carnitine may also be included in the delivery vehicle.
US20060094734 Al relates to composition and method for inducing alertness. The composition contains the active ingredients caffeine and taurine and various inert substances in a dry formulation. Caffeine and taurine are delivered in an oral formulation that obviates the need for ingesting significant quantities of liquid or sugar. US20050244510 Al describes compositions for improving mental performance. The invention provides formulas for producing compositions for the structural/functional
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nutritional support for those who struggle with poor focus, concentration and/or memory. The above prior art also provided compositions comprising nutritional/botanical factors helpful to those who subjectively experience transient mental fatigue or poor cognitive function. The composition primarily consists of B-complex vitamins, antioxidants, minerals, phosphatidyl serine (PS), choline, dimenthyl-aminoethanol (DMAE), docosahexaenoic acid (DHA), L-pyroglutamic acid, and herbal extracts from Bacopa monniera, Vinca minor, and Huperzia serrata. The invention also relates to the administration of these compounds.
US20040166184 Al, describes Withania somnifera composition, method for obtaining same and pharmaceutical, nutritional and personal care formulations thereof. The composition of the plant Withania Somnifera, and, more particularly to a high purity extract composition with advantageous levels of withanolide glycosides and oligosaccharides, a minimum of polysaccharides, and substantially low levels of free withaferin A and equivalents (withanolide aglycones), which composition provides enhanced cognition-enhancing effects for the user, and an extraction process for obtaining such composition, as well as pharmaceutical, nutritional and personal care use products thereof.
US2002068728 describes a natural composition for boosting the libido of an individual, the composition including an effective amount of an aphrodisiac and a compound to increase blood flow to the pelvic area in a pharmaceutically acceptable carrier.
Viagra RTM. available from Pfizer contains sildenafil citrate for oral administration that also acts as an aphrodisiac but many persons are not candidates for this as a result of their physiological condition since oral administration of sildenafil citrate is contraindicated for individual's currently taking organic nitrates, such nitroglycerine.
There are many herbs available in nature that is used as aphrodisiac. But of these few

herbs like Kawach beej

(Mucuna pruriens), Safed Musli (Chlorophytum arundinaceum),

Ashwagandha (Withania somnifera), Shatavari (Asparagas racemosus) etc have been
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used to a larger extent as contain these herbs.

aphrodisiacs. This is the reason most of the herbal combinations

120 g of Sida cordifolia Piper longum; 20 g of
RO117897 relates to a revitalizing Ayurveda supplement for males, prepared of oriental plants and East- and West-European flora, employed for prophylactic purposes in the treatment of several metabolic malfunctions and/or for stimulating some physiological functions of the organism, playing a nutritive part with respect thereto. The claimed supplement comprises 80 g of Asparagus racemosus (sin A javanicus); 90 g Asphaltum (shilajit); 60 g of Boerhavia diffuza; 70 g of Centipeda minima; 10 g of Cinnamomi cortex (cinnamon); 30 g of Chlorophytum arundinaceum; 20 g of Corallium rubrum (Coral Bhasm); 10 g of Elletaria cardamomum; 100 g of Gummi accacia; 10 g of Mesua ferrea; 80 g of Mucuna prurita; 10 g of Myristica fragrans; 40 g of Spheranthus indicus;
70 g of Strichnos potatorum; 80 g of Tribulus terrestris; 10 g of Zinci carbonas and 20 g of Zingiber officinale. All these components, as powder, | are mixed, homogenized and processed as uncoated tablets of 500 mg.
But the major drawback with all these natural herbal ingredients are that they have a bitter taste and masking this taste is a challenging task, in addition to this another task is to provide an acceptable formulation throughout the shelf life of the product. One way would be to formulate as various forms like health drinks, food items etc. But since the drugs are extremely bitter, a better option would be to formulate them as dosage forms like tablet, granules, capsules, liquids etc. But incase of some of the unpleasant taste still exists, also it has a bad appearance and so it is often necessary to mask an unpleasant, e.g. bitter, taste of the active compound. Another problem faced with such formulations is the decrease in patient compliance and hence there is a need to improve the patient compliance.
Yet another problem associated with dosage forms containing herbal ingredients is that along with disagreeable odor; bad appearance, they tend to absorb moisture on storage and thus further affect the appearance. For example tablets on absorption of moisture
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become sticky. One way to overcome this is to pack these moisture sensitive dosage forms in special containers or use special packing material to limit the exposure of the dosage forms to the atmosphere. But in territories where the climate is very humid specialized packing does not provide a total satisfactory answer against moisture.
A formulation marketed by Baidyanath also contains Ashwagandha, Shilajit, Araka bhasma, safed musli with other ingredients and is available as a capsule to be taken with milk or water for richer, fuller and energetic life.

There are many other containing a number of herbal
formulations available in the market for use as aphrodisiacs ingredients possessing aphrodisiac activity.

Medicines containing synthesized actives since

herbal active are generally preferred over the chemically there are less chance of any side effects.

But a problem associated with dosage forms containing herbal ingredients is that they have a disagreeable odor, taste, a bad appearance and they tend to absorb moisture on storage and thus further! affect the appearance. Most of these drugs are extremely bitter

and masking the taste to

make it palatable is a challenging task, in addition to this another

task is to provide an acceptable formulation throughout the shelf life of the product.
Hence, the present invention is aimed to ameliorate atleast some of the problems faced by the prior art by providing herbal medicinal compositions as a oral tablet with suitable coatings, thereby protects the formulation from absorbing atmospheric moisture as well as masks the disagreeable odor, taste, and appearance of the formulation. Thus the present invention provides herbal medicinal compositions as a solid oral dosage form

with linger shelf-life for

use an aphrodisiac and as a general health tonic.

Object of the invention:
The object of the present invention is to provide a herbal medicinal composition comprising herbal ingredients that solves the problem associated with the prior art.
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It is an another object of the invention to provide herbal medicinal composition as a tablet using suitable coatings, thereby protects the formulation from absorbing atmospheric moisture as well as masks the disagreeable odor, taste, and appearance of the formulation.
It is an another object of the present invention to provide a herbal medicinal composition comprising Chlorophytum species (spp) and Withania species (spp) as coated oral dosage formulations.
It is a further object of the invention to provide shatavari (Asparagus racemosus), Gokhru (Tribulus terrestris) alone or in combination with other bitter tasting drugs as coated tablets.
It is yet another object of the present invention to provide herbal medicinal compositions for use as an aphrodisiac, as a general health tonic.
It is another object of the present invention to provide a herbal medicinal composition that increases vigor and vitality and reduces fatigue, stress and strain.
It is another object of the present invention to provide herbal medicinal compositions for use as an aphrodisiac, as a general health tonic, that increases vigor and vitality and reduces fatigue, stress land strain, which comprises administering a therapeutically effective amount of a medicinal composition provided by the present invention.
It is yet another object of the present invention to provide a process for manufacture of herbal medicinal composition as a moisture resistant coated tablet.
Summary of the invention:
According to the present invention there is provided herbal medicinal compositions comprising therapeutically effective amount of Chlorophytum species, Withania species, Asparagus species, Pueraria species, Gokhru (Tribulus terrestris) alone or in combination
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with suitable pharmaceutically acceptable excipients as coated tablet using suitable coatings for oral administration. These coating protects the formulation from absorbing
atmospheric moisture as formulation.

well as masks the disagreeable odor, taste, and appearance of the

According to another aspect of the present invention there is provided a process to manufacture of herbal medicinal compositions.

According to yet another aspect of the present invention there is provided a herbal medicinal composition for use as an aphrodisiac, as a general health tonic, that increases vigor and vitality and reduces fatigue, stress and strain, which comprises dispensing a
therapeutically effective present invention.
amount of a herbal medicinal composition as provided by the

Detailed description of the invention:
The aphrodisiacs are substances that excite sexual desire in a person. There are several drugs that are commercially available for use as aphrodisiacs.
Several natural drugs are also reported in literature having aphrodisiac activity like
Kawach beej (Mucuna pruriens), Safed Musli (Chlorophytum borivilianum and
arundinaceum), Ashwagandha (Withania somnifera), Shatavari (Asparagas racemosus),
Yohimbine, Gokhru (Tribulus terrestris) but the preferred ones according to the present
invention are those belonging to the Chlorophytum species, Withania species, Pueraria
species, Asparagas species and Gokhru (Tribulus terrestris).
The term "species" (spp) described in the specification and claims refers to various species falling under the specified genus.
The present invention therefore provides suitable coated oral formulations that overcome all the problems associated with the prior art.
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In a preferred embodiment, the present invention provides a medicinal composition comprising Chlorophytum species, Withania species, Asparagus species and Gokhru (Tribulus terrestris) as coated oral dosage formulations.
Thus the present invention provides medicinal compositions comprising Chlorophytum species, Withania species, Asparagus species and Gokhru (Tribulus terrestris) using different types of coatings to mask the taste, odor as well as to protect from the atmospheric moisture.
According to one aspect of the present invention, the composition is provided with film coating. The film coating helps to mask the disagreeable odor, taste and appearance of the formulation.

Thus the present invention species, Withania species suitable film coating which coating protects the formulation the disagreeable odor,
provides a medicinal composition comprising Chlorophytum
Asparagus species and Gokhru (Tribulus terrestris) with a
also acts as a moisture barrier coat. The moisture barrier
from absorbing atmospheric moisture as well as masks and appearance of the formulation.

According to another aspect of the present invention, the composition is provided with moisture barrier coating. The moisture barrier coating reduces the rate at which the dosage forms absorb atmospheric moisture. In addition to this, it also masks the disagreeable odor, taste and appearance of the formulation.
Chlorophytum spp.
The Chlorophytum species is belongs to the family liliaceae. The different species include for eg. Chlorophytum arundinaceum, Chlorophytum borivilianum, Chlorophytum tuberosum, Chlorophytum laxum. The preferred species according to the present invention are Chlorophytum arundinaceum, Chlorophytum borivilianum. It is also known as Safed Musli, and is a potent herb whose root tubers have been in use for aphrodisiac and health promotion purposes since 11th century A.D. is rich source of over 25
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alkaloids, vitamins, minerals, proteins, carbohydrates, steroid, saponins and polysaccharides etc. It contains saponins like sigmasterol and hecogenin that are herbal steroids. Roots are used for the preparation of nutritive tonic used in general sexual weakness. It has got wide usage in Ayurveda, Unani and Allopathy. It is very useful as a curative for Physical weakness and many illnesses, As a Curative for Natal and Post-natal problems, As an Aphrcdisiac Agent and Vitalizer, As a General Sex tonic, As an Immunity-improving drug, As a Remedy for Diabetes, As a Remedy for Arthritis. The therapeutically effective range of Chlorophytum spp is about 500mg to l.0gm. Hence the formulation may contain varying amount of Chlorophytum spp such that the patient takes the formulation in such a therapeutic regime that he receives a desired therapeutic dose. Preferably water extracts of dried roots of Chlorophytum spp is used. The chlorophytum arundinaceum is used in the present invention ranges from 200 to 500 mg; preferably 300mg.
Withania spp:
The plant Withania, Somnifera Dunn. (Solanaceae) is commonly known as
Ashwagandha. It is used in herbal formulations of the Ayurvedic or Indian system of
medicine to attenuate a cerebral function deficit in the geriatric population, and to
augment learning and memory to provide a non-specific host defense. These beneficial

effects help to ward off stress and act as an adaptive. Ashwagandha also shows
significant protection against pentylene tetrazole-induced seizures in experimental
models of epilepsy, indicating its potential utility for treatment of petitmal epilepsy.
Administrating Ashwagandha causes a decrease in the core body temperature suggesting
a reduced Body Metabolic Rate (BMR), enhanced body growth and increased longevity.
The preferred species according to the present invention is Withania somnifera. Also known as ashwagandha , is used as tonic, astringent, aphrodisiac action. The roots also have diuretic and debasement, tonic, alterative and aphrodisiac activity. It is also useful in cases of general debility, nervous exhaustion, loss of muscular energy and spermatorrhoea. The main constituents of ashwagandha are alkaloids and steroidal lactones. Among the alkaloids, withanine is an important constituent. Besides the
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alkaloids the roots also contain a group of steroidal lactones called withanolides. It also contains several sitoindosides. It is said to work mainly on the reproductive and nervous systems coupled with rejuvenating qualities. It is commonly used to increase vitality, recover from chronic illnesses and pain management for arthritic conditions. The
therapeutically effective formulation may contain
range of Withania spp is about 200mg to l.0gm. Hence the varying amount of Withania spp such that the patient takes the

formulation in such a therapeutic regime that he receives a desired therapeutic dose. Preferably water extracts of the dried roots of Withania spp is used in the present invention. The concentration of the extracts of the Withania somnifera is used in the composition ranges 50 mg to 200mg, preferably lOOmg.
Asparagus spp.
The plant Asparagus racemosus (Asparagus) is commonly known as Shatavari. The Shatavari plant has been used in ayurveda for various conditions. Its main use has been as a galactogogue -to increase milk secretion during lactation. It is also used as a general tonic, and as an aphrodisiac. It is useful in nervous disorders, dyspepsia, and tumors, scalding of urine, throat infections, tuberculosis, cough bronchitis and general debility. Recent chemical analysis indicates that the active constituents of Shatavari plant are Steroidal saponins, known as shatavarins I-IV. Shatavarin I is the major glycoside with 3 glucose and rhamnose moieties attached to sarsasapogenin, Isoflavones including 8-methoxy-5,6,4'- trihydroxyisoflayone 7-O-beta-D-glucopyranoside, Asparagamine (a polycyclic alkaloid), Racemosol, a cyclic hydrocarbon (9,10- dihydrophenanthrene), Polysaccharides, mucilage. Preferably an alcoholic extract of the dried roots of Asperagus spp is used in the present invention. The amount of extracts of Asperagus racemosus used in the range of 200mg to l000 mg, preferably 200mg to 500mg.
Family - Zygophyllaceae
The botanical name for Gokhru is Tribulus Terrestris. The whole plant and its seeds are useful w.r.t various pharmacological activity. The roots and fruits are sweet, cooling, emollient, appetizer, alternate, laxative, cardiotonic, styptic, lithontriptic and tonic. They are useful in strangury, dysuria, vitiated conditions of vat and pitta, renal and vesical
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calculi, anorexia, dyspepsia, helminthiasis, cough, asthma. The seeds are astringent,
strengthening and are useful in epistaxis, hemorrhages and ulcerative stomatitis. The ash
of the whole plant is good for external application in rheumarthritis. The preferred

extracts are hydro alcoholic extracts. The amount of the extracts of Tribulus Terrestris is

in the range of 200 to 600mg; preferably in the range of 200mg to 500mg.
different processes. The water extracts of safed
In the present invention, the dried extracts of the roots of Safed musli, Shatavari, Gokru and Ashwagandha are used. The extracts can be of different types and can be made by
extracts used according to the present invention are preferably musli and ashwagandha, alcoholic extract of shatavari and hydroalcoholic extract of for gokhru. The water extracts may be obtained by different methods. The dried extract of the roots of Safed Musli (belonging to the Chlorophytum spp) can be obtained by extracting the powdered root of Safed Musli with water. The water extract is then dried for few days and the dried extract is then collected. The dried extract of the roots of Ashwagandha (belonging to the Withania spp) can be prepared by extracting the powdered roots of Ashwagandha with water and then drying the aqueous extract to get a fine powder.
It is preferred that the defined constituents should be in a pharmaceutically acceptable dosage form. The dosage form can be tablet. The tablets can be formulated using suitable pharmaceutically acceptable excipients. Tablet compositions offer many advantages, including ease of product handling, portability (in particular, allowing ready availability to the consumer when! needed), aesthetic acceptability, and dosage precision, (i.e., ensuring consistent and accurate doses of the active). However, it is also possible for the constituents to be in the 'form of Hard gelatin capsules, Soft gelatin capsules, paste, beads, Dry syrup, Sachet, Liquid orals, powder, syrup, pharmaceutically acceptable oil, a solution or a suspension.
The tablets can be formulated by techniques well known in the art like wet granulation method.
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The skilled person can utilize known methods to select excipients, which provides hardness, friability and disintegration time required for pharmaceutical advantage. The desired excipients can be selected based on content uniformity, hardness, and friability and disintegration time. The skilled person can use known techniques to achieve the desired physical properties.
The diluents may be selected from one or more of the following but not limited to dextrates, dextrins, dextrose excipients, fructose, lactitol, lactose, mannitol, sorbitol, starch, pregelatinized starch, microcrystalline cellulose, sucrose, sugar compressible, sugar confectioners, branded grades like microcelac and equivalents thereof. The preferred diluent is lactose, starch and/or microcrystalline cellulose. The most desired form of lactose and microcrystalline cellulose can be used. The diluents can be added in a

quantity ranging from 15 to 60%.

The skilled person may binders may be selected
further select appropriate binders using known methods. The
from one or more of the following but not limited to methyl
cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose,
polyvinylpyrrolidone, gelatin, gum arabic, ethyl cellulose, polyvinyl alcohol, lactose, starch, various forms of starch including pregelatinized, agar, tragacanth, sodium alginate, propylene glycol, alginate and other cellulose derivatives and equivalents thereof. The binders can be added in a quantity up to 15%.

The skilled person may also include appropriate disintegrants in the tablet. Suitable

disintegrants may be selected from one or more of the following but not limited to
hydroxypropyl cellulose, carboxymethylcellulose, calcium carboxymethylcellulose,
sodium carboxymethylcellulose, croscarmellose sodium, starch, crystalline cellulose,
sodium starch glycollate, hydroxypropyl starch, partly pregelatinized starch,
crospovidone and equivalents thereof. Preferably, the disintegrants used may be
hydroxypropyl cellulose, to 20%
microcrystalline cellulose, sodium starch glycollate, starch, croscarmellose sodium,
etc. The disintegrants can be added in a quantity ranging from 5
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A tablet formulation according to the present invention may also include a hydrophobic lubricant. The skilled person can select appropriate lubricants to prevent sticking and picking of the tablets to the compression tooling. Suitable lubricants/glidants include talc, fatty acids, and salts of fatty acids, mineral oil, colloidal silicon dioxide and hydrogenated vegetable oils. An example of a suitable fatty acid material is stearic acid or its magnesium salt like magnesium stearate. Suitable lubricants/glidants may be selected from one or more of the following but not limited to stearic acid, magnesium stearate, calcium stearate, talc, hydrogenated caster oil, microcrystalline wax, colloidal silicon dioxide and equivalents thereof. The lubricants/glidants can be added in a quantity ranging from 0.5 to 5%.; Optionally suitable coloring agents or flavoring agents may be added.
The present invention further provides a process to manufacture the formulation according to the present invention which process comprises mixing the herbal active ingredients with diluents and other ingredients like disintegrants, glidants and lubricant. The resulting mixture may then be compressed.
In another aspect the tablet can be prepared by mixing the active drugs with diluents, and other ingredients blending well and wet granulating with binders and then sizing and mixing with lubricant/glidant followed by compressing. Alternatively the tablets may be prepared using roller compaction technique.
The tablets are further coated. In one aspect of the present invention the coating can be a

film coating. The film

coat may comprise polymers like celluloses selected from the

group consisting of hydroxypropyl methyl cellulose, hydroxypropyl cellulose, methyl celluose, carboxymethyl cellulose. The coating composition may comprise one or more additives but not limited to plasticisers such as propylene glycol, polyethylene glycol, triacetine, triethyl citrate, dibutyl sebecate, polysorbates; Opacifiers such as titanium dioxide, magnesium oxide; glidants like talc, magnesium stearate; water-soluble and
t
water insoluble coloring agents. The polymers may be used in vehicles such as water, isopropyl alcohol, methylene chloride, ethanol etc or mixtures thereof.
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hydroxypropyl methyl carboxymethyl cellulose
In another aspect of the present invention the coating may also be moisture barrier coating. The moisture barrier coating may comprise one or more polymers for eg polyvinyl alcohol, ethyl cellulose, acrylic polymers like eudragits. In addition they may contain viscosity modifying agents like natural gums, alginates celluloses like
cellulose, hydroxy propyl cellulose, methyl cellulose,
The coating composition may comprise one or more additives

but not limited to plasticisers such as propylene glycol, polyethylene glycol, triacetine,
triethyl citrate, dibutyl sebecate, polysorbates, lecithin; Opacifiers such as titanium

dioxide, magnesium oxide; glidants like talc, magnesium dioxide; water-soluble and
water insoluble coloring agents. The polymers may be used in vehicles such as water,
isopropyl alcohol, methylene chloride, ethanol etc or mixture thereof. Optionally redimix
moisture barrier coatings may also be used for eg Opadry AMB. The moisture barrier
coating protects the formulation from absorbing atmospheric moisture as well as masks
the disagreeable odor, taste, and appearance of the formulation.
If the coating used is moisture barrier coating then the composition may optionally comprise a seal coat. |The seal coat may comprise polymers like celluloses like hydroxypropyl methyl cellulose, hydroxypropyl cellulose, methyl cellulose, carboxymethyl cellulose. The coating composition may comprise one or more additives but not limited to plasticisers such as propylene glycol, polyethylene glycol, triacetine, triethyl citrate, dibutyl \ sebecate, polysorbates; Opacifiers such as titanium dioxide, magnesium oxide; glidants like talc, magnesium stearate; water-soluble and water insoluble coloring agents. The polymers may be used in vehicles such as water, isopropyl alcohol, methylene chloride, ethanol etc or mixtures thereof.
The coating solutions jean be prepared by techniques well known in the art. The techniques used for coating may be the ones that are known to a person skilled in the art.
The coated tablets may further be polished using pharmaceutically acceptable waxes. The optional wax polish includes a waxy material. Suitable waxy materials include one or more of shellac, modified shellac Opagloss, carnuba wax, bees wax, paraffin wax,
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polyethylene glycol and the like using appropriate additives and vehicles as required. One application is usually sufficient to obtain the desired effect.
The medicinal composition according to the present invention boosts performance, improves mood and revitalizes the body and mind. It is good for men to increase vigor and vitality, to reduce fatigue, stress and strain, as an aphrodisiac, as a general health
tome.
The herbal composition was monitored for stability at ambient temperature and accelerated conditions and the results indicate that this formulation complies as per the standard physico-chemical parameters.
The present invention also provides a medicinal composition for use as an aphrodisiac, as
a general health tonic, that increases vigor and vitality and reduces fatigue, stress and
strain, which comprises administering a therapeutically effective amount of a medicinal
composition.
It will be readily apparent to one skilled in the art that varying substitutions and
modifications may be made to the invention disclosed herein without departing from the
spirit of the invention. Thus, it should be understood that although the present invention
has been specifically disclosed by the preferred embodiments and optional features,
modification and variation of the concepts herein disclosed may be resorted to by those
skilled in the art, and such modifications and variations are considered to be falling
within the scope of the invention.

The following examples! are for the purpose of illustration of the invention only and are
not intended in any way to limit the scope of the invention.
Example:1

Sr.No Ingredients ' Qty(mg/tab)
1. Safed Musli (Chlorophytum arundinaceum) 300.00
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2. Ashwagandha (Withania somnifera) 100.00
3. Microcelac 385.00
4. Crosscarmellose sodium 100.00
5. Colloidal silicon dioxide1 6.00
6. Magnesium stearate 9.00
Coating I
7. Hydoxypropyl methyl cellulose 8.00
8. Talc 2.00
9. Isopropyl alcohol -qs
10. Purified water -qs
Coating II
11. Opadry AMB 40.00
12. Colour beet juice powder 7.00
13. Purified water -qs
Opagloss coating
14. Opagloss 3.00
15. Isopropyl alcohol -qs
The dried powder of the extracts of the roots of Safed musli and Ashwagandha, microcellac, crosscarmellose sodium, colloidal silicon dioxide were sifted and blended. This blend was then lubricated with magnesium stearate and compressed to form tablets.
The tablets so formed were then coated with coating I. The coating composition I was prepared by dispersing HPMC in specified quantity of isopropyl alcohol. To this was added purified water to form a clear solution. This was followed by the addition of talc and finally straining the coating suspension so formed.
These coated tablets were further coated with coating II. The coating composition II was prepared by dispersing opadry AMB in purified water to prepare a homogenous dispersion. This was followed by the dissolution of color in water and adding this solution to the above dispersion and finally straining the same.
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Finally the coated tablets were coated using opagloss coating , prepared by dispersing opagloss in isopropyl alcohol to form a homogenous dispersion and straining the resulting coating.
Example: 2

Sr.No Ingredients Qty(mg/tab)
1. Safed Musli (Ghlorophytum arundinaceum) 300.00
2. Gokhru {Tribulus terrestris) 300.00
3. Microcelac ,i 385.00
4. Crosscarmello'se sodium! 100.00
5. Colloidal silicon dioxide 6.00
6. Magnesium stearate 9.00
Coating I
7. Hydoxypropyl methyl cellulose 8.00
8. Talc 1 2.00
9. Isopropyl alcohol -qs
10. Purified water -qs.
Coating II
11. Opadry AMB 40.00
12. Colourant 7.00
13. Purified water -qs
Example: 3

Sr.No Ingredients Qty(mg/tab)
1. Gokhru {Tribulus terrestris) 300.00
2. Ashwagandha (Withania somnifera) 100.00
3. Microcelac 385.00
4. Crosscarmellose sodium 100.00
5. Colloidal silicon dioxide 6.00
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6. Magnesium stearate 9.00
Coating I
7. Hydoxypropyl methyl cellulose 8.00
8. Talcl 2.00
9. Isopropyl alcohol -qs
10. Purified water -qs
Coating II
11. Opadry AMB 40.00
12. Colourant 1 7.00
13. Purified water -qs
Example: 4

Sr.No Ingredients Qty(mg/tab)
1. Gokhru (Tribulus terrestris) 500.00
3. Microcelaci 385.00
4. Crosscarmello'se sodium 100.00
5. Colloidal silicon dioxide 6.00
6. Magnesium stearate 9.00
Coating I
7. Hydoxypropyl methyl cellulose 8.00
8. Talc 2.00
9. Isopropyl alcoholi -qs
10. Purified water; -qs
Coating II
11. Opadry AMB 40.00
12. Colour beet juice powder 7.00
13. Purified water! -qs
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Example: 5

Sr.No. Ingredients Qty(mg/tab)
1. Shatavari (Asparagus racemosus) 200.00
2. Ashwagandha (Withania somnifera) 100.00
3. Microcelac 385.00
4. Crosscarmellose sodium 100.00
5. Colloidal silicon dioxidei 6.00
6. Magnesium stearate 9.00
Coating Ii
7. Hydroxypropyl methyl cellulosei 8.00
8. Talc 2.00
9. Isopropyl alco hol -qs
10. Purified water! -qs
Coating II
11. Opadry AMB 40.00
12. Colour beet juice powder 7.00
13. Purified water! -qs
Opagloss coating
14. Opagloss 3.00
15. Isopropyl alcohol -qs
1
Example: 6

Sr.No. Ingredients Qty(mg/tab)
1. Shatavari (Asparagus racemosus) 200.00
2. Gokhru (Tribulus terrestris) 300.00
3. Microcelac 385.00
4. Crosscarmellose sodium 100.00
5. Colloidal silicon dioxide 6.00

6. Magnesium stearate 9.00
Coating I
7. Hydroxypropyl methyl cellulosei 8.00
8. Talc 2.00
9. Isopropyl alcohol -qs
10. Purified water -qs
Coating II
11. Opadry AMB 40.00
12. Colour beet juice powder 7.00
13. Purified wateri -qs
Example: 7

Sr.No Ingredients Qty(mg/tab)
1. Shatavari (Asparagus racemosus) 500.00
3. Microcelac 385.00
4. Crosscarmellose sodium 100.00
5. Colloidal silicon dioxide 6.05
6. Magnesium stearate 9.00
Coating I
7. Hydoxypropyl methyl cellulose 8.00
8. Talc 2.00
9. Isopropyl alcohol -qs
10. Purified water -qs
Coating II
11. Opadry AMB : 40.00
12. Colour beet jui ce powder 7.00
13. Purified water -qs
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We claim:
1. A stable herbal medicinal composition comprising a therapeutically effective amount of dried root extracts of Chlorophytum species, Withania species, Asperagus species, and Gokhru (Tribulus Terrestris) alone or in combination with suitable pharmaceutically acceptable carriers, formulated as coated tablet for use as aphrodisiac and as general health tonic.
2. The medicinal composition as claimed in claim 1 wherein said composition comprises Chlorophytum arundinaceum; Withania somnifera; Asparagus racemosus and Tribulus Terrestris either alone or in combination.
3. The medicinal composition as claimed in claims 1 and 2 wherein said composition comprises water extracts of Chlorophytum arundinaceum and Withania somnifera; alcoholic extracts of Asparagus racemosus and hydroalcoholic extracts of Tribulus Terrestris.
4. The medicinal composition as claimed in claims 1 to 4, wherein said chlorophytum arundinaceum is present in an amount of 200mg to 500mg.
5. The medicinal composition as claimed in claims 1 to 4, wherein said Withania somnifera is present in an amount of 50mg to 200mg.
6. The medicinal composition as claimed in claims 1 to 4, wherein said Asparagus
recomposes is present in an amount of 200mg to l000 mg. j
7. The medicinal composition as claimed in claims 1 to 4, wherein said Tribulus
Terrestris is present in an amount of 200 to 600mg.
8. The medicinal composition as claimed in claims 1 and 2, wherein said
pharmaceutically suitable excipients are selected from diluents, carriers, fillers,
colourants, binders, disintegrating agents, super-disintegrating agents, lubricants, pigments, adjuvants for preserving, wetting or emulsifying agents, dispersing agents and plastisizers.
9. The medicinal composition as claimed in any of the preceding claims wherein
j said tablet is a moisture resistant coated tablet.
10. A process for the manufacture of coated tablet comprising the steps of;
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a) sifting of

a therapeutically effective amount of Chlorophytum species,

Withania species, Asperagus species, Gokhru (Tribulus Terrestris) either alone or in combination along with suitable intragranular and extra granular excipients to obtain a blend;
b) lubricating the above blend and compressing into tablets and
c) coating the said tablets using moisture resistant coat.
11. A stable herbal medicinal composition and the process for preparation as substantially described herein with reference to the foregoing examples 1 to 7.

Dated this 14w day of July 2006


Dr. Gopakumar G. Nair Agent for the Applicant
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ABSTRACT:
Disclosed herein are stable herbal medicinal compositions which comprise a therapeutically effective amount of Chlorophytum species, Withania species, Asperagus species, and Gokhru (Tribulus Terrestris) alone or in combination with suitable pharmaceutically acceptable carriers, formulated as coated tablet for use as aphrodisiac and as general health tonic. The invention further discloses a process for preparing the said compositions.
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