Title of Invention

"ANTICIGARETTE HERBAL FORMULATION AS AN ANTI-DOTE TO TOBACCO"

Abstract The invention provides a novel nicotine free anticigarette herbal formulation as an anti-dote to the poisoning effects of tobacco products such as Cigarettes, Gutka, Pan masala and other similar tobacco related products. Formulation(s) comprises of sterilized dried plant powder/extracts together with the conventional additives to form the oral dosage forms, which include tablets, capsules, syrup and powders ready for suspension and mouth spray. The anti tobacco addiction herbal formulation comprises of Sesbania grandiflora, Catharanthus roseus, Ocimum sanctum, Myristica fragrans, Elettaria cardamomum, Carum copticum, Syzygium aromaticum, Cinnamomum tamala, Acorus calamus, Zingiber officinale, Piper nigrum, Cinnamomum zeylanicum, Cuminum cyminum, Nigella sativum, Cinnamomum camphora, Piper longum Ocimum gratssimum and Hemidesmus indicus.
Full Text There have also been various proposed treatments for the administration of nicotine (the putative addictive substance in tobacco smoking) as a replacement for tobacco smoking. One of the most successful approaches, which have been used to date in reducing the incidence of tobacco smoking, relies upon nicotine containing chewing gum. The use of this type of gum suffers from several problems, including not only the bad taste and destruction of dental appliances, but the gastrointestinal upset which results there from and which also reduces compliance. Moreover, the nicotine containing chewing gums do not satisfy that craving which most smokers experience for the distinct sensations in the throat and chest elicited by the nicotine in smoke. Over the course of many years of tobacco smoking, these particular sensations have become an important part of and conditioned with the habit of smoking and help maintain tobacco smoke dependency.
There have also been several proposals for administering nicotine through various aerosol
sprays. However, the aerosol sprays are designed to supply that amount of nicotine,
which would have been acquired by a user through the normal channel of tobacco
smoking. The sprays result in severe respiratory tract irritation. There is no available
means to orally provide the nicotine either by means of an oral or nasal spray and
attenuate the severe irritating effects of the nicotine.
Therefore an urgent need for a nicotine free antidote to tobacco smoking or addiction to tobacco related products. Hitherto, we provide a novel nicotine free herbal formulation as an anti-dote to the poisoning effects of tobacco products such as Cigarettes, Gutka, Pan masala and other similar tobacco products comprising of sterilized dried plant powder/extracts together with the conventional additives to form the oral dosage forms, which include tablets, capsules, syrup, powders ready for suspension and mouth spray.
OBJECTS OF THE INVENTION
The main object of the present invention is to provide a novel nicotine free herbal formulation as an anti-dote to the poisoning effects of tobacco products such as Cigarettes, Gutka, Pan masala and other similar tobacco products comprising of sterilized dried plant powder/extracts together with the conventional additives to form the oral
dosage forms, which include tablets, capsules, syrup, powders ready for suspension and mouth spray.
SUMMARY OF THE INVENTION
The present invention provides a synergistic herbal nicotine free pharmaceutical
composition as an anti-dote to the poisoning effects of tobacco and related products like
cigarettes, said composition comprising an effective amount of sterilized dried plant
powder/ extracts obtained from Sesbania grandiflora, Catharanthus roseus, Ocimum
sanctum, Myristica fragram, Elettaria cardamomum, Carum copticum, Syzygium
aromaticum, Cinnamomum tamala, Acorus calamus, Zingiber officinale. Piper nigrum,
Cinnamomum zeylanicum, Cuminum cyminum, Nigella sativum, Cinnamomum
camphora. Piper longum Ocimum gratssimum, Hemidesmus indicus.and optionally with
pharmaceutical additives to form solid dosage forms like tablet, capsule, syrup, aerosol
spray etc. Sesbania grandiflora and Ocimum gratissimum potentiated the free radical
scavenging and 89.5% stopped smoking with the formulation containing the two
(Sesbania grandiflora and Ocimum gratissimum) than that of the composition containing
the other components. The plants selected in development of herbal formulation of the
present invention as an anti-dote to tobacco are enlisted below:
Acorus calamus Family:
Araceae
A semi-aquatic, perennial, aromatic herb with creeping rhizomes, growing wild and also cultivated throughout India, ascending to an altitude of 2,200 m in the Himalayas. Rhizome horizontal, jointed, somewhat vertically compressed, spongy within, 1.25-2.5 cm in thickness, pale to dark brown or occasionally orange-brown in colour; leaves grasslike or swored shaped, long and slender; flowers small, yellow-green, in a spadix; berries green, angular, 1-3 seeded; seeds oblong. Chemical constituents
The dry rhizomes contain 1.5 to 3.5% of a yellow aromatic volatile oil. It has a mellow odor resembling that of patchouli. The chief constituent of the oil is asaryl-aldehyde. There are also present a bitter glycoside named acorin and some other substances such as eugenol, ascarone, pinene and camphene. The Indian oil has much higher asarone content
than the European commercial oil. Kelkar and Roe (1934) found that in addition to asarone, C12H16O3 (mp 62 to 63 C), the oil contains a small amount of sesquiterpenes and sequiterpenic alcohols. Fractionation of the active principle from volatile oil by gas phase chromatography revealed the presence of two components isolated in a pure state, i.e., a-asarone and p-asarone (Govindarajan et al., 2004), which were trans and cis isomers, respectively, of 2,4,5-trimethoxy-l-propenyl benzene. Acorus sp. is reported to contain an alkaloid choline (Williaman and Li, 1970). Pharmacological action
The rhizome is an aromatic, stimulant, bitter, tonic, carminative, antispasmodic, emetic, expectorant, emmenagogue, aphrodisiac, laxative, and diuretic (Nandakami, 1954). The alcoholic extract of the plant has been shown to possess sedative and analgesic properties; it causes a moderate depression in the blood pressure and respiration. The water-soluble fraction of the dealcoholized extract produced relaxation of isolated intestine and negative inotropic action on frog's heart. 1 The insecticide activity of the solvent extracts and steam-distilled volatile principle of rhizome against common houseflies is quite marked. The insecticidal activity of the oil and the extract appears to be due to the presence of the trans-isomer of asarone (Agarwar et al, 1956). Medicinal properties and uses
Its infusion is given in diarrhea, dysentery, bronchial and chest affections, and epilepsy. The burned root mixed with some bland oil is applied over the abdomen in flatulent colic; the poultice is also usefully applied to paralyzed limbs and rheumatic swelling. In Ayurvedic syste, of medicine, the rhizomes are considered to possess anti-spasmodic, carminative and anthelmintic properties and are used for the treatment of a host of disease such as epilepsy and other mental ailments, chronic diarrhoea and dysentery, bronchial catarrh, intermittent fevers and glandular and abdominal tumours.
Cinnamomum camphora Family:
Lauraceae
A large, handsome, evergreen tree, native to China and Japan, introduced and cultivated in India as an ornamental and as a source of camphor; Leaves glabrous, chartaceous to sub-coriaceous, ovate-elliptic to elliptic to sub ovate elliptic, 3-10 cm x 1-5 cm; panicles
axillary, slender, glabrous, many flowered; fruits one seeded berries, globose, slightly fleshy, 5-10 mm in diameter, seated on a shallow, thin cup, turning black when ripe. C. camphora comprises many forms, some of them morphologically not differentiated but physiologically distinct. A few contain camphor while others produce only aromatic oil. The forms are distinguished based on principal chemical components like safrole, linalool, sesquiterpenes, camphor, caryophyllene, cineol, besides the physical constants of oil.
Chemical constituents
Camphor treated with chloride of zinc and distilled is converted into cymene, a substance contained in many essential oils. When it is treated with nitric acid it oxidizes and forms camphoric acid, a crystalline body, odorless and soluble in alcohol, ether and fatty oil. All parts of C camphora on distillation yield semisolid oil from which camphor can be separated by a mechanical process. Seed fat contains glycerides of lauric, capric and oleic acid (Chopra et al., 1969). Pharmacological action
Camphor is a local irritant with a benumbing influence upon the peripheral sensory nerve. Camphor is diaphoretic, stimulant, antiseptic, antispasmodic, internally expectorant, sedative, temporary aphrodisiac, narcotic, internally carminative and externally anodyne, carminative (Chopra et al., 1956). Medicinal properties and uses
Camphor is esteemed as an analeptic in various cardiac depressions and has been used in the treatment of myocarditis. In doses of 0.2 g, it is very useful in hysteria and nervousness and is used in the treatment of serious diarrhoea. It is also employed in external application as an counterirritant in the treatment of muscular strains, rheumatic conditions, and inflammations. In combination with menthol or phenol it relieves itching of the skin. It is good in typhus, confluent smallpox, and all fevers and eruptions of the typhoid class; also in febrile delirium, whooping cough, hiccup, spasmodic asthma, dysmenorrhea, puerperal mania, cholera, epilepsy, atonic gout, melancholia, toothache and chronic bronchitis. In uterine pains, the liniment of camphor is rubbed on the abdomen.
Cinnamomum tamala Family: Lauraceae
A medium-sized tree, 7.5 m in height and 1.35 m in girth, distributed in tropical and subtropical Himalayas at aliitudes of 1,002-2,400 m, in Khasi and Jaintia hills in Meghalaya at altitudes of 1,000-1,800 m, in Sikkim, Assam and Mizoram, and found cultivated in Tripura. Bark dark brown; leaves opposite or sometimes alternate, elliptic to oblong-lanceolate, glabrous, 3-nerved at base, pink when young; flowers pale yellow, pubescent, in panicles; fruits black, ovoid, in the thickened pedinccle and enlarged base of the perianth. The plant are raised from seeds sown in nursery beds in March-April, Seedlings appear 30-45 days after sowing and are transplanted when 4-5 years old in the field at a spacing of 3 m x 2 m. Sufficient shade is provided in the early stages of growth, and shade trees are cleared after 8-9 years. The fields are not usually manured; vmder-growth is occasionally removed. Chemical constituents
The leaves yield an essential oil, which is soluble in 1.2 vol of 70% alcohol. The oil resembles cinnamon leaf oil and contains d-a-phellandrene and 78% eugenol (Chopra et al., 1956). The essential oil from the bark is pale yellow and contains 70 to 85% aldehyde.
Pharmacological action
Carminative, stimulant, diuretic, diaphoretic, deobstruent, and lactagogue. Oil is a powerful stimulant (Kapoor LD, 2001). Medicinal properties and uses
It is used anorexia, bladder disorders and dryness of mouth, coryza, diarrhoea, nausea,
and spermatorrhea. The bark in the form of infusion, decoction, or powder is prescribed
in bowl complaints such as dyspepsia, flatulence, and vomiting.
Cinnamomum zeylanicum Family:
Lauraceae
A moderate sized tree, up to 16 m in height, native to Sri Lanka and cultivated in South India for its aromatic bark. The tree is also found to a limited extent in eastern India. Bark smooth, light pinkish brown, thin; live bark brown, up to 10 mm in thickness, with a strong, pleasant smell and spicy, burning taste; leaves opposite or sub-opposite, glabrous,
thinly to stiffly coriaceous, oval or elliptic to lanceolate-oval or narrowly ellipsoid to
oblong-ovoid, dark purple, up to 12.5 mm long.
Chemical constituents
Cinnamon bark oil contains cirmamaldehyde (60 to 75%); eugenol , benzaldehyde,
methyl amyl ketone, phellandrene; pinene, cymene, nonyl aldehyde, linalool cumic
aldehyde, carophyllene, and ester of isobutyric acid (Thorpe, 1950). The British
Pharmacopoeia prescribed 50 to 65% cirmamic aldehyde content. Green leaves yield
dark-colored oil on distillation, which differs from cinnamon bark oil. It contains 70 to
80% of eugenol with traces of cinnamic aldehyde, pinene, and linalool.
Pharmacological action
Bark is carminative, antispasmodic, aromatic, stimulant, hemostatic, astringent,
antiseptic, stomachic, and germicide. Oil is a vascular and nervine stimulant; in large
doses it is an irritant and narcotic poison (Kapoor LD, 2001).
Medicinal properties and uses
Infiision, decoction, or powder of the bark is effective in bowl complaints such as
dyspepsia, flatulency, diarrhoea, and vomiting. It is frequently employed as an adjunct to
bitter tonic and purgatives. As a stimulant of the uterine muscular fiber it is employed in
menorrhagia and protracted labor due to defective uterine contractions. The crj'stalline
cinnamic acid is antitubercular and is used as injection in phthisis (Mitra and Prasad,
1941).
Myristicafragrans Family:
Myristicaceae
A dioecious or occasionally monoecious evergreen, aromatic tree, usually 9-12 m. high,
but sometimes reaching a height of 20 m. or more. Bark grayish black, longitudinally
fissured in old trees; leaves elliptic or oblong-lanceolate, coriaceous; flowers in umbellate
cymes, creamy yellow, fragrant; fruits yellow, broadly pyriform or globose, 6-9, cm.
Long, glabrous, often drooping: pericarp fleshy, 1.25 cm, thick, splitting in to 2 halves at
maturity; seed broadly ovoid, arillate, albuminous, with a shell-like purplish brown testa;
aril red, fleshy laciniate.
Chemical constituents
Nutmegs yield 5 to 15% of a volatile oil and also 30 to 405 of fat, photosterin, starch, amylodextrin, coloring matter, and a saponin (Trease and Evans, 1983). They yield about 3% of total ash and about 0.2% of acid-insoluble ash. Essential oil of mace is of a yellowish color with the odor of mace, and consists of macene. Mace (arillus) contains a volatile oil (8 to 17%), a fixed oil, resin, fat, sugar, destrin, and mucilage. The volatile oil (Oleum myristicae, British Pharmacopoeia) contains pinene and camphene (80%), dipentene (8%), alcohols (about 6%), myristicin (about 4%), safi-ole (0.6%), and eugenol and isoeugenol (0.2%). By expression or by means of solvents, nutmegs yield a product known as "nutmeg butter" or expressed oil of nutmegs. This consists of 12.5% of volatile oil, 73% of trimyristicin (the glyceride of myristic acid), small quantities of oleic, linoleic, and other acids, and about 8.5% of imsaponifiable matter (Chopra et al., 1982). Varshney and Sharma (1968) found triterpenic saponin and 15% of free myristic acid in the seeds of M.fragrans. The arils yield a new neolignan, characterized as dl-dehydro-di-isoeugenol, and five other neolignans (Purushottaman and Sharda 1980), Raw nutmeg contained 1.5% of total polyphenols and 0.6% tannins. The extract of nutmeg revealed the presence of epicatechin and cyaniding (Gopalakrishnan and Mathew, 1983). Nutmeg is also reported to contain calcium, phosphorus, iron, thiamin, riboflavin and niacin (Gopalan et al., 1948) Pharmacological action
Nutmeg is aromatic, stimulant, and carminative; in large doses, narcotic. Mace is carminative and aphrodisiac. The extract of the seed and essential oil showed antibacterial activity. The seed oil exhibited a depressent effect on isolated frog rectus and a direct relaxant effect on rat ileum (Kapoor 2001). Medicinal properties and uses
Essential oil is administered in atonic diarrhea and dysentery to relieve pain and is used in combination without stimulating oils for a stimulant action and in plasters for chronic rheumatism. A compound powder called Jatiphaladi chuma made of nutmeg, Indian hemp, camphor, cardamon, cloves, bamboo maima and Plumbago zeylanica is used as a sedative, anodyne antispasmodic in asthma, colic, neualgia, menorrhagia, dysmenorrhea, spasmodic cough, and lumbago, in doses of 1 to 1.5 gr twice daily with honey. Mace is
useful in low stages of fever, in consumptive complaints, and humoral asthma Roasted
nutmeg is useful in obstructions of the liver and spleen.
Zingiber officinale Family:
Zingiberaceae
An herbaceous, rhizomatous perennial, reaching up to 90 cm. in height under cultivation.
Rhizomes are aromatic, thick-lobed, pale yellowish, differing in shape and size in the
different cultivated types. The herb develops several lateral shoots in clumps which begin
to dry when the plant matures; Leaves narrow, distichous sub-sessile, linear-lanceolate,
17 cm. X 1.8 cm., dark green, evenly narrowed to form a slender tip; flowers in spikes,
greenish yellow with a small dark purple or purplish black tip.
Chemical constituents
Indian ginger contains 1 to 2% volatile oil of yellow colour, having a characteristic odor
and containing camphene, phellandrene, zingiberine, cineol and bomeol; gingerol, a
yellow pungent liquid; an oleoresin "gingerin" the active principle, resin, starch, and K
oxalate. The pungency of gingerol and ginger is destroyed when boiled with 2%
potassium hydroxide.
Pharmacological action
Aromatic, carminative, stimulant to the gastrointestinal tract and stomachic; also sialgoge
and digestive. Extermally a local stimulant and rubefacient.
Medicinal properties and uses
Ginger is exteremely valuable in dyspepsia, flatulence, colic, vomiting, spas and other
painful affections of the stomach, and the bowels unattended by fevers for cold, cough,
asthma, dyspepsia, and indigestion. A paste of ginger is a local stimulant and rubefacient
in headche, toothache, and near sightedness due to deficient contractile power of the iris;
ginger powder rubbed on the extremities of the limbs checks cold perspiration and
improves blood circulation in the collapse stage of cholera. Dry ginger is best given
either in powder in doses of 1 to 2 gr, which may be taken with 0.5 gr of sodium
carbonate or potash in gout and chronic rheumatism, or in the form of infiision in doses
of 28 to 56 ml every hour for indigenous and want of appetite.
Piper longum Family:
Piperaceae
A slender aromatic climber with perennial woody roots occurring in the hotter parts of India, from Central Himalayas to Assam, Khasi and Mikir hills, lower hills of Bengal and evergreen forests of western ghats from Konkan to Travancore; it has been recorded also from Car Nicobar Islands; Stems creeping. Jointed: young shoots downy; leaves 5-9 cm. long, 3-5 cm wide, ovate, cordate with broad rounded lobes at base, subacute, entire, glabrous; spikes cylindrical pedunculate, male larger and slender, female 1.3-2.5 cm long and 4-5 mm. diam; fruits ovoid, yellowish orange, sunk in fleshy spike. Chemical constituents
The fruits gave positive tests for the presence of volatile oil, starch, protein and alkaloids, saponins, carbohydrates, and amygadalin, but no tannins (Dasgupta and Datta, 1980). The alkaloids isolated from roots and stems were identified as piperine and piperlongumine and also methyl 1-3,4,5-trimethoxycinnamate (Chatterjee and Datta, 1963). Pharmacological action
Infusion is stimulant, carminative, alterative, and tonic; more powerful than black peeper; also aphrodisiac, diuretic, vermifuge, and emmenagogue. Root is stimulant. P. longum is reported to exhibit significant antitubercular activity (Gupta et al., 1980). The essential oil of fruit showed antibacterial, antifungal and anthelmintic activity (Bhargav and Chauhan, 1968), as well as insecticidal and insect-repellant activity. Sharma and Singh (1980) observed a marked anti-inflammatory activity of fruit decoction against carrageenin-induced rat paw edema. Kholkute et al (1979) observed that benzene extract of P. longum in combination with methanol extract of Embelia ribes berries led to inhibition of pregnancy in 80% of the animals. Medicinal Properties and uses
The berries are a cardiac stimulant, carminative, alternative, tonic, laxative, digestive, stomachic, and antiseptic. It is given with honey in doses of 5 to 10 gr for indigestion. Dyspepsia, flatulent colic, cough, chronic bronchitis, chest affections, and in asthma. It is also very useful in enlarged spleen, palsy, gout, rheumatism, and lumbago. Fruit is vermifuge and also used after childbirth to check post-partum hemorrhage. Root is used
as stimulant. The drug is also used in snakebite and scorpion sting (Mitra and Prasad,
1941).
Piper nigrum Family:
Piperaceae
A branching, climbing, perennial shrub, mostly round cultivated in the hot moist parts of
India, Ceylon and other tropical countries; Branches stout, trailing and rooting at the
nodes; leaves entire, 12.5-17.5 by 5.0-12.5 cm. very varible in breadth, some times
glaucous beneath, base acute rounded or cordate, equal or unequal; flowers minute in
spikes, usually dioecious, but often the female bears 2 anthers, and the male pistillode;
fruiting very variable in length and robustness, rachis glabrous, fruits ovoid or globose
bright nad when ripe seeds usually globose, testa thin, albumin hard.
Chemical constituents
The black pepper contains an alkaloid piperine (5 to 9%), piperdine (5%), a balsamic
volatile essential oil (1 to 2%), fat (7%); mesocarp contains chavicine, a balsamic volatile
oil, starch, lignin, gum, fat (1%); proteids (7%) and ash containing organic matter (5%).
Chavacine is a soluble pungent concrete resin. The fruits yielded N-isobutyl eicosa-trans-
2-trans-4-dienamide in addition to earlier reported piperine, piperetine, piperidine amides,
viz., piperlin, piperolein A, and piperolein B (Raina et al., 1976).
Pharmacological action
P. nigrum is acrid, pungent hot, carminative, also used as antiperiodic. Extermally, it is
rubefacient and stimulant to the skin and resolvent. The extract and essential oil of P.
nigrum is reported to the antibacterial and antiftingal. The fruits exhibited taenicidal
activity (Satyavati et al., 1987).
Medicinal properties and uses
A paste of black pepper is a rubefacient and stimulant; it is locally used for boils, relaxed
sore throat, piles, paralytic affections, rheumatic pain, headache, prolapsed rectum, and
toothache. Black pepper is aromatic, given in dyspepsia, flatulence, debility, diarrhea,
cholera, disorders of the urinary system, cough, gonorrhea, and malarial fever (Nadkami,
1954).
Trachyspermum ammi (Carum copticum) Family:
Apiaceae
almost throughout India; Stems striate; leaves rather distant, 2-3-pinnateIy divided, segments linear, ultimate segments 1.0-2.5 cm. long; flowers in terminal or seemingly-lateral pedunculate, compound umbels, white small; fruits ovoid, muricate, aromatic cremocarps, 2-3 mm. Long, grayish brown, mericarps compressed with distinct ridges and tubercular surface, 1-seeded. Chemical constituents
It yields aromatic volatile oil and a crystalline substanc-steroptin-which collects on the surface of distilled water; also cumene and a lerpene, "thymene". The steroptin known as crude thymol is identical with English thymol. The seeds of Carum copticum contain the antiseptic thymol and they yield 2 to 3% of an essential oil, which is official as oil of ajowan and contains not less than 40 to 50% of thymol C10H4O. Pharmacological action
Seeds are stimulant, carminative, tonic, aromatic, antispasmodic, and antiseptic (Kapoor,
2001).
Medicinal properties and uses
Seeds are useful in flatulence, indigestion, colic, atonic dyspepsia, diarrhoea, cholera, and
spasmodic affections of the bowels. Oil is also used in flatulent colic, atonic dyspepsia or
diarrhea, hysteria, and indigestion. The chief importance of ajowan seeds is for
production of thymol, which is used in medicine in a number of preparations. Leaves of
the tender plant are used as vermicide; its juice is given for worms (Nadkami 1954).
Hemidesmus indicus R.Br. Family: Asclepiadaceae
Botanical Description:
A slender, twining or prostate perennial shrub with cylindrical stems, thickened at the nodes and aromatic roots. Leaves simple, opposite or whorled, short petioled, variable in shape from broadly ovate to oblong-elliptic, linear or linear-lanceolate, 3-10 cm long 0.3-3.8 cm wide, base acute, rounded or truncate, apex rounded or emarginated and apiculate, leathery, dark green, petioles 0.1-0.6 cm long. Flowers are small, greenish- yellow
outside and purplish inside, 0.6-0.8 cm in diameter when expanded, lobes thick, ovate-oblong.
Medicinal properties and uses:
The dried root and root bark are considered tonic, alternative, demulscent, diaphoretic, diuretic and blood purifying. They are used in several well-known Ayurvedic preparations for treating bowel complaints, elephantiasis, fever, hemiplegia, nausea, syphilis and vomiting. Administered in powdered from or as an infusion, decoction or syrup. The root paste is applied to the fore head to reduce fever among the Paharia in southern Bihar. A hot infusion of the root bark with milk and sugar is given to children to relieve chronic cough and diarrhoea.
Ocimum gratissimum Liim Family:
Labiatae/Lamiaceae Botanical Description:
A tall, much branched perennial shrub, generally 1.2-1.8 m tall, more strongly scented than other species of the genus; stem and branches sub quadrangular, woody below. Leaves 6.3-12.5 cm long and 3.8-5.7 cm wide, elliptic-lanceolate, apex acute, base cuneate, margins coarsely crenate-serrate, petioles 2.5-6.3 cm long. Flowers pale greenish-yellow, borne in simple or branched racemes, moderately closely whorled; bracts sessile, longer than the calyx 3 mm long in flower and to 6 mm long in fruit. Medicinal properties and uses:
The plant is considered digestive, tonic, stimulant, demulcent, diuretic, anti emetic, anti septic and styptic. In Ayurveda the plant is used to treat skin diseases, erysipelas, inflammations and strangury. In Unani practice, the plant in considered carminative and aphrodisiac and used to treat diseases of the brain, heart, liver and spleen, to relieve griping and piles. In Siddha, the whole plant is used as a carminative and diuretic. A decoction of the leaves is considered a useful remedy for gonorrhoea and for seminal weakness. The leaf juice is sometimes given to relieve stomachache. The oil is also used to relieve earache, toothache and abdominal colic in children.
Sesbania grandiflora Family:
Fabaceae
A short-lived, quick-growing; soft-wooded tree, 6-9 m. high and 0.6 m. in girth. It is a native of Malaysia and is grown in many parts of India such as Punjab, Delhi, Bengal, Assam and the Andmans; Leaves 15-30 cm. long, abruptly pinnace, leaflets 41-61, linear-oblong, glabrous, 2.5-5.0 cm x 0.5-1.6 cm.; racemes 2-4-flowered, short, axillary; flowers 6.0-10 cm,, long with showy, fleshy white, pink, or crimson petals; pods pendulous 30.0-45.0 cm. X 0.6-0.8 cm., rather flat and somewhat 4-comered non-torulose, septate with swollen margins and 15-50 pale coloured seeds.
Ocimum sanctum Family:
Lamiaceae
An erect, herbaceous, much-branched, softly hairy armual, 30-75 cm. high, found throughout India ascending up to 800 m in the Himalayas, and in Andman and Nicobar islands. Leaves elliptic oblong, acute or obtuse, entire or serrate, pubescent ob both sides minutely gland-dotted; flowers purplish or crimson, in racemes, close whorled, nitlets sub-globose or broadly ellipsoid, slightly compressed, nearly smooth, pale brown or reddish, with small black markings. Chemical constituents
The leaf contains the highest percentage of essential oil, followed by inflorescence and stem, but roots are devoid of any oil (Dey and Choudhury, 1984). Seeds contain a large amount of mucilage. Lai et al. (1979) reported the presence of 70% eugenol as a major constituent in the essential oil. The other components identified were nerol, eugenol methyl ether, caryophyllene, terpinene-4-ol, decyladehyde, yselinene, a-pinene, P-pinene, camphor, and carvacrol. The leaves also yield ursolic acid, apigenin, luteolin, apigenin 7-o-glucuronide, luteolin, orientin, and moUudistin.Old leaves of O. sanctum contained 3.15% calcium, 0.34% phosphorus, and 4.97% insoluble oxalate (Singh et al., 1969).
Pharmacological action
Demulcent, expectorant, and antiperiodic. Root is fibrifuge; seeds are mucilaginous and demulcent. Dried plant is stomachic and expectorant. Leaves are anticatarrhal, expectorant, fragrant, and aromatic. O. sanctum leaves are reported to show abortifacient and antifertility activity (Vohra et al., 1969). Ethanolic extract (50%) of leaves shoed a hypoghcemic effect in rats and antispasmodic activity agamst spasmogen-induced
spasms in isolated guinea pig ileum. Singh et al. (1970) reported that crude watery extract
of leaves showed a transient hypotensive effect in anesthetized dogs and cats and a
negative intropic and chronotropic effect on rabbit's heart. The extract inhibited the
spasm of smooth muscles induced by acetylcholine, carbachol, and histamine and
potentiated hexobarbitone-induced hyposis in mice.
Medicinal properties and uses
Infusion of the leaves is given in malaria and as a stomachic in gastric disease of children
and hepatic affections. Juice of the leaves should be taken internally and is very effective
in skin disease such as itches, ringworm, and leprosy, and in impurities of the blood.
Dried plant in decoction is a domestic remedy for catarrh, bronchitis, and diarrhea. Fresh
leaves also cure chronic fever, hemorrhage, dysentery, and dyspepsia. With honey and
ginger juice, it is a good expectorant, useful in cough, bronchitis, and children's fever.
Popular as herbal tea (Nadkami, 1954).
Elletaria cardamomum Family:
Zingiberaceae
A tall, herbaceous perennial, with branching subterranean rootstock, from which arise a
number of upright leafy shoots, 5-18 ft. high, bearing alternate, elliptical or lanceolate
sheathing leaves 1-3 ft. long. Flowers borne in panicles 2.4 ft. long, arising from the base
of vegetative shoots; panicles upright throughout their length or upright at first and
ultimately pendent or prostrate; flowers about 1.5 in. long, white or pale green in colour
with a central lip streaked with violet, borne in a close series on the rachis; they are
bisexual, but self-sterile, and open in succession from the base towards the tip; Fruits
trilocular capsules, fusiform to ovoid, pale green to yellow in colour, containing 15-20
hard, brownish black, angled and rugose seeds, covered by a thin mucilaginous
membrane.
Chemical constituents
The seeds contain essential oil to the extent of 4 to 8%. Principal constituents of the oil
are cineol, terpineol, terpinene, limonene, sabinene, and terpineol in the form of formic
and acetic acids. The aqueous portion of the steam distillate of cardamom contained 0.5%
of essential oil with the following constants: sp gr 0.0920, nD25 1.4606; and [a] D25, O;
cineol content, 80%. Borneol was identified in cil from the aqueous distillate of Malabar
ANTICIGARETTE HERBAL FORMULATION AS AN ANTIDOTE TO
TOBACCO
FIELD OF THE INVENTION
The present invention relates to the development of anticigarette herbal nicotine free formulation as an antidote to tobacco.
BACKGROUND AND PRIOR ART OF THE INVENTION
The personal and societal habit of tobacco smoking has existed for centuries, but the severity of its potential detrimental health effects has only undergone serious scrutiny in the last several decades. It is now commonly accepted that tobacco smoke contains mutagenic and carcinogenic compounds that relate to serious adverse health consequences. The presence of these compounds in tobacco smoke creates a significant cost to society by increasing health costs and causing premature mortality. The adverse affects of tobacco smoke are linked to major pathological conditions such as: cancer, cardiovascular disease, stroke, chronic obstructive lung diseases (including chronic bronchitis, asthma and emphysema), periodontal disease etc. While recent efforts at educating consumers about the harmful effects of tobacco smoke and smoking prevention programs have been helpful, people continue to smoke despite these educational efforts to the contrary.
Attempts to reduce the harmful effects of tobacco smoke have included positioning filters of varying compositions within tobacco products. Current filters that are available, such as those made from cellulose acetate have only been moderately successful at decreasing the particulate portion of tobacco smoke that contains tar and nicotine. While reduction of tar mid nicotine are believed to be helpful, conventional filters have been unsuccessful at effectively removing components within the gas-vapor portion of tobacco smoke containing the most toxic components, with the exception of activated carbon filters which are known to remove small amounts of cyanide and carbon monoxide. Additionally, the relative health benefits of removing particulate matter and toxic components in the gas-vapor phase from tobacco smoke are not well understood and its effect on the health of smokers is without standards.
cardamom oil. Analysis of cardamom capsule gave the following results: moisture
(20.0%), protein (10.2%), ether extract (2.2%), mineral matter (5.4%), crude fiber
(20.1%), carbohydrate (42.1%), calcium (0.13%), phosphorus (0.16%), and iron (5.0
mg/lOOg) (Anon, 1951).
Pharmacological action
The seeds are aromatic, pungent, cardiac, tonic, stomachic, lexative, diuretic, and
carminative (Kapoor 2001).
Medicinal properties and uses
The seeds are very useful in asthma, bronchitis, piles, strangury, and diseases of the
bladder. As diuretic the seeds are given with honey as a corrective; the seeds are
administrated in flatulence and in griping of purgative. A decoction of cardamom
together with its pericarp and jaggary added is a popular home remedy to relieve
giddiness caused by biliousness. A compound powder containing rqual parts of cardmom
seeds, ginger, cloves, and caraway is a good stomachic in 1.5- gr doses in atonic
dyspepsia. It is also very useful to check vomiting.
Syzygium aromaticum Family:
Myrtaceae
A pyramidal or conical evergreen tree 9-12 m. high sometimes taller; Main stems erect, c.
100 cm. in girth, often forking at a height of 1.5-1.8 m.; bark smooth, grey; leaves
lanceolate, in pairs, acute at both ends, 7.5-12.3 cm.x2.5-3.75 cm., gland-dotted, fragrant;
flower-buds borne in small clusters at the ends of branches, greenish, turning pink at the
time of maturity, aromatic; drupes (MOTHER-OF-CLOVE), fleshy, dark pink, 2.5 cm.
long X 1.5 cm. thick; seeds oblong, soft, grooved on one side, 1.5 cm. long.
Catharanthus roseus Family:
Apocynaceae
An erect, much branched, annual or perennial herb 30-90 cm in height, probably native to Malagasy, occasionally foimd wild but mostly naturalized up to an altitude of 1,300m, and commonly grown in gardens throughout the country. Leaves oblong-elliptic, acute, rounded apex glossy, slightly foetid; flowers fragrant, white to pinkish purple in terminal
or axillary cymose clusters; follicle hairy, many seeded, 2-3 cm long; seeds oblong,
minute, black.
Cuminum cyminum Family:
Apiaceae
A small, slender annual herb about 1 ft. high, with a much-branched angular or striated
stem bearing 2 or 3 partite linear leaves; leaves bluish green in colour and having
sheathing bases. The flowers are white or rose coloured borne in compound umbels;
fruits are grayish, about 1/4 in. long, tapering towards both base and apex and compressed
laterally with ridges covered by papillose hairs. The hairs may be absent in some forms.
Chemical constituents
Analysis of seeds gave the following results: moisture (11.9%), protein (18.7%), ether
extract (15.0%), carbohydrates (36.6%), fiber 912.05), mineral matter (5.8%), calcium
(1.08%), phosphorus (0.49%), iron (31.0 mg/100 g), carotene calculated as vitamin A
(870 IU/100 g), and vitamin C 3 mg/100 g) (Anon, 1941).
Pharmacological action
Seeds are carminative, aromatic, stomachic, stimulant, and astringent (Kapoor 2001).
Medicinal properties and uses
Seeds have cooling effect and therefore form an ingredient of most prescriptions for
gonorrhea, chronic diarrhea, and dyspepsia. It is also useful in hoarseness of voice,
dyspepsia, and chronic diarrhea in a dose of 1 to 2 gr. Cumin oil can be readily converted
artificially in to thymol; thymol is used as an anthelmintic against hook worm infections
and is also an antiseptic, forming part of many proprietary preparations.
Nigella sativum Linn. Family:
Ranunculaceae
A small herb, c. 45 cm. high, native of Levant, said to be cultivated or occasionally found
as a weed of cultivation in Punjab, Himachal Pradesh, Bihar and Assam. Leaves 2-3
pinnatisect, 2.5-5.0 cm. long, cut into linear-lanceolate segments; flowers pale blue, 2.0-
2.5 cm. across, without an involucre, on solitary long peduncles; seeds trigonous, black,
rugulose-tubercular.
Chemical constituents
Analysis of black cumin gave the following values: total ash, 3.8-5.3: ash insol. In HCL, 0.0-0.05; volatile oil, 0.5-1.6; either extr, (fatty oil), 35.6-41.6; and alcoholic acidity (as oleic acid), 3.4-6.3%. The seeds give on steam-distillation a yellowish brown volatile oil with an unpleasant odour. It has the following characteristics: d15, 0.875-0.886; 1.4836-1.4844; [a]D, + 1.43° to +2.86°; acid val., up to 1.9; ester val., 1-31.6; ester val. after acetylation, 15-73; solution in 2-4.5 or more volumes of 90% alcohol. The oil contains carvone (45-60%), d-limonene and cymene. A carbonyl compound, nigellone (C18H22O4, m.p. 195-97°), which protects guinea pigs against histamine induced bronchospasm has been isolated from the oil. Preliminary clinical trials indicate its possible therapeutic use in some conditions of cough and bronchial asthma.
The fatty oil obtained by the expression of seeds is reported to be used for edible purposes. The fatty acids of the oil are as follows: myristic, 0.26; palmatic, 6.31; stearic, 2.45; oleic, 44.45; and linoleic, 35.99%. the component glycerides of the oil are the following: trilinolein, 2: oleodilinolein, 25; dioleolinolein, 43; palmito-oleolinolein (containing small amount of myristic acid.), 24; and stearo-oleolinolein, 7%; glycerides of some volatile acids are also present in the oil in small quantities. DETAILED DESCRIPTION OF THE INVENTION
Accordingly, The invention provides a novel nicotine free anticigarette herbal formulation as an anti-dote to the poisoning effects of tobacco products such as Cigarettes, Gutka, Pan masala and other similar tobacco related products. Novelty of the invention is a said herbal formulation being nicotine free, purely herbal and helps prevent the smoking sensation.
In an embodiment of the invention, a synergistic anticigarette herbal nicotine free pharmaceutical composition as an anti-dote to the poisoning effects of tobacco and related products like cigarettes, said composition comprising an effective amount of sterilized dried plant powder/ extracts obtained from Sesbania grandiflora, Catharanthus roseus, Ocimum sanctum, Myristica fragrans, Elettaria cardamomum, Carum copticum, Syzygium aromaticum, Cinnamomum tamala, Acorus calamus, Zingiber officinale, Piper nigrum, Cinnamomum zeylanicum, Cuminum cyminum, Nigella sativum, Cinnamomum camphora. Piper longum Ocimum gratssimum, Hemidesmus indicus and optionally with pharmaceutical additives.
In another embodiment of the invention, additives are selected from the powdered plant parts or lyophilized extracts of plants Sesbania grandiflora, Ocimum sanctum, Myristica fragrans, Elettaria cardamomum, Carum copticum, Syzygium aromaticum, Cinnamomum tamala, Acorus calamus, Zingiber officinale, Piper nigrum, Cinnamomum zeylanicum, Cuminum cyminum, Nigella sativum, Cinnamomum camphora. Piper longum, Ocimum gratssimum, Hemidesmus indicus and Catharanthus roseus.
In yet another embodiment of the invention, the extracts of the plants are mixed in the ratio Sesbania grandiflora (15-20%), Hemidesmus indicus (1-2%), Ocimum sanctum (2-4 %), Myristica fi'agrans (2-3 %), Elettaria cardamomum (1-2 %>), Carum copticum (0.5-1 %%), Syzygium aromaticum (1-2 %), Cinnamomum tamala (1-2 %), Acorus calamus (0.5-1 %), Zingiber officinale (1-2 %), Piper nigrum (1-2 %»), Cinnamomum zeylanicum (1-2 %), Cuminum cyminum (1-2 %), Nigella sativum (1-2 %), Cinnamomum camphora (0.2-0.5 %), Piper longum (1-2 %), Ocimum gratissimum (1-2 %) and Catharanthus roseus (10-15 %) along with conventional additives to form an oral dosage form.
In yet another embodiment of the invention the said composition is nicotine free. In still another embodiment of the invention, said composition acts as an anti-dote to the poisoning effects of tobacco and tobacco related products. In another embodiment of the invention, the said composition is effective in controlling a number of complications associated with cigarette smoking. In yet another embodiment of the invention, the said composition is non-toxic and safe to use.
In still another embodiment of the invention the said composition reduces tobacco-induced toxicity.
In another embodiment of the invention, the said composition has the potential to maintain the homeostasis in general and has the potential to provide a supportive and protective cover to the cellular and organic functions of the heart, the lungs, the blood vessels, and the gastro-intestinal epithelium and mucosa in particular. In yet another embodiment of the invention, the said composition acts as an anti-dote to the slow and systemic poisoning experienced by tobacco smokers.
In still another embodiment of the invention, said composition in an oral dosage form
selected from a group consisting of syrup, tablet, capsule and a powder/ spray.
In yet another embodiment of the invention, the alcohol used is ethanol.
In another embodiment of the invention, the extracts of plants are 50% aqueous
alcoholic extract.
In still another embodiment of the invention, the said composition comprises about
15-50% wt. of the total formulation.
In yet another embodiment of the invention, the plant powder/ extract of Sesbania
grandiflora is obtained from seeds or leaves.
In another embodiment of the invention, the plant powder/ extract of Catharanthus
roseus is obtained from leaves.
In another embodiment of the invention, the plant powder/ extract of Hemidesmus
indicus is obtained from stem.
In still another embodiment of the invention, the plant powder/ extract of Ocimum
sanctum is obtained from leaves.
In yet another embodiment of the invention, the plant powder/ extract of Myristca
fragrans is obtained from fruits.
In another embodiment of the invention, the plant powder/ extract of Elettaria
cardamomum is obtained from fruits.
In yet another embodiment of the invention, the plant powder/ extract of Carum
copticum is obtained from fruits.
In still another embodiment of the invention, the plant powder/ extract of Syzygium
aromaticum is obtained from flowers.
In another embodiment of the invention, the plant powder/ extract of Cinnamomum
tamala is obtained from leaves.
In yet another embodiment of the invention, the plant powder/ extract of Acorus
calamus is obtained from rhizomes.
In still another embodiment of the invention, the plant powder/ extract of Zingiber
officinale is obtained from rhizome.
In another embodiment of the invention, wherein the plant powder/ extract of Piper
nigrum is obtained from fruits.
In yet another embodiment of the invention, the plant powder/ extract of
Cinnamomum zeylanicum is obtained from bark.
In still another embodiment of the invention, the plant powder/ extract of Cuminum
cyminum is obtained from fruit.
In another embodiment of the invention, the plant powder/ extract of Carum carvi is
obtained from fruit.
In yet another embodiment of the invention, the plant powder/ extract of
Cinnamomum camphora is obtained from bark or leaves.
In still another embodiment of the invention, the plant powder/ extract of Piper
longum is obtained from fruit or roots.
In another embodiment of the invention, the binders used are starch, starch paste, gum
acacia and carboxy methyl cellulose. Talc (Purified), Magnesium Stearate, Sodium
Methyl Paraben & Sodium Propyl Paraben.
In yet another embodiment of the invention, the diluents used are lactose.
In still another embodiment of the invention, the lubricants used are from starch and
lactose.
In yet another embodiment of the invention, the 66.7% w/w sugar syrup is used as a
vehicle.
A method of preparing a herbal formulation as claimed in claim 1 wherein the said
method comprising:
Obtaining the part of medicinal plants from a group comprising leaves, root
and aerial parts, rhizomes
Drying the plant material in shade.
Powdering the dried plant material to a coarse powder.
Sterilizing the plant powder
Using the powder as such or extracting the powdered dried plant material with
(40-50% aqueous ethanol) at 25 - 35 °C.
Extracting the plant material with the aqueous alcohol in the ratio of 1:8 to
1:15 for 4-7 days
Concentrating the obtained extract at under reduced pressure at 40-60 °C.
Lyophilising the concentrated extract for complete removal of solvent.
In another embodiment of the invention, the formulation at a dose of more than 1000 mg/ kg did not cause any biochemical changes in serum.
In another embodiment of the invention, the formulation at a dose of 1000 mg/ kg do not cause any significant change in the organ weight.
In another embodiment of the invention, the formulation at a dose of 1000 mg/ Kg showed no change in hematological parameters.
In another embodiment of the invention, the formulation at a dose of 100-200-mg/ kg showed stoppage of smoking in 3-10 weeks treatment
In yet another embodiment of the invention, the formulation at a dose of 100-200-mg/ kg showed free radical scavenging property
In still another embodiment of the invention, the formulation at a dose of 100-200-mg/ kg showed potent antioxidant activity. The formulation is useful as an antidote to effects of tobacco and helps prevent smoking. The invention is further illustrated by the following non-limiting example:
Formulation (Fl)
Sesbania grandiflora (18%)
Ocimum sanctum (3 %)
Myristica fragrans (2 %)
Elettaria cardamomum (1 %)
Carum copticum (1 %)
Syzygium aromaticum (2 %)
Cinnamomum tamala (2 %)
Acorus calamus (0.5%)
Zingiber officinale (1.5%)
Pipernigrum (1%)
Cinnamomum zeylanicum (2 %)
Cuminum cyminum (2 %)
Nigella sativum (2 %)
Cinnamomum camphora (0.5 %)
Piper longum (2 %)
Culharanthus roseus (l- Starch (2%)
Lactose (QS to make 100%)
The first step in the preparation of these formulations involves a process for making, the plant material suitable for formulating into a tablet, capsule and liquid dosage form. The specified portion of the plant is collected and dried under shade at room temperature (25 -35°C) for 72 hours or until the material gets dried. The material is then powdered into a fine powdered. The dried material (1Kg) is then powdered and used as such or extracted with 50 % aqueous alcohol (3 L) for 5 days. At the end of this, the solvent is decanted and filtered if necessary to remove the plant debris. The extract is then concentrated under vacuum at less than 500C. Then the extract is lyophilised to obtain the extract in powder form. 15 g of starch is mixed with water and heated to form a paste. The weighed quantities of the plant extracts are then blended with starch paste and then lactose is added quantity sufficient to make 100 g. The ingredients are then mixed properly with the starch paste to form a mass. The mass is then granulated in a granulator and then the dry at 104 °F and screen through 16-mesh screen. Talc is added to the dried granules and then they are punched in the tablet-punching machine to form uniform tablets. Extracts were added in proper ratio to prepare the Syrup. The Syrup was prepared according to Indian Pharmacopoeia 1966.
Formulation (F2) (The critical components in this formulation F2 are Sesbania
grandiflora and Ocimum gratissimum)
Sesbania grandiflora (20%)
Hemidesmus indicus (2%)
Ocimum sanctum (3 %)
Myristica fi-agrans (3 %)
Elettaria cardamomum (1%)
Carum copticum (0.5 %)
Syzygium aromaticum (2 %)
Cinnamomum tamala (2 %)
Acorus calamus (0.5 %)
Zingiber officinale (2 %)
Piper nigrum (1 %)
Cinnamomum zeylanicum (2 %)
Cuminum cyminum (2 %)
Nigella sativum (1%)
Cinnamomum camphora (0.2 %)
P/per longum (2 %)
Ocimum gratissimum (2 %)
Catharanthus roseus (15%)
Starch (2 %)
Lactose (QS to make 100%)
The first step in the preparation of these formulations involves a process for making, the
plant material suitable for formulating into a tablet, capsule and liquid dosage form. The
specified portion of the plant is collected and dried vmder shade at room temperature (25 -
350C) for 72 hours or until the material gets dried. The material is then powdered into a
fine powdered. The dried material (1Kg) is then powdered and used as such or extracted
with 50 % aqueous alcohol (3 L) for 5 days. At the end of this, the solvent is decanted
and filtered if necessary to remove the plant debris. The extract is then concentrated
under vacuum at less than 50°C. Then the extract is lyophilised to obtain the extract in
powder form. 15 g of starch is mixed with water and heated to form a paste. The weighed
quantities of the plant extracts are then blended with starch paste and then lactose is
added quantity sufficient to make 100 g. The ingredients are then mixed properly with the
starch paste to form a mass. The mass is then granulated in a granulator and then the dry
at 104 "F and screen through 16-mesh screen. Talc is added to the dried granules and then
they are pimched in the tablet-punching machine to form uniform tablets. Extracts were
added in proper ratio to prepare the Syrup. The Syrup was prepared according to Indian
Pharmacopoeia 1966.
Table 1: Effect of anticigarette herbal formulation on antioxidant enzymes

(Table Removed)
The values represent the means ± S. E. M; n=6.
P: a0.5, ' %), Myristica fragrans (2-3 %), Elettaria cardamomum (1-2 %), Carum copticum (0.5-1
%), Syzygium aromaticum (1-2 %), Cinnamomum tamala (1-2 %), Acorns calamus (0.5-1
%), Zingiber officinale (1-2 %), Piper nigrum (1-2 %), Cinnamomum zeylanicum (1-2
%), Cuminum cyminum (1-2 %), Nigella sativum (1-2 %), Cinnamomum camphora (0.2-
0.5 %), ?/per longum (1-2%), and Catharanthusroseus (10-15%).
The formulation F2 contains the Sesbania grandiflora (15-20%), Hemidesmus indicus (1-
2%), Ocimum sanctum (2-4 %), Myristica fragrans (2-3 %), Elettaria cardamomum (1-2
%), Carww copticum (0.5-1 %), Syzygium aromaticum (1-2 %), Cinnamomum tamala (1-
2 %), Acorus calamus (0.5-1 %), Zingiber officinale (1-2 %), Pzper nigrum (1-2 %),
Cinnamomum zeylanicum (1-2 %), Cuminum cyminum (1-2 %), Nigella sativum (1-2 %),
Cinnamomum camphora (0.2-0.5 %), P/per longum (1-2 %), Ocimum gratissimum (1-2
%) and Catharanthus roseus (10-15 %).
The results of the above table 1 indicates that there is a significant increase in glutathione
peroxidase (GSH), Superoxide dismutase(SOD) and Catalase (CAT) in formulation F2
than that of Fl. It indicates that the enzymatic antioxidants (GSH, SOD and CAT);
Thiobarbituric acid reactive substances (TEARS) were decreased there radicals are
scavenged by the formulation F2.Therefore the body defensive system was increased.
Table2. Toxicity Profile on haematological changes of formulation F2.

(Table Removed)
The formulation F2 contains the Sesbania grandiflora (15-20%), Hemidesmus indicus (1-2%), Ocimum sanctum (2-4 %), Myristica fragrans (2-3 %), Elettaria cardamomum (1-2 %), Carum copticum (0.5-1 %), Syzygium aromaticum (1-2 %), Cinnamomum tamala (1-2 %), Acorus calamus (0.5-1 %), Zingiber officinale (1-2 %), Piper nigrum (1-2 %), Cinnamomum zeylanicum (1-2 %), Cuminum cyminum (1-2 %), Nigella sativum (1-2 %), Cinnamomum camphora (0,2-0.5 %), Piper longum (1-2 %), Ocimum gratissimum (1-2 %) and Catharanthus roseus (10-15 %).
The results of the table 2 indicate that there is no change in the hematological parameters with the active formulation F2.
Table 3.Cliiiical trials: Weekly analysis of subjects regarding smoking of effective formulation F2

(Table Removed)
The formulation F2 contains the Sesbania grandijlora (15-20%), Hemidesmus indicus (1-
2%), Ocimum sanctum (2-4 %), Myristica fragrans (2-3 %), Elettaria cardamomum (1-2
%), Carum copticum (0.5-1 %), Syzygium aromaticum (1-2 %), Cinnamomum tamala (1-
2 %), Acorus calamus (0.5-1 %), Zingiber officinale (1-2 %), Piper nigrum (1-2 %),
Cinnamomum zeylanicum (1-2 %), Cuminum cyminum (1-2 %), Nigella sativum (1-2 %),
Cinnamomum camphora (0.2-0.5 %), Piper longum (1-2 %), Ocimum gratissimum (1-2
%) and Catharanthus roseus (10-15 %).
Group I contains 19 volunteers habituated to smoking : On 8th' week 17 volunteers
stopped smoking out of 19 volunteers.
Group II contains 56 volunteers habituated to smoking : On 8th week 41 volunteers
stopped smoking out of 56 volunteers.
Group III contains 25 volunteers habituated to smoking : On 8th week 14 volunteers
stopped smoking out of 25 volunteers.
Table 4. Effect of anticigarette herbal formulation F2 on productive cough
(Table Removed)
The formulation F2 contains the Ocimum sanctum (2-4 %), Myristica fragrans (2-3 %), Elettaria cardamomum (1-2 %), Carum copticum (0.5-1 %), Syzygium aromaticum (1-2 %), Cinnamomum tamala (1-2 %), Acorus calamus (0.5-1 %), Zingiber officinale (1-2 %), Piper nigrum (1-2 %), Cinnamomum zeylanicum (1-2 %), Cuminum cyminum (1-2 %), Nigella sativum (1-2 %), Cinnamomum camphora (0.2-0.5 %), Pipgr longum (1-2 %), Ocimum gratissimum (1-2 %) and Catharanthus roseus (10-15 %). Group I: Randomly selected smokers having productive cough (14 volunteers) after exposure to the formulation F2 only 3 smokers showed suffering from dry cough and the percent protection is 78.6%.
Group II: Randomly selected smokers having productive cough (46 volunteers) after exposure to the formulation F2 only 11 smokers showed suffering from dry cough and the percent protection is 76.08%.
Group III: Randomly selected smokers having productive cough (22 volimteers) after exposure to the formulation F2 only 11 smokers showed suffering from dry cough and the percent protection is 72.7%.
Table 5. Biochemical parameters: A 14-day repeated oral toxicity study of anticigarette herbal formulation F2 in rats

T
The formulation F2-contains the Sesbania grandiflora (15-20%), Hemidesmus indicus (1-
2%), Ocimum sanctum (2-4 %), Myristica fragrans (2-3 %), Elettaria cardamomum (1-2
%), Carum copticum (0.5-1 %), Syzygium aromaticum (1-2 %), Cinnamomum tamala (1-
2 %), Acorns calamus (0.5-1 %), Zingiber officinale (1-2 %), Piper nigrum (1-2 %),
Cinnamomum zeylanicum (1-2 %), Cuminum cyminum (1-2 %), Nigella sativum (1-2 %),
Cinnamomum camphora (0.2-0.5 %), Piper longum (1-2 %), Ocimum gratissimum (1-2
%) and Catharanthus roseus (10-15 %).
BUN: Biliruin
GOT: Aspartate amino transferase
GPT: Alanine amino transferase
ALP: Alkaline phosphatase
The results of the table 5 indicate that there is no change in the biochemical parameters
with the active formulation F2.
Table 6. Individual Percent Organ Weights (%) after administration of anticigarette
herbal formulation F2

F-FEMALE
The formulation F2 contains the Sesbania grandiflora (15-20%), Hemidesmus indicus (1-2%), Ocimum sanctum (2-4 %), Myristica fragrans (2-3 %), Elettaria cardamomum (1-2 %), Carum copticum (0.5-1 %), Syzygium aromaticum (1-2 %), Cinnamomum tamala (1-2 %), Acorus calamus (0.5-1 %), Zingiber officinale (1-2 %), Piper nigrum (1-2 %), Cinnamomum zeylanicum (1-2 %), Cuminum cyminum (1-2 %), Nigella sativum (1-2 %), Cinnamomum camphora (0.2-0.5 %), Piper longum (1-2 %), Ocimum gratissimum (1-2 %) and Catharanthus roseus (10-15 %).
The results of the table 6 indicate that there is no change in the organ weight parameters with the active formulation F2.




We claim:
1. A synergistic herbal nicotine free pharmaceutical composition as an anti-dote to the poisoning effects of tobacco and related products like cigarettes, said composition comprising an effective amount of sterilized dried plant powder/ extracts obtained from Sesbania grandiflora, Catharanthus roseus, Ocimum sanctum, Myristica fragrans, Elettaria cardamomum, Carum copticum, Syzygium aromaticum, Cinnamomum tamala, Acorus calamus, Zingiber officinale, Piper nigrum, Cinnamomum zeylanicum, Cuminum cyminum, Nigella sativum, Cinnamomum camphora. Piper longum, Ocimum gratssimum, Hemidesmus indicus and optionally with pharmaceutical acceptable additives.
2. The composition as claimed in claim 1, wherein the additives are selected from the powdered plant parts or lyophilized extracts of plants Sesbania grandiflora, Ocimum sanctum, Myristica fragrans, Elettaria cardamomum, Carum copticum, Syzygium aromaticum, Cinnamomum tamala, Acorus calamus. Zingiber officinale, Piper nigrum, Cinnamomum zeylanicum, Cuminum cyminum, Nigella sativum, Cinnamomum camphora. Piper longum, Ocimum gratssimum, Hemidesmus indicusand Catharanthus roseus
3. Herbal formulation (s) as claimed in claim 1, wherein the extracts of the plants are mixed in the ratio Sesbania grandiflora (15-20%), Hemidesmus indicus (1-2%), Ocimum sanctum (2-4 %), Myristica fragrans (2-3 %), Elettaria cardamomum (1-2 %), Carum copticum (0.5-1 %), Syzygium aromaticum (1-2 %), Cinnamomum tamala (1-2 %), Acorus calamus (0.5-1 %), Zingiber officinale (1-2 %), Piper nigrum (1-2 %), Cinnamomum zeylanicum (1-2 %), Cuminum cyminum (1-2 %), Nigella sativum (1-2 %), Cinnamomum camphora (0.2-0.5 %), Piper longum (1-2 %), Ocimum gratissimum (1-2 %) and Catharanthus roseus (10-15 %) along with conventional additives to form an oral dosage form.

4. Herbal formulation(s) as claimed in claim 1, wherein the said composition is nicotine free.
5. Herbal formulation(s) as claimed in claim 1, wherein the said composition acts as an anti-dote to the poisoning effects of tobacco and tobacco related products.
6. Herbal formulation(s) as claimed in claim 1, wherein the said composition is effective in controlling a number of complications associated with cigarette smoking.
7. Herbal formulation(s) as claimed in claim 1, wherein the said composition is nontoxic and safe to use.
8. Herbal formulation(s) as claimed in claim 1, wherein the said composition reduces tobacco induced toxicity.
9. Herbal formulation(s) as claimed in claim 1 and 7, wherein the said composition has the potential to maintain the homeostasis in general and has the potential to provide a supportive and protective cover to the cellular and organic functions of the heart, the lungs, the blood vessels, and the gastro-intestinal epithelium and mucosa in particular.
10. Herbal formulation(s) as claimed in claim 1 and 7, wherein the said composition acts as an anti-dote to the slow and systemic poisoning experienced by tobacco smokers.
11. Herbal formulation (s) as claimed in claim 1, wherein said composition in an oral dosage form selected from a group consisting of a syrup, tablet, capsule and a powder/ spray.
12. Herbal formulation (s) as claimed in claim 1, wherein the alcohol used is ethanol.
13. Herbal formulation (s) as claimed in claim 1, wherein the extracts of plants are 50% aqueous alcoholic extract.

14. Herbal formulation (s) as claimed in claim 1, wherein the said composition comprises about 15-50% wt. of the total formulation.
15. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Sesbania grandiflora is obtained from seeds or leaves.
16. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Catharanthus roseus is obtained from leaves.
17. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Hemidesmus indicus is obtained from stem.
18. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Ocimum sanctum is obtained from leaves.
19. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Myristca fragrans is obtained from fruits.
20. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Elettaria cardamomum is obtained from fruits.
21. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Carum copticum is obtained from fruits.
22. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Syzygium aromaticum is obtained from flowers.
23. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Cinnamomum tamala is obtained from leaves.
24. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Acorus calamus is obtained from rhizomes.
25. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Zingiber officinale is obtained from rhizome.
26. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Piper nigrum is obtained from fruits.
27. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Cinnamomum zeylanicum is obtained from bark.
28. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Cuminum cyminum is obtained from fruit.
29. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ exfract of Carum carvi is obtained from fruit.

30. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Cinnamomum camphora is obtained from bark or leaves.
31. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Piper longum is obtained from fruit or roots.
32. Herbal formulation (s) as claimed in claim 1, wherein the plant powder/ extract of Ocimum gratissimum is obtained from leaves.
33. Herbal formulation(s) as claimed in claim 1, wherein the binders used are starch, starch paste, gum acacia and carboxy methylcellulose. Talc (Purified), Magnesium Stearate, Sodium Methyl Paraben & Sodium Propyl Paraben.
34. Herbal formulation(s) as claimed in claim 1 wherein the lubricants used are from starch and lactose.
35. Herbal formulation(s) as claimed in claim 1, wherein the 66.7% w/w sugar syrup is used as a vehicle.
36. A method of preparing a herbal formulation as claimed in claim 1 wherein the said method comprising:
a. Obtaining the part of medicinal plants from a group comprising leaves,
root and aerial parts, rhizomes
b. Drying the plant material in shade.
c. Powdering the dried plant material to a coarse powder.
d. Sterilizing the plant powder
e. Using the powder as such or extracting the powdered dried plant material
with (40-50% aqueous ethanol) at 25 - 35 0C.
f. Extracting the plant material with the aqueous alcohol in the ratio of 1:8 to
1:15 for 4-7 days
g. Concentrating the obtained extract at under reduced pressure at 40-60 °C.
h. Lyophilising the concentrated extract for complete removal of solvent.
38. Herbal formulation as claim 1 where in the formulation at a dose of more than 1000 mg/ kg did not cause any biochemical changes in serum.
39. Herbal formulation as claim 1 where in the formulation at a dose of 1000 mg/ kg do not cause any significant change in the organ weight.
40. Herbal formulation as claim 1 where in the formulation at a dose of 1000 mg/ Kg showed no change in hematological parameters.
41. Herbal formulation as claim 1 where in the formulation at a dose of 100-200 mg/ kg showed stoppage of smoking in 3-10 weeks treatment
42. Herbal formulation as claim 1 where in the formulation at a dose of 100-200 mg/ kg showed free radical scavenging property
3. Herbal formulation as claim 1 where in the formulation at a dose of 100-200 mg/
kg showed potent antioxidant activity,

Documents:

2504-DEL-2004-1-Abstract-(04-02-2011).pdf

2504-DEL-2004-1-Claims-(04-02-2011).pdf

2504-DEL-2004-1-Correspondence-others-(04-02-2011).pdf

2504-DEL-2004-1-Description (Complete)-(04-02-2011).pdf

2504-DEL-2004-1-Drawings-(04-02-2011).pdf

2504-DEL-2004-1-Form-1-(04-02-2011).pdf

2504-DEL-2004-1-Form-2-(04-02-2011).pdf

2504-del-2004-abstract.pdf

2504-del-2004-assignment.pdf

2504-del-2004-claims.pdf

2504-del-2004-Correspondence-others-(04-02-2011).pdf

2504-del-2004-correspondence-others.pdf

2504-del-2004-description (complete).pdf

2504-del-2004-form-1.pdf

2504-del-2004-form-18.pdf

2504-del-2004-form-2.pdf

2504-del-2004-form-3.pdf

2504-del-2004-form-5.pdf

2504-del-2004-form-6.pdf

2504-DEL-2004-GPA-(27-11-2006).pdf

2504-del-2004-Petition 137-(04-02-2011).pdf


Patent Number 248560
Indian Patent Application Number 2504/DEL/2004
PG Journal Number 30/2011
Publication Date 29-Jul-2011
Grant Date 25-Jul-2011
Date of Filing 16-Dec-2004
Name of Patentee COUNCIL OF SCIENTIFIC & INDUSTRIAL RESEARCH
Applicant Address ANUSANDHAN BHAWAN, RAFI MARG, NEW DELHI-110 001, INDIA.
Inventors:
# Inventor's Name Inventor's Address
1 AJAY KUMAR SINGH RAWAT NATIONAL BOTANICAL RESEARCH INSTITUTE, LUCKNOW, UP, INDIA.
2 CHANDANA VENKATESWARA RAO NATIONAL BOTANICAL RESEARCH INSTITUTE, LUCKNOW, UP, INDIA.
3 RAGHAVAN GOVINDARAJAN NATIONAL BOTANICAL RESEARCH INSTITUTE, LUCKNOW, UP, INDIA.
4 ARUN KUMAR KARERAT MIR HOLISTIC PVT. LTD. THANGAM BUILDING, METHEW PLLLOY ROAD, KOCHI-682018, INDIA
5 MOHANMMAD IFTHIKAR MIR HOLISTIC PVT. LTD. THANGAM BUILDING, METHEW PLLLOY ROAD, KOCHI-682018, INDIA
6 JOY VARGHESE MIR HOLISTIC PVT. LTD. THANGAM BUILDING, METHEW PLLLOY ROAD, KOCHI-682018, INDIA
7 VELLAPPILLIL ACHUTHAN VENUGOPAL NATIONAL BOTANICAL RESEARCH INSTITUTE, LUCKNOW, UP, INDIA.
8 PALPU PUSHPANGADAN NATIONAL BOTANICAL RESEARCH INSTITUTE, LUCKNOW, UP, INDIA.
PCT International Classification Number A61K00/00
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA