FORM 2
THE PATENTS ACT, 1970
(39of 1970)
AND
THE PATENT RULES, 2003
COMPLETE SPECIFICA T I O N (See section 10; rule 13)
COMPOSITION OF OILY, PUNGENT AND ODORIFEROUS SUBSTANCES AND A PROCESS OF PREPARATION THEREOF
OMNIACTIVE HEALTH TECHNOLOGIES LTD., an Indian Company,
registered under the Indian Companies Act, 1956 having its registered office
located at Rajan House, Appasaheb Marathe Marg, Pmhhadevi, Maharashtra,
India 400025
The following specification particularly describes the invention and the manner in which it is to be performed

FIELD OF THE INVENTION
The present invention generally relates to a composition of oily, pungent and odoriferous substances and a process for preparation thereof. The present invention particularly relates to an extended and sustained release stable, free flowing, solid composition of capsicum extract or capsaicinoids and/or analogs thereof and a process for its preparation.
BACKGROUND OF THE INVENTION
In modern times, obesity is identified as a cause of serious complications during diseases such as diabetes and myocardial infarction. It is also a major factor for a number of diseases, including CHD, hypertensions, non-insulin dependent diabetes mellitus, pulmonary dysfunction, osteoarthritis and certain types of cancer. Serious attention is being given for weight reduction and anti-oxidam. protective effects. Factors suggested as being related to the development of obesity are decreased physical activity and increased energy intake, especially fat intake. Weight loss and loss of body fat can thus be achieved by reducing energy intake and/or increasing energy expenditure.
The limited long-term effectiveness of conventional weight management (dietary intervention, physical activity and behavioral therapy) requires alternative weight-reduction strategies. A rapidly growing therapeutic area, largely embraced by the general public, is the use of natural herbal supplements. A wide range of herbal products are currently being marketed as weight-loss agents. These include various compounds of spice and herbal origin, such as red hot peppers (Capsicum species) or Capsicum Extracts (for weight management) or Cinnamon. Cinnamon extracts (for blood glucose management), Garlic oil and extracts (for cholesterol management) Mustard oil and turmeric derivatives (as anti-oxidant) etc. The use of herbal or plant based products have gained importance because of their safety, availability and absence of after effects.

Capsaicin is the pungent principle associated with cayenne/red pepper. It is a prominent chemical entity in plants of Capsicum genus which includes chili peppers, red pepper, and paprika. Capsaicin is actually a class of compounds of branched and straight chain alkyl vannilamides. The antimicrobial and analgesic properties of capsaicin have been known for centuries. Other human studies and animal models report the weight reduction benefits of capsaicin. These studies show diet-induced thermo genesis (i.e.. an increase in energy expenditure in the body) and a reduction in appetite levels (shown by decreased cumulative food intake) after consumption of Capsaicin from red peppers or their concentrated extracts, h also shows a beneficial reduction in body mass, percentage body fat, waist circumference, and a desirable reduction in levels of critical markers of weight maintenance such as blood glucose, insulin, triacylglycerol and leptin. All these point towards the immense potential for nutritionists to incorporate Capsicum and its active compounds. Capsaicinoids in dietary formulations curb excess appetite, prevent weight gain and facilitate weight loss inducing behavior.
Due to the enhanced awareness of weight loss properties of capsicum or capsicum extract or capsaicin and their ability to reduce complications of excessive fat in diseases such as diabetes, there is a great demand for such drugs which not only aim for weight reduction but also which are cheap, based on herbs and natural products and which have no side effects during their prolonged continuous use.
These compounds are associated with reducing energy intake, enhancing energy expenditure and facilitating weight control. However, effective dosage forms require minimum capsaicinoids levels of much greater than 10-20.000 Scoville Heal Units to be delivered to the consumer in a non-bulky form, and for thai the ingredients which need to be used as starting material in manufacturing systems are found at heat levels typically as high as 250,000-10, 00,000 SHU (i.e. 25-50 times "hotter than what is to be "consumed" by the end user).

Furthermore; substances such as capsicum or capsicum extracts or capsaicin, mustard oil, turmeric, onions etc are oily, irritating and odoriferous. These substances are also extremely pungent and irritating to the skin and mucus membrane. They cannot be easily converted in to dosage forms such as lablels/capsules due to their intense pungency and skin irritation properties. Converting Ihein into dosage forms such as tablets or capsule was found to be impractical. In addition, the operators working on the granulation or tablet compression machine could not tolerate the intense pungency arising out of the very fine dust particles of capsicum.
In order to find a satisfactory solution to the persisting problems, there was a need to develop a novel technology which could not only facilitate their administration at doses adequate for nutritional and health benefits but which also addresses the handling difficulties of such pungent and irritating substances during formulation and manufacture.
This discomfort can be eliminated by providing a composition that can facilitate complete intestinal absorption of the active ingredient and thereby minimize/eliminate the discomfort caused by residual unabsorbed active ingredient. Accordingly, there exists a need to provide a composition comprising oily, pungent and odoriferous substance for weight reduction providing for extended and sustained release of the active ingredient.
Various ready to use formulations are available in the market for reduction or weight loss reduction.
US 2007/0264411 provides a process of producing a capsaicinoid containing food and drink with superior stability. The patent discloses an emulsion composition comprising capsaicinoid compound and a process thereof. The process described in the patent entails blending an oil phase containing capsaicinoid compound with an

aqueous phase and an emulsifier. The capsaicinoids mentioned in this patent are non-pungent and are different from the pungent components of red pepper, capsaicinoids.
GB 2469658 provides a beverage containing capsaicinoid. This patent discloses a beverage comprising a flavored component, water and capsaicinoid composition extracted from Capsicum as a heat providing component and a process for its preparation.
US 2008/0008770 provides a composition for weight reduction in capsule form with effective amount of capsaicin, L-tyrosine, supplemental caffeine and green tea extract containing catechin and caffeine.
US 6326031 discloses nutritional supplements to the human diet used to increase levels of HDL and decreases levels of O-LDL, cholesterol, and triglycerides in the human plasma. The nutritional supplement contains a novel combination offish oil, garlic, rutin and capsaicin. It further includes methods of preparing the nutritional supplements.
US 2008/0268092 provides a nutritional supplement to reduce body fat which comprises a synergistic combination of vanilloid receptor subtype 1 agonist and methylxanthine.
US patent no. 5273754 discloses an appetite suppressant composition for oral administration. The composition includes a heating and a cooling carminative substance, and may also include an amino acid and an anxiolytic substance. Also disclosed are methods for decreasing appetite by oral administration of the appetite suppressant composition, and for manufacture of the appetite suppressant composition.
IN254661 provides a free flowing solid composition of oily or pungent and odoriferous substances and a process for their preparation thereof. It particularly discloses solid compositions such as beadiets which are suitable for formulating into

tablets, capsules, blended powders, licaps, ointments, pastes, lotions, liniments, mouthwashes, and gargles etc.
While the above prior art disclosures provide a wide range of processes and formulations for the use of capsicum and other weight controlling agents, none of these prior art processes are adequate for reducing the irritation caused by these substances. Further, these disclosures do not provide an extended and sustained release formulation which eliminates the discomfort by facilitating complete intestinal absorption of the active ingredient and thereby minimizing/ eliminating the discomfort caused by the residual unabsorbed active ingredient. The extended and sustained release stable, free flowing, solid microspheres of the present invention are particularly suitable for formulating into consumable dry syrups, tablets, capsules, liquid syrups, health drinks, diet drinks, fruit juices, soft drinks and the like which are useful in reduction of body weight.
Such a need is appropriately addressed by the present invention which provides an extended and sustained release composition comprising an oily, pungent and odoriferous substance, preferably capsicum or capsicum extracts or capsaicin and/or analogs thereof, which is characterized by:
1. longer release time to prevent the release of the active ingredient in other parts of the digestive system;
2. complete intestinal absorption of the active ingredient and thereby minimize/eliminate the discomfort caused by residual unabsorbed active ingredient;
3. increased shelf life of the solid composition;
4. better taste masking due to presence of flavors and sugar components in the formulation;

5. enabling consumers to consume the active ingredients of materials without being seriously exposed to the associated disagreeable or uncomfortable odours, aromas, colours and sensory characteristics of such materia! at sufficiently high dosages on a regular basis through standardized formulated products.
OBJECTIVES OF THE INVENTION
Therefore, the main objective of the present invention is to provide a stable, free flowing, solid composition of oily, pungent, irritating, odoriferous substances which is suitable for formulating into tablets, capsules, blended powders. Heaps, ointments, pastes, lotions, liniments, mouthwashes, gargles, consumable dry syrups, liquid syrups, health drinks, diet drinks, fruit juices, soft drinks and the like.
Another objective of the present invention is to provide a stable, free flowing, solid composition of oily, pungent, irritating, odoriferous substances wherein the composition contains 0.1-90% of the oily, pungent, irritating and odoriferous substance of the total weight.
Still another objective of the present invention is to provide a stable, free flowing, solid composition of oily, pungent, irritating, odoriferous substances which facilitates extended and sustained release of the active ingredient,
Yet another objective of the present invention is to provide a stable, free flowing, solid composition of oily, pungent, irritating, odoriferous substances which has increased shelf life.
Yet another objective of the present invention is to provide a beverage grade stable, free flowing, solid composition of oily, pungent, irritating, odoriferous substances

which is characterized by better taste masking due to presence of flavors and sugar components in the formulation.
Another objective of the present invention is to provide a process for preparation of stable, free flowing, solid composition of oily, pungent, irritating, odoriferous substances which are useful for fortifying aqueous/liquid systems such as foods, beverages and syrups.
Another objective of the present invention is to provide a process for preparation of stable, free flowing, solid composition of oily, pungent, irritating, odoriferous substances which can be manufactured using extrusion speronization or beadlet technology.
The present invention has been developed based on the fact that the use of cellulosic derivatives along with the combination of sugar, surfactant, binder and other excipients at high shear pressure leads to the entrapment of the active ingredient that remarkably delays or extends the release of the active ingredient thus reducing the pungency and irritation characteristic of die active ingredient. Further coating helps in achieving the desired complete release in the intestine and thus makes the present formulation palatable and safe for human consumption. Present composition is stable on accelerated stability conditions as per ICH. The resulting solid composition can be then formulated into tablets, capsules, blended powders. licaps, ointments, pastes, lotions, liniments, mouthwashes, gargles, consumable dry syrups, liquid syrups, health drinks, diet drinks, fruit juices, soft drinks and the like.
Summary of the invention
Accordingly the present invention provides an extended and sustained release stable, free flowing, solid composition of oily, pungent, irritating, odoriferous active

substances. More particularly, the present invention provides an extended and sustained release stable, free flowing, solid composition of Capsicum/Capsicum extracts/Capsaicin suitable for formulating into tablets, capsules, blended powders, licaps, ointments, pastes, lotions, liniments, mouthwashes, gargles, consumable dry syrups, liquid syrups, health drinks, diet drinks, fruit juices, soft drinks and the like.
The invention further provides a process for the preparation of the extended and sustained release stable, free flowing, solid composition of oily, pungent, irritating, odoriferous active substances.
Detailed Description
Accordingly the present invention provides an extended and sustained release stable, free flowing, solid composition of Capsicum/Capsicum extracts/Capsaicin suitable for formulating into tablets, capsules, blended powders, licaps, ointments, pastes, lotions, liniments, mouthwashes, gargles, consumable dry syrups, liquid syrups, health drinks, diet drinks, fruit juices, soft drinks and the like.
In the present invention, the pungency and the irritation characteristics of the oily natural substances is overcome by entrapping the said substances in a complex formed by cellulosic derivatives along with combination of sugar, surfactant, binder and other excipients at high shear pressure. Due to the high shear pressure the active ingredient is entrapped which remarkably delays or extends the release of the active ingredient thus reducing the pungency and irritation characteristic of the active ingredient. The pungency can be further reduced or masked by coating the polymer entrapped substance with a polymer that can form an effective barrier, between the oily, pungent, odoriferous substance and the outside environment and thus further sustains the release of the active substance and makes the present formulation palatable and safe for human consumption.

The extended and sustained release composition comprises of:
a) a spheroidal nutrient core containing the active substance;
b) a protective polymeric enteric coat; wherein the said coating facilitates gradual and uniform release of hish dosatie of the said active substance to reduce irritation and minimize abdominal pain and gastric discomfort associated with its release.
The oily, pungent, irritating, odoriferous active substance is selected from a group consisting of capsicum extract; capsicum oleoresin; capsaicin crystals: black pepper, ginger, mustard, turmeric oleoresin, cinnamon, garlic, paprika; their chemical equivalents, preferably capsicum extract.
The oily, pungent, irritating, odoriferous active substance used is in the range of O.t-90% of the total weight.
The cellulosic polymer used is selected from microcrystalline cellulose, Avicel®PH 101.Avicel®PH 102, Avicef PH 103. Avicel® PH 105. Avicel®PH 112. Avicel®PH 113, Avicel® PH300, Avicel® PH212, Avicel® PH 301, Avicel® PH 302, colloidal grades Carboxymethyl cellulose Sodium and other cellulose containing polymers and their derivatives or mixtures thereof.
The sugar used is selected from the derivatives of sugar such as Mannitol, sucrose, xylitol, sorbitol, Maltitol, Lactitol, Isomalt or mixtures thereof.
The surfactants used are selected from Polysorbate, sodium lauryi sulfate, Sorbitanemonooleate, other surfactants of the same class or mixtures thereof.
The polymers used for preventive coating and/or binders are selected from Methyl Cellulose, Agar, Sodium Alginate, Hydroxy Propyl Methyl Cellulose, Hydroxy Propyl Cellulose, Microcrystalline Cellulose, Polyvinyl Pyrrolidone, Starch, Gum Arabic, Xanthan Gum, Polyethylene Glycols, preferably. Microcrystalline Cellulose.

Hydroxy Propyl Cellulose, Methyl Cellulose, Hydroxy Propyl Methyl Cellulose, etc, more preferably, Hydroxy Propyl Methyl Cellulose, Methacryiates, Phthalate methyl acrylate-methacrylic acid copolymers, cellulose acetate succinate, polyvinyl acetate phthalate, Marcoat containing polymers and there derivatives or mixtures thereof.
In another preferred embodiment the solvent employed may be selected from Acetone, Hexane, Ethyl Acetate, Isopropyl Alcohol, Ethanol, Dichloromethane, Methanol, etc, more preferably form Acetone. Ethanol. Dichloromethane. Isopropyl alcohol, and more preferably Dichloro Methane and Isopropyl Alcohol.
The release of the active ingredient is not more than 1% up to 2 hours, not more than 70% up to 3 hours, more than 90% up to 6 hours.
The process involves the preparation of capsicum beadlets by extrusion and speronization method. In the present invention capsicum oleoresin or extract is dispersed in water to form a solution. The solution is further added to the powder blend of cellulosic polymer, sugar, surfactants, binders and other excipients. The mixing of pungent, odoriferous oil or oleoresin with the powder blend can be effected in a rapid mixing granulator and/or planetary mixer. After uniform mixing, the granules are extruded and spheronized to form uniform spheroidal beadlets. These uniform spheroidal beadlets core/ spheroidal nutrient cores are further coated with polymer coating to form sustained release beadlets. The following steps provide a detailed process of the present invention.
(i) preparing a dispersion of active substance in water and non ionic
surfactants to form homogeneous dispersion, (ii) mixing the dispersion obtained in step (i) with cellulosic polymer along
with other excipients at high shear speed of blade and chopper to form
uniform matrix.

(iii) further processing the matrix of step (ii) by extrusion and speronization
to form uniform spheroidal nutrient cores. (iv) coating the solid spheroidal nutrient cores of step (iii) with protective polymeric enteric coat. The temperature used in step (i) to form homogeneous dispersion is preferably in the range of 5 deg C to 60 deg C and for a period in the range of 10 min to 4 hrs.
The said spheroidal nutrient core of step (iii) has a diameter of about 100 microns to 2000 microns.
The organic solvent is selected from a group consisting of Dichloromethane (DCM). Ethyl acetate, Acetone. Isopropanol (IPA), Ethanol.
The protective polymeric enteric coating comprises of titanium dioxide, purified talc, an additional polymer for gradual release and a soothing agent.
The temperature used in step (iv) preferably ranges from 20deg C to 55 deg C.
The final formulation obtained has a diameter of about 210 microns to 707 microns.
The extrudes were spheronized at a pitch plate speed of 500 to 1700 rpm.
The process is carried out by using rapid mixing granulator and/or planetary mixer.
The process for coating the spheroidal solid composition of step (iii) with the protective polymer is carried out by using bottom spray and/or tangential spray and/or top spray coating and/or Flex stream granulator.
The said composition is stable and free flowing.
These beadlets can be further formulated into tablets, capsules, blended powders, Heaps, ointments, pastes, lotions, liniments, mouthwashes, gargles, consumable dry

syrups, tablets, capsules, liquid syrups, health drinks, diet drinks, fruit juices, soft drinks and the like.
The details of the present invention are described in the Examples given below which are provided to illustrate the invention and therefore should not be construed to limit the scope of the present invention.
EXAMPLES
Examplesl-6 represents a process for preparation of capsicum beadlets by extrusion and speronization method. In the present invention capsicum oleoresin is dispersed in water under stirring to form a dark brownish to black solution. The solution is added slowly and in a continuous manner to a powder blend of cellulose, Mannitol. Tween 80 and other excipients in planetary mixer, at a speed of 5-25 rpm/min, same procedure can be carried out by using rapid mixing gramilator at following parameters- Impeller speed between 750-1500 rpm/min and chopper speed is in between 1440-2800 rpm/min. After uniform mixing the granules are added to extruder; process can be carried out either by using single and/or twin Screw extruder. The extrusion process is carried out at a speed of 20-44 rpm/min. extrudes are further spheronized by using 0.5 mm Chequered plate, initially speronization is carry out at a slow speed of 500-750 rmp/min for 1-2 min followed by increase in speed up to 1500 rpm/min. Capsicum oleoresin beadlets are dried in tray dryer at 40-50°C for 20-30 min.
The Capsicum oleoresin beadlets are further coated with a protective polymer by using fluid-bed system with bottom spray mechanism at inlet temperature of 35 to 55°C, spray rate of 10 g/hour to about 600 g/hour and atomization pressure in the range of about 0.1 kg/'cm2 to about 3 kg/cm2. After completion of the coating process the beadlets are dried at a temperature of 40°C for 30min.

Sr. No Ingredients 1 2 3 4 5 6

% W/W
1 Capsicum oleoresin S.6 S3 8.3 8.3 8.3 8.3
2 NPS (Sugar) 0 0 0 0 39.9 80
3 HPMC-EI5 4.3 0 0 0 0 0
4 SSG 7 8 8 8 8 0
5 MCCPH 101 69.6 40.3. 39.9 32.6 0 0
6 Talc 9.9 0 0 0 0 0
7 Mannitol 0 40.6 39.9 46.6 39.9 9.1
8 Methocel VLV 0 0.7 0.7 0.7 0.7 0.7
9 Tween 80 0 1.7 2.7 3.3 0 0
10 Sodium Docusate 0 0 0 0 0 0
]] Marcoat 1.8 1.8 1.8 1.8 1.8 1.8
12 Purified talc 0 0 0 0 0 0
13 Titanium dioxide 0.1 0.1 0.1 0.1 0.1 0.1
Total 100 100 100 100 100 100
Stability Data
The Capsicum compositions of Example 1,2,3,4 and 5 were subjected to accelerated stability studies as per ICH guidelines at 40±2°C/75±5% RH. The result ofthe study were as follows,

Sr.
No. Example No (Total fatty acid content %) % loss

Initial Assay After 6 months
40±2°C/75±5%
mi

1 1 2.3 2.29 0.43
2 2 2.33 2.31 0.85
i J
3 2.28 2.27 0.43
4 4 2.39 2.35 1.67
5 5 2.36 2.34 0.84

Conclusion:
The 3 months stability data at 40°C and 75% RH was found satisfactory for assay and dissolution.
Dissolution Data

Dissolution Study ol'Capsimax Beadlets
Apparatus USP Type-I RPM :- 125
Medium Time % Release

Trial 1 Trial 2 Trial 3 Trial 4
IN hydrochloric acid solution Oh 0.00 0.00 0.00 0.00

1h 0.00 0.00 0.00 0.00

2h 0.00 0.00 0.00 0.00
Phosphate
buffer pH
7.4 with
SLS 0.5% 3h 68.06 63.48 61.10 64.50

4h 92.87 92.79 . 92.18 91.20

5h 95.18 94.24 93.91 93.24

6h 96.98 96.40 96.04 96.57
Conclusion:
The dissolution study did not show any release of capsaicinoids in 0.1 N HC1 within 2 hours and there was complete release of capsaicinoids in phosphate buffer pH 7.4 with SLS within 6 hours time period.
ADVANTAGES OF THE INVENTION
1. Provides free flowing, non-sticky solid composition of oily, pungent, irritating, odoriferous substances which retain the inherent nutritional and biological benefits with high concentration of the active substance, without the associated discomfort which are suitable for subsequent formulation into

consumable dry syrups, liquid syrups, health drinks, diet drinks, fruit juices, soft drinks and the like which are useful in reduction of body weight.
2. The product is an extended and sustained delivery product which facilitates gradual release of the dosage in the intestine without causing irritation/discomfort in the mouth, esophagus or stomach,
3. Provides the products in a user-friendly form which does not cause skin irritation or pungency during tableting or capsule-filling.
4. Provides a free flowing solid composition of oily, pungent, irritating odoriferous substances which has a high bulk density (i.e. consistently higher than 0.5 g/ml, and preferably in the range >0.60 g/ml) high bulk density (>0.60 g/ml).
5. Provides novel free flowing solid compositions of oily, pungent, irritating and odoriferous substances wherein the composition contains 0.1-90% of the oily pungent and odoriferous substance.
6. Protects the oily, pungent, irritating, odoriferous substances from environmental factors such as light, oxygen & heat.
7. Retains the volatile materials present in the oily, pungent, irritating, odoriferous substances.
8. Retains the inherent beneficial nutritional and biological benefits through an appropriately high concentration of the active volatile and oily active ingredient, without the associated discomfort and disadvantages experienced in industrial use or in regular consumption.
9. Provides a convenient means of delivering highly pungent, irritating and odoriferous substances such capsicum extract, garlic oil. fish oils, spice oils and extracts, herb oils and extracts in high doses by oral route.

We claim:
1. An extended and sustained release composition of oily, pungent, irritating, odoriferous active substance, wherein the said composition is suitable for subsequent formulation into tablets, capsules, blended powders, licaps. ointments, pastes, lotions, liniments, mouthwashes, gargles, consumable dry syrups, liquid syrups, health drinks, diet drinks, fruit juices, soft drinks and the like.
2. An extended and sustained release composition as claimed in claim 1, comprises of:

c) a spheroidal nutrient core containing the active substance;
d) a protective polymeric enteric coat; wherein the said coating facilitates gradual and uniform release of high dosage of the said active substance to reduce irritation and minimize abdominal pain and gastric discomfort associated with its release.

3. The extended and sustained release composition as claimed in claims 1 or 2, wherein the oily, pungent, irritating, odoriferous active substance is 0.1-90% of the total weight.
4. The extended and sustained release composition as claimed in claims 1 or 2, wherein the spheroidal nutrient core containing active substance further contains celtulosic polymer, sugar, starch and optionally a surfactant.
5. The extended and sustained release composition as claimed in claims 1 to 4, wherein the release of the active ingredient is not more than 1% up to 2 hours, not more than 70% up to 3 hours, more than 90% up to 6 hours.
6. A process for preparation of an extended and sustained release composition of oily, pungent, irritating, odoriferous active substance, comprises-

(i) preparing a dispersion of active substance in water and non ionic
surfactants; (ii) mixing the dispersion obtained in step (i) with cellulosic polymer along
with other excipients such as sugar, starch to form a uniform matrix; (iii) further processing the matrix of step (ii) by extrusion and speronization
to form uniform spheroidal nutrient core; and (iv) coating the spheroidal nutrient core of step (iii) with protective
polymeric enteric coat.
7. The process for preparation of an extended and sustained release composition as claimed in claim 6 step (ii). wherein the process is carried out by using rapid mixing granulator and/or planetary mixer.
8. The process for preparation of an extended and sustained release composition as claimed in claim 6 step (iv). wherein the coating of protective polymer is carried out by using bottom spray and/or tangential spray and/or top spray coating and/or Flex stream granulator.
9. The extended and sustained release composition as claimed in any of the presiding claims, wherein the oily, pungent, irritating, odoriferous active substance is selected from a group consisting of capsicum extract; capsicum oleoresin; capsaicin crystals; black pepper, ginger, garlic, mustard, turmeric oleoresin, cinnamon, paprika; their chemical equivalents.
10. The extended and sustained release composition as claimed in any of the presiding claims, wherein the oily, pungent, irritating, odoriferous active substance is capsicum extract.
11. The extended and sustained release composition as claimed in any of the presiding claims, wherein the cellulosic polymer used is selected from

microcryslalline cellulose, colloidal grades carboxy methyl cellulose sodium and other cellulose containing polymers and their derivatives or mixtures thereof.
12. The extended and sustained release composition as claimed in any of the presiding claims, wherein the sugar used is selected from the derivatives of sugar such as Mannilol, Sucrose, Xylitol, Sorbitol, Maltitol, Lactitol, lsomalt or mixtures thereof.
13. The extended and sustained release composition as claimed in any of the presiding claims, wherein the surfactants used are selected from Polysorbate, Sodium lauryl sulfate. Sorbitan monooleate. other surfactants of the same class or mixtures thereof
14. The extended and sustained release composition as claimed in any of the presiding claims, wherein the protective polymeric coating comprises of polymers and/or binders, titanium dioxide, purified talc, an additional polymer for gradual release and optionally a soothing agent such as menthol or peppermint.
15. The extended and sustained release composition as claimed in any of the presiding claims, wherein the polymers used for preventive coating and/or binders are selected from Methyl Cellulose, Agar, Sodium Alginate, Hydroxy Propyl Methyl Cellulose, Hydroxy Propyl Cellulose, Microcrystalline Cellulose, Polyvinyl Pyrrolidone. Starch, Gum Arabic, Xanthan Gum, Polyethylene Glycols. preferably, Microcrystalline Cellulose, Hydroxy Propyl Cellulose, Methyl Cellulose, Hydroxy Propyl Methyl Cellulose, etc, more preferably, Hydroxy Propyl Methyl Cellulose, Methacrylates, Phthalate methyl acrylate-methacrylic acid copolymers,

cellulose acetate succinate, polyvinyl acetate phthalate, Marcoat containing polymers and their derivatives or mixtures thereof.
16. The extended and sustained release composition as claimed in any of the presiding claims, wherein the additional polymer for gradual release is selected from hypromellose, cellulose acetate phthalate, zein, aqueous shellac solution, shellac (ammonium) salts, methacrylate copolymers ethyl cellulose and/or mixtures thereof.
17. The extended and sustained release composition as claimed in any of the presiding claims, wherein the said composition is free flowing and stable.
18. The extended and sustained release composition as claimed in any of the presiding claims, wherein the said composition is suitable for subsequent formulation into tablets, capsules, blended powders, heaps, ointments, pastes, lotions, liniments, mouthwashes, gargles, consumable dry syrups, liquid syrups, health drinks, diet drinks, fruit juices, soft drinks and the like.