FORM 2
THE PATENTS ACT 1970
(39 of 1970)
AND
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. TITLE OF THE INVENTION:
"A NOVEL PHARMACEUTICAL FLOATING DOSAGE FORM"
2. APPLICANT (S):
(a) NAME: FDC Limited
(b)NATIONALITY: Indian company incorporated under the Companies Act 1956
(c) ADDRESS: 142-48, S.V. Road, Jogeshwari (West), Mumbai - 400 102, Maharashtra, India.
3. PREAMBLE TO THE DESCRIPTION:
The following specification describes the invention and the manner in which it is to be performed.

TECHNICAL FIELD OF INVENTION:
The present invention relates to a novel pharmaceutical floating dosage form comprising a combination of antacid(s) and a raft-forming agent, along with an anti-flatulent(s) and/or local anesthetic(s) and pharmaceutically acceptable excipients. The floating dosage form is a tablet, capsule, suspension or a powder for suspension, which is useful for the treatment of gastro-intestinal disorders such as peptic ulcer, duodenal ulcer and esophageal reflux disease (GERD). The invention further relates to a process for preparation of said floating dosage form.
BACKGROUND OF THE INVENTION:
Gastric or duodenal ulcer, gastritis and heart burn are common problems in day to day life; affecting the patient's capability of work. If problems are not treated properly it can lead to complications like gastrointestinal bleeding and perforation.
Antacids are used as an adjunct to other drugs, for the relief of peptic ulcer pain and to promote the healing of peptic ulcers. Antacids are also used for the relief of esophageal reflux, acid indigestion, heartburn, dyspepsia, sour stomach and for the prevention of stress ulceration and gastrointestinal (GI) bleeding, thus reducing the risk associated with gastric aspiration and managing hyperphosphatemia.
An ulcer is an open sore formed when the lining of the gut is corroded by acidic digestive juices. Peptic ulcers can be formed in the lining of the stomach (gastric ulcers), duodenum or the esophagus. Peptic ulcers are quite common, and it is known that 5-10% of the world's population suffer from peptic ulcers at least once. For many years, excess acid was believed to be the major cause of ulcer disease. Accordingly, treatment emphasis was on neutralizing and inhibiting the secretion of stomach acid. While acid is still considered significant in ulcer formation, the leading cause of ulcer disease is currently believed to be the infection of the stomach by bacteria called "Helicobacter pyloricus" (H. pylori), Another major cause of ulcers is the chronic use of anti-inflammatory medications, commonly referred to as NSAIDs (non-steroidal anti-inflammatory drugs), including

aspirin. Cigarette smoking is also an important cause 0of ulcer formation and ulcer treatment failure.
As precise cause of peptic ulcer is unknown, the therapy is still empirical. However, the basic principle of ulcer therapy consists of controlling gastric acid, promoting ulcer healing, while preventing the complications and reocurrence and treating H. Pylori infection. Controlling gastric acid using antacids not on|y produces the systemic relief but also prevent the mucosal injury caused by the acid. Antacids are widely used to control the acid in the stomach.
An antacid is a substance, generally a base or a basic salt, which counteracts stomach acidity. Antacids are stomach acid neutralisers which increases the pH of the stomach. Antacid buffers the gastric pH and reduces acidity in the stomach. When gastric hydrochloric acid reaches the nerves of the gastrointestinal mucosa, they signal pain to the central nervous system.
The clinical use of antacids is based on their ability to increase the pH of the gastric secretions. With usual doses, antacids generally do not maintain gastric pH above 4-5.
Some examples of antacids include aluminum hydroxide, magnesium hydroxide aluminum carbonate gel, Magaldrate, calcium carbonate, magnesium carbonate, sodium bicarbonate, hydrotalcite and bismuth subsalicylate.
Aluminium hydroxide, Al(OH)3, is the most stable form 0f aluminium in normal conditions. It is found in nature in its mineral form such as Gibbsite (also known as hydrargillite) and its three rare polymorphs: bayerite, doyleite and nordstrandite. Closely related forms are aluminium oxide hydroxide (AlO(OH)) and aluminium oxide (Al2O3), differing only by loss of water, and which are the major components of the aluminium ore bauxite. Aluminium hydroxide reacts with excess acid in the stomach, reducing its acidity. It can also cause constipation, and is therefore often used with magnesium hydroxide or magnesium carbonate, which have counterbalancing laxative effect.
Magnesium hydroxide is an inorganic compound with th, chemical formula Mg(OH)2. As a suspension in water, it is often called milk of magnesia because of its milk-like appearance. The solid mineral form of magnesium hydroxide is known as Brucite.

Magnesium hydroxide is common component of antacids and laxatives, it interferes with the absorption of folic acid and iron. Magnesium hydroxide has low solubility in water; and the amount of magnesium hydroxide that does dissolve gets dissociated. Since the dissociation of this small amount of dissolved magnesium hydroxide is complete, magnesium hydroxide is considered to be a strong base.
Flatulence is a normal human excretory function and is the result of production of gases in gastrointestinal tract by anaerobic microbes, primarily bacteria. Excessive gas may accumulate either in stomach or intestine. An excessive gas in stomach may be expelled via belching, whereas intestinal gas passed through rectus may be expelled as flatus. Gas in the stomach is the result of swallowing air, usually while eating, drinking and talking. Another reason in recent days for gas generation is ingestion of large quantities of carbonated beverages. Intestinal gas also results mostly from the swallowing air, which is forced through the tract by peristalsis and putrification of intestinal contents by bacterial enzymatic system. Flatulence can cause symptoms like cramping, fullness and general distress.
An antiflatulent agent is a drug used for the alleviation or prevention of excessive intestinal gas, i.e., flatulence. Some examples of antiflatulent include mineral oils, vegetable oil, wax, fatty acids, dimethicone and semithicone. Dimethicone is a silicone oil consisting of dimethylsiloxane polymers. Simethicone is an oral anti-foaming agent used to reduce bloating, discomfort and pain caused by excess gas in the stomach or intestinal tract. Simethicone is a mixture of polydimethylsiloxane and silica gel. Simethicone decreases the surface tension of gas bubbles, causing them to combine into larger bubbles in the stomach that can be expelled more easily by burping. It does not reduce or prevent the formation of gas in the digestive tract, rather it increases the rate at which the gas exits the body, thus relieving pain caused by the gas in the intestines. Simethicone is not absorbed by the body into the bloodstream, and is therefore considered relatively safe.
Pain in the gastrointestinal tract is the most important clinical symptom of gastrointetinal disorders such as peptic ulcer, duodena! ulcer, GERD and other gastrointetinal related disoders. Hydrochloric acid is an irritant substance, which when applied to mucosa produces erythema, burning sensation and pain. Being a complex system, GIT consists of rich neuronal network that has been exposed to the gastric acid, due to reduction in

mucous turnover and ulceration. Hence, there should be addition of a local anaesthetic in the formulation to be used, to reduce the pain associated with peptic ulcer and duodenal ulcer.
A local anesthetic is a drug that causes reversible local anesthesia and loss of nociception. When it is used on specific nerve pathways (nerve block), effects such as analgesia (loss of pain sensation) and paralysis (loss of muscle co-ordination) can be achieved.
Clinical local anesthetics belong to one of two classes: aminoamide and aminoester local anesthetics. Synthetic local anesthetics are structurally related to cocaine. They differ from cocaine mainly in that they do not have abuse potential and do not act on the sympathoadrenergic system, i.e. they do not produce hypertension or local vasoconstriction, with the exception of Ropivacaine and Mepivacaine that do produce weak vasoconstriction.
Oxetacaine and Tetracaine are potent local anesthetics. Oxetacaine is administered orally (usually in combination with an antacid) for the relief of pain associated with peptic ulcer disease or esophagitis. Oxetacaine is also used topically in the management of hemorrhoid pain. Unlike most local anesthetics, Oxetacaine is active even in strong acidic conditions. Tetracaine can be considered as a local anesthetic for the treatment of pain associated with peptic ulcer.
Sodium alginate is used in the treatment of gastric esophageal reflux disease (GERD). Alginates when administered, form raft between oesophagus and stomach, and hence prevent acid exposure to the oesophagus. Sodium alginate, when combined with antacids and other active ingredients, forms a gel inside the gastrointestinal-tract (GIT) upon contacting with the gastric acid, while carbonates present in the formulation react with gastric acid and get trapped in the gel network. The gas-entrapped gel network has low density than that of the gastric fluid, and thus floats in the stomach. The novel combination of active and inactive ingredients in floating controlled-release liquid dosage form, will provide immediate relief (antacids and local anaesthetic) and prolonged action (controlled release of antacids), and prevent oesophagal reflux (raft formation due to sodium alginate), thus making this system useful in controlling and treating acid-related gastrointestinal (GI) disorders.

US4140460 discloses a pharmaceutical composition for the suppression of gastric reflux which comprises a low viscosity grade sodium alginate.
US6348502 discloses a pharmaceutical composition for the treatment of gastro-oesophageal reflux disease which comprises a carrier vehicle such as an alginate, and cross-linked polyacrylic acid along with at least one active ingredient selected from capsaicin, zingerone, curcumin, piperine and resiniferatoxin.
US5447918 discloses a method of relieving symptoms of gastrointestinal mucosal irritation in mammals comprising administering to said mammals, a composition comprising sucralfate in combination with one or more antacid epigastralgic relieving agents.
US4869902 discloses a pharmaceutical composition including magnesium alginate and an antacid material such as magnesium carbonate and aluminum hydroxide, useful in the treatment of reflux esophagitis.
US4198390 discloses a tablet containing at least two separate and discrete volume portions, one of which contains simethicone and the other of which contains antacid.
None of the above prior arts specifically discloses the combination of antacid(s) and a raft-forming agent, along with an anti-flatuient(s) and/or local anesthetic(s). Such a combination has exceptional advantages and synergistic potential for effective treatment of gastric esophageal reflux disease (GERD). Hence, the present inventors have come up with an oral pharmaceutical composition comprising said combination in a floating dosage form, preferably a tablet, capsule, suspension or a powder for suspension, useful for treatment of gastric esophageal reflux disease (GERD).
OBJECT OF THE INVENTION
Accordingly, the main object of the present invention is to provide a novel floating dosage form.

Another object of the present invention is to provide gastro-retentive technology which retains the antacid for longer period of time, and hence improves the acid neutralization capacity with reduced the side effects, prolonged duration and patient compliance.
SUMMARY OF THE INVENTION:
In accordance with the above objective, the present invention provides a pharmaceutical composition comprising a combination of antacid(s) and a raft-forming agent, along with an anti-flatulent(s) and/or local anesthetic(s) and pharmaceutically acceptable excipients, in a floating dosage form such as tablet, capsule, suspension or a powder for suspension. Such floating dosage form is useful for the treatment of gastric esophageal reflux disease (GERD). The invention further provides a process for preparation of said pharmaceutical composition.
DETAILED DESCRIPTION OF THE INVENTION:
The invention will now be described in detail in connection with certain preferred and optional embodiments, so that various aspects thereof may be more fully understood and appreciated.
In a preferred embodiment, the present invention provides, a pharmaceutical composition comprising a combination of antacid(s) and a raft-forming agent, along with an anti-flatulent(s) and/or local anesthetic(s) and pharmaceutically acceptable excipients, useful
Accordingly, the antacid used in present invention is a combination of acid soluble antacid(s) and/or poorly acid soluble antacid(s). The acid soluble antacid(s) are selected from a group consisting of sodium bicarbonate, sodium carbonate and magnesium carbonate, preferably sodium bicarbonate, ranging from 5mg/5ml to 600mg/5ml. The poorly acid soluble antacid(s) are selected from a group consisting of aluminium hydroxide, magnesium hydroxide, aluminium carbonate, calcium carbonate, aluminium silicates, Magaldrate and other metal hydroxides, preferably calcium carbonate, aluminium hydroxide and magnesium hydroxide, ranging from 25mg/5ml to 500mg/5ml.

The raft-forming agent used in the present invention is selected from a group consisting of alginic acid, sodium alginate and magnesium alginate, preferably sodium alginate, in the range of 20mg/5ml to 500mg/5ml.
The anti-flatulent used in the present invention is selected from a group consisting of mineral oils, vegetable oil, wax, fatty acids, dimethicone and semithicone, preferably semithicone, dimethicone and castor oil, in the range of 5mg/5ml to 250mg/5ml.
The local anesthetic used in the present invention is selected from a group consisting of derivates of para-amino benzoic acid, acetamide, acetaniiide, quinoline, acryline, nonhydrogenous compounds, natural volatile oils, certain antihistaminics and chlorpromazine, preferably acetamide derivates such as Oxetacaine and para-amino benzoic acid derivatives such as Tetracaine, in the range of lmg/5ml to 100mg/5ml.
The pharmaceutically acceptable excipients in the present invention are selected from surfactant, polyol, lubricants, buffers, sweeteners, preservatives, colors and flavors.
The surfactant used in the present invention is selected from a group consisting of polysorbate, sodium lauryl sulphate, Tyloxapol, triglycerides, fatty acid esters, preferably polysorbates, sodium lauryl sulphate and tyloxapol, most preferably polysorbates.
The polyol used in the present invention is selected from a group consisting of glycerol, sugars, polyethylene glycol and polypropylene glycol, preferably glycerol and sorbitol.
In another preferred embodiment, the present invention provides a floating dosage form such as a tablet, capsule, suspension or a powder for suspension.
In yet another embodiment, a process for making the pharmaceutical composition is described as follows:-

Tablet:
Mixing the antacids and anti-flatulent, followed by adding the raft-forming agent, local anesthetics and other excipients. Granulating the mixture. Sieve the granules and mix it with lubricants and flavors, and then press into tablets.
Capsule:
Mixing the antacids and anti-flatulent, followed by adding the raft-forming agent, local anesthetics and other excipients except magnesium stearate (All the ingredients were individually weighed and passed through appropriate sieves). Granulating the mixture. Sieve the granules and mix it with lubricants, and encapsulate it in capsule dosage forms.
Suspension:
Dispersing the local anesthetic agent in polyol and/or aqueous vehicle, with or without surfactant(s). Mixing the resulting homogeneous dispersion with raft-forming agent, anti-flatulent, antacids, preservative, stabilizers, colors, flavors, sweetener and antioxidant. Homogenize the mixture to get uniform suspension, and make up the final volume with aqueous vehicle.
The following examples, which include preferred embodiments, will serve to illustrate the practice of this invention, it being understood that the particulars shown are by way of examples and for purpose of illustrative discussion of preferred embodiments of the invention.
EXAMPLE
Examples of Tablet:
Example 1

Sr. No. Ingredient Qty./ Unit
1. Magnesium Hydroxide 250mg
2. Aluminium. Hydroxide 250mg
3. Sodium Alginate 200mg
4. Oxetacaine l0mg
5. Calcium Carbonate 50mg

6. Sodium bicarbonate 50mg
7. Sodium Citrate l0mg
8. Sucralose 2.5mg
9. Simethicone 50mg
10. Shahi Gulab flavour q.s
11. Ponceau Supra C/R q.s
12. Magnesium Stearate 17.5mg
1. Mixing magnesium hydroxide, aluminium hydroxide and simethicone;
2. adding sodium alginate, oxetacaine and other excipients such as calcium carbonate, sodium bicarbonate, sodium citrate, sucralose;
3. granulating the mixture and passing the granules in sieve 30 # size and mixing it with magnesium stearate;
4. adding shahi gulab flavour, ponceau supra C/R and then compressing into tablets.
Example 2

Sr. No. Ingredient Qty/ Unit
1. Magaldrate 480mg
2. Sodium Alginate l00mg
3. Oxetacaine l0mg
4. Calcium Carbonate 50mg
5. Sodium Bicarbonate 50mg
6. Sodium Citrate 20mg
7. Sucralose 2.5mg
8. Simethicone 50mg
9. Orange flavor q.s
10. Sunset Yellow Supra q.s
11. Magnesium stearate 20mg
1. Mixing Magaldrate and simethicone;
2. adding sodium alginate, oxetacaine and other excipients such as calcium carbonate, sodium bicarbonate, sodium citrate, sucralose;
3. granulating the mixture and passing the granules in sieve 30 # size and mixing it with magnesium stearate;
4. adding orange flavour, sunset yellow supra C/R and then compress into tablets.

Examples of Capsule: Example 3

Sr. No. Ingredient Qry./ Unit
1. Magnesium Hydroxide 250mg
2. Aluminium Hydroxide 250mg
3. Sodium Alginate 200mg
4. Oxetacaine l0mg
5. Calcium Carbonate 50mg
6. Sodium bicarbonate 50mg
7. Sodium Citrate l0mg
8. Simethicone 50mg
9. Magnesium Stearate 17.5mg
1. Mixing magnesium hydroxide, aluminium hydroxide and simethicone;
2. Adding sodium alginate, oxetacaine and other excipients such as calcium carbonate, sodium bicarbonate, sodium citrate;
3. granulating the mixture and passing the granules in sieve 30 # size and mixing it with magnesium stearate;
4. encapsulating it in capsule dosage form.
Examples of powder for suspension* Example 4

Sr. No. Ingredient Qty./ Unit
1. Magnesium Hydroxide 250mg
2. Aluminium Hydroxide 250mg
3. Sodium Alginate 75mg
4. Oxetacaine l0mg
5. Calcium Carbonate 50mg
6. Sodium Bicarbonate 50mg
7. Sodium Citrate 20mg
8. Tyloxapol 0.6mg
9. Sucralose 2.5mg
10. Simethicone 50mg
11. Methylparaben l0mg

■^_ 12. Propylparaben Img

13. Ponceau Supra C/R 0.25mg
14. Shahi Gulab flavour 0.013ml
15. Sorbitol solution 70% 125mg
*to be reconstituted with 5ml of water
1. Mixing magnesium hydroxide, aluminium hydroxide and simethicone;
2. adding sodium alginate, oxetacaine and other excipients such as calcium carbonate, sodium bicarbonate, sodium citrate, sucraiose, tyloxapol, methylparaben, propylparaben;
3. granulating the mixture and dry it;
4. passing the dried granules through Sieve 30 # size and mixing it with magnesium stearate;
5. adding shahi gulab flavour, ponceau supra C/R.
Examples of Suspension Example 5

Sr. No. Ingredient Qty./ Unit
1. Magnesium Hydroxide 250mg
2. Aluminium Hydroxide 250mg
3. Sodium Alginate 200mg
4. Oxetacaine l0mg
5. Calcium Carbonate 50mg
6. Sodium Bicarbonate 50mg
7. Sodium Citrate 20mg
8. Sucraiose 2.5mg
9. Dimethicone 40mg
10. Methylparaben 0.25mg
11. Propylparaben 1mg
12. Flavor Orange 0.25mg
13. Sunset Yellow Supra 0.013ml
14. Sorbitol solution 70% 125mg
15. Purified Water q.s. to 5ml

1. Dispersing sodium citrate, sucralose, sodium bicarbonate, calcium carbonate in hot water,'
2. adding sodium alginate under homogenization in step 1. Homogenize till it hydrate completely;
3. dissolving bronopol, methyl paraben, propyl paraben sodium in water and adding this solution in step 2;
4. adding both the paste homogenize;
5. preparing dispersion of oxetacain in sorbitol 70% with Tween 80 and adding this dispersion in step 4;
6. adding dimethicone in step 5 under homogenization;
7. adding colour solution and flavour and filter through muslin cloth.
Example 6

Sr. No. Ingredient Qty./ Unit
I. Magnesium Hydroxide 250mg
2. Aluminium Hydroxide 250mg
3. Sodium Alginate 200mg
4. Oxetacaine 10mg
5. Calcium Carbonate 50mg
6. Sodium Bicarbonate 50mg
7. Sodium Citrate 20mg
8. Polysorbate 80 0.6mg
9. Chloroform 5mg
10. Bronopol 5mg
11. Sucralose 3.75mg
12. Simethicone emulsion 166.66mg
13. Methylparaben sodium 7.5mg
14, Propylparaben sodium 2mg
15. Sunset Yellow Supra 0.335mg
16. Orange flavour 0.335ml
17. Sorbitol solution 70% l000mg
18. Purified Water q.s. to 5ml
1. Dispersing sodium citrate, sucralose, sodium bicarbonate, calcium carbonate in hot water;

2. adding sodium alginate under homogenization in step 1. Homogenize till it hydrate completely;
3. adding chloroform under homogenization;
4. dissolving bronopol, methyl paraben sodium, propyl paraben sodium in water and adding this solution in step 3;
5. adding both the paste homogenize;
6. preparing dispersion of oxetacain in sorbitol 70% with Tween 80 and adding this dispersion in step 5;
7. adding simethicone emulsion in step 6 under homogenization;
8. adding colour solution and flavour and filter through muslin cloth
Example 7

Sr. No. Ingredient Qty./Unit
1. Magaldrate 250mg
2. Sodium alginate 200mg
3. Calcium Carbonate 50mg
4. Sodium Bicarbonate 50mg
5. Sodium Citrate 20mg
6. Tyloxapol 2.5mg
7. Sucralose 2.5mg
8. Simethicone 50mg
9. Bronopol 2.5 mg
10. Flavored Orange 0.25mg
11. Sunset yellow 0.013ml
12. Sorbitol 125mg
13. Purified Water q.s. 5ml
1. Dispersing sodium citrate, sucralose, sodium bicarbonate, calcium carbonate in hot water;
2. adding sodium alginate under homogenization in step 1. Homogenize till it hydrate completely;
3. dissolving bronopol and Tyloxapol in water and adding this solution in step 2;
4. adding magaldrate under homogenization;

5. preparing dispersion of oxetacain in sorbitol 70% and adding this dispersion in step 4;
6. adding simethicone in step 5 under homogenization;
7. adding colour solution and flavour and filter through muslin cloth.
Example 8

Sr. No. Ingredient Qty.1 Unit
1. Magnesium Hydroxide 500mg
2. Aluminium Hydroxide 500mg
3. Sodium Alginate l00mg
4. Oxetacaine l0mg
5. Calcium Carbonate 50mg
6. Sodium Bicarbonate 50mg
7. Sodium Citrate 20mg
8. Polysorbate 80 0.6mg
9. Acesulfame potassium 13mg
10. Simethicone 50mg
11. Methylparaben l0mg
12. Propylparaben 1mg
13. Ponceau Supra C/R 0.25mg
14. Shahi Gulab flavour 0.013ml
15. Sorbitol solution 70% 125mg
16. Purified Water q.s. to 5ml
1. Dispersing sodium citrate, Acesulfame potassium, sodium bicarbonate, calcium carbonate in hot water;
2. adding sodium alginate under homogenization in step 1. Homogenize till it hydrate completely;
3. dissolving bronopol, methyl paraben, propyl paraben in water and adding this solution in step 2;
4. adding both the paste homogenize;
5. preparing dispersion of oxetacain in sorbitol 70% with Tween 80 and adding this dispersion in step 4;
6. adding simethicone in step 6 under homogenization;
7. adding colour solution and flavour and filter through muslin cloth.

Example 9

Sr. No. Ingredient Qty./ Unit
1. Magaldrate 480mg
2. Sodium Alginate l00mg
3. Oxetacaine l0mg
4. Calcium Carbonate 50mg
5. Sodium Bicarbonate 50mg
6. Sodium Citrate 20mg
7. Polysorbate 80 0.6mg
8. Sucralose 2.5mg
9. Simethicone 50mg
10. Bronopol 2.5mg
11. Ponceau Supra C/R 0.25mg
12. Shahi Gulab flavour 0.013ml
13. Sorbitol solution 70% 125mg
14. Purified Water q.s. to 5ml
1. Dispersing sodium citrate, sucralose, sodium bicarbonate, calcium carbonate in hot water;
2. adding sodium alginate under homogenization in step 1. Homogenize till it hydrate completely;
3. dissolving bronopol in water and adding this solution in step 2;
4. adding magaldrate under homogenization:
5. preparing dispersion of oxetacain in sorbitol 70% with Polysorbate 80 and adding this dispersion in step 4;
6. adding simethicone in step 5 under homogenization;
7. adding colour solution and flavour and filter through muslin cloth.
Example 10

Sr. No. Ingredient Qty./ Unit
1. Magnesium Carbonate 250mg
2. Aluminium Hydroxide 250mg
3. Sodium Alginate 200mg
4. Oxetacaine l0mg
5. Sodium Bicarbonate l00mg

6. Sodium Citrate 20mg
7. Polysorbate 0.6mg
8. Sucralose 2.5mg
9. Simethicone 50mg
10. Methyl paraben l0mg
11. Propylparaben 1mg
12. Flavor Orange 0.25mg
13. Sunset Yellow Supra 0.013ml
14. Sorbitol solution 70% 125mg
15. Purified Water q.s. to 5ml
1. Dispersing sodium citrate, Sucralose, sodium bicarbonate, calcium carbonate in hot water;
2. adding sodium alginate under homogenization in step 1 Homogenize till it hydrate completely;
dissolving bronopol, methyl paraben, propyl paraben in water and adding this solution in step 2; solution in step 2;
4. adding both the paste homogenize;
5. preparing dispersion of oxetacain in sorbitol 70% with Polysorbate and adding this dispersion in step 4;
6. adding simethicone in step 6 under homogemzation;
7. adding colour solution and flavour and filter through muslin cloth.
Example 11

Sr. No. Ingredient Qty./ Unit
1. Magnesium Hydroxide 250mg
2. Aluminium Hydroxide 250mg
3. Sodium Alginate 200mg
4. Oxetacaine l0mg
5. Calcium Carbonate l00mg
6. Sodium Citrate 20mg
7. Polysorbate 0.6mg
8. Sucralose 2.5mg
9. Simethicone 50mg

10. Methylparaben l0mg
11. Propylparaben lmg
12. Flavor Orange 0.25mg
13. Sunset Yellow Supra 0.013ml
14. Sorbitol solution 70% 125mg
15. Purified Water q.s. to 5ml
1. Dispersing sodium citrate, Sucralose, calcium carbonate in hot water;
2. adding sodium alginate under homogenization in step 1. Homogenize till it hydrate completely;
3. dissolving bronopol, methyl paraben, propyl paraben in water and adding this solution in step 2;
4. adding both the paste homogenize;
5. preparing dispersion of oxetacain in sorbitol 70% with Polysorbate and adding this dispersion in step 4;
6. adding simethicone in step 6 under homogenization;
7. adding colour solution and flavour and filter through muslin cloth.

We claim,
1. A novel pharmaceutical composition comprising a combination of antacid(s) and a raft-forming agent along with anti-flatulent(s) and/or local anesthetic(s) and pharmaceutically acceptable excipients, in a floating dosage form.
2. The pharmaceutical composition as claimed in claim 1, wherein the antacid(s) is a combination of acid soluble antacid(s) and/or poorly acid soluble antacid(s).
3. The pharmaceutical composition as claimed in claim 2, wherein the acid soluble antacid{s) are selected from a group consisting of sodium bicarbonate, sodium carbonate and magnesium carbonate, present in an amount ranging from 5mg/5m! to 600mg/5ml.
4. The pharmaceutical composition as claimed in claim 2, wherein the poorly acid soluble antacid(s) are selected from a group consisting of aluminium hydroxide, magnesium hydroxide, aluminium carbonate, calcium carbonate, aluminium silicates, Magaldrate and other metal hydroxides, present in an amount ranging from 25mg/5ml to 500mg/5ml.
5. The pharmaceutical composition as claimed in claim 1, wherein the raft-forming agent is selected from a group consisting of alginic acid, sodium alginate and magnesium alginate, present in an amount ranging from 20mg/5ml to 500mg/5ml.
6. The pharmaceutical composition as claimed in claim 1, wherein the anti-flatulent(s) are selected from a group consisting of mineral oils, vegetable oil, wax, fatty acids, castor oil, dimethicone and semithicone, present in an amount ranging from 5mg/5ml to 250mg/5ml.
7. The pharmaceutical composition as claimed in claim 1, wherein the local anesthetic(s) are selected from a group consisting of derivatives of para-amino benzoic acid such as Tetracaine, acetamide derivatives such as Oxetacaine, acetanilide, quinoline, acryline, non-hydrogenous compounds, natural volatile

oils, certain antihistaminics and chlorpromazine, present in an amount ranging from lmg/5ml to 100mg/5ml.
8. The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutically acceptable excipients are selected from surfactant, polyol, lubricants, buffers, sweeteners, preservatives, colors and flavors.
9. The pharmaceutical composition as claimed in claim 8. wherein the surfactant is selected from a group consisting of polysorbates, sodium lauryl sulphate, Tyloxapol, triglycerides, fatty acid esters.
10. The pharmaceutical composition as claimed in claim 8, wherein the polyol is selected from a group consisting of glycerol, sugars, sorbitol, polyethylene glycol and polypropylene glycol.
11. The floating dosage form as claimed in claim I, is in the form of tablet, capsule, suspension or a powder for suspension.