DESC:“ORAL EFFERVESCENT COMPOSITION OF METFORMIN HYDROCHLORIDE & METHOD OF MANUFACTURING THEREOF”
FIELD OF THE INVENTION:
The present invention relates to oral effervescent composition of Metformin hydrochloride. Moreover, the invention relates to providing a stable and moisture controlled method of manufacturing fixed dosage form of Metformin hydrochloride. Additionally, the present invention also provides a unit dosage oral effervescent composition of metformin hydrochloride with excipients that also act as antacids.
BACKGROUND OF THE INVENTION:
Metformin hydrochloride (CAS: 1115-70-4) is used to treat Type-2 diabetes mellitus. Metformin hydrochloride is approved in the USA under brand name Glucophage® (immediate release form), Glucophage XR® (extended release form) and Glumetza® (extended release form). It is sold by Bristol-Myers. A solution of Metformin hydrochloride is also approved and it is sold by Ranbaxy Pharmaceuticals, Inc under brand name Riomet®. Patients on metformin therapy frequently experience a lingering metallic taste in the mouth evidently due to a persistent presence of metformin in the saliva.
Metformin hydrochloride is chemically known as N,N-dimethylimidodicarbonimidic diamide hydrochloride and is structurally represented as below:

Metformin hydrochloride, a very old molecule. The orally administered composition of Metformin hydrochloride was disclosed in 1965 patent US3174901. The mentioned US patent discloses a method of treating diabetes by oral administration as well as to the pharmaceutical compositions useful therefor.
Metformin hydrochloride or Metformin hydrochloride combinations with other anti-diabetic agents marketed under brand names ACTOPLUS MET®, ACTOPLUS MET® XR, AVANDAMET®, FORTAMET®, GLUCOPHAGE®, GLUCOPHAGE® XR, GLUCOVANCE®, GLUMETZA®, INVOKAMET®, JANUMET®, JANUMET® XR, JENTADUETO®, KAZANO®, KOMBIGLYZE® XR, METAGLIP®, PRANDIMET®, RIOMET®, SYNJARDY® and XIGDUO® XR etc.
The recommended dose of Metformin hydrochloride is 500 to 1000 mg. GLUCOPHAGE tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg and 850 mg tablets contains hypromellose and the coating for the 1000 mg tablet contains hypromellose and polyethylene glycol. Another dosage form is oral solution sold under brand Name RIOMET® (Cherry Flavor or Strawberry Flavor) contains 500 mg of Metformin hydrochloride (the equivalent of 389.93 mg metformin) per 5 mL and the following inactive ingredients: flavor, hydrochloric acid, potassium bicarbonate, purified water, saccharin calcium, and xylitol.
WO2007/038979 discloses an effervescent metformin composition comprising pharmaceutically acceptable salt of metformin, an acid compound or an acid salt, an alkaline effervescent compound, compressible binders, and one or more other excipients.
WO2015/040460 discloses an effervescent composition of Metformin hydrochloride comprising pharmaceutically acceptable salt of metformin and sodium free alkaline effervescent compound such as potassium carbonate or potassium bicarbonate salts.
WO2017/098481 discloses an effervescent combination comprising metformin with retained carbon dioxide content of at least 90% of the input blend and a different antidiabetic agent.
Most of the prior-arts of an effervescent composition of Metformin hydrochloride discloses use for the treatment of diabetes. However, there are side effects associated with Metformin hydrochloride such as acid indigestion, heartburn and stomach upset symptoms. Hence, separate medication is required to treat the side effects associated with metformin hydrochloride. Therefore, to overcome the drawbacks of the prior-art, the inventors have arrived at the present invention of a unit dosage form for the treatment of diabetes and to simultaneously treat the side effects associated with Metformin hydrochloride without the need for separate medication.
The present invention provides improved oral effervescent compositions comprising Metformin hydrochloride with one or more pharmaceutically acceptable excipients; wherein one of the excipient acts as an antacid. Furthermore, the present invention provides improved oral effervescent compositions of Metformin hydrochloride in the form of a tablet, capsule, granules or powder which is desirable for patients, particularly for pediatric or geriatric who have difficulty swallowing.
Therefore, there is an unmet need for an oral effervescent compositions of Metformin hydrochloride in the form of a tablet, capsule, granules or powder that ensures easy administration for patients which also treats Metformin related side effects. Hence, the inventors of the present invention have developed a stable and moisture controlled oral effervescent composition of Metformin hydrochloride with one or more pharmaceutically acceptable excipients, wherein one of the excipient acts as an antacid.
OBJECTIVES OF THE INVENTION:
The principal object of the present invention is to provide improved fixed dosage pharmaceutical compositions of Metformin hydrochloride in the form of a tablet, capsule, granules or powder which is stable and moisture controlled oral effervescent composition.
Another object of the present invention is to provide oral effervescent compositions of Metformin hydrochloride with one or more pharmaceutically acceptable excipients, wherein one of the excipients act an antacid.
SUMMARY OF THE INVENTION
The present invention relates to improved stable and moisture controlled oral effervescent compositions of Metformin hydrochloride preferably as powder with pharmaceutically acceptable excipients and method of preparation thereof.
In another general aspect, an oral effervescent composition as per the present invention may be in the form of a tablet, capsule, caplet, pellets, beads, granules or powder.
In another general aspect, an oral effervescent composition as per the present invention comprises Metformin or pharmaceutically acceptable salt thereof.
In one general aspect, an oral effervescent composition comprising Metformin hydrochloride and one or more pharmaceutically acceptable excipients wherein the excipients are fillers or diluents, organic acid, effervescing agents, antacids, taste masking agents, gliding agents or lubricating agents, sweeteners, coloring and flavoring agents.
An another aspect, an oral effervescent composition as per the present invention comprising Metformin hydrochloride with one or more pharmaceutically acceptable excipients, wherein one of the excipient acts as an antacid.
In yet another aspect, an oral effervescent composition as per the present invention also provides a unit dosage oral effervescent composition of metformin hydrochloride with antacids.
One more general aspect, an oral effervescent composition as per the present invention comprising Metformin hydrochloride and one or more pharmaceutically acceptable effervescing agents.
Embodiments of an oral effervescent composition may include Metformin hydrochloride as an active ingredient with pharmaceutically acceptable excipients like fillers or diluents, organic acid, effervescing agents, antacids, taste masking agents, gliding agents or lubricating agents, sweeteners, coloring and flavoring agents and the like.
In one embodiment, an oral effervescent composition as per the present invention is preferably in the form of a granules or powder comprising:
a) Metformin or pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable excipients;
c) followed by blending and lubrication with one or more pharmaceutically acceptable excipients.
In another embodiment, Metformin hydrochloride with fillers or diluents, organic acid, effervescing agents, antacids, taste masking agents, gliding agents or lubricating agents, sweeteners, coloring and flavoring agents and other suitable pharmaceutical excipients, by the any of the above-mentioned techniques may be filled in a capsule or compressed into tablets to provide a final dosage form.
The details of one or more embodiments of the invention are set forth in the description below. Other features of the invention will be apparent from the description.
DETAILED DESCRIPTION OF THE INVENTION:
The present invention will now be disclosed by describing certain preferred and optional embodiments to facilitate various aspects thereof.
References to “an”, “one”, or “various” embodiments in this disclosure are not necessarily to the same embodiment, and such references contemplate more than one embodiment. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope is defined only by the appended claims, along with the full scope of legal equivalents to which such claims are entitled.
Metformin hydrochloride, chemically known as, N,N-dimethylimidodicarbonimidic diamide hydrochloride with molecular weight 165.63 g/mol. Metformin hydrochloride is considered a Bio-pharmaceutics Classification System (BCS) Class III drug substance due to high solubility and low permeability.
In accordance with the present invention, a pharmaceutical compositions of Metformin hydrochloride comprising of Metformin hydrochloride as an active ingredient with pharmaceutically acceptable excipients may include fillers or diluents, organic acid, effervescing agents, antacids, taste masking agents, gliding agents or lubricating agents, sweeteners, coloring and flavoring agents and the like.
Suitable organic acid may include, one or more from the group consisting of ascorbic acid, citric acid, lactic acid, oxalic acid, tartaric acid, malic acid and the like.
Suitable effervescent agents may include, but are not limited to, selected from one or more from sodium bicarbonate, potassium bicarbonate, sodium carbonate, potassium carbonate, calcium carbonate and mixtures thereof.
Suitable fillers or diluents may include one or more of sugars such as lactose, sucrose glucose, fructose, dextrose, galactose, starch; cellulose derivatives such as microcrystalline cellulose; carbonates like calcium carbonate; sugar alcohols such as mannitol, sorbitol, erythritol; magnesium carbonate, calcium phosphates kaolin, magnesium oxide, magnesium hydroxide and mixtures thereof.
Suitable antacids may include, but are not limited to, , aluminum hydroxide, magnesium carbonate, magnesium trisilicate, magnesium hydroxide, calcium carbonate, sodium bicarbonate and mixtures thereof.
Antacids having additional property around such as aluminum hydroxide that acts as a drug taste masking agent, magnesium carbonate that acts as a filler or diluent, magnesium trisilicate that acts as a gliding agent or lubricating agent, magnesium hydroxide that acts as a fillers or diluents, calcium carbonate that acts as an effervescent agent and fillers or diluents and sodium bicarbonate that acts as effervescent agent are preferred.
Suitable taste masking agents may include one or more such as Fexofenadine Hydrochloride (Indion 204), aluminum hydroxide, flavoring agents and mixtures thereof.
Suitable gliding agents or lubricating agents may include one or more of talc, metallic stearates such as magnesium stearate, calcium stearate, zinc stearate; colloidal silicon dioxide, finely divided silicon dioxide, stearic acid, hydrogenated vegetable oil, glyceryl palmitostearate, glyceryl monostearate, glyceryl behenate, polyethylene glycols, powdered cellulose, starch, sodium stearyl fumarate, sodium benzoate, mineral oil, magnesium trisilicate, kaolin; and mixtures thereof.
Suitable sweeteners may include, but are not limited to, one or more from sucralose, saccharin, neotame, Aspartame, Cyclamate, Glycyrrhizin, sucrose, molasses, glucose, fructose, mannitol, sorbitol, xylitol, erythritol, Isomalt, maltiol, lactiol, hydrogenated starch and mixtures thereof.
Suitable flavoring agents may include, one or more from the group consisting of peppermint, grapefruit, orange, lime, lemon, mandarin, pineapple, strawberry, raspberry, mango, passion fruit, kiwi, apple, pear, peach, apricot, cherry, grape, banana, cranberry, blueberry, black currant, red currant, gooseberry, lingon berries, cumin, thyme, basil, camille, valerian, fennel, parsley, chamomile, tarragon, lavender, dill, bargamot, salvia, aloe vera balsam, spearmint, piperine, eucalyptus, and mixtures thereof.
Suitable coloring and flavoring agents may include, but are not limited to, one or more from orange flavor, pineapple flavor, vanilla flavor, strawberry flavor, lemon flavor and mixtures thereof.
An oral effervescent composition as described herein may be prepared by processes known to the person having ordinary skill in the art of pharmaceutical technology such as direct compression, wet granulation, dry granulation or hot melt granulation.
Another embodiment describes an oral effervescent composition comprising Metformin hydrochloride with pharmaceutically acceptable excipients, in the form of a tablet, granules, beads, pellets, powder, particles, agglomerates, microspheres, minitablets, capsules and the like.
In another embodiment, the process comprises a step for providing Metformin hydrochloride, wherein the Metformin hydrochloride is preferably in the form of a granules or powder that may be prepared by the steps comprising:
a) mixing Metformin hydrochloride with one or more pharmaceutically acceptable excipients;
b) followed by blending and lubrication with one or more pharmaceutically acceptable excipients.
In another embodiment, Metformin hydrochloride with fillers or diluents, organic acid, effervescing agent, antacids, taste masking agents, gliding agents or lubricating agents, sweeteners, coloring and flavoring agents and other suitable pharmaceutical excipients, by any of the above-mentioned techniques may be filled in a capsule or compressed as tablets to provide a final dosage form.
The invention will now be further described with respect to the following examples. However, the scope of the invention is not limited thereby. All percentages stated in this specification are by weight, unless otherwise specified. While the present invention has been described in terms of its specific embodiments, certain modifications and equivalents will be apparent to those skilled in the art and are intended to be included within the scope of the present invention.

EXAMPLE-1:
Table-1
Sr. No. Ingredients mg/unit %w/w
1 Metformin Hydrochloride 1000.00 24.39
2 Citric Acid Anhydrous 1700.00 41.46
3 Sorbitol 150.00 3.66
4 Sodium Bicarbonate 600.00 14.63
5 Sodium Carbonate Anhydrous 260.00 6.34
6 Calcium Carbonate 300.00 7.32
7 Sucralose 30.00 0.73
8 Flavor Pineapple 40.00 0.98
9 Colloidal Silicon Dioxide 20.00 0.49
Average Weight 4100.00 100.00
Process for preparation:
1. All the materials were dispensed.
2. Metformin hydrochloride, citric acid anhydrous and sorbitol were passed through sieve mesh size 30.
3. Sodium bicarbonate, sodium carbonate anhydrous, calcium carbonate, sucralose and flavor pineapple were passed through sieve mesh size 30.
4. Materials of Step-2 was shifted in blender for 15 minutes.
5. Materials of Step-3 was shifted in above Step-4 and blended for 10 minutes.
6. Load sifted granules of Step-5, sifted Colloidal Silicon Dioxide into blender and mix it.

EXAMPLE-2:
Table-2
Sr. No. Ingredients mg/unit %w/w
1 Metformin Hydrochloride 1000.00 33.33
2 Citric Acid Anhydrous 780.00 26.00
3 Sorbitol 230.00 7.67
4 Sodium Bicarbonate 600.00 20.00
5 Calcium Carbonate 300.00 10.00
6 Sucralose 30.00 1.00
7 Flavor Pineapple 40.00 1.33
8 Colloidal Silicon Dioxide 20.00 0.67
Average Weight 3000.00 100.00
Process for preparation:
1. All the materials were dispensed.
2. Metformin hydrochloride, citric acid anhydrous and sorbitol were passed through sieve mesh size 30.
3. Sodium bicarbonate, calcium carbonate, sucralose and flavor pineapple were passed through sieve mesh size 30.
4. Materials of Step-2 was shifted in blender for 15 minutes.
5. Materials of Step-3 was shifted in above Step-4 and blended for 10 minutes.
6. Load sifted granules of Step-5, sifted Colloidal Silicon Dioxide into blender and mix it.
EXAMPLE-3:
Table-3
Sr. No. Ingredients mg/unit %w/w
1 Metformin Hydrochloride 1000.00 36.10
2 Citric Acid Anhydrous 780.00 28.16
3 Sodium Hydrogen Carbonate (Sodium Bicarbonate) 600.00 21.66
4 Calcium Carbonate 300.00 10.83
5 Sucralose 30.00 1.08
6 Flavor Pineapple 40.00 1.44
7 Colloidal Silicon Dioxide 20.00 0.72
Average Weight 2770.00 100.00
Process for preparation:
1. All the materials were dispensed.
2. Metformin hydrochloride and citric acid anhydrous were passed through sieve mesh size 30.
3. Sodium bicarbonate, calcium carbonate, sucralose and flavor pineapple were passed through sieve mesh size 30.
4. Materials of Step-2 was shifted in blender for 15 minutes at 10 ± 2 RPM.
5. Materials of Step-3 was shifted in above Step-4 and blended for 10 minutes at 10 ± 2.
6. 6. Load sifted granules of Step-5, sifted Colloidal Silicon Dioxide into blender and mix it.

EXAMPLE-4:
Table-4
Sr. No. Ingredients mg/unit %w/w
1 Metformin Hydrochloride 1000.00 34.84
2 Citric Acid Anhydrous 780.00 27.18
3 Sodium Hydrogen Carbonate (Sodium Bicarbonate) 600.00 20.91
4 Aluminum hydroxide 200.00 6.97
5 Magnesium Carbonate 200.00 6.97
5 Sucralose 30.00 1.05
6 Flavor Pineapple 40.00 1.39
7 Colloidal Silicon Dioxide 20.00 0.70
Total Weight 2870.00 100.00

Process for preparation:
1. All the materials were dispensed.
2. Metformin hydrochloride and citric acid anhydrous were passed through sieve mesh size 30.
3. Sodium bicarbonate, Aluminum hydroxide, Magnesium Carbonate, sucralose and flavor pineapple were passed through sieve mesh size 30.
4. Materials of Step-2 was shifted in blender for 15 minutes.
5. Materials of Step-3 was shifted in above Step-4 and blended for 10 minutes.
6. Load sifted granules of Step-5, sifted Colloidal Silicon Dioxide into blender and mix it.

EXAMPLE-5:
Table-5
Sr. No. Ingredients mg/unit %w/w
1 Metformin Hydrochloride 1000.00 34.84
2 Citric Acid Anhydrous 780.00 27.18
3 Sodium Hydrogen Carbonate (Sodium Bicarbonate) 600.00 20.91
4 Aluminum hydroxide 200.00 6.97
5 Calcium Carbonate 200.00 6.97
5 Sucralose 30.00 1.05
6 Flavor Pineapple 40.00 1.39
7 Colloidal Silicon Dioxide 20.00 0.70
Total Weight 2870.00 100.00
Process for preparation:
1. All the materials were dispensed.
2. Metformin hydrochloride and citric acid anhydrous were passed through sieve mesh size 30.
3. Sodium bicarbonate, Aluminum hydroxide, Calcium Carbonate, sucralose and flavor pineapple were passed through sieve mesh size 30.
4. Materials of Step-2 was shifted in blender for 15 minutes.
5. Materials of Step-3 was shifted in above Step-4 and blended for 10 minutes.
6. Load sifted granules of Step-5, sifted Colloidal Silicon Dioxide into blender and mix it.

EXAMPLE-6:
Table-6
Sr. No. Ingredients mg/unit %w/w
1 Metformin Hydrochloride 1000.00 34.84
2 Citric Acid Anhydrous 780.00 27.18
3 Sodium Hydrogen Carbonate (Sodium Bicarbonate) 600.00 20.91
4 Aluminum hydroxide 200.00 6.97
5 Magnesium hydroxide 200.00 6.97
5 Sucralose 30.00 1.05
6 Flavor Pineapple 40.00 1.39
7 Colloidal Silicon Dioxide 20.00 0.70
Total Weight 2870.00 100.00
Process for preparation:
1. All the materials were dispensed.
2. Metformin hydrochloride and citric acid anhydrous were passed through sieve mesh size 30.
3. Sodium bicarbonate, Aluminum hydroxide, Magnesium hydroxide, sucralose and flavor pineapple were passed through sieve mesh size 30.
4. Materials of Step-2 was shifted in blender for 15 minutes.
5. Materials of Step-3 was shifted in above Step-4 and blended for 10 minutes.
6. Load sifted granules of Step-5, sifted Colloidal Silicon Dioxide into blender and mix it.
The invention described herein comprises in various objects as mentioned above and their description in relation to characteristics, compositions and process adopted. While these aspects are emphasised in the invention, any variations of the invention described above are not to be regarded as departure from the spirit and scope of the invention as described.
,CLAIMS:We claim:
1. A unit dosage of oral effervescent composition comprising:

a) Metformin or pharmaceutically acceptable salt thereof
b) one or more pharmaceutically acceptable excipients wherein one or more pharmaceutically acceptable excipients are selected from fillers or diluents, organic acid, effervescing agents, antacids, taste masking agents, gliding agents or lubricating agents, sweeteners, coloring and flavoring agents.
2. The unit dosage of oral effervescent composition as claimed in claim 1 wherein
the fillers or diluents are selected from sorbitol, calcium carbonate, magnesium carbonate, magnesium hydroxide and mixtures thereof,
the organic acids are selected from ascorbic acid, citric acid, lactic acid, oxalic acid, tartaric acid, malic acid and mixtures thereof,
the effervescing agents are selected from sodium bicarbonate, sodium carbonate, calcium carbonate and mixtures thereof,
the taste masking agents are aluminum hydroxide, flavoring agents and mixture thereof,
the gliding agents or lubricating agents are selected from colloidal silicon dioxide, magnesium stearate, magnesium trisilicate and mixtures thereof.
the sweeteners are selected from sucralose, sorbitol, mannitol and mixtures thereof.
the coloring and flavoring agents are selected from orange flavor, pineapple flavor, vanilla flavor, strawberry flavor, lemon flavor and mixtures thereof.
3. The unit dosage of oral effervescent composition as claimed in claim 1 wherein
the drug taste masking agent is aluminum hydroxide,
the filler or diluent is magnesium carbonate,
the gliding agent or lubricating agent is magnesium trisilicate,
the fillers or diluents is magnesium hydroxide,
the effervescent agent or fillers or diluents is calcium carbonate,
the effervescent agent is sodium bicarbonate
all are antacids.

4. The unit dosage of oral effervescent composition of Metformin hydrochloride comprising of following formula:
Sr. No. Ingredients mg/unit %w/w
1 Metformin Hydrochloride 1000.00 24.39
2 Citric Acid Anhydrous 1700.00 41.46
3 Sorbitol 150.00 3.66
4 Sodium Bicarbonate 600.00 14.63
5 Sodium Carbonate Anhydrous 260.00 6.34
6 Calcium Carbonate 300.00 7.32
7 Sucralose 30.00 0.73
8 Flavor Pineapple 40.00 0.98
9 Colloidal Silicon Dioxide 20.00 0.49
Average Weight 4100.00 100.00
wherein the composition is in the form of a tablet, capsule, granules or powder.
5. The unit dosage of oral effervescent composition of Metformin hydrochloride comprising of following formula:
Sr. No. Ingredients mg/unit %w/w
1 Metformin Hydrochloride 1000.00 33.33
2 Citric Acid Anhydrous 780.00 26.00
3 Sorbitol 230.00 7.67
4 Sodium Bicarbonate 600.00 20.00
5 Calcium Carbonate 300.00 10.00
6 Sucralose 30.00 1.00
7 Flavor Pineapple 40.00 1.33
8 Colloidal Silicon Dioxide 20.00 0.67
Average Weight 3000.00 100.00
wherein the composition is in the form of a tablet, capsule, granules or powder.
6. The unit dosage of oral effervescent composition of Metformin hydrochloride comprising of following formula:
Sr. No. Ingredients mg/unit %w/w
1 Metformin Hydrochloride 1000.00 36.10
2 Citric Acid Anhydrous 780.00 28.16
3 Sodium Hydrogen Carbonate (Sodium Bicarbonate) 600.00 21.66
4 Calcium Carbonate 300.00 10.83
5 Sucralose 30.00 1.08
6 Flavor Pineapple 40.00 1.44
7 Colloidal Silicon Dioxide 20.00 0.72
Average Weight 2770.00 100.00
wherein the composition is in the form of a tablet, capsule, granules or powder.
7. The unit dosage of oral effervescent composition of Metformin hydrochloride comprising of following formula:
Sr. No. Ingredients mg/unit %w/w
1 Metformin Hydrochloride 1000.00 34.84
2 Citric Acid Anhydrous 780.00 27.18
3 Sodium Hydrogen Carbonate (Sodium Bicarbonate) 600.00 20.91
4 Aluminum hydroxide 200.00 6.97
5 Magnesium Carbonate 200.00 6.97
5 Sucralose 30.00 1.05
6 Flavor Pineapple 40.00 1.39
7 Colloidal Silicon Dioxide 20.00 0.70
Total Weight 2870.00 100.00
wherein the composition is in the form of a tablet, capsule, granules or powder.
8. The unit dosage of oral effervescent composition of Metformin hydrochloride comprising of following formula:
Sr. No. Ingredients mg/unit %w/w
1 Metformin Hydrochloride 1000.00 34.84
2 Citric Acid Anhydrous 780.00 27.18
3 Sodium Hydrogen Carbonate (Sodium Bicarbonate) 600.00 20.91
4 Aluminum hydroxide 200.00 6.97
5 Calcium Carbonate 200.00 6.97
5 Sucralose 30.00 1.05
6 Flavor Pineapple 40.00 1.39
7 Colloidal Silicon Dioxide 20.00 0.70
Total Weight 2870.00 100.00
wherein the composition is in the form of a tablet, capsule, granules or powder.
9. The unit dosage of oral effervescent composition of Metformin hydrochloride comprising of following formula:
Sr. No. Ingredients mg/unit %w/w
1 Metformin Hydrochloride 1000.00 34.84
2 Citric Acid Anhydrous 780.00 27.18
3 Sodium Hydrogen Carbonate (Sodium Bicarbonate) 600.00 20.91
4 Aluminum hydroxide 200.00 6.97
5 Magnesium hydroxide 200.00 6.97
5 Sucralose 30.00 1.05
6 Flavor Pineapple 40.00 1.39
7 Colloidal Silicon Dioxide 20.00 0.70
Total Weight 2870.00 100.00
wherein the composition is in the form of a tablet, capsule, granules or powder.
10. The unit dosage of oral effervescent composition of Metformin hydrochloride as claimed in claims 1 to 9 for the treatment of diabetes and to simultaneously treat the side effects associated with Metformin hydrochloride.