FIELD OF THE INVENTION:

The present invention relates to a synergistic pharmaceutical composition for the treatment of diabetes mellitus. More specifically the present invention relates to a synergistic composition comprising of alphaglucosidase inhibitor.

BACKGROUND OF THE INVENTION AND PRIOR ART:

Diabetes mellitus, often simply referred to as diabetes, is a group of metabolic diseases in which a person has high blood sugar, either because the body does not produce enough insulin, or because cells do not respond to the insulin that is produced. Diabetes Mellitus is the most common endocrine disease. This disease is characterized by poor regulation of blood glucose levels in human beings Diabetes is one of the most common diseases affecting human population today.

Diabetes is a chronic disease with diverse pathologic manifestations and is accompanied by lipid metabolism disorders and circulatory disorders as well as glycometabolism disorders. As the results, diabetes tends to progress entailing various complications in many cases. Therefore, it is necessary to select the drug of choice for the prevailing disease state in each individual case. However, this selection is often difficult in clinical settings because single use of each individual drug can not bring sufficient effects in some disease states and there are various problems such as side effect which is caused by an increased dose or a long-term administration.

US 5,952,356 discloses a pharmaceutical composition which comprises an insulin sensitivity enhancer in combination with an .alpha.-glucosidase inhibitor for treating diabetes. The composition in which the insulin sensitivity enhancer is pioglitazone and the .alpha.-glucosidase inhibitor is voglibose.

US 7,888,382 discloses a pharmaceutical preparation which includes a combination of mitiglinide, a pharmacologically acceptable salt thereof or a hydrate thereof and an alpha.-glucosidase inhibitor such as voglibose or acarbose for controlling the condition of type 2 diabetes.

US 7,956,198 discloses a medicament comprising at least one novel substituted pyrrole derivative and one or more dyslipidemic agents, antiobesity agents, antihyperglycaemic agents, anti-inflammatory agents or mixture thereof for the treatment of diabetes.
US 7,163,952 discloses a pharmaceutical composition for treating diabetes comprising an azole compound or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, in combination with a different therapeutic drug selected from the group consisting of nateglide, glimepiride, glibenclamide, gliclazide, acetohexamide, tolbutamide, glyclopyramide, tolazamide, glybuzole, metformin hydrochloride, buformin hydrochloride, voglibose, acarbose, insulin and pioglitazone hydrochloride.

US Application number 20050215489 discloses a methods relating to treatment of diabetes, particularly type 2 diabetes, and related disorders by administration of a PDE11A inhibitor. Such PDE11A inhibitors may be administered in conjunction with alpha-glucosidase inhibitors, insulin sensitizers, insulin secretagogues, hepatic glucose output lowering compounds, beta3 agonist or insulin.

US 20070197602 discloses a pharmaceutical composition including a combination of (a) at least one hyperlipidemic agent selected from the group consisting of a fibrate compound and a hydroxymethylglutaryl-CoA reductase inhibitor with (b) an .alpha.-glucosidase inhibitor.

US 20040110693 discloses a Composition for the treatment of diabetes mellitus, comprising at least one plant bulk material in combination with at least one alpha-glucosidase inhibitor

WO 99/26606 discloses a sustained release formulations comprising of alphaglucosidase inhibitor for the treatment or prevention of diabetes obesity or arteriosclerosis

US 7,141,254 discloses a synergistic composition for the treatment of diabetes comprising Trigonelline , amino acids, and soluble galactomannan fiber, optionally along with pharmaceutically acceptable additives, a process thereof and also, a method of treating diabetes.

US 6,875,793 discloses a controlled release sulfonylurea formulation comprising: a) a therapeutically effective amount of sulfonylurea suspended or dissolved in an alkaline aqueous medium; and, b) a controlled release matrix (galactomannan) and an inert diluent for treating diabetes.

US Application number 20090274732 discloses a rapidly disintegrating oral dosage forms for the application of active agent combinations for diabetes therapy. The dosage forms contain at least two active agents suitable for treating type-2 diabetes. The antidiabetic active agents are selected from the group comprising sulfonylureas, glitazones, glinides, biguanides, and absorption-delaying agents.

The prior arts discussed above disclose various combinations of anti-diabetes drugs for the treatment of diabetes mellitus. From the prior art it is inferred that the drug for treating diabetes includes alpha.-glucosidase inhibitor in combination with other antidiabetic drugs. Further the polysaccharide galactomannan is also used along with anti-diabetic drugs. Galactomannan provides texture, gelling, thickening, emulsifying, stabilizing and encapsulating properties. Further it is also used for controlled release of the active agent in the drug.

Research article Biotechnology and Bioprocess Engineeering 15(3), 407-413 discloses the inhibitor effect of fenugreek galactomannan on digestive enzymes related to diabetes.

OBJECT OF THE INVENTION:

The object of the invention is to formulate a synergistic pharmaceutical composition for the treatment of diabetes mellitus.

Another object of the present invention is to formulate a synergistic pharmaceutical composition comprising of alphaglucosidase inhibitor.

Yet another object of the present invention is to formulate a synergistic pharmaceutical composition comprising of combination of galactomannan and voglibose.

Yet another object of the present invention is to formulate a synergistic pharmaceutical composition comprising therapeutically acceptable amount of combination of galactomannan and voglibose.

Yet another object of the present invention is to formulate a synergistic pharmaceutical composition comprising of combination of galactomannan and voglibose along with pharmaceutically acceptable additives.

Yet another object of the present invention is to administer the formulated synergistic composition to the subjects (animals including humans) suffering from diabetes mellitus

Yet another object of the present invention is to formulate synergistic composition to reduce blood glucose level in subjects (animals including humans) with diabetes mellitus.

Yet another object of the present invention is to administer the synergistic combination in capsules, tablets, powders or any other form known to a person skilled in the art.

Further object of the present invention is to formulate a synergistic pharmaceutical composition which is devoid of side effects.

SUMMARY OF THE INVENTION:

The prior art discloses the usage of various combinations of anti-diabetes drugs for the treatment of diabetes mellitus which includes alpha.-glucosidase inhibitor in combination with other antidiabetic drugs. Further the polysaccharide galactomannan is also used along with anti-diabetic drugs. The present invention directs to use the new combination comprising of alpha glucosidase inhibitor with galactomannan to reduce blood glucose level in diabetes patients which has not been envisaged in any of the prior art. The most preferred alpha glucosidase inhibitor used in the present invention is Voglibose

Thus the present invention relates to a synergistic pharmaceutical composition for the treatment of diabetes mellitus. The synergistic composition comprises of comprising of combination of galactomannan and voglibose. The ratio of galactomannan and Voglibose ranges from 0.01g-100g galactomannan:0.01mg-0.5mg Voglibose and more preferably from 1g-10g galactomannan:0.1mg-0.5mg Voglibose The composition further includes pharmaceutically acceptable additives.

DESCRIPTION OF THE INVENTION:

The present invention relates to a synergistic pharmaceutical composition comprising of combination of galactomannan and voglibose.

Galactomannans are polysaccharides consisting of a mannose backbone with galactose side groups (more specifically, a (1-4)-linked beta-D-mannopyranose backbone with branch points from their 6-positions linked to alpha-D-galactose, i.e. 1 -6-linked alpha-D-galactopyranose).

The galactomannan used in the present study is obtained from fenugreek seed through a proprietary milling method without any chemical modification. Fenugreek is the only source of galactomannan where units of the backbone, mannose, exist in a 1:1 ratio with the side groups of galactose. This ratio is highly unique compared to other galactomannans. It is Non gelling hydrocolloid soluble in cold water. It hydrates and thickens faster. It is a Stabilized oil in water emulsion. It Bind moisture, reduce staling, provide texture and increase fiber content.

Galactomannan provides texture, gelling, thickening, emulsifying, stabilizing and encapsulating properties. It acts as a dietary fiber, in nutrition and cereal bars, yogurts, dairy products and nutritional beverages. Plain powders of soluble fiber or total dietary fiber can be mixed with fruit juices, other spice mixes and seasonings.

Voglibose is an alpha-glucosidase inhibitor used for lowering post-prandial blood glucose levels in people with diabetes mellitus. Voglibose delays the absorption of glucose thereby reduces the risk of macrovascular complications. Voglibose competitively and reversibly inhibits the alpha glucosidase enzymes in the brush border in the small intestine, which delays the hydrolysis of complex carbohydrates mostly disaccharides.

The combination of galactomannan and Voglibose exerts a notable synergistic effect in reduction of blood glucose levels in patients with diabetes mellitus.

In one of the preferred embodiment the present invention shall disclose a synergistic pharmaceutical composition comprising of synergistically effective combination of galactomannan and voglibose.

In another preferred embodiment, the present invention shall discloses a synergistic composition comprises of combination of galactomannan and Voglibose in a ratio ranging from from 0.01g-100g galactomannan : 0.01mg-0.5mg Voglibose and more preferably from 1g-10g galactomannan:0.1mg-0.5mg Voglibose.

As per the invention the synergistic composition further includes pharmaceutically acceptable additives carriers, excipients and/or diluents.

The synergistic composition of the present invention may be administered orally In another preferred embodiment the present invention shall discloses a pharmaceutical formulation comprising a therapeutically effective amount of composition comprises of combination of galactomannan and voglibose in combination with pharmaceutically acceptable additives.

In another preferred embodiment the present invention shall discloses a method for use in treating diabetes mellitus, comprising of administering to the subject (animals including humans) with diabetes, an effective amount of a composition comprises of combination of galactomannan and Voglibose

According to the invention each dosage of the formulated composition in the form of hard gelatin capsules comprises of Voglibose - 0.1 mg, 0.2mg, 0.3mg and Galactomannan- 1g

According to the invention each dosage of the formulated composition in the form of sachet comprises of: Voglibose - 0.1 mg, 0.2mg, 0.3mg and Galactomannan-3g

Example 1:

In one preferred embodiment the present invention shall disclose a synergistic pharmaceutical composition comprising of synergistically effective combination of galactomannan and voglibose. The exemplary composition of this example is orally administered to animals including humans for the treatment of diabetes mellitus.

Example 2:

In another preferred embodiment, the present invention shall discloses a synergistic composition comprises of combination of galactomannan and Voglibose in a ratio ranging from 0.01g-100g galactomannan:0.01mg-0.5mg Voglibose and more preferably from 1g-10g galactomannan:0.1mg-0.5mg Voglibose. The exemplary composition of this example is orally administered to animals including humans for the treatment of diabetes mellitus.

Example 3:

In further preferred embodiment the present invention discloses the following synergistic formulation Administration of the formulation of this example to animals including humans suffering from diabetes mellitus results in significant reduction of blood glucose level.

Example 4:

In further preferred embodiment the present invention discloses the following synergistic formulation

Administration of the formulation of this example to animals including humans suffering from diabetes mellitus results in significant reduction of blood glucose level.

Example 5:

In further preferred embodiment the present invention discloses the following synergistic formulation

Administration of the formulation of this example to animals including humans suffering from diabetes mellitus results in significant reduction of blood glucose level.

In further preferred embodiment the present invention discloses the following synergistic formulation

Administration of the formulation of this example to animals including humans suffering from diabetes mellitus results in significant reduction of blood glucose level.

Example 7:

In further preferred embodiment the present invention discloses the following synergistic formulation

Administration of the formulation of this example to animals including humans suffering from diabetes mellitus results in significant reduction of blood glucose level.

Example 8:

In further preferred embodiment the present invention discloses the following synergistic formulation

Administration of the formulation of this example to animals including humans suffering from diabetes mellitus results in significant reduction of blood glucose level.

Example 9:

In further preferred embodiment the present invention discloses the following synergistic formulation

Administration of the formulation of this example to animals including humans suffering from diabetes mellitus results in significant reduction of blood glucose level.

The described embodiments are to be considered in all respects only as illustrative and not restrictive. Any changes which come within the meaning and range of equivalency of the present invention are to be embraced within their scope.

WE CLAIM:

1. A synergistic pharmaceutical composition comprising a synergistically effective combination of galactomannan and Voglibose.

2. The composition as claimed in claim 1 wherein the ratio galactomannan and voglibose ranges from about from 0.01g-100g galactomannan : 0.01mg-0.5mg Voglibose.

3. The composition as claimed in claim 1 wherein the ratio of galactomannan and Voglibose ranges more preferably from about 1g-10g galactomannan : 0.1 mg-0.5mg Voglibose.

4. A pharmaceutical formulation comprising a therapeutically effective amount of composition of claim 1 in combination with pharmaceutically acceptable excipient.

5. A method for use in effective treatment of diabetes mellitus, which method comprises administering to the subject an effective amount of a composition of claim 1.