DESCRIPTION
FIELD OF THE INVENTION
The present invention is related to the pharmaceutical field. More clearly, the
present invention is related to the combination of Metformin and
Ursodeoxycholic acid (UDCA) for the treatment of fatty liver disease.
BACKGROUND OF THE INVENTION
WO 2010/037173 relates to methods of preserving the integrity of peptides in
the gut. In particular, it concerns the new use of certain compounds as inhibitors
of gut proteases.
WO 2006/057637 discloses compositions for pharmaceutical and other uses
comprising clear aqueous solutions of bile acids which do not form any
detectable precipitates over selected ranges of pH values of the aqueous
solution and methods of making such solutions are disclosed. Compositions of
the disclosure may comprise water; a bile acid in the form of a bile acid, bile
acid salt, or bile acid conjugated with an amine by an amide linkage; and either
or both an aqueous soluble starch conversion product and an aqueous soluble
non-starch polysaccharide. The composition remains in solution without forming
a precipitate over a range of all pH values obtainable in an aqueous system.
The composition, according to some embodiments, may further contain a
pharmaceutical compound in a pharmaceutically effective amount. The
disclosure further provides dried forms of primary aqueous solubilized bile acid
formulations and methods of preparing such dried forms.
OBJECTIVES OF THE INVENTION
The object of the present invention is to provide a pharmaceutical formulation
comprising Metformin and UDCA.
Another object of the present invention is to provide a treatment for fatty liver
disease.
It is another object of the present invention to provide a dosage form for
effective administration with the help of pharmaceutically acceptable excipients.
DETAILED DESCRIPTION OF THE INVENTION
Metformin is an oral ant diabetic drug in the biguanide class. It is the drug of
choice for the treatment of type 2 diabetes, especially, in overweight and obese
people. It is also used in the treatment of polycystic ovary syndrome.

UDCA is a bile acid which is used in the treatment of gallstones.
The present invention relates to the pharmaceutical composition comprising the
pharmaceutically accepted salts of Metformin and Ursodeoxycholic acid and
there formulation thereof.
The present invention comprises of the formulation comprising pharmaceutically
acceptable salts of Metformin and Ursodeoxycholic acid and the required
excipients thereof and the process of preparing the formulation.
The Metformin or its pharmaceutically acceptable salts used in the formulation
is in the range of 50mg to 1500mg, preferably 200mg to 1000mg, more
preferably 250 mg to 500mg.
The Ursodeoxycholic acid used in the present formulation is in the range of 50
mg to 300 mg, preferably 100 mg to 250mg, more preferably 150 mg..
Suitable fillers may be microcrystalline cellulose, powdered cellulose, lactose,
starch, pregelatinized starch, or sucrose preferably microcrystalline cellulose
and lactose.
The formulation according to this invention may be formulated in the form of a
bilayer tablet, wherein one Active Pharmaceutical ingredient is in one layer and
the other active Pharmaceutical ingredient in another layer of the tablet.
Suitable binders are starch, polyvinylpyrrolidone, alginic acid, methylcellulose,
hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose,
polymethacrylates, and others preferably hydroxypropyl cellulose,
hydroxypropyl methylcellulose and polyvinylpyrrolidone.
Suitable disintegrants are starch, pregelatinized starch, sodium starch glycolate,
sodium carboxymethylcellulose, cross-linked sodium carboxymethylcellulose,
cross-linked polyvinylpyrrolidone, alginic acid, sodium alginate, and others
preferably sodium starch glycolate, cross-linked sodium carboxymethylcellulose
and cross-linked polyvinylpyrrolidone.
Suitable glidants are magnesium stearate, calcium stearate, aluminium
stearate, stearic acid, palmitic acid, cetanol, stearol, colloidal silicon dioxide,
talc, powdered cellulose, starch and others, preferably, colloidal silicon dioxide.
Suitable lubricants are stearic acid, calcium, magnesium, zinc or aluminium
stearate, siliconized talc, glycerol monostearate, and others. Preferred
lubricants are calcium or magnesium stearate and stearic acid.

The release of Metformin and Ursodeoxycholic acid from the pharmaceutical formulations of the present invention can be immediate or modified, controlled, delayed, sustained, and extended. The release rate for both active drugs can be the same or different.
The pharmaceutical formulations of the present invention may comprise formed particles with the same composition or formed particles with different composition and different release rate of Metformin and Ursodeoxycholic acid.

We Claim:
1. A pharmaceutical formulation comprising Metformin in the range of 50mg to 1500mg, preferably 200mg to 1000mg, more preferably 250 mg to 500mg and Ursodeoxycholic acid in the range of 50 mg to 1500 mg, preferably 200 mg to 1000mg, more preferably 250 mg to 500mg.useful for the treatment of a variety of bacterial infections, along with pharmaceutically acceptable excipients.
2. The pharmaceutically acceptable excipients claimed in 1 are selected from diluents, binding agents, disintegrants, and lubricants.
3. The diluents as claimed in claim 2 can be selected from lactose, sucrose, glucose, mannitol, sorbitol, calcium carbonate, and magnesium stearate.
4. The binding agents as claimed in claim 2 can be selected from polyvinylpyrrolidone (PVP), Hydroxy propyl cellulose, polyethylene glycol (PEG), xylitol, sorbitol and maltitol which are mixed with the appropriate solvent.
5. The solvent as claimed in claim 4 can be selected from purified water or isopropyl alcohol or the mixture of both.
6. The disintegrants as claimed in claim 2 can be selected from polyvinylpyrrolidone (crospovidone), crosslinked sodium carboxymethyl cellulose (croscarmellose sodium) and sodium starch glycolate.
7. The lubricants as claimed in claim 2 can be selected from talc or silica, and fats, e.g. vegetable stearin, magnesium stearate or stearic acid.
8) The formulation as claimed in claim 1 can be coated with Hydroxypropyl Methyl Cellulose, along with suitable plasticizer, opacifier, coloring agent and the solvent.