FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
The Patent Rules, 2003
COMPLETE SPECIFICATION
[Section 10, and Rule 13]
TITLE OF THE INVENTION:
PHARMACEUTICAL COMPOSITIONS COMPRISING REPAGLINIDE AND METFORMIN.
APPLICANT(S):
Name: Torrent Pharmaceuticals Limited
Nationality: Indian
Address: Torrent House, Off Ashram Road, Near Dinesh Hall, Ahmedabad 380 009,
Gujarat, India
The following specification particularly describes the invention and the manner in which it is to be performed.

FIELD OF THE INVENTION
The present invention provides a pharmaceutical composition comprising repaglinide in combination with metformin or pharmaceutically acceptable salt thereof.
BACKGROUND OF THE INVENTION
Repaglinide belongs to the meglitinide class of blood glucose-lowering drugs, used to treat diabetes Type 2 and is commercially available as PRANDIN®. Megli tin ides bind to an ATP-dependent K+ (KATP) channel on the cell membrane of pancreatic beta cells in a similar manner to sulfonylureas but at a separate binding site. Repaglinide is a short-acting hypoglycemic antidiabetic with the chemical name (S)-(+)-2-ethoxy-4-[2-[[3-methyl-l-[2-(l-piperidinyl) phenyl] butyl] amino]-2-oxo-ethyl] benzoic acid (formula I).

FORMULA I

FORMULA II
Among the agents applied to enhance tissue sensitivity towards insulin, metformin is a representative example. Metformin is a long-acting biguanide antidiabetic, widely used in the treatment of non-insulin dependent diabetes mellitus (NIDDM) and commercially available as GLUCOPHAGE®. Chemically metformin is N,N-dimethylimidodicarbon-imidic diamide (formula II).

U.S. Patent No. 5216167 discloses repaglinide.
U.S. Patent No. 3,174,901 discloses metformin.
International (PCT) Publication WO 98/56378 disclosed a pharmaceutical composition comprising repaglinide and metformin together with a suitable carrier.
U.S. Published Application No. 2003/0224046 relates to a unit-dose combination composition for the treatment of diabetes comprising: a high-dose, water-soluble, long-acting, orally active, hypoglycemic, antidiabetic agent (such as metformin); and a low-dose, water-insoluble, short-acting, orally active, hypoglycemic, antidiabetic agent (such as repaglinide).
International (PCT) Publication WO 2007/131930 relates to a pharmaceutical tablet comprising repaglinide and metformin in a disintegrating tablet matrix.
U.S. Published Application No. 2010/0029721 relates to a pharmaceutical composition and a method for its preparation comprising repaglinide in combination with metformin or a salt thereof in unit dosage form wherein a pre-formulation of the repaglinide has a pH independent dissolution profile and a relative humidity of less than about 25% prior to mixing with the metformin or a salt thereof; and optionally one or more pharmaceutically acceptable excipients.
Combination of repaglinide and metformin is commercially available as PRANDIMET® which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide and metformin HC1 or who have inadequate glycemic control on a meglitinide alone or metformin HC1 alone.
SUMMARY OF THE INVENTION
In one embodiment there is provided a pharmaceutical composition comprising repaglinide and metformin or pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients.

In another embodiment there is provided a process for preparation of a pharmaceutical composition comprising repaglinide and metformin or pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the process comprises:
a) granulating at least one pharmaceutically acceptable excipient with a solution or dispersion comprising repaglinide,
b) granulating at least one pharmaceutically acceptable excipient with metformin or pharmaceutically acceptable salt thereof,
c) blending the granules of step a) and step b) and,
d) optionally compressing the blend of step c) into tablets,
e) optionally coating the tablets of step d).
The solution or dispersion of repaglinide further comprises a surfactant and an alkalinizer. Preferably, the surfactant is poloxamer and the alkalinizer is meglumine.
The pharmaceutically acceptable excipient used in granulation of repaglinide part may comprise a diluent and a disintegrant. Preferably the diluent is microcrystalline cellulose and the disintegrant is polacrilin potassium.
The granulation of repaglinide part can be performed in rapid mixer granulator or fluid bed processor. Preferably, the granulation of repaglinide part can be performed in fluid bed processor.
The repaglinide granules may further optionally be milled and blended with one or more pharmaceutically acceptable excipients such as a diluent, a lubricant and a disintegrant. Preferably, the diluent is microcrystalline cellulose, the lubricant is polyethylene glycol 6000 and the disintegrant is polacrilin potassium.
Granulation of metformin part can be performed in rapid mixer granulator.
The blending time of the granules of repaglinide with the granules of metformin should be at least about 20 minutes to achieve appropriate blend uniformity.

The blended granular mixture of repaglinide with metformin can be further compressed to tablets and optionally the tablets can be coated.
In another embodiment, the granulation step comprises slugging the repaglinide and metformin part together.
In yet another embodiment, repaglinide and metformin may be granulated together in fluid bed processor.
In yet another embodiment, repaglinide and metformin may be directly compressed together.
In yet another embodiment there is provided a process for preparation of a pharmaceutical composition comprising repaglinide and metformin or pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the process comprises:
a) blending of repaglinide with at least one pharmaceutically acceptable excipient,
b) granulating at least one pharmaceutically acceptable excipient with metformin or pharmaceutically acceptable salt thereof,
c) blending the powder mixture of step a) with the granules of step b) and,
d) optionally compressing the blend of step c) into tablets,
e) optionally coating the tablets of step d).
Repaglinide can be blended with at least a diluent, a disintegrant, a surfactant, a lubricant and an alkalinizer. Preferably the diluent is microcrystalline cellulose, the disintegrant is polacrilin potassium, the surfactant is poloxamer, the lubricant is polyethylene glycol 6000 and the alkalinizer is meglumine.
The blending time of repaglinide with the pharmaceutical excipients should be at least about 10 minutes to achieve appropriate blend uniformity.
Granulation of metformin part can be performed in rapid mixer granulator.

The blending of repaglinide with the granules of metformin is performed by double sandwich blending (alternate layering) method. The blending time should be at least about 20 minutes to achieve appropriate blend uniformity.
The blended mixture of repaglinide and metformin granules can be further compressed to tablets and optionally the tablets can be coated.
DETAILED DESCRIPTION OF THE INVENTION
The composition of the present invention comprises repaglinide and metformin or pharmaceutically acceptable salt thereof as active ingredients and one or more pharmaceutically acceptable excipients.
The pharmaceutically acceptable excipients comprise one or more of diluents, binders. disintegrants, lubricants, glidants, surfactants, alkalinizers and the like.
Suitable diluents may include one or more of microcrystalline cellulose, mannitol, sorbitol starch, lactose, pregelatinized starch and the like.
Suitable binders may include those well known to a person skilled in the art, as exemplified can be celluloses such as hydroxypropyl cellulose, hydroxy ethyl cellulose, hydroxypropyl methylcellulose, methylcellulose or mixtures thereof, acrylates, methacrylates, povidone, starch, stearic acid, gums, and other materials known to have cohesive and desirable binding properties.
Suitable disintegrants may include one or more of starch, pregelatinized starch, L-HPC, croscarmellose sodium, crospovidone, sodium starch glycolate, polacrilin potassium and the like.
Suitable lubricants rnay include those well known to a person skilled in the art, as exemplified can be talc, magnesium stearate, calcium stearate, polyethylene glycol, hydrogenated vegetable oils, hydrogenated castor oil, stearic acid, sodium stearyl fumarate and sodium benzoate,

sodium lauryl sulphate, colloidal silicon dioxide, palmitic acid, carnauba wax, glyceryl monostearate, palmitic acid, carnauba wax, and the like.
Suitable glidants may include one or more of colloidal silicon dioxide, talc or cornstarch and the like.
Suitable alkalinizers may include meglumine, Glycine, N-methyl glucamine, L-lysine and the like.
Suitable surfactants may include poloxamer 188 and the like.
The pharmaceutical composition of the present invention is meant for oral administration.
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: Repaglinide and Metformin Tablets 2 + 500 mg /1 +500mg

Sr. No. Ingredient 2/500 mg 1/500 mg

%w/w mg/Tab %w/w mg/Tab
Repaglinide Granules
1 Repaglinide 0.31 2.00 0.16 1.00
2 Poloxamer 188 0.09 0.60 0.09 0.60
3 Polyvinyl pyrrolidone K30 0.31 2.00 0.31 2.00
4 Meglumine 0.16 1.00 0.16 1.00
5 Micro crystalline cellulose 5.98 38.15 6.14 39.15
6 Purified water — qs — qs
Metformin granules
7 Metformin Hydrochloride 78.43 500.00 78.43 500.00
8 Polyvinyl pyrrolidone K30 3.14 20.00 3.14 20.00

9 Sorbitol 1.57 10.00 1.57 10.00
10 PEG 8000 0.78 5.000 0.78 5.000
11 Purified water - q.s — q.s
Blending and Lubrication
12 Mi emery stal line Cellulose 3.81 24.32 24.32 24.255
13 Polacrilin potassium 2.95 18.800 18.800 18.800
14 Magnesium stearate 0.49 3.130 3.130 3.13
Coating
15 Opadry red 1.96 12.500 — —
16 Opadry yellow - - 1.96 12.500
17 Purified water ™ q.s — q.s
METHOD OF MANUFACTURING:
A) For Repaglinide Granules:
1. Dissolve Povidone and Poloxamer in water with continuous stirring.
2. Disperse Repaglinide in the solution of step I by mixing uniformly.
3. Add Meglumine to the step 2 solution and mixed uniformly.
4. Sift microcrystalline cellulose and transfer into fluid bed processor.
5. Granulate the step 4 sifted material using drug binder suspension of step 3 using top spray in a fluid bed processor and dry the granules. Sift the dried granules. Pass the oversize granules if any through oscillating granulator.
B) For Metformin Granules:
1. Mill Metformin HC1.
2. Sift Metformin HCJ through 60# appropriate sieve.
3. Dissolve Povidone and Sorbitol in purified water.
4. Load the material of step 2 in RMG and granulate with the step-3 binder solution till dough like consistency.
5. Dry the wet mass of step no. 4 and size through appropriate sieve.

C) Blending, Lubrication and Compression:
1. Sift Polacrilin potassium and microcrystaliine cellulose and mix uniformly with Metformin granules and Repaglinide granules in a blender.
2. Sift the Magnesium stearate and add to the mixture of step 1.
3. Compress the lubricated blend into tablets.
D) Film Coating:
1. Disperse the coating material in Purified water and coat the tablets.
Example 2:

Sr. No. Ingredient 2/500 mg 1/500 mg

%w/w mg/Tab %w/w mg/Tab
1 Repaglinide 0.29 2.00 0.15 1.00
2 Poloxamer 188 0,09 0.60 0.09 0.60
3 Polyvinyl pyrrolidone K30 0.29 2.00 0.29 2.00
4 Meglumine 0.15 1.00 0.15 1.00
5 Microcrystaliine cellulose 4,90 33.30 5.05 34.30
6 Glycerol 0.21 1.40 0.21 1.40
7 Starch 1.77 12.00 1.77 12.00
8 Dibasic Calcium Phosphate anhydrous 4.74 32.20 4.74 32.20
9 Purified water - qs ~ qs
10 Metformin Hydrochloride 73.61 500.00 73.61 500.00
11 Polyvinyl pyrrolidone K90 2.94 20.00 2.94 20.00
12 Microcrystaliine cellulose 2.94 20.00 2.94 20.00
13 Purified water - q.s - q.s
14 Isopropyl alcohol - q.s - q.s
15 Microcrystaliine Cellulose 0.74 5.00 0.74 5.00
16 Polacrilin potassium 4.42 30.00 4.42 30.00
17 Magnesium stearate 0.97 6.60 0.97 6.60
18 Hypromellose 0.72 4.91 0.72 4.91

19 Talc 0.79 5.40 0.79 5.40
20 Colloidal silicon dioxide 0.11 0.75 0.11 0.75
21 Titanium dioxide 0.17 1.17 0.17 1.17
22 Polyethylene glycol 0.11 0.74 0.11 0.74
23 Iron oxide red 0.03 0.20 — -
24 Iron oxide yellow - ~ 0.03 0.20
25 Purified water — q.s — q.s
METHOD OF MANOTACTURING:
The composition of Example 2 was prepared by a process similar to that of Example 1.

Example 3:

Sr.
No Ingredient 2/500 mg 1/500 mg

%wAv mg/Tab %w/w mg/Tab
1 Repaglinide 0.32 2.00 0.16 1.00
2 Poloxamer 188 0.09 0.60 0.09 0.60
3 Polyvinyl pyrrolidone K30 0.32 2.00 0.32 2.00
4 Meglumine 0.16 1.00 0.16 1.00
5 Microcrystalline cellulose 5.26 33.30 5.42 34.30
6 Purified water — qs — qs
7 Metformin Hydrochloride 79.00 500.00 79.00 500.00
8 Polyvinyl pyrrolidone K90 3.16 20.00 3.16 20.00
9 Microcrystalline cellulose 3.16 20.00 3.16 20.00
10 Purified water — q.s — q.s
11 Isopropyl alcohol - q.s — q.s
12 Microcrystalline Cellulose 0.79 5.00 0.79 5.00
13 Polacrilin potassium 4.74 30.00 4.74 30.00
14 Magnesium stearate 1.04 6.60 1.04 6.60
15 Hypromellose 0.73 4.63 0.73 4.63
16 Talc 0.80 5.09 0.80 5.09
17 Colloidal silicon dioxide 0.11 0.71 0.11 0.71
18 Titanium dioxide 0.17 1.10 0.17 1.10
19 Polyethylene glycol 0.11 0.70 0.11 0.70
20 Iron oxide red 0.03 0.19 — —
21 Iron oxide yellow — — 0.03 0.19
22 Purified water ~ q.s — q.s
METHOD OF MANUFACTURING:
The composition of Example 3 was prepared by a process similar to that of Example 1.

Example 4:

Sr. No Ingredient 2/500 mg 1/500 mg

%w/w mg/Tab %w/w mg/Tab
1 Metformin Hydrochloride 78.45 500.00 78.45 500.00
2 Polyvinyl pyrrolidone K90 3.14 20.00 3.14 20.00
3 Microcrystalline cellulose 3.14 20.00 3.14 20.00
4 Purified water ~ q.s — q.s
5 Isopropyl alcohol ~ q.s — q.s
6 Repaglinide 0.31 2.00 0.16 1.00
7 Meglumine 0.16 1.00 0.16 1.00
8 Microcrystalline Cellulose 7.18 45.75 7.33 46.75
9 Polacrilin potassium 4.71 30.00 4.71 30.00
10 Magnesium stearate 0.98 6.25 6.25
11 Hypromellose 0.72 4.61 0.72 4.61
12 Talc 0.79 5.06 0.79 5.06
13 Colloidal silicon dioxide 0.11 0.71 0.11 0.71
14 Titanium dioxide 0.17 1.10 0,17 1.10
15 Polyethylene glycol 0.11 0.70 0,11 0.70
16 Iron oxide red 0.03 0.20 -- —
17 Iron oxide yellow - - 0.03 0.20
18 Purified water q.s q.s
METHOD OF MANUFACTURING:
The composition of Example 4 was prepared by a process similar to that of Example 1.

Example 5:

Sr. No. Ingredient 2/500 mg 1/500 mg

%w/w mg/Tab %w/w mg/Tab
1 Repaglinide 0.31 2.00 0.16 1.00
2 Poloxamer 188 0.09 0.60 0.09 0.60
3 Polyvinyl pyrrolidone K30 0.31 2.00 0.31 2.00
4 Meglumine 0.16 1.00 0.16 1.00
5 Microcrystalline cellulose 5.98 18.15 6.14 39.15
6 Purified water ~ q.s. — q.s.
7 Metformin Hydrochloride 78.43 500.00 78.43 500.00
8 Polyvinyl pyrrolidone K30 3.14 20.00 3.14 20.00
9 Sorbitol 1.57 10.00 1.57 10.00
10 PEG 8000 0.78 5.000 0.78 5.000
11 Purified water - q.s - q.s
12 Microcrystalline Cellulose 3.81 24.32 24.32 24.255
13 Polacrilin potassium 2.95 18.800 18.800 18.800
14 Magnesium stearate 0.49 3.130 3.130 3.13
15 Opadry red 1.96 12.500 ~ —
16 Opadry yellow — — 1.96 12.500
17 Purified water - q.s — q.s.
METHOD OF MANUFACTURING:
The composition of Example 5 was prepared by a process similar to that of Example 1.

Example 6:

Sr. No. Ingredients 2/500 mg 1/500 mg

mg/Tab mg/Tab
Repaglinide granules
1 Repaglinide 2.000 1.000
2 Meglumine 1.000 1.000
3 Microcrystalline cellulose (Avicel PH 101) 57.500 58.500
4 Polacrilin potassium (Amberlite IRP88) 25.000 25.000
5 Magnesium stearate 3.500 3.500
Metformin granules
6 Metformin Hydrochloride 500.000 500.000
7 Polyvinyl pyrrolidone K30 30.000 30.000
8 MCC (Avicel PH 101) 3.000 3.000
9 Sorbitol 3.000 3.000
10 Water q.s. q.s.
Coating
11 Opadry yellow 12.500 12.500
12 Purified water q.s q.s
Total 637.58 637.58
METHOD OF MANUFACTURING:
The composition of Example 6 was prepared by a process similar to that of Example 1.

Stability data for Example 6:

Strength Test Specification Initial 3 month storage

Repaglinide Metformin Repaglinide Metformin
1/500 mg Dissolution NLT 75% in 15 min. 90.5 98.6 94.1 99.5

Assay NLT 95% and NMT105%of label claim 98.05 100.74 97.7 100.9
2/500 mg Dissolution NLT 75% in 15 min. 88.5 98.5 86.3 98.5

Assay NLT 95% and NMT105%of label claim 97.00 98.1 96.5 100.00

Example 7:

Sr.
No Ingredients 2/500 mg 1/500 mg

mg/Tab mg/Tab
Metformin hydrochloride Sized Granules
1 Metformin Hydrochloride 500.000 500.000
2 Polyvinyl pyrrolidone K30 30.000 30.000
3 MCC(AvicelPH 101) 3.000 3.000
4 Sorbitol 3.000 3.000
5 Water q.s. q.s.
Total wt of Metformin Granules 536.000 536.000
Extragranular material
Metformin granules 536.000 536.000
6 Repaglinide 2.000 1.000
7 PEG 6000 1.000 1.000
8 Poloxamer 0.573 0.573
9 Meglumine 1.000 1.000
10 Microcrystalline cellulose (Avicel PH 101) 49.857 50.857
11 Polacrilin potassium (Amberlite IRP88) 25.000 25.000
12 Magnesium stearate 3.500 3.500
Total wt of uncoated tablets 618.930 618.930
Coating
13 Opadry yellow - 18.57
14 Opadry pink 18.57 -
15 Purified water q.s q.s
Total wt of coated tablets 637.58 637.58

METHOD OF MANUFACTURING (for Example 7);
A) For Metformin Granules:
1. Co-sift metformin hydrochloride with microcrystalline cellulose and PVP K-30.
2. The blended metformin mixture is then granulated with binder solution of sorbitol and purified water in the rapid mixer granulator.
3. Dry the granules in a fluidized bed dryer.
4. Sizing of granules using oscillating granulator with screen size of 0.5 mm.
B) For Repaglinide Blend, Lubrication, Compression and Coating:
1. Co-sift Repaglinide with Meglumine and microcrystalline cellulose.
2. Sift and mix Polyethylene Glycol 6000. polacrilin potassium and poloxamer.
3. Uniformly mix the powder mixtures of steps 1 and 2.
4. The blended mixture of step 3 is then added extra-granularly to sized metformin granules.
5. The blend of step 4 is lubricated and then compressed into tablets.
6. The compressed tablets are then coated with Opadry.

Example 8:

Sr. No Ingredients 2/500 mg 1/500 mg

mg/Tab mg/Tab
Metformin hydrochloride Sized Granules
1 Metformin Hydrochloride 500.000 500.000
2 Polyvinyl pyrrolidone K30 30.000 30.000
3 MCC(AvicelPH 101) 3.000 3.000
4 Sorbitol 3.000 3.000
5 Water q.s. q.s.
Total wt of Metformin Granules 536.000 536.000
Repaglinide Sized Granules
6 Repaglinide 2.000 1.000
7 Poloxamer 0.573 0.573
8 Meglumine 1.000 1.000
9 Polacrilin potassium (Amberlite IRP88) 5.000 5.000
10 Microcrystalline cellulose (Avicel PH 101) 22.000 23.000
11 Water q.s. q.s.
Total wt of Repaglinide Granules 30.573 30.573
Extragranular material
12 Metformin granules 536.000 536.000
13 Milled repaglinide granules 30.573 30.573
14 PEG 6000 1.000 1.000
15 Microcrystalline cellulose (Avicel PH 101) 27.857 27.857
16 Polacrilin potassium (Amberlite IRP88) 20.000 20.000
17 Magnesium stearate 3.500 3.500
Total wt of uncoated tablets 618.930 618.930
Coating
18 Opadry yellow - 18.57
19 Opadry pink 18.57 -

20 Purified water q.s q.s
Total wt of coated tablets 637.58 637.58
METHOD OF MANUFACTURING (for Example 8):
A) For Metformin Granules:
1. Co-sift metformin hydrochloride with microcrystalline cellulose and PVP K-30.
2. The blended metformin mixture is then granulated with binder solution of sorbitol and purified water in the rapid mixer granulator.
3. Dry the granules in a fluidized bed dryer.
4. Sizing of granules using oscillating granulator with screen size of 0.5 mm.
B) For Repaglinide granules
1. Dissolve meglumine and poloxamer in water with continuous stirring.
2. Disperse Repaglinide in the solution of step 1 by mixing uniformly.
3. Sift microcrystalline cellulose and polacrilin potassium, and transfer into fluid bed processor.
4. Granulate the sifted material of step 3 using drug binder suspension of step 2 using top spray in a fluid bed processor and obtain dry granules. Sift the dried granules. Pass the oversize granules if any through oscillating granulator.
C) Blending, Lubrication and Compression:
1. Sift and mix Polyethylene glycol 6000, microcrystalline cellulose and Polacrilin potassium. Mix the sifted material uniformly with Metformin granules and Repaglinide granules in a blender.
2. Sift Magnesium stearate and add to the mixture of step 1.
3. Compress the lubricated blend into tablets.
D) Film Coating:
1. Disperse the coating material in Purified water and coat the tablets.

Claims:
1. A process for preparation of a pharmaceutical composition comprising repaglinide and
metformin or pharmaceutically acceptable salt thereof and one or more pharmaceutically
acceptable excipients,'wherein the process comprises;
a) granulating at least one pharmaceutically acceptable excipient with a solution or dispersion comprising repaglinide,
b) granulating at least one pharmaceutically acceptable excipient with metformin or pharmaceutically acceptable salt thereof,
c) blending uniformly the granules of step a) and step b) and
d) optionally compressing the blend of step c) into tablets
e) optionally coating the tablets of step d).

2. The process according to claim 1, wherein the solution or dispersion of repaglinide further comprises a surfactant and an alkalinizer.
3. The process according to claim 2, wherein the surfactant comprises poloxamer.
4. The process according to claim 2, wherein the alkalinizer comprises meglumine.
5. The process according to claim 1, wherein the pharmaceutically acceptable excipient used in granulation of repaglinide part may comprise a diluent and a disintegrant.
6. The process according to claim 5, wherein the diluent is microcrystalline cellulose and the disintegrant is polacrilin potassium.
7. The process according to claim 1, wherein the repaglinide granules may further optionally be milled and blended with one or more pharmaceutically acceptable excipients such as a diluent, a lubricant and a disintegrant.
8. The process according to claim 7, wherein the diluent is microcrystalline cellulose, the lubricant is polyethylene glycol 6000 and the disintegrant is polacrilin potassium.

9. A process for preparation of a pharmaceutical composition comprising repaglinide and metformin or pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the process comprises:
a) blending of repaglinide with at least one pharmaceutically acceptable excipient,
b) granulating at least one pharmaceutically acceptable excipient with metformin or pharmaceutically acceptable salt thereof,
c) blending the powder mixture of step a) with the granules of step b) and,
d) optionally compressing the blend of step c) into tablets,
e) optionally coating the tablets of step d).
10. The process according to claim 9, wherein repaglinide can be blended with micro crystal line cellulose, polacrilin potassium, poloxamer, polyethylene glycol 6000 and meglumine.