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Claims for Patent: 6,303,146

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Claims for Patent: 6,303,146

Title: Solid oral dosage form comprising a combination of metformin and glibenclamide
Abstract:The present invention relates to a solid oral dosage form comprising a combination of metformin and glibenclamide in which the size of glibenclamide is such that the glibenclamide bioavailability is comparable to the glibenclamide bioavailability obtained with a separate administration of metformin and glibenclamide.
Inventor(s): Bonhomme; Yves (Charbonnieres les Bains, FR), Nicholson; Geoffrey (Aylesbury, GB), Cave; Gillian (Ellesmere Port, GB), Nicholson; Sarah J. (Helsby, GB)
Assignee: LIPHA (Lyons, FR)
Application Number:09/353,141
Patent Claims: 1. A solid oral dosage form comprising a combination of metformin and glibenclamide in which the size of the glibenclamide is such that at most 10% of the particles are less than 2 .mu.m and at most 10% of the particles are greater than 60 .mu.m, so that the glibenclamide bioavailability is comparable to the glibenclamide bioavailability obtained with a separate administration of metformin and glibenclamide.

2. A solid pharmaceutical composition comprising metformin and glibenclamide in particulate form, wherein the size of the glibenclamide particles is such that at most 10% of the particles are less than 2 .mu.m and at most 10% of the particles are greater than 60 .mu.m.

3. A solid oral dosage form as claimed in claim 1 in which the size of the glibenclamide is such that at most 10% of the particles are less than 3 .mu.m and at most 10% of the particles are greater than 60 .mu.m.

4. A solid oral dosage form comprising a combination of metformin and glibenclamide in which the size of glibenclamide is such that at most 25% of the particles are less than 11 .mu.m and at most 25% of the particles are greater than 46 .mu.m.

5. A solid oral dosage form in which 50% of particles are less than 23 .mu.m.

6. A solid oral dosage form as claimed in claim 1 in which metformin is present as metformin salt and the weight ratio of metformin salt to glibenclamide is 50/1 to 250/1.

7. A solid oral dosage form as claimed in claim 1 which is a tablet.

8. A tablet as claimed in claim 7 which is obtained by a process comprising:

a) forming granules by wet granulation of a mixture of metformin and glibenclamide;

b) blending the granules with a tabletting aid

c) tabletting the blend thus obtained into tablets.

9. A method for treating non-insulin dependent diabetes or hyperglycaemia, comprising administering to a subject in need thereof, the composition of claim 1.

10. A method for treating non-insulin dependent diabetes or hyperglycemia, comprising administering to a subject in need thereof, the composition of claim 2.
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