PHARMACY 753 : REGULATORY AFFAIRS
LOG BOOK ASSIGNMENT
Name of the Patent : “Solid Oral Dosage form comprising a combination of
Metformin and Glibenclamide .”
What is the Patent for :
The given patent ” Solid Oral Dosage form comprising a combination of Metformin and Glibenclamide” is an invention in the treatment of Type 2 Non- Insulin Dependent Diabetes, which is basically a metabolic disorder characterized by hyperglycaemia caused due to insulin deficiency, resistance and decrease in glucose tolerance levels. The anti-diabetic drugs are broadly classified as Sulphonylureas and biguanides, which have entirely different mechanism of actions. Initially, diet and weight management is used for the management of type 2 diabetes. The monotherapy helps in management of diabetes for a certain period of time however, with time monotherapy proves to be inadequate. Therefore, a combination of sulphonylureas and biguanides is recommended which also improves patient compliance wherein the patient instead of taking multiple doses can simply take one dose.
A solid dosage form containing a combination of Metformin and Glibenclamide wherein Glibenclamide has a particle size in such a way that minimum particle size of 10% particles is 2µm and the maximum size is not greater than 60µm .
As claimed in claim 1, it is a solid dosage form wherein the particle size of 10% of glibenclamide is less than 3µm and more than 40µm.
It is a oral solid dosage form containing the combination of Metformin and Glibenclamide, wherein the particle size of glibenclamide is such that 25% of particles have a size less than 11µm and more than 46 µm.
As claimed in claim 3, it is a solid oral dosage form in which the particle size of 50% of the components is less than 23µm.
As claimed in any one of the claims 1 to 3 , it is a solid dosage form in which metformin is present as metformin salt and the ratio of weight of metformin salt to glibenclamide is 50/1 to 250/1 .
As claimed on any one of the claims from claim 1 to 5 , it is a solid oral dosage form which is a tablet .
A tablets as claimed in claim 6 which is produced using the following processes :
Formulation of granules of Metformin and glibenclamide using the Wet Granulation method.
Blending the granules by using a tabletting aid.
Tabletting the blend into tablets.
Registration of Patent : 12 August 2007