Combination drug for the control and management of type 2 diabetes mellitus
AssigneeLaboratorios Silanes S.A. de C.V.
InventorsPaola Yazmín Ollervides Rubio, Sixto Serafin Espinoza León, Ernesto Cuahutencos Escobar, Jorge Alejandro González Canudas
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Abstract
An innovative stable immediate release drug for the treatment, control, and better management of type 2 diabetes mellitus containing a sulfonylurea such as glimepiride, a dipeptidyl peptidase-4 (DPP4) inhibitor such as vildagliptin, and a biguanidine such as metformin. At the same time, this invention allows solving a set of important technological challenges in the manufacture of said drug product due to the physicochemical properties and the difference in dosage of the synergistic combination of the drugs.
Claims15
A combination drug in the form of a single solid immediate-release dosage unit, comprising:
- (a) glimepiride,
- (b) vildagliptin, and
- (c) metformin hydrochloride, or a pharmaceutical salt of any of the same, in pharmaceutically acceptable amounts in the range between 1-4 mg, 50 mg, and 500-1000 mg respectively,
- wherein the components (a), (b) and (c) are co-formulated within a single homogeneous solid matrix;
- and further comprising an excipient system comprising:
- microcrystalline cellulose PH 101 as a diluent,
- crospovidone as a disintegrant,
- magnesium aluminum metasilicate as an adsorbent, and
- poloxamer 188 as a solubilizer,
- optionally in combination with one or more pharmaceutically acceptable excipients and/or vehicles selected from the group of binders, lubricants, solvents and/or coatings;
- wherein the excipient system is configured to provide immediate release of each of the components (a), (b) and (c) from said dosage unit;
- and
- wherein said drug product is further in solid form selected from tablet, caplet, granules, lozenges and pills.
Dependencies are inferred from the claim text.