Oral tablet formulation consisting of immediate release rosuvastatin and extended release metformin
AssigneeAlthera Life Sciences, LLC
InventorMarie Charmaine Dias
Life of this patent
Estimating the term…
Abstract
A solid dosage product and formulation containing a fixed combination of rosuvastatin and metformin is provided here. In the formulation rosuvastatin is delivered immediately to the patient and metformin is delivered in a slower controlled fashion over a longer course of time. A method to make the formulations as well as a method to treat patients with fixed combination solid dosage form of immediate release rosuvastatin and extended release metformin are provided here.
Claims19
A solid dosage form of metformin and rosuvastatin combined in one tablet wherein rosuvastatin dosage is from 5 mg to 40 mg, and metformin dosage is from 250 mg to 2000 mg, and wherein rosuvastatin is released immediately and metformin is provided in granules releasing metforminin a controlled fashion.
The solid dosage form of claim 6, wherein the metformin granules are further packed in the polymer to the weight of 5-30% of the weight of the metformin layer along with a lubricant 0.2-5% of the weight of the metformin layer.
A method of treating hyperlipidemia, simultaneously with type 2 diabetes, said method comprising administering orally a solid dosage form of rosuvastatin and metformin to a patient in need of such a treatment, wherein the solid dosage form is one tablet comprising 5 mg to 40 mg of rosuvastatin in immediately releasing form and 250 mg to 2000 mg of metformin in delayed releasing form.
A solid dosage form of metformin and rosuvastatin combined in one tablet with 5 mg to 40 mg of rosuvastatin and 250 mg to 1000 mg of metformin,
- wherein rosuvastatin is released immediately, and
- metformin is released in controlled fashion and being provided in granules packed in a polymer, said granules comprising cellulose, a polymer, water and organically soluble cellulose.
A method to manufacture a solid dosage form of metformin and rosuvastatin combined in one tablet having an outer rosuvastatin layer with rosuvastatin dosage of 5 mg to 40 mg and an inner metformin layer with metformin dosage of 250 mg to 2000 mg, and wherein rosuvastatin is released immediately and metformin is provided in granules releasing metformin in a controlled fashion, said method comprising the steps of:
- a) Developing a blend for the metformin extended release layer with the steps of:
- i) Mixing intragranular ingredients in a granulator;
- and granulating resulting blend with a binding agent;
- ii) Drying the granules partially, sizing the granules by passing through a mill, and drying the sized granules until optimum LOD is obtained;
- iii) Sizing the dried granules by passing them through a mill, sifting the sized dried granules, and blending the resulting granules;
- and
- iv) Lubricating the resulting granules of step iii);
- b) Developing a blend for the rosuvastatin layer by blending selected excipients with rosuvastatin in a blender, and lubricating the blend with a lubricant;
- c) Compressing the blends of steps a) and b) into bi-layer tablets with a compression pressure ranging between 20 kilonewtons to 100 kilonewtons;
- and
- d) Providing a film-coat on the bi-layer tablets.
Dependencies are inferred from the claim text.