UNTO - This medicine prepared for Weight loss
DESCRIPTION :
PHARMACEUTICAL COMPOSITE CAPSULE FORMULATION COMPRISING IRBESARTANAND HMG-COA REDUCTASE INHIBITOR FIELD OF THE INVENTION
The present invention relates to a pharmaceutical composite capsule formulation, improved in stability and dissolution rate, comprising 1) an independent irbesartan unitcomprising irbesartan or a pharmaceutically acceptable salt thereof; and 2) an independent HMG-CoA reductase inhibitor unit comprising an HMG-CoA reductase inhibitor or apharmaceutically acceptable salt thereof, and an alkaline additive, wherein said independent units are separated from each other within a capsule, and a method for preparing the same.
COMPOSITION EACH CAPSULE CONTAINS

S.R.No NAME OF INGREDIENTS LATIN NAME QTYPER CAPSULES REF.PG. NO.
1 MEDOHAR VADANGDI LOHA 180 mg ASS-580
2 MEDOHARGUGGUL 100 mg ASS
3 TRIFAL (EXT.) . 150 mg BPN-12
4 PUNARNAVA (EXT.) BOERHAAVIA DIFFUSA 100 mg BPN-406
5 VADANG (EXT.) EMBELIARIBES 50 mg BPN-50
6 METHI (EXT.) TRIGONELLA FOENUM GRAECUM 50 mg BPN-36
7 KUKTI (EXT.) PICRORHIZA KURROA 50 mg BPN-67
8 KUMARI (EXT.) ALEO BARBADENSIS 50 mg BPN-404
9 NEEM (EXT.) AZADIRACHTA INDICA 20 mg BPN-314
10 SONAMUKHI CASSIA ANGUSTIFOLIA 30 mg BPN-453
EXCIPIENTS Qs.

DETAILED DESCRIPTION OF THE INVENTION :
A detailed description will be given of the present invention, below.The present invention provides a pharmaceutical composite capsule formulation comprising: 1) an independent irbesartan unit comprising irbesartan or a pharmaceutically acceptable salt thereof; and 2) an independent HMG-CoA reductase inhibitor unit comprising an HMG-CoA reductase inhibitor or a pharmaceutically acceptable salt thereof, and an alkaline additive, wherein said independent units are separated from each other within a capsule. An embodiment of the pharmaceutical composite capsule formulation according to the present invention is shown in FIG. 7. In the inventive pharmaceutical composite capsule formulation, the independent irbesartan unit and the independent HMG-CoA reductase inhibitor unit are each in a granule or tablet form. At least one of the independent irbesartan unit and the independent HMG-CoA reductase inhibitor unit may take a tablet form. In other words, the capsule formulation may comprise the irbesartan granules or tablets, and the HMGCoA reductase inhibitor granules or tablets, with the proviso that at least one of the active ingredients is in the form of a tablet. In one embodiment of the present invention, therefore, the capsule formulation is a hard capsule into which 1) the irbesartan granules or tablets comprising irbesartan or a pharmaceutically acceptable salt thereof; and 2) the HMG-CoA reductase inhibitor granules or tablets comprising an HMG-CoA reductase inhibitor or a pharmaceutically acceptable salt thereof, and an alkaline additive, are loaded while remaining separate from each other. Preferably, the tablet may be a mini-tablet with dimensions of 3 mm or less in both diameter and thickness. Each of the independent units may be coated to ensure a more complete physical shield between them. According to another embodiment thereof, the present invention provides a capsule formulation in the form of a hard capsule in which tablets comprising irbesartan or a pharmaceutically acceptable salt thereof; and tablets comprising an HMG-CoA reductase inhibitor or a pharmaceutically acceptable salt thereof, and an alkaline additive, are loaded. The capsule formulation may be prepared, for example, by compressing irbesartan or a pharmaceutically acceptable salt thereof into tablets, separately compressing an HMG-CoA reductase inhibitor or a pharmaceutically acceptable salt thereof, together with an alkaline additive, into tablets, and loading both the tablets into a capsule with an appropriate size, e.g., capsule size 1. In another embodiment, the present invention provides a capsule formulation in the form of a hard capsule in which granules comprising irbesartan or a pharmaceutically acceptable salt thereof; and tablets comprising an HMG-CoA reductase inhibitor or a pharmaceutically acceptable salt thereof, and an alkaline additive, are loaded. In another embodiment, the present invention provides a capsule formulation in the form of a hard capsule in which tablets comprising irbesartan or a pharmaceutically acceptable salt thereof; and granules comprising an HMG-CoA reductase inhibitor or a pharmaceutically acceptable salt thereof, and an alkaline additive, are loaded. The independent irbesartan unit according to the present invention comprises irbesartan or a pharmaceutically acceptable salt thereof as an active ingredient. Irbesartan or a pharmaceutically acceptable salt thereof is a potent long-acting angiotensin II receptor antagonist with high affinity for angiotensin II ATi receptors. When binding to the receptors, irbesartan blocks the activities of angiotensin including vasoconstriction, the release of aldosterone and the retention of water and sodium in the kidney. With these angiotensin antagonistic activities, irbesartan is applicable to the treatment of cardiovascular diseases, inter alia, hypertension and heart failure. So long as it is readily available to those skilled in the art, any pharmaceutically acceptable salt may be used in the present invention. Examples of the salts include a sodium salt, a potassium salt, a calcium salt, a magnesium salt and an ammonium salt. The independent irbesartan unit according to the present invention may contain irbesartan or a pharmaceutically acceptable salt in an amount of from about 20 to 70 wt%, based on the total weight of the unit, preferably from about 40 to 70 wt%, and may be contained in the unit formulation form in a therapeutically effective amount, for example, corresponding to 8 to 600 mg of the active ingredient, and preferably, 100 to 200 mg of the active ingredient, per unit formulation, but the content is not limited thereto. In the present invention, the independent irbesartan unit, for example, the irbesartan granules or tablets, may further comprise a pharmaceutically acceptable additive selected from the group consisting of, but not limited to, a binder, a disintegrant, a lubricant, a diluent, a colorant, an anti-tackifier, a surfactant and a mixture thereof.

CLAIM:
I claim a pharmaceutical composite capsule formulation comprising:
1) an independent irbesartan unit comprising irbesartan or a pharmaceutically acceptable salt thereof; and
2) an independent HMG-CoA reductase inhibitor unit comprising an HMG-CoA reductase inhibitor or a pharmaceutically acceptable salt thereof, and an alkaline additive, wherein said independent units are separated from each other within a capsule.
2. The pharmaceutical composite capsule formulation of claim 1, wherein the HMG-CoA reductase inhibitor is selected from the group consisting of rosuvastatin, lovastatin, atorvastatin, pravastatin, fluvastatin, pravastatin, simvastatin, rivastatin, cerivastatin, velostatin, mevastatin, a pharmaceutically acceptable salt thereof, a precursor thereof and a mixture thereof. . 3. The pharmaceutical composite capsule formulation of claim 2, wherein the HMG-CoA reductase inhibitor is atorvastatin calcium.
4. The pharmaceutical composite capsule formulation of claim 1, wherein the independent irbesartan unit and the independent HMG-CoA reductase inhibitor unit are each in a granule or tablet form.
5. The pharmaceutical composite capsule formulation of claim 4, wherein at least one of the independent irbesartan unit and the independent HMG-CoA reductase inhibitor unit takes a tablet form.
6. The pharmaceutical composite capsule formulation of claim 4, wherein the tablet has a diameter of 3 mm or less.
7. The pharmaceutical composite capsule formulation of claim 4, wherein the tablet has a thickness of 3 mm or less.

8. The pharmaceutical composite capsule formulation of claim 4, wherein the tablet further comprises a coating layer.
9. The pharmaceutical composite capsule formulation of claim 8, wherein the coating layer is made of a coating material selected from the group consisting of methyl cellulose, ethyl cellulose, polyvinyl alcohol, polyvinyl pyrrolidone, hydroxyethyl cellulose, hydroxypropyl methyl cellulose and a mixture thereof.
10. The pharmaceutical composite capsule formulation of claim 9, wherein the coating material is
employed in an amount of from 1 to 20 wt%, based on the total weight of the tablet.