ASHWAMEGH - This Medicine prepare for Sex
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 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, and a method for preparing the same.
COMPOSTION : EACH CAPSULE CONTAINS

S; R. No. NAME OF INGREDIENTS LATIN NAME QTY PER CAPSULE R.PG. No.
1. ASWAGANDA (EXT) WHITHANIA SOMANIFERA 200 mg BPN -379
2 SAFED MUSLI (EXT.) CHILOROPHYLUM ARUNDINACEUM 200 mg BPN=377
3. KAUCHA BIJ (EXT.) MUCUNA PREPITA 200 mg BPN-342
4. GOKHARU (EXT.) PEDAL1UM MUREX 50 mg BPN-280
5. SUDDHA SHILAJIT 50 mg BPN-600
6. JAIPHAL MYRISTICA FRAGRANS 25 mg BPN-206
7. AKKALKARA ANACYCLUS PYRCTHRUM 20 mg DG2-578
8. LAVANG SYZYGIUM AROMATICUM 20 mg BPN-209
9. KESAR CROCUS SATIVUS 3mg BPN-222
10. TRIBANG BHASMA 30 mg ASS-132
11. ABHRAK BHASMA 20 mg ASS-103
EXCIPIENTS as

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.

I CLAIM:
I Claimed 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, pitavastatin, simvastatin, rivastatin, cerivastatin, velostatin, mevastatin, a pharmaceutically acceptable salt thereof, a precursor thereof and admixture 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 thickness of 3 mm or less.
7. 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.
8'. 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.
9. The pharmaceutical composite capsule formulation of claim 11, wherein the capsule is made of a
material selected from the group consisting of hypromellose, pullulan, gelatin and polyvinyl alcohol.
10. The pharmaceutical composite capsule formulation of claim 1, wherein the alkaline additive is
selected from the group consisting of NaHCO 3, CaCO 3, MgCO 3, KH2P0, K2HP0 3, calcium phosphate
tribasic, argini'ne, lysine, histidine, meglumine, aluminum magnesium silicate, aluminum magnesium
metasilicate, a salt thereof and a mixture thereof.