Synergistic composition for inhibiting vascular calcification
The invention disclosed herein relates to synergistic bioactive compositions for inhibiting vascular calcification. Particularly, the present invention relates to exogenous blend of magnesium 2-acetylamino ethane sulfonic acid and 2-methyl-4-aminomethyl-5-hydroxymethyl-3-pyridinol and salts thereof which are present in the weight ratio of 1:0.002 to 1:1.8 along with pharmaceutically acceptable excipients. More particularly, the synergistic composition is useful for treating cardiovascular diseases and renal vascular diseases.
1 . A synergistic bioactive composition for inhibiting vascular calcification, comprising a therapeutically active exogenous combination of an effective amount of magnesium 2-acetylamino ethane sulfonic acid and 2-methyl-4-aminomethyl-5-hydroxymethyl-3-pyridinol or salts thereof, along with at least one pharmaceutically acceptable excipient wherein the magnesium 2-acetylamino ethane sulfonic acid and 2-methyl-4-aminomethyl-5-hydroxymethyl-3-pyridinol or salts thereof are present in a weight ratio of 1:0.002 to 1:1.8 along with the at least one pharmaceutically acceptable excipient, and wherein the magnesium 2-acetylamino ethane sulfonic acid is white crystalline and present in a range of 25% to 99% by weight of the total composition and the 2-methyl-4-aminomethyl-5-hydroxymethyl-3-pyridinol salt is white crystalline and present in a range of 0.1% to 60% by weight of the total composition.
2 . The synergistic bioactive composition as claimed in claim 1 , wherein the at least one pharmaceutically acceptable excipient is selected from a group consisting of: a diluent in a range of 1 to 30%, a binder present in a range of 0.5 to 25%, a lubricant in a range of 0.1 to 10.0%, a glidant in a range of 0.1 to 5.0%, an additive in a range of 0.1 to 10%, a surfactant in a range of 0.1 to 5.0%, a stabilizer in a range of 0.1 to 5.0%, an antioxidant in a range of 0.1 to 5.0%, and a plasticizer in a range of 0.1 to 5.0%, by weight of the total composition.
3 . The synergistic bioactive composition as claimed in claim 1 , wherein an effective unit dose for an oral administration is formulated in a range of 10 to 1000 mg.
4 . The synergistic bioactive composition as claimed in claim 3 , wherein the effective unit dose is useful for treating disorders or diseases selected from the group consisting of hypertension, diabetes, chronic kidney diseases, diabetic nephropathy, coronary artery diseases, cardiovascular diseases, kidney function decline, dialysis vintage, disordered mineral metabolism, elevated serum phosphate levels, elevated serum calcium levels, elevated parathyroid hormone levels, changes in vitamin D metabolism, elevated FGF 23 levels, inflammation and oxidative stress, osteogenesis factors (Cbfa1), heart attack, heart failure, diabetes stroke, dementia, renal insufficiency, inadequate blood supply to arms and legs, peripheral artery disease (PAD), loss of elasticity of arteries, increase in pulse pressure, development of left ventricular hypertrophy (LVH), heart failure (HF), lower coronary artery perfusion and myocardial ischemia, impaired calcium-phosphate metabolism, diastolic dysfunction, cardiac valve calcification, ischemic heart disease, and episodes of cardiac failure.
5 . The synergistic bioactive composition as claimed in claim 1 , wherein the composition improves cell viability from 48% to 93%.