Solubility Enhancement of Atorvastatin Tablets by Solid Dispersions Using Fenugreek Seed Mucilage

Abstract

Fenugreek seed mucilage (FSM) is isolated from the seeds of Trigonella Foenum-graecum, commonly known as Fenugreek, which is herbaceous plant. Fenugreek seeds contain high percentage of mucilage, which does not dissolve in water, but swell up and become slick when exposed to fluids. Atorvastatin is one of the HMG-CoA reductase inhibitors (statins), which are lipid-lowering medications used in the primary and secondary prevention of coronary heart disease. Atorvastatin is poorly absorbed orally, its oral bioavailability is very low (about14%) because it is very slightly soluble in distilled water and pH 7.4 phosphate buffer, which would limit its clinical application. The objective of this study is to enhance atorvastatin solubility in order to increase its bioavailability by the formulation of solid dispersion using fenugreek seed mucilage. Mucilage was extracted from the seed and evaluated for flow properties, pH value, FTIR spectroscopy and percentage practical yield. Then solid dispersions with different drug to polymer ratios were prepared from fenugreek mucilage and hydroxy propyl methyl cellulose (HPMC), after that saturation solubility was tested for fenugreek seed mucilage solid dispersion (FSMSD), hydroxxy propyle methyl cellulose solid dispersion (HPMCSD) and pure drug. Tablets were prepared from solid dispersion with the highest saturation solubility, then tablets were tested and evaluated. The tablets showed satisfactory physicochemical properties as 1.77%RSD in tablet weight variation, 1 min disintegration time, 5.24±0.457 Hardness and 89% drug release in 45 min. it is concluded that FSM is a promising excipient that can be used in dosage forms formulation to enhance solubility of low soluble drugs.