Abstract
Simvastatin is a lipid lowering agent which has been used recently as drug delivery system for stimulating bone regeneration. Because of low therapeutic efficacy and bioavailability, it is necessary to deliver simvastatin by local administration e.g. by hydrogel system. However, simvastatin has very poor solubility which restricts to prepare hydrogel formulation. The aim of this study is to improve solubility of simvastatin with arginine as co-solvent for developing a controlled released drug delivery system by loading simvastatin into gelatin hydrogel. The solubility study was performed by addition of an excess mass of simvastatin into the specified molar solutions of the arginine. All conical flasks were placed in a mechanical water bath shaker at the temperature of 25, 40, and 50 °C and shaken for a maximum period of 72 hours. The drug concentration was analyzed by UV/Visible spectroscopy at 238 nm. The hydrogel was prepared by a dehydrothermal method. The results showed that simvastatin solubility increases with increasing arginine concentrations and temperature. Characterizations showed a successful preparation of simvastatin-loaded gelatin hydrogel. The arginine simvastatin hydrogel and the gelatin hydrogel (as a blank) exhibited a comparable swelling index (ca. 6.5). Furthermore, microparticles of the material show a narrow particle size distribution in the range between 150-250 μm.
Highlights
Bone damage due to trauma, osteoporosis, and genetic diseases is a health issue that requires serious treatment
To investigate the amount of simvastatin that can be dissolved in water solution as solvent in hydrogel preparation, solubility study was carried out by introducing arginine in different concentrations
The solubility of simvastatin in water is ca. 0.01 mmol L-1 at room temperature. This result is in agreement with other studies of simvastatin solubility in pure water [10]
Summary
Bone damage due to trauma, osteoporosis, and genetic diseases is a health issue that requires serious treatment. Bone injury can decrease the quality of life, so is needed therapy to accelerate the bone healing process. Without the aid of drugs and bone substitution, healing of bones takes a long time and is less than perfect [1]. One of the drugs known to have effects on bone healing is simvastatin. Simvastatin is a drug used to lower cholesterol in the blood through inhibition of cholesterol-forming enzymes [2]. Simvastatin could induce bone formation by increasing bone morphogenetic protein expression (BMP-2) and inhibiting bone resorption by reducing RANKL expression [3,4]. Systemic administration of high doses of simvastatin is required to obtain statin effects on bone, but increased doses will enhance the toxicity of a drug [5]. It is necessary to modify the simvastatin formulas given either injections or implants locally to obtain the optimal therapeutic effect on bone
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