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KMID : 0369820130430050363
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Jorunal of Korean Pharmaceutical Sciences
2013 Volume.43 No. 5 p.363 ~ p.373
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Formulation of highly purified fenugreek gum based silica lipid drug delivery system for simvastatin with enhanced dissolution rate and in vitro characterization
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Sav Ajay Kumar
Ali Meer Tarique
Fule Ritesh Amol
Amin Purnima Dhanraj
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Abstract
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In current study, highly purified fenugreek gum (HPFG) isolated by patented method explored as emulsifier and hydrophilic solid carrier in drug delivery system. Anti-hyperlipidemic drug simvastatin (SIM) was selected as drug model for the study as it is associated with poorly water solubility and low bioavailability problems (<5 %). A suitable HPFG-based silica lipid system composed of SIM (1.5 %), medium chain triglyceride Capmul® MCM (10 %) as lipid phase, 0.6 % HPFG as emulsifier and HPFG 2.5 %, different grades colloidal silica (7.5 %) (Aerosil® 300 Pharma, Aerosil® 380 Pharma and Aeroperl® 300 Pharma) as hydrophilic solid carriers was developed. The optimized HPFG-based silica lipid systems were characterized for physical characteristics like flow ability, compressibility, redispersiblity, solubility and in vitro drug release using USP apparatus II in pH 6.8 phosphate buffer. The system was also characterized for Fourier transform infrared spectroscopy, powder X-ray diffractometry (PXRD), differential scanning calorimetry (DSC) and scanning electron microscopy (SEM). The developed formulation was found to have excellent flow property, readily redispersiblity, better aqueous solubility and showed 3?4-fold increase in dissolution rate as compared to plain drug and marketed formulation (Simlo® 10). Transition of crystalline drug to amorphous state was confirmed by DSC, PXRD and SEM studies. Enhanced dissolution rate and solubility possibly attributed to improved wetting, amorphous drug state and facilitated diffusion from lipid-based system. Thus developed HPFG-based silica lipid system provides an alternative means for SIM with enhanced dissolution rate and stability in oral solid dosage form.
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KEYWORD
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Simvastatin, Highly purified gum (HPFG), Colloidal silica, Dissolution rate
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