preparation, characterization and pharmacodynamic evaluation of fused dispersions of simvastatin using peo-ppo block copolymer

نویسندگان

harjeet singh department of pharmaceutics, rajiv academy for pharmacy, mathura, uttar pradesh, india.

betty philip department of pharmaceutics, school of pharmacy, college of pharmacy and nursing, university of nizwa, birkat al mouz, nizwa 616, sultanate of oman.

kamla pathak department of pharmaceutics, rajiv academy for pharmacy, mathura, uttar pradesh, india.

چکیده

the solubility enhancement of poorly soluble compounds is an important task in pharmaceutical technology as it leads to better bioavailability and a more efficient application. fused dispersions (fds) of simvastatin (sim) using peo-ppo block copolymer were prepared which paved the way for the formation of an amorphous product with enhanced dissolution and bioavailability. the accumulative solubility of simvastatin (sim) from peo-ppo block copolymer (lutrol nf 127 prill surfactant) was found to be superior to the drug alone which may be due to the increased oxyethylene content that played the major role in solubility enhancement. a 32 full factorial approach was used for optimization wherein the temperature to which the melt-drug mixture cooled (x1) and the drug-to-polymer ratio (x2) were selected as the independent variables and the time required for 90% drug dissolution (t90%) was selected as the dependent variable. a low level of x1 and a high level of x2 were suitable for obtaining higher dissolution of sim from sim fds. on increasing melt to cool drug temperature, t90% increased thus improving dissolution rate of fd2 batch with the maximum drug release (99.63%) in 120 min. the optimized fds were characterized by saturation solubility study, drug content, in-vitro dissolution, fourier transform infrared spectroscopy, scanning electron microscopy, differential scanning calorimetry, x-ray diffraction, 1hnmr spectroscopy and pharmacodynamic evaluation. capsules containing optimized fds were prepared and compared with marketed brand (simvotin®). finally, it can be concluded that the optimized fds of sim ameliorate the solubility and dissolution of drug with improved pharmacodynamic activity.

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عنوان ژورنال:
the iranian journal of pharmaceutical research

جلد ۱۱، شماره ۲، صفحات ۴۳۳-۴۴۵

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