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The goal of this study was to identify the most significant factors affecting the CQAs using Plackett�CBurman design. Plackett�CBurman design can estimate the significance of the main factor from large numbers of factors with very high efficiency and accuracy [17], thus assuring to quickly reduce the number of high-risk factors needed to be studied in the next step. An eight factors-two levels-12 runs Plackett�CBurman screening study was performed using Minitab statistical experiment design software and the responses were Y1 and Y2. [http://www.selleckchem.com/products/chir-99021-ct99021-hcl.html this website] As learned from Table 1, Y1 and Y2 varied from 3.37% (PB-8) to 12.47% (PB-6), and from 72.47% (PB-8) to 90.11% (PB-6), respectively, for the various factor combinations. Fig.?4 indicated that among all of the factors, coating weight gain, TEC percentage and GMS percentage [http://www.selleckchem.com/products/PLX-4032.html MAPK inhibitor] (P?[http://en.wikipedia.org/wiki/PDGFRB PDGFRB] decreasing the coating weight gain would resulted in the increase of Y2. Eudragit L30D-55 was enteric-coated material, which dissolves merely in pH 5.5 or above medium. The larger the coating weight gains the thicker of coating film. An attempt to decrease the coating film excessively would result in discontinuous coating film so that leading to too much drug release in the gastric region. In contrary, exorbitant thick film might handicap drug releasing from formulation and Y2 turned out to be too low. TEC was plasticizer which can decrease the film forming temperature to favor coating. Besides, TEC was also hydrophilic material, which was easily dissolved in water thus playing a pore-forming agent role in the enteric-coated film. For this reason, too high levels of TEC will result in too much drug release in gastric environment, while the low value TEC can't decrease the film forming temperature during coating process in efficiency. GMS was an antisticking agent, which can decrease the viscosity of the coating aqueous dispersion to avoid the adhesion among pellets and it also benefits for coating process. As emulsifier Tween-80 was always accompany with GMS, which was 40% of the amount of GMS.
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Версія за 14:23, 3 травня 2017

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