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KMID : 0043320110340030463
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Archives of Pharmacal Research
2011 Volume.34 No. 3 p.463 ~ p.468
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Comparative study of telmisartan tablets prepared via the wet granulation method and pritor™ prepared using the spray-drying method
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Park Jun-sung
Park Hee-Jun
Cho Won-Kyung
Cha Kwang-Ho
Yeon Won-Ki
Kim Min-Soo
Kim Jeong-Soo
Hwang Sung-Joo
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Abstract
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The wet granulation method was successfully used to manufacture amorphous telmisartan tablets (CNU) for comparison with the spray-drying method, used for Pritor™. Drug crystallinity in the tablet was characterized using differential scanning calorimetry and powder X-ray diffraction, and pharmaceutical properties of the tablets such as hardness, friability, water absorption, and in vitro dissolution in pH 1.2, 4.0, 6.8 and 7.5 were characterized. Especially with regard to the water absorption feature, the CNU tablets showed better performance by maintaining their original structures and by absorbing less water. Since both Pritor™ and CNU tablets had similar physical properties of crystallinity, hardness, friability, and > 50 f2 value in an in vitro dissolution study, the bioequivalence of CNU tablets should be analyzed in a future in vivo study. Therefore, telmisartan tablets can be produced using a more economical and easier method than that used to produce Pritor™ tablets.
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KEYWORD
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Telmisartan, Amorphous, Wet granulation, Pritor™, Spray-drying
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