title: Comparative study of telmisartan tablets prepared via the wet granulation method and pritor™ prepared using the spray-drying method.
abstract: 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 f(2) 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.
authors.affiliation: Center for Nanotechnology-based New Drug Dosage Form, College of Pharmacy, Chungnam National University, Daejeon, Korea.
authors.forename: Junsung
authors.initials: J
authors.lastname: Park
authors.forename: Hee Jun
authors.initials: HJ
authors.lastname: Park
authors.forename: Wonkyung
authors.initials: W
authors.lastname: Cho
authors.forename: Kwang-Ho
authors.initials: KH
authors.lastname: Cha
authors.forename: Wonki
authors.initials: W
authors.lastname: Yeon
authors.forename: Min-Soo
authors.initials: MS
authors.lastname: Kim
authors.forename: Jeong-Soo
authors.initials: JS
authors.lastname: Kim
authors.forename: Sung-Joo
authors.initials: SJ
authors.lastname: Hwang
mesh_terms: D047228:Angiotensin II Type 1 Receptor Blockers / Q000737:chemistry*; D001562:Benzimidazoles / Q000737:chemistry*; D001565:Benzoates / Q000737:chemistry*; D002152:Calorimetry, Differential Scanning; D002851:Chromatography, High Pressure Liquid; D004339:Drug Compounding / Q000379:methods*; D004355:Drug Stability; D006244:Hardness; D006863:Hydrogen-Ion Concentration; D012995:Solubility; D013607:Tablets; D000077333:Telmisartan; D017155:Wettability; D014961:X-Ray Diffraction
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D001562:Benzimidazoles; D001565:Benzoates; D013607:Tablets; D000077333:Telmisartan