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KMID : 0369820110410060371
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Jorunal of Korean Pharmaceutical Sciences
2011 Volume.41 No. 6 p.371 ~ p.376
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Solid State of Tulobuterol : Characterization, Dissolution, Transformation
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Do Eui-Seon
Sohn Young-Taek
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Abstract
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The objective of this work was to investigate the existence of new crystal forms of tulobuterol which is used to prevent morning asthma attacks by β2 agonist and the transformation of crystal forms. Three crystal forms of tulobuterol have been isolated by recrystallization and Form 2 was transformed to Form 4 at 52% RH and 95% RH and these four crystal forms are characterized by differential scanning calorimetry (DSC), powder X-ray diffractometry (PXRD) and thermogravimetric analysis (TG). The DSC and PXRD patterns of four crystal forms of tulobuterol were different respectively. The dissolution patterns of these three crystal forms of tulobuterol were studied and they showed significant differences in the dissolution rate. After storage of 2 months at 0% RH (silica gel, 20o C), 52% RH (saturated solution of Na2Cr2O7·2H2O/ 20oC) and 95% RH (saturated solution of Na2HPO4 / 20oC), Form 1 and Form 3 were not transformed. But Form 2 was transformed to Form 4 at 52% RH and 95% RH.
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KEYWORD
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Tulobuterol, Polymorphism, Crystal form, DSC, PXRD, Dissolution
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