수종의 붕해제가 살리실아미드정제의 제제특성에 미치는 영향 = The Effect of Disintegrants on the Properties of Salicylamide Tablets

다국어 초록 (Multilingual Abstract)

Six common tablet disintegrants (corn starch, Avicel PH102, calcium carboxymethylcellulose, Primojel, Kollidon CL and Ac-Di-Sol) were used at the concentration of 0, 2, 4 and 6% (w/w) in salicylamide tablets made with wet granulation method. Certain physical parameters of the disintegrants (moisture sorption, hydration capacity and bulk density) were determined to evaluate their relative efficiency. The disintegration time and dissolution rate of the tablets were correlated well with the ranks of initial rate of moisture sorption for each disintegrant as follows; Ac-Di-Sol, Kollidon CL, primojel, calcium CMC, corn starch and Avicel PH102. The initial rate of moisture sorption was important for the disintegration capacity as well as hydration capacity. The effect of storage at different temperatures and relative humidity upon the tablets containing various disintegrants was evaluated in terms of tablet hardness and disintegration time. Storage at high temperature reduced the hardness substantially and retarded the disintegration of the all tablets studied. Especially, the hardness of tablets containing Kollidon CL was significantly reduced. Although the tablet hardness was decreased and the disintegration time was increased under a moderate humid condition, both of them were decreased under the severely high humid condition of 80 or 90% RH, which was due to the breakrupture of tablet matrix bonds by the excessive uptake of moisture. Therefore, the stability caused by moisture sorption should be considered, when disintegrants having high moisture sorption such as Kollidon CL, Ac-Di-Sol and Primojel were employed in the tablets containing water-labile or hygroscopic drugs.