|
KMID : 0369820080380030157
|
|
Jorunal of Korean Pharmaceutical Sciences
2008 Volume.38 No. 3 p.157 ~ p.162
|
|
|
Improved Stability against Moisture of Amlodipine Maleate Tablets using Microcrystalline Cellulose and Pregelatinized Starch
|
|
Park Ho-Seock
Hwang Woo-Sin
Bang Kyu-Ho
Park Jeong-Sook
Cho Cheong-Weon
Hwang Sung-Joo
|
|
|
Abstract
|
|
|
|
The aim of the study was to formulate the stable amlodipine maleate tablet by selecting and combining of suitable ingredients. Amlodipine tablets were designed by using different manufacturing methods or formulations. Dissolution rate at 30 min of newly formulated tablets was over 98% in 0.1 M HCl medium. After 4 months storage under accelerated condition, the changes of appearance, loss on drying, content and total impurity were investigated. For long-term stability tests, two formulations of K017 (direct compressed tablets consisting of microcrystalline cellulose and pregelatinized starch) and K018 (wet granulated tablets by OpadryAMB) were stored under , 60% RH for 24 months. Under the accelerated condition, moisture content in K017 formulation was increased as 5.96% for 4 months, while other formulations with anhydrous monobasic phosphoric potassium or by wet granulation showed higher increase in moisture content compared to K017. In addition, K017 formulation showed a low decrease in contents and total relative substance as 0.8% and 0.7%, respectively. Similar stability of amlodipine in K017 was obtained under the long-term stability test. These results indicate that the K017 combined with microcrystalline cellulose and pregelatinized starch as ingredients is very stable formulation to protect active substance from moisture contact and sustain stability. Therefore, suitable combination of ingredients such as microcrystalline cellulose and pregelatinized starch could attribute to enhance the stability of moisture-labile drug such as amlodipine maleate.
|
|
|
KEYWORD
|
|
|
Amlodipine maleate, Stability, Microcrystalline cellulose, Pregelatinized starch
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|