Optimization of tamsulosin hydrochloride controlled release pellets coated with Surelease and neutralized HPMCP.
This study was to optimize the coating level in the development of controlled release pellets coated with Surelease and neutralized hydroxypropyl methylcellulose phthalate (HPMCP) by a computer optimization technique based on a response surface methodology utilizing polynomial equation. A full factorial 3(2) design was used for the optimization procedure with coating level (X(1)) and HPMCP content (X(2)) as the independent variables. The drug release percent at 2, 3 and 5 h were the target responses, which were restricted to 12-39% (Y(1)), 44-70% (Y(2)) and 70-100% (Y(3)), respectively. The quadratic model was well fitted to the data, and the resulting equation was used to predict the responses in the optimal region. It was shown that the optimized coating formulation was achieved at the ratio of 3:1 (Surelease: neutralized HPMCP) with 20% coating level. The optimized formulation showed release profiles and responses, which were close to predicted responses. Therefore, a full factorial 3(2) design and optimization technique can be successfully used in the development of optimized coating formulations based on Surelease and neutralized HPMCP to achieve a controlled release drug delivery system containing tamsulosin hydrochloride.
Kim
Min-Soo
MS
National Research Lab. of Pharmaceutical Technology, College of Pharmacy, Chungnam National University, 220 Gung-dong, Yuseong-gu, Daejeon 305-764, Korea.
Kim
Jeong-Soo
JS
Lee
Sibeum
S
Jun
Seoung Wook
SW
Park
Jeong-Sook
JS
Woo
Jong-Soo
JS
Hwang
Sung-Joo
SJ
D000317:Adrenergic alpha-Antagonists / Q000737:chemistry / Q000493:pharmacokinetics; D000465:Algorithms; D002482:Cellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D003692:Delayed-Action Preparations / Q000737:chemistry / Q000493:pharmacokinetics*; D004339:Drug Compounding / Q000379:methods; D006863:Hydrogen-Ion Concentration; D008747:Methylcellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D010316:Particle Size; D012984:Software; D013449:Sulfonamides / Q000737:chemistry / Q000493:pharmacokinetics*; D013499:Surface Properties; D000077409:Tamsulosin
D000317:Adrenergic alpha-Antagonists; D003692:Delayed-Action Preparations; D013449:Sulfonamides; C013517:ethyl cellulose; D002482:Cellulose; D008747:Methylcellulose; C053309:hydroxypropyl methylcellulose phthalate; D000077409:Tamsulosin