Optimization of Formulation Technology of the Ibuprofen Sustained-release Dropping Pill and Evaluation of Its in vitro Drug-release Behavior
10.6039/j.issn.1001-0408.2017.28.26
- VernacularTitle:布洛芬缓释滴丸的处方工艺优化及体外释药行为评价
- Author:
Rongqian MENG
1
;
Shengjuan SHAO
;
Xuelian ZHU
Author Information
1. 太原工业学院化学与化工系
- Keywords:
Ibuprofen sustained-release dropping pill;
Preparation technology;
Orthogonal test;
in vitro drug-release
- From:
China Pharmacy
2017;28(28):3984-3987
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To optimize the formulation technology of Ibuprofen sustained-release dropping pill and evaluate its in vitro drug-release characteristics. METHODS:Using stearic acid as sustained-release matrix,polyethylene glycol 6000 as imme-diate-release matrix,melting method was used to prepare the Ibuprofen sustained-release dropping pill. Using the comprehensive scores of roundness,weight difference,drug loading rate,in vitro drug-release time as indexes,drug-matrix mass ratio,liquid tem-perature,condensation temperature,dropping distance as factors,orthogonal test was adopted to optimize the formulation technolo-gy,and verification test was conducted. In media of deionized water,hydrochloric acid solution (pH 1.2),phosphate buffer (pH 4.5,6.8),the in vitro drug-release were compared between self-made sustained-release dropping pill and commercially available Ibuprofen sustained-release capsule,which were fitted for former drug-release behavior. RESULTS:The optimal formulation tech-nology was as follows as mass ratio of ibuprofen-polyethylene glycol 6000-stearic acid of 4.0:15.3:0.7,liquid temperature of 83 ℃,condensation temperature of 8 ℃,and dropping distance of 11 cm. The weight difference of prepared 3 batches of Ibupro-fen sustained-release dropping pill was 2.067%(RSD=1.19%),roundness was 96.73%(RSD=0.28%),drug loading rate was 96.31%(RSD=0.19%),cumulative release rate in 12 h was 93.05%(RSD=0.81%). The f2 values of self-made sustained-re-lease dropping pill and commercially available Ibuprofen sustained-release capsule were greater than 50,the former one fitted more into Higucci equation(r=0.9881-0.9972). CONCLUSIONS:The formulation technology of Ibuprofen sustained-release dropping pill is successfully optimized,and in vitro drug-release behavior of prepared sustained-release dropping pill is similar to commercial-ly available Ibuprofen sustained-release capsule.
