Preparation and in vitro evaluation of pregabalin controlled porosity osmotic pump tablets
10.11665/j.issn.1000-5048.20190107
- VernacularTitle:普瑞巴林微孔渗透泵片的制备及体外评价
- Author:
Ling ZHU
1
;
Chao QIN
;
Jinlian WU
;
Yuhong CHEN
;
Lifang YIN
Author Information
1. 中国药科大学药学院药剂学教研室
- Publication Type:Journal Article
- Keywords:
pregabalin;
controlled porosity osmotic pump tablets;
preparation;
assessment;
zero-order release;
osmotic pressure
- From:
Journal of China Pharmaceutical University
2019;50(1):53-58
- CountryChina
- Language:Chinese
-
Abstract:
In this study, pregabalin controlled porosity osmotic pump tablets which are taken once a day were prepared. Single-factor tests were carried out to investigate the influence of excipients and manufacturing process. The formulation was optimized through orthogonal experiment on three levels of three significant factors including the amount of sodium citrate, and polyethylene glycol 400 and coating weight gain. On the basis of the results of the single-factor tests and the orthogonal experiment, optimal formulation and manufacturing process were obtained. The final tablet formulation contained pregabalin(82. 5 mg), microcrystalline cellulose(40%), sodium citrate(27. 5%), magnesium stearate(0. 5%)and 5% povidone K30 solution as the tablet binder; the coating formulation consisted of cellulose acetrate and 60% of polyethylene glycol 400 as a porogen; the coating weight gain was 3%. In vitro drug release kinetic study suggested that the drug release from controlled porosity osmotic pump tablets was mainly driven by osmotic pressure, which was barely affected by the pH of the release medium. The drug release behavior of the tablets within 12 hours complied with zero-order release rule and the linear correlation coefficient was 0. 991 6. The obtained porosity osmotic pump tablets could effectively slow the drug release rate, reduce concentration fluctuation and improve the safety and convenience for the patients, hence with broad prospects.
