Preparation and<i> in vitro</i> evaluation of pregabalin controlled porosity osmotic pump tablets

ZHU Ling; QIN Chao; WU Jinlian; CHEN Yuhong; YIN Lifang

doi:10.11665/j.issn.1000-5048.20190107

Journal of China Pharmaceutical University > 2019 > 50(1): 53-58. > DOI: 10.11665/j.issn.1000-5048.20190107

ZHU Ling, QIN Chao, WU Jinlian, CHEN Yuhong, YIN Lifang. Preparation and in vitro evaluation of pregabalin controlled porosity osmotic pump tablets[J]. Journal of China Pharmaceutical University, 2019, 50(1): 53-58. DOI: 10.11665/j.issn.1000-5048.20190107

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Preparation and in vitro evaluation of pregabalin controlled porosity osmotic pump tablets

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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.
- pregabalin,
- controlled porosity osmotic pump tablets,
- preparation,
- assessment,
- zero-order release,
- osmotic pressure

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