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Formulation and development of multiparticulates dosage form of propranolol hydrochloride

机译:盐酸普萘洛尔多颗粒剂型的研制

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Aim: The objective of the present research work was to develop stable extended release (ER) pellets of propranolol hydrochloride, an antihypertensive drug, for which drug release profi le is compared with reference to the multiple conventional dosage form i.e. marketed product “Inderal LA” (160 mg). Method: ER formulations were developed using fl uid bed layering and coating techniques on sugar spheres. Pellets were characterized in reference to the drug content, size distribution, scanning electron microscopy (SEM); dissolution study of various formulations was performed in 1.2 pH HCl buffer for 1.5 hours followed by testing in 6.8 pH phosphate buffer for 24 hours (USP Criteria). Stability studies of the optimized formulation were carried out for a period of 30 days at 40 ± 2°C and 75 ± 5% relative humidity and were found to be stable. SEM photograph confi rmed that the prepared pellets were spherical in nature. The drug content of the formulations was found in the range of 98 to 99.7% and the mean particle size of the drug loaded pellets was in the range of 1190 to 420 μm (F1 to F3 formulation). Read more.....
机译:目的:本研究工作的目的是开发一种稳定的盐酸普萘洛尔的缓释(ER)颗粒,这是一种抗高血压药,其药物释放特性与多种常规剂型即市售产品“ Inderal LA”进行了比较(160毫克)。方法:使用糖层上的流化床分层和包衣技术开发了ER配方。参照药物含量,大小分布,扫描电子显微镜(SEM)对药丸进行表征。在1.2 pH的HCl缓冲液中进行1.5小时的各种制剂的溶解研究,然后在6.8 pH的磷酸盐缓冲液中进行24小时的测试(USP标准)。优化配方的稳定性研究在40±2°C和75±5%相对湿度下进行了30天,发现是稳定的。 SEM照片证实,所制备的颗粒本质上是球形的。发现制剂的药物含量在98至99.7%的范围内,且载药丸粒的平均粒径在1190至420μm的范围内(F1至F3制剂)。阅读更多.....

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