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中心复合设计快速分散片提高盐酸昂丹司琼负载药物的溶解度。

Central Composite Designed Fast Dissolving Tablets for Improved Solubility of the Loaded Drug Ondansetron Hydrochloride.

机构信息

Faculty of Pharmaceutical Science, Assam Down Town University, Panikhaiti, Guwahati, Assam 781026, India.

Department of Physics, Faculty of Sciences, University 20 Août 1955, Skikda, Algeria.

出版信息

Biomed Res Int. 2022 Aug 21;2022:2467574. doi: 10.1155/2022/2467574. eCollection 2022.

DOI:10.1155/2022/2467574
PMID:36046453
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9420627/
Abstract

Ondansetron tablets that are directly compressed using crospovidone and croscarmellose as a synthetic super disintegrant are the subject of this investigation. A central composite, response surface, randomly quadratic, nonblock (version 13.0.9.0) 3 factorial design is used to optimize the formulation (two-factor three-level). To make things even more complicated, nine different formulation batches (designated as F1-F9) were created. There were three levels of crospovidone and croscarmellose (+1, 0, -1). In addition to that, pre- and postcompressional parameters were evaluated, and all evaluated parameters were found to be within acceptable range. Among all postcompressional parameter dispersion and disintegration time, drug release experiments (to quantify the amount of medication released from the tablet) and their percentage prediction error were shown to have a significant influence on three dependent variables. Various pre- and postcompression characteristics of each active component were tested . Bulk density, tap density, angle of repose, Carr's index, and the Hausner ratio were all included in this analysis, as were many others. This tablet's hardness and friability were also assessed along with its dimension and weight variations. Additional stability studies may be conducted using the best batch of the product. For this study, we utilised the Design-Expert software to select the formulation F6, which had dispersion times of 17.67 ± 0.03 seconds, disintegration times of 120.12 ± 0.55 seconds, and percentage drug release measurements of 99.25 ± 0.36 within 30 minutes. Predicted values and experimental data had a strong correlation. Fast dissolving pills of ondansetron hydrochloride may be created by compressing the tablets directly.

摘要

采用直压法,以交联聚维酮和交联羧甲纤维素钠为合成超级崩解剂压片,对盐酸昂丹司琼片进行了研究。采用中心复合、响应面、随机二次、非阻塞(版本 13.0.9.0)3 因子设计(两因子三水平)对处方(九水平)进行优化。更复杂的是,制备了 9 个不同处方批次(标记为 F1-F9)。交联聚维酮和交联羧甲纤维素钠的水平分别为+1、0、-1。此外,还评估了压片前和压片后的参数,所有评估的参数都在可接受的范围内。在所有的压片后参数分散和崩解时间中,药物释放实验(定量评估片剂中药物的释放量)及其预测误差百分比对三个因变量有显著影响。对每个活性成分的各种压片前和压片后的特性进行了测试。本分析包括堆密度、振实密度、休止角、卡尔指数和豪斯纳比,还包括许多其他参数。对该片剂的硬度和脆碎度以及其尺寸和重量变化进行了评估。可能会使用产品的最佳批次进行更多的稳定性研究。在这项研究中,我们使用 Design-Expert 软件选择了处方 F6,其分散时间为 17.67 ± 0.03 秒,崩解时间为 120.12 ± 0.55 秒,30 分钟内药物释放测量值为 99.25 ± 0.36%。预测值和实验数据有很强的相关性。可以通过直接压片的方法来制备盐酸昂丹司琼速溶片。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/7598c004ca7b/BMRI2022-2467574.010.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/cc91d8a96220/BMRI2022-2467574.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/8b99ad819dd2/BMRI2022-2467574.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/d25ba2ac5b0e/BMRI2022-2467574.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/9e69a4ee88fc/BMRI2022-2467574.004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/a5bec98629a0/BMRI2022-2467574.005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/bbac68d3dd3c/BMRI2022-2467574.006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/6dbd10ad65b3/BMRI2022-2467574.007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/2749dda10c9a/BMRI2022-2467574.008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/4248c82e2fbb/BMRI2022-2467574.009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/7598c004ca7b/BMRI2022-2467574.010.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/cc91d8a96220/BMRI2022-2467574.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/8b99ad819dd2/BMRI2022-2467574.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/d25ba2ac5b0e/BMRI2022-2467574.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/9e69a4ee88fc/BMRI2022-2467574.004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/a5bec98629a0/BMRI2022-2467574.005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/bbac68d3dd3c/BMRI2022-2467574.006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/6dbd10ad65b3/BMRI2022-2467574.007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/2749dda10c9a/BMRI2022-2467574.008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/4248c82e2fbb/BMRI2022-2467574.009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afce/9420627/7598c004ca7b/BMRI2022-2467574.010.jpg

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