Enhancing Flowability and Compactibility of Glutinous Rice Starch Through Co-Precipitation: A Central Composite Design Approach

IF 2.7 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Jomjai Peerapattana, Chonticha Amornrojvaravut
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引用次数: 0

Abstract

Purpose

Flowability and compactibility are essential properties for excipients in direct compression tablet formulations. Native starches often exhibit limitations in these aspects. They exhibit poor flow characteristics due to their small particle size and high moisture sensitivity, and their limited plastic deformation leads to low compactibility. This study aimed to optimize a co-precipitation method to enhance the flow and compaction properties of glutinous rice starch (GRS), providing an alternative excipient for direct compression. The influence of key formulation parameters on the physicomechanical properties of modified starch was investigated, and optimal conditions for achieving superior performance were established.

Methods

Co-precipitated GRS (cpGRS) was prepared by swelling native starch in an alkaline sodium hydroxide solution, followed by incorporation of excipients (polyvinylpyrrolidone K30 (PVP K30) and calcium carbonate), and subsequent acid neutralization to precipitate modified starch granules. A Central Composite Design (CCD) was employed to systematically evaluate the effects of sodium hydroxide concentration, mixing time, endpoint pH, PVP K30, and calcium carbonate concentration on the flowability and compactibility of cpGRS. The modified starch was characterized in terms of yield, Carr’s Index, Hausner Ratio, tensile strength, and disintegration time.

Results

Higher sodium hydroxide concentrations and calcium carbonate levels significantly improved flowability and compactibility, while endpoint pH influenced particle size distribution. The optimized conditions (0.43 M sodium hydroxide, 95 min of mixing, endpoint pH 6.97, 7.09% w/w PVP K30, and 14.02% w/w calcium carbonate) produced cpGRS with a tensile strength of 3.05 MPa, a disintegration time of 222.95 s, a yield of 68.80%, and improved flow properties (Carr’s Index 17.16, Hausner Ratio 1.21).

Conclusion

This optimized co-precipitation approach effectively enhances the functional properties of GRS, making it a viable excipient for direct compression tablet formulations. This study provides a novel starch modification strategy that broadens the application of rice-derived excipients in pharmaceutical sciences.

Abstract Image

Abstract Image

通过共沉淀提高糯米淀粉的流动性和致密性:一种中心复合设计方法
目的流动性和压实性是直接压缩片剂中赋形剂的基本性质。原生淀粉在这些方面往往表现出局限性。由于颗粒尺寸小,水分敏感性高,流动特性差,塑性变形有限,压实性低。本研究旨在优化共沉淀法提高糯米淀粉(GRS)的流动性和压实性,为直接压缩提供一种替代赋形剂。研究了关键配方参数对变性淀粉物理力学性能的影响,确定了获得优异性能的最佳工艺条件。方法采用天然淀粉在碱性氢氧化钠溶液中溶胀,加入辅料(聚乙烯吡咯烷酮K30 (PVP K30)和碳酸钙),酸中和沉淀改性淀粉颗粒,制备co -沉淀法制备改性淀粉颗粒。采用中心复合设计(CCD)系统评价氢氧化钠浓度、混合时间、终点pH、PVP K30和碳酸钙浓度对cpGRS流动性和致密性的影响。用收率、卡尔指数、豪斯纳比、抗拉强度和崩解时间等指标对改性淀粉进行了表征。结果较高的氢氧化钠浓度和碳酸钙水平显著改善了颗粒的流动性和致密性,而终点pH值影响颗粒的粒径分布。在氢氧化钠浓度为0.43 M、混合时间为95 min、终点pH为6.97、PVP K30含量为7.09%、碳酸钙含量为14.02%的条件下,cpGRS的抗拉强度为3.05 MPa,崩解时间为222.95 s,产率为68.80%,流动性能得到改善(卡尔指数为17.16,Hausner比为1.21)。结论优化后的共沉淀法有效提高了GRS的功能特性,可作为直接压片的辅料。该研究提供了一种新的淀粉改性策略,拓宽了大米衍生辅料在制药科学中的应用。
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来源期刊
Journal of Pharmaceutical Innovation
Journal of Pharmaceutical Innovation PHARMACOLOGY & PHARMACY-
CiteScore
3.70
自引率
3.80%
发文量
90
审稿时长
>12 weeks
期刊介绍: The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories: Materials science, Product design, Process design, optimization, automation and control, Facilities; Information management, Regulatory policy and strategy, Supply chain developments , Education and professional development, Journal of Pharmaceutical Innovation publishes four issues a year.
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