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Preparation of solid pharmaceutical forms of celecoxib with immediate-release and sustained-release by using wet granulation techniques and evaluation of their in vitro characteristics

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Journal of Chinese Pharmaceutical Sciences 2022年第7期31卷 536-544页

作者： Ahmed Alkhodri Svetlana Suslina Department of General Pharmaceutical and Biomedical Technology Medical InstitutePeoples’Friendship University of RussiaStreet Miklukho-Maklaya 6Moscow 117198Russia

In the present study,we aimed to formulate matrix tablets of celecoxib with immediate-release(IR)and sustained-release(SR)and evaluate the influence of different types and concentrations of polymers on drug release characteristics in vitro.All formulations were prepared by using the wet granulation technique.One formulation(F5)with the traditional release was composed without release-control polymers.In contrast,four formulations(F1–F4)with prolonged action were designed by using different cellulosic polymers,such as hydroxypropyl methylcellulose polymers(hpmc-K100M and hpmc-Е6),hydroxypropyl cellulose with high viscosity grade(HPCh),carboxymethyl cellulose(CMC),and ethylcellulose(EC-10 cps).All tablet formulations contained sodium lauryl sulfate(SLS),polyvinylpyrrolidone(PVP-k30),microcrystalline cellulose(MCC),and lactose monohydrate.The MCC and PVP-k30 were used in a fixed quantity in all formulations except for formulation F5,which contained 10%and 2.7%of them,respectively.The effects of polymer viscosity grade and its quantity on celecoxib release from two formulations containing the same polymer were studied.Drug release in vitro was evaluated in phosphate buffer(pH=7.4).The amount of celecoxib released in phosphate medium was calculated by preparing a standard series.In vitro profile indicated that formulations F1(hpmc-K100M)and F2(hpmc-E6)extended the drug release for 18 h(82%)and 10 h(96.001%),respectively.Formulations F3and F4 released 72.09%and 59.8%of their contents during 18 h,respectively,and thus their effects could last for more than a day.However,IR formulation(F5)released more than 90%of its content within 1–2 h.MS Excel was used to analyze the dissolution profile data for drug release kinetics,such as first-order,Zero-order,Higuchi,and Korsmeyer-Peppas models.The release mechanism of all formulations was CaseⅡrelaxation release.This study showed that cellulosic derivative polymers could successfully prolong IR of matrix tablet formulation.

关键词： Immediate release Sustained release Celecoxib hpmc Wet granulation Dissolution profile

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hpmc添加量及烧结温度对粉煤灰支撑体性能的影响

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材料科学与工艺 2023年第1期31卷 57-62页

作者：翟维铭同帜李大川杨小雨张博怡龚亮西安工程大学环境与化学工程学院西安710048 陕西科控技术产业研究院有限公司西安710076

以燃煤电厂燃烧后的废弃物粉煤灰为原料,二氧化锰(MnO_(2))为烧结助剂,羟丙基甲基纤维素(hpmc)为粘结剂,通过滚压成型法和固态粒子烧结法制备单管式陶瓷膜支撑体,通过对原料的热稳定性、成品的纯水通量、抗折强度、微观形貌、晶相组成... 详细信息

以燃煤电厂燃烧后的废弃物粉煤灰为原料,二氧化锰(MnO_(2))为烧结助剂,羟丙基甲基纤维素(hpmc)为粘结剂,通过滚压成型法和固态粒子烧结法制备单管式陶瓷膜支撑体,通过对原料的热稳定性、成品的纯水通量、抗折强度、微观形貌、晶相组成以及耐酸碱度进行表征,探究hpmc的添加量对于支撑体性能的影响。结果表明,hpmc的引入可以增强粉煤灰基支撑体泥料的粘性和塑性,在烧结温度为1 150℃,hpmc的添加量为2wt.%时,抗折强度为24.65 MPa、纯水通量为6 794.71 L/(m^(2)·h·MPa)、耐酸碱腐蚀性能优异且稳定。hpmc作为粘结剂在苛刻条件下仍然可以制备出低成本、效果优的粉煤灰基陶瓷膜支撑体,达到资源化利用的目的。

关键词：陶瓷膜粉煤灰 hpmc 粘结剂添加量支撑体制备

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Cooperative effect of polyvinylpyrrolidone and hpmc E5 on dissolution and bioavailability of nimodipine solid dispersions and tablets

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Asian Journal of Pharmaceutical Sciences 2019年第6期14卷 668-676页

作者： Zhisu Sun Huicong Zhang Huiyang He Lingling Sun Xiaorui Zhang Qun Wang Kexin Li Zhonggui He Wuya College of Innovation Shenyang Pharmaceutical UniversityShenyang 110016China School of Pharmacy Shenyang Pharmaceutical UniversityShenyang 110016China Examination and Certification Center Liaoning InspectionShenyang 110036China

Solid dispersion(SD)systems have been extensively used to increase the dissolution and bioavailability of poorly water-soluble drugs.To circumvent the limitations of polyvinylpyrrolidone(PVP)dispersions,hpmc E5 was applied in the formulation process and scaling-up techniques,simultaneously.In this study,SD of nimodipine(NMP)and corresponding tablets were prepared through solvent method and fluid bed granulating one step technique,respectively.Discriminatory dissolution media were used to obtain reliable dissolution results.Meanwhile,the stability study of SDs was investigated with storage under high temperature and humidity conditions.Moreover,the solubility of SDs was measured to explore the effect of carriers.The preparations were characterized by DSC,PXRD,and FTIR.Dramatical improvements in the dissolution rate of NMP were achieved by the ingenious combination of the two polymers.Binary NMP/PVP/hpmc-SDs released steadily,while the dissolution of single NMP/PVP-SDs decreased rapidly in water.The fluid-bed tablets(FB-T)possessed a similar dissolution behavior to the commercial Nimotop TM tablets.The characterization patterns implied that NMP existed in an amorphous state in our SDs.Furthermore,the results of stability tests suggested a better stability of the binary SDs.A special cooperative effect of PVP and hpmc was discovered on dissolution characteristics of NMP SDs and tablets,which could be extended to other drugs henceforth.Finally,the bioavailability of FB-T was evaluated in beagle dogs with Nimotop TM as the reference,and the results showed a higher AUC 0–12h value for FB-T.

关键词： Solid dispersion Nimodipine hpmc E5 Fluid-bed Bioavailability

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Coupled effect of viscosity enhancing admixtures and superplasticizers on rheological behavior of cement paste

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Journal of Central South University 2017年第9期24卷 2172-2179页

作者：元强刘文涛王超邓德华刘赞群龙广成 School of Civil Engineering National Engineering Laboratory for High Speed Railway ConstructionCentral South UniversityChangsha 410075China

The coupled effect of viscosity enhancing admixtures(VEA)and superplasticizer(SP)on the rheological behavior of cement paste was investigated in this work.Two types of VEAs,including hydroxypropyl methylcellulose(hpmc)and Welan gum,and two types of SPs,i.***.polycarboxylate(PCA)and polynaphthalenesulfonate(PNS)were used as admixtures for cement paste.Rheological curves of cement paste and simulated pore solution containing VEA and SP were tested.Simulated pore solution test results show that molecules of different SPs may generate different effects on the viscosity of VEA solutions.Hershel-Bulkley(H-B)model was used to fit rheological curve of cement paste.Strong interaction between PNS and hpmc was observed in this work.

关键词：水泥浆外加剂水泥浆体溶液粘度耦合效应流变性能掺合料羟丙基甲基纤维素 hpmc

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Cellulose based polymers in development of amorphous solid dispersions

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Asian Journal of Pharmaceutical Sciences 2019年第3期14卷 248-264页

作者： Rahul B Chavan Sneha Rathi Vaskuri G S Sainaga Jyothi Nalini R Shastri Solid State Pharmaceutical Research Group(SSPRG) Department of Pharmaceutics National Institute of Pharmaceutical Education and Research

Cellulose derivatives have gained immense popularity as stabilizers for amorphous solid dispersion owing to their diverse physicochemical properties. More than 20 amorphous solid dispersion-based products that have been approved for marketing consist of cellulose derivatives as stabilizers, thus highlighting their importance in generation of amorphous solid dispersions. These polymers offer numerous advantages like drug solubilization, crystallization inhibition and improvement in release patterns of drugs. Exploring their potential and exploiting their chemistry and p H responsive behaviour have led to the synthesis of new derivatives that has broadened the scope of the use of cellulose derivatives in amorphous formulation development. The present review aims to provide an overview of different mechanisms by which these cellulose derivatives inhibit the crystallization of drugs in the solid state and from supersaturated solution. A summary of different categories of cellulose derivatives along with the newly explored polymers has been provided. A special segment on strengths, weaknesses, opportunities, and threats(SWOT) analysis and critical quality attributes(CQAs) which affect the performance of the cellulose based amorphous solid dispersion will aid the researchers in identifying the major challenges in the development of cellulose based solid dispersion and serve as a guide for further formulation development.

关键词： Supersaturation hpmc Amorphous form Crystallization Polymers

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In vitro-in vivo correlation study on nimesulide loaded hydroxypropylmethylcellulose microparticles

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药学学报 2010年第6期45卷 772-777页

作者： Shujaat Ali KHAN Mahmood AHMAD Ghulam MURTAZA Muhammad Naeem AAMIR Rozina KOUSAR Fatima RASOOL Shahiq-u-ZAMAN Faculty of Pharmacy & Alternative Medicine the Islamia University of Bahawalpur

This study involves mathematical simulation model such as in vitro-in vivo correlation(IVIVC) development for various extended release formulations of nimesulide loaded hydroxypropylmethylcellulose(hpmc) microparticles(M1,M2 and M3 containing 1,2,and 3 g hpmc,respectively and 1 g drug in each) having variable release characteristics.In vitro dissolution data of these formulations were correlated to their relevant in vivo absorption profiles followed by predictability worth analysis of these Level A IVIVC.Nimaran was used as control formulation to validate developed formulations and their respective models.The regression coefficients of IVIVC plots for M1,M2,M3 and Nimaran were 0.834 9,0.831 2,0.927 2 and 0.898 1,respectively.The internal prediction error for all formulations was within limits,i.e.,hpmc floating M3 microparticles.In other words,this mathematical simulation model is best fit for biowaiver studies which involves study parameters as those adopted for M3 because the value of its IVIVC regression coefficient is the closest to 1 as compared to M1 and M2.

关键词： nimesulide modelling hpmc Wagner-Nelson method

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基于粘性材料改性微生物诱导碳酸钙沉淀加固粉土表层试验研究

基于粘性材料改性微生物诱导碳酸钙沉淀加固粉土表层试验研究

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作者：袁梦楠华北水利水电大学

学位级别：硕士

微生物诱导碳酸钙沉淀技术(MICP)作为一种新型的土体改良技术,通过微生物促进尿素水解生成的CO与人工提供的Ca相结合,在微生物周围矿化生成Ca CO,从而达到胶结土颗粒并固化土体的效果,由于其具有优秀的生物相容性、可持续性并对于环境... 详细信息

微生物诱导碳酸钙沉淀技术(MICP)作为一种新型的土体改良技术,通过微生物促进尿素水解生成的CO与人工提供的Ca相结合,在微生物周围矿化生成Ca CO,从而达到胶结土颗粒并固化土体的效果,由于其具有优秀的生物相容性、可持续性并对于环境保护有重要的意义,已经被广泛的应用在包括土体改良等诸多领域中。目前MICP技术在砂土加固中的应用较多,但对于黄河粉土等细粒土的研究相对较少。本文基于MICP技术,引入三种粘性材料(羟丙基甲基纤维素、羟乙基纤维素、海藻酸钠),并在不同菌液和胶结液剂量梯度和不同处理次数下对MICP联合粘性材料加固粉土表层进行相关试验和分析,主要内容及研究结论如下:(1)基于MICP技术联合羟丙基甲基纤维素(hpmc)对粉土表层加固,设置不同菌液和胶结液剂量梯度和不同处理次数,通过宏观测试(表层力学特性测试、试样表层抗风、抗雨蚀测试)和微观测试(Ca CO含量测试、氨保留率测试以及SEM、XRD测试)对hpmc-MICP加固粉土表层后的试样性能进行测试,并与相同处理条件下传统MICP和hpmc水溶液加固后的试样进行分析对比。结果表明:hpmc-MICP处理试样相比于传统MICP和hpmc水溶液处理后的试样具有更优秀的抗侵蚀性能、表层强度和氨保留率,处理后试样的表层强度最高达到401.95 k Pa,风损率最大为0.083%,降雨侵蚀测试中试样质量损失最低为9.28 g,氨保留率最高达到73.53%。另外添加hpmc有效增加了表层结壳中Ca CO的比例。SEM和XRD表明hpmc联合MICP处理后的试样表层微观结构致密且产物Ca CO的矿物成分并未发生改变。(2)本研究通过在常规MICP固化粉土表层处理中添加羟乙基纤维素(HEC),达到固定化Ca CO成核点、促使更多Ca CO在表层区域生成并形成粉土胶结壳的目的。试验中通过改变菌液、胶结液的剂量以及MICP处理次数,探究HEC-MICP加固粉土表层的效果。试验表明,HEC可以与MICP协同工作,提供一种多功能、高性能的粉土表层固化方法。HEC-MICP处理具有许多优点,包括促使胶结反应的局部化使得更多的Ca CO在粉土表层生成、有害副产物铵的减少以及实现较好的土壤强度和抗侵蚀性能。试验获得的粉土表层结壳可以承受达到474.69 k Pa的强度,氨的保留率最高达到了83.21%,试样在14 m/s风速下损失率最小为0.018%,2.5 mm/min雨强下质量损失最低为7.13 g。另外,微观结果表明HEC-MICP处理后Ca CO矿物的主晶型并未改变,且有效的减少了颗粒间隙。这些结果证明了HEC辅助MICP为粉土表层侵蚀控制和粉土体固化提供有效土壤改良和氨缓解的潜力。(3)在这项研究中,进行了一系列小规模的实验室试验,以探究在粉土表面固化中使用MICP和海藻酸钠(SA)溶液的混合物加固粉土表层的可行性。粉土表层处理是通过在土壤表面喷洒SA和施用MICP处理液来实现的。通过宏观试验和微观物理试验,采用不同的方法对其抗侵蚀性等性能进行了评价。进行了表层强度测试、小型模拟风洞试验和降雨试验来研究MICP联合SA处理的粉土的机械性能。对抗风蚀性能、抗雨蚀性能和表面结皮的强度进行了测量和介绍。还研究了处理后土壤的氨吸附情况,以及该技术用于处理粉土表层后的Ca CO生成量。试验结果表明添加SA后试样相对于传统MICP和SA水溶液处理后的试样具有更好的性能,SA-MICP处理后SA和Ca交联虽然降低了Ca CO生成量,但处理后形成的海藻酸钙-Ca CO-土颗粒土壤结壳有效改善了粉土试样表层性能:SA-MICP处理试样的抗风蚀率最低为0.016%,降雨质量损失最低为9.83 g,氨保留率最高达到67.19%,表层强度最高达到342.83 k Pa。另外利用扫描电子显微镜和X射线衍射分析技术得出了Ca CO矿物的主晶型不会因为SA的添加而发生改变。(4)对hpmc-MICP处理、HEC-MICP处理、SA-MICP处理后试样在最优MICP处理液剂量和最优处理次数下的宏观性能(表层强度、抗风蚀性能和抗雨蚀性能)和微观特性(Ca CO生成量和氨保留率)进行对比总结,结果表明:当处理次数为3且MICP处理液剂量梯度为Ⅳ时,在增强土体强度、改善降雨侵蚀方面的应用中,HEC-MICP处理试样具有相比于另外两种粘性材料更优秀的表层强度和抗雨蚀性能,表层强度达到474.69 k Pa,降雨质量损失最低为7.13 g。SA-MICP处理试样的Ca CO生成量因SA交联反应最低,HEC-MICP和hpmc-MICP处理试样的总Ca CO生成量几乎相同。在减少MICP过程中NH的排放量方面,HEC-MICP具有相比于hpmc和SA更优秀的氨保留率,氨保留率相比于hpmc和SA分别提高9.68%和16.02%。在粉尘控制方面,hpmc、HEC、SA联合MICP处理后的试样均具有较优秀的抗风蚀性能,14 m

关键词： MICP 碳酸钙粘性材料 hpmc HEC 海藻酸钠抗风性能抗雨蚀性能

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神经网络多目标同步优化hpmc缓释片处方

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中国药学杂志 2004年第10期39卷 768-771页

作者：范彩霞梁文权浙江大学药学院浙江杭州310031

目的　通过建立BP神经网络模型,预测hpmc缓释片中药物释放;并和优化算法结合实现缓释片处方的多目标同步优化。方法　选取溶解度为难溶到略溶的5种药物(别嘌醇,甲氧苄氨嘧啶,阿昔洛韦,替硝唑,对乙酰氨基酚)作为模型药物,压制hpmc骨架片... 详细信息

目的　通过建立BP神经网络模型,预测hpmc缓释片中药物释放;并和优化算法结合实现缓释片处方的多目标同步优化。方法　选取溶解度为难溶到略溶的5种药物(别嘌醇,甲氧苄氨嘧啶,阿昔洛韦,替硝唑,对乙酰氨基酚)作为模型药物,压制hpmc骨架片,并进行体外释放情况考察,考察52个处方中药物的溶解度、含药量、hpmc的量、hpmc的固有黏度、辅料的量、黏合剂的浓度、溶出仪的转速对药物释放情况的影响。将各因素作为神经网络的输入,药物的累计释放量作为输出,对网络进行训练,建立BP神经网络模型,并和优化算法相结合实现以对乙酰氨基酚、甲氧苄氨嘧啶、米诺地尔、氧氟沙星为模型药物,在不同的含药量、不同转速的条件下对处方进行优化。结果利用神经网络预测药物的释放,训练处方和测试处方的实测值和预测值能很好吻合,4个优化处方的释放值均和目标值很接近。结论　神经网络可用于预测不同药物不同处方组成的hpmc缓释片中药物的释放,并能同步优化hpmc缓释骨架片的处方。

关键词：人工神经网络多目标同步优化 hpmc 缓释片

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Formulation development of nifedipine controlled-release coated tablets

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Asian Journal of Pharmaceutical Sciences 2016年第1期11卷 118-119页

作者： Ananya Ubonratana Sirachaya Choosakul Nara Nilnakara Chaisan Sriwichupong Garnpimol Ritthidej Department of Pharmaceutics and Industrial Pharmacy Faculty of Pharmaceutical Sciences Chulalongkorn University

Due to frequent administration of oral nifedipine tablet, controlled or sustained release of the drug will improve patient compliance, stable blood level and side effect decrement [1,2].Various extended release nifedipine products have been commercially available. In this study, extended release tablets of this drug were formulated using sodium alginate,hydroxypropylmethylcellulose (hpmc) as controlled release matrix materials.

关键词： Nifedipine Extended release tablet Matrix Sodium alginate hpmc

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Controlled release tablets of verapamil hydrochloride

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Asian Journal of Pharmaceutical Sciences 2016年第1期11卷 219-220页

作者： Treephu Kimlek Tossaporn Prasertporn Jiramet Sawantranon Chaisan Sriwichupong Garnpimol Ritthidej Pharmaceutical Technology Field Department of Pharmaceutics and Industrial Pharmacy Faculty of Pharmaceutical Sciences Chulalongkorn University

Verapamil is a calcium channel blocker drug which reduces heart rhythm and blood pressure in high blood pressure patient.The steady state of this drug has to be continually controlled to obtain optimal efficacy.In addition,patient compliance needs to be considered.Therefore,controlled release tablet of verapamil hydrochloride was essentially developed using hydrophilic matrix polymer,namely hydroxypropylmethyl cellulose(hpmc)and sodium alginate,and compared to marketed product[1].hpmc,a pH-independent polymer,hydrates to form a gel layer at the surface of the tablet to sustain the drug release.Sodium alginate,a pH-dependent gelling polymer,converts to insoluble alginic acid after exposure to acidic condition in stomach.

关键词： Verapamil Controlled release hpmc Sodium alginate

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