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| 1 | Application of quality by design in the current drug development显示文摘Quality by Test was the only way to guarantee quality of drug products before FDA launched current Good Manufacturing Practice. To clearly understand the manufacture processes, FDA generalized Quality by Design(QbD) in the field of pharmacy, which is based on the thorough understanding of how materials and process parameters affect the quality profile of final products. The application of QbD in drug formulation and process design is based on a good understanding of the sources of variability and the manufacture process. In this paper,the basic knowledge of QbD, the elements of QbD, steps and tools for QbD implementation in pharmaceutics field, including risk assessment, design of experiment, and process analytical technology(PAT), are introduced briefly. Moreover, the concrete applications of QbD in various pharmaceutical related unit operations are summarized and presented. | Lan Zhang Shirui Mao | 2017 | Asian Journal of Pharmaceutical Sciences2017，12，1： | 9 |
| 2 | Evaluation of chitosaneanionic polymers based tablets for extended-release of highly watersoluble drugs显示文摘The objective of this study is to develop chitosaneanionic polymers based extendedrelease tablets and test the feasibility of using this system for the sustained release of highly water-soluble drugs with high drug loading.Here,the combination of sodium valproate(VPS)and valproic acid(VPA)were chosen as the model drugs.Anionic polymers studied include xanthan gum(XG),carrageenan(CG),sodium carboxymethyl cellulose(CMC-Na)and sodium alginate(SA).The tablets were prepared by wet granulation method.In vitro drug release was carried out under simulated gastrointestinal condition.Drug release mechanism was studied.Compared with single polymers,chitosaneanionic polymers based system caused a further slowdown of drug release rate.Among them,CS exanthan gum matrix system exhibited the best extended-release behavior and could extend drug release for up to 24 h.Differential scanning calorimetry(DSC)and Fourier transform infrared spectroscopy(FTIR)studies demonstrated that polyelectrolyte complexes(PECs)were formed on the tablet surface,which played an important role on retarding erosion and swelling of the matrix in the later stage.In conclusion,this study demonstrated that it is possible to develop highly water-soluble drugs loaded extendedrelease tablets using chitosaneanionic polymers based system. | Yang Shao Liang Li Xiangqin Gu Linlin Wang Shirui Mao | 2015 | Asian Journal of Pharmaceutical Sciences2015，10，1： | 2 |
| 3 | Applications of quality by design(QbD) and its tools in drug delivery显示文摘Quality by Test (Qb T) was the only way to guarantee the quality of drug products before FDA launches current Good Manufacturing Practice (c GMP)[1], which is an approach without clear understanding of the processes. In order to solve this problem,FDA generalized Quality by Design (QbD) in the field of pharmacy (2)In pharmaceutical industry, Qb D brings cost-efficiency and simplicity of manufacturing process into reality. | Lan Zhang Shirui Mao | 2016 | Asian Journal of Pharmaceutical Sciences2016，11，1： | 2 |
| 4 | Effect of formulation variables on in vitro release of a water-soluble drug from chitosanesodium alginate matrix tablets显示文摘The objective of this study is to investigate the feasibility of using chitosanesodium alginate(CSeSA)based matrix tablets for extended-release of highly water-soluble drugs by changing formulation variables.Using trimetazidine hydrochloride(TH)as a water-soluble model drug,influence of dissolution medium,the amount of CSeSA,the CS:SA ratio,the type of SA,the type and amount of diluents,on in vitro drug release from CSeSA based matrix tablets were studied.Drug release kinetics and release mechanisms were elucidated.In vitro release experiments were conducted in simulated gastric fluid(SGF)followed by simulated intestinal fluid(SIF).Drug release rate decreased with the increase of CSeSA amount.CS:SA ratio had only slight effect on drug release and no influence of SA type on drug release was found.On the other hand,a large amount of water-soluble diluents could modify drug release profiles.It was found that drug release kinetics showed the best fit to Higuchi equation with Fickian diffusion as the main release mechanism.In conclusion,this study demonstrated that it is possible to design extended-release tablets of watersoluble drugs using CSeSA as the matrix by optimizing formulation components,and provide better understanding about drug release from CSeSA matrix tablets. | Liang Li Jinfeng Li Shanshan Si Linlin Wang Chenjun Shi Yujiao Sun Zhenglin Liang Shirui Mao | 2015 | Asian Journal of Pharmaceutical Sciences2015，10，4： | 2 |
| 5 | Development and evaluation of vinpocetine inclusion complex for brain targeting显示文摘The objective of this paper is to prepare vinpocetine(VIN)inclusion complex and evaluate its brain targeting effect after intranasal administration.In the present study,VIN inclusion complex was prepared in order to increase its solubility.Stability constant(Kc)was used for host selection.Factors influencing properties of the inclusion complex was investigated.Formation of the inclusion complex was identified by solubility study and DSC analysis.The brain targeting effect of the complex after intranasal administration was studied in rats.It was demonstrated that properties of the inclusion complex was mainly influenced by cyclodextrin type,organic acids type,system pH and host/guest molar ratio.Multiple component complexes can be formed by the addition of citric acid,with solubility improved for more than 23 times.Furthermore,In vivo study revealed that after intranasal administration,the absolute bioavailability of vinpocetine inclusion complex was 88%.Compared with intravenous injection,significant brain targeting effect was achieved after intranasal delivery,with brain targeting index 1.67.In conclusion,by intranasal administration of VIN inclusion complex,a fast onset of action and good brain targeting effect can be achieved.Intranasal route is a promising approach for the treatment of CNS diseases. | Jiaojiao Ding Jinfeng Li Shirui Mao | 2015 | Asian Journal of Pharmaceutical Sciences2015，10，2： | 2 |
| 6 | Intranasal administration of melatonin starch microspheres 显示文摘 | Shirui Mao Jianming Chen Zhenping Wei | 2004 | International Journal of Pharmaceutics2004，272，： | 1 |
| 7 | Intranasal administration of melatonin starch microspheres 显示文摘 | SHIRUI MAO JIANMING CHEN ZHENPING WEI | 2004 | International Journal of Pharmaceutics2004，272，12： | 1 |
| 8 | Intranasal administration of melatonin starch microspheres显示文摘 | Shirui Mao Jianming Chen Zhenping Wei Huan Liu Dianzhou Bi | 2004 | International Journal of Pharmaceutics2004，272，12： | 1 |
| 9 | Intranasal administration of melatonin starch micro-spheres显示文摘 | Shirui Mao Jianming Chen Zhenping Wei | 2004 | International Journal of Pharmaceutics2004，272，12： | 1 |
| 10 | Intranasal administration of melatonin starch microspheres显示文摘 | Shirui Mao Jianrning Chen Zhenping Wei Huan Liu Dianzhou Bi | 2004 | International Journal of Pharmaceutics2004，272，12： | 1 |
| 11 | Intranasal ad- ministration of melatonin starch microspheres 显示文摘 | Mao Shirui Chcn Jianming Wei Zhenping | 2004 | International Journal of Pharmaceutics2004，272，12： | 1 |
| 12 | Exploring the potential to enhance drug distribution in the brain subregion via intranasal delivery of nanoemulsion in combination with borneol as a guider显示文摘The number of people with Alzheimer’s disease(AD)is increasing annually,with the nidus mainly concentrated in the cortex and hippocampus.Despite of numerous efforts,effective treatment of AD is still facing great challenges due to the blood brain barrier(BBB)and limited drug distribution in the AD nidus sites.Thus,in this study,using vinpocetine(VIN)as a model drug,the objective is to explore the feasibility of tackling the above bottleneck via intranasal drug delivery in combination with a brain guider,borneol(BOR),using nanoemulsion(NE)as the carrier.First of all,the NE were prepared and characterized.In vivo behavior of the NE after intranasal administration was investigated.Influence of BOR dose,BOR administration route on drug brain targeting behavior was evaluated,and the influence of BOR addition on drug brain subregion distribution was probed.It was demonstrated that all the NE had comparable size and similar retention behavior after intranasal delivery.Compared to intravenous injection,improved brain targeting effect was observed by intranasal route,and drug targeting index(DTI)of the VIN–NE group was 154.1%,with the nose-to-brain direct transport percentage(DTP)35.1%.Especially,remarkably enhanced brain distribution was achieved after BOR addition in the NE,with the extent depending on BOR dose.VIN brain concentration was the highest in the VIN-1-BOR-NE group at BOR dose of 1 mg/kg,with the DTI reaching 596.1%and the DTP increased to 83.1%.BOR could exert better nose to brain delivery when administrated together with the drug via intranasal route.Notably,BOR can remarkably enhance drug distribution in both hippocampus and cortex,the nidus areas of AD.In conclusion,in combination with intranasal delivery and the intrinsic brain guiding effect of BOR,drug distribution not only in the brain but also in the cortex and hippocampus can be enhanced significantly,providing the perquisite for improved therapeutic efficacy of AD. | Xin Shen Zhixiang Cui Yidan Wei Yingnan Huo Duo Yu Xin Zhang Shirui Mao | 2023 | Asian Journal of Pharmaceutical Sciences2023，18，6： | 1 |
| 13 | Synthesis, characterization and cytotoxicity of poly(ethylene glycol)-grafttrimethyl chitosan block copolymers显示文摘 | Mao Shirui Shuai Xintao Unger F | 2005 | Biomaterials2005，26，32： | 1 |
| 14 | Intranasal administration of melatonin starch microspheres 显示文摘 | Mao Shirui Chen Jianming Wei Zhenping | 2004 | International Journal of Pharmaceutics2004，272，12： | 1 |
| 15 | Effect of WOW process parameters on morphologyand burst release of FITC dextran loaded PLGA microspheres 显示文摘 | MAO Shirui XU Jing CAI Cuifang | 2007 | Interna- tional Journal of Pharnlaceutics2007，334，12： | 1 |
| 16 | Intranasal administration of melatonin starch microspheres显示文摘 | Shirui Mao Jianming Chen Zhenping Wei | 2004 | International Journal of Pharmaceutics2004，272，12： | 1 |
| 17 | Effect of WOW process parameters on morphologyand burst release of FITC dextran loaded PLGA microspheres显示文摘 | MAO Shirui XU Jing CAI Cuifang | 2007 | Int J Pharm2007，334，12： | 1 |
| 18 | Intranasal administration of melatonin starch microspheres显示文摘 | Mao Shirui Chen Jianming Wei Zhenping | 2004 | International Journal of Pharmaceutics2004，272，12： | 1 |
| 19 | Tunable and sustained-release characteristics of venlafaxine hydrochloride from chitosan–carbomer matrix tablets based on in situ formed polyelectrolyte complex film coating显示文摘The objective of this study is to design sustained-release tablets using matrix technology, which can well control the release of highly water-soluble drugs with good system robustness and simple preparation process. Taking venlafaxine hydrochloride(VH) as a drug model, the feasibility of using chitosan(CS), carbomer(CBM) combination system to achieve this goal was studied. Formulation and process variables influencing drug release from CS–CBM matrix tablets were investigated. It was found that CS–CBM combination system weakened the potential influence of CS, CBM material properties and gastric emptying time on drug release profile. Demonstrated by direct observation, differential scanning calorimetry(DSC) and Fourier transform infrared spectroscopy(FTIR), in situ self-assembled polyelectrolyte complex(PEC) film was formed on the tablet surface during gastrointestinal tract transition, which contributed to the tunable and robust control of drug release. The sustained drug release behavior was further demonstrated in vivo in Beagle dogs, with level A in vitro and in vivo correlation(IVIVC) established successfully. In conclusion, CS–CBM matrix tablets are promising system to tune and control the release of highly water-soluble drugs with good system robustness. | Xiaofei Zhang Xiangqin Gu Xiaodan Wang Huimin Wang Shirui Mao | 2018 | Asian Journal of Pharmaceutical Sciences2018，13，6： | 1 |
| 20 | Intranasal administration of melatonin starch microspheres显示文摘 | Shirui Mao Jianming Chen Zhenping Wei Huan Liu Dianzhou Bi | 2004 | International Journal of Pharmaceutics2004，272，12： | 1 |
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