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Intranasal administration of stem cell-derived exosomes for central nervous system diseases

Neural Regeneration Research 2024年第6期19卷 1249-1255页

作者： Shuho Gotoh Masahito Kawabori Miki Fujimura Department of Neurosurgery Hokkaido University Graduate School of Medicine

Exosomes, lipid bilayer-enclosed small cellular vesicles, are actively secreted by various cells and play crucial roles in intercellular communication. These nanosized vesicles transport internalized proteins, mRNA, miRNA, and other bioactive molecules. Recent findings have provided compelling evidence that exosomes derived from stem cells hold great promise as a therapeutic modality for central nervous system disorders. These exosomes exhibit multifaceted properties including antiapoptotic, anti-inflammatory, neurogenic, and vasculogenic effects. Furthermore, exosomes offer several advantages over stem cell therapy, such as high preservation capacity, low immunogenicity, the ability to traverse the blood-brain barrier, and the potential for drug encapsulation. Consequently, researchers have turned their attention to exosomes as a novel therapeutic avenue. Nonetheless, akin to the limitations of stem cell treatment, the limited accumulation of exosomes in the injured brain poses a challenge to their clinical application. To overcome this hurdle, Intranasal administration has emerged as a non-invasive and efficacious route for delivering drugs to the central nervous system. By exploiting the olfactory and trigeminal nerve axons, this approach enables the direct transport of therapeutics to the brain while bypassing the blood-brain barrier. Notably, exosomes, owing to their small size, can readily access the nerve pathways using this method. As a result, Intranasal administration has gained increasing recognition as an optimal therapeutic strategy for exosomebased treatments. In this comprehensive review, we aim to provide an overview of both basic and clinical research studies investigating the Intranasal administration of exosomes for the treatment of central nervous system diseases. Furthermore, we elucidate the underlying therapeutic mechanisms and offer insights into the prospect of this approach.

关键词： central nervous system disease exosome extracellular vesicle Intranasal administration stem cell

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Intranasal administration nanosystems for brain-targeted drug delivery

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Nano Research 2023年第12期16卷 13077-13099页

作者： Yue Jiang Xueting Pan Tao Yu Hai Wang CAS Key Laboratory for Biomedical Effects of Nanomaterials&Nanosafety CAS Center for Excellence in NanoscienceNational Center for Nanoscience and TechnologyBeijing 100190China University of Chinese Academy of Sciences Beijing 100049China Beijing Institute of Functional Neurosurgery Xuanwu HospitalCapital Medical UniversityBeijing 100053China

The existence of the blood-brain barrier(BBB)restricts the entry of drugs from the circulation into the central nervous system(CNS),which severely affects the treatment of neurological diseases,including glioblastoma,Parkinson’s disease(PD),and Alzheimer’s disease(AD).With the advantage of bypassing the BBB and avoiding systemic distribution,Intranasal administration has emerged as an alternative method of delivering drugs to the brain.Drug delivery directly to the brain using intranasal nanosystems represents a new paradigm for neurological disease treatment because of its advantages in improving drug solubility and stability in vivo,enabling targeted drug delivery and controlled release,and reducing non-specific toxicity.And it has shown efficacy in animal models and clinical applications.Herein,this review describes the mechanisms of intranasal delivery of brain-targeted drugs,the properties of nanosystems for Intranasal administration(e.g.,liposomes,nanoemulsions,and micelles),and strategies for intranasal drug delivery to enhance brain-targeted drug delivery.Recent applications of nanosystems in intranasal drug delivery and disease treatment have been comprehensively reviewed.Although encouraging results have been reported,significant challenges still need to be overcome to translate these nanosystems into clinics.Therefore,the future prospects of intranasal drug delivery nanosystems are discussed in depth,expecting to provide useful insights and guidance for effective neurological disease treatment.

关键词： Intranasal administration nanosystems brain-targeted delivery neurological diseases drug delivery

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HR121 targeting HR2 domain in S2 subunit of spike protein can serve as a broad-spectrum SARS-CoV-2 inhibitor via Intranasal administration

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Acta Pharmaceutica Sinica B 2023年第8期13卷 3339-3351页

作者： Ying Lu Fan Shen Wen-Qiang He An-Qi Li Ming-Hua Li Xiao-Li Feng Yong-Tang Zheng Wei Pang Key Laboratory of Animal Models and Human Disease Mechanisms of the Chinese Academy of Sciences/Key Laboratory of Bioactive Peptides of Yunnan Province KIZ-CUHK Joint Laboratory of Bioresources and Molecular Research in Common DiseasesCenter for Biosafety Mega-ScienceKunming Institute of ZoologyChinese Academy of SciencesKunming 650223China University of Chinese Academy of Sciences Beijing 100049China Kunming National High-level Biosafety Research Center for Non-human Primates Center for Biosafety MegaScienceKunming Institute of ZoologyChinese Academy of SciencesKunming 650107China

The continuously emerging SARS-CoV-2 variants pose a great challenge to the efficacy of current drugs,this necessitates the development of broad-spectrum antiviral drugs.In the previous study,we designed a recombinant protein,heptad repeat(HR)121,as a variant-proof vaccine.Here,we found it can act as a fusion inhibitor and demonstrated broadly neutralizing activities against SARS-CoV-2 and its main variants.Structure analysis suggested that HR121 targets the HR2 domain in SARS-CoV-2 spike(S)2 subunit to block virus-cell fusion.Functional experiments demonstrated that HR121 can bind HR2 at serological-pH and endosomal-pH,highlighting its inhibition capacity when SARS-CoV-2 enters via either cellular membrane fusion or endosomal route.Importantly,HR121 can effectively inhibit SARS-CoV-2 and Omicron variant pseudoviruses entering the cells,as well as block authentic SARSCoV-2 and Omicron BA.2 replications in human pulmonary alveolar epithelial cells.After Intranasal administration to Syrian golden hamsters,it can protect hamsters from SARS-CoV-2 and Omicron BA.2 infection.Together,our results suggest that HR121 is a potent drug candidate with broadly neutralizing activities against SARS-CoV-2 and its variants.

关键词： SARS-CoV-2 S2 subunit Heptad repeat 2 HR121 Fusion inhibitor Intranasal administration Variants Omicron BA.2

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Protective effects of resveratrol nanosuspensions loaded in situ hydrogel on Alzheimer disease model mice after Intranasal administration

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中国药理学与毒理学杂志 2017年第5期31卷 468-469页

作者： WANG Hong-shen XU Yan-hao CHANG Sheng LI Li WANG Hao HAO Ji-fu College of Pharmacy Taishan Medical university

OBJECTIVE To evaluate the protective effects of resveratrol nanosuspensions loaded in situ hydrogel on Alzheimer disease model mice after Intranasal administration. METHODS Resveratrol nanosuspensions were fabricated by antisolvent nano-precipitation method,and then dispersed into0.5% gellan gum to form resveratrol nanosuspenisons loaded ionic sensitive in situ hydrogel. The Alzheimer′s disease models were induced by lateral ventricle injection of Aβ_(25~35)and the protection and treatment effects of resveratrol nanosuspensions loaded in situ hydrogel on study and memory capability were performed after Intranasal administration in water maze experiments. The analyses of the changes of cholinergic neurotransmitters in the brain were also determined according to the contents of acetylcholine(ACh),choline acetyltransferase(ChAT) and acetylcholinesterase(AChE). RESULTS Behavior assessment disclosed that in position navigation,escape latency test,each of experimental animals showed a decreased trend with swim training days increase,indicating that in the training process they had the ability of learning and memory in looking for the platform. Compared with the control group,average latency of model group significantly increased. While compared with the model group,treatment group′s average latency was significantly shorter. Space exploration experiment results showed that the times of model group across target quadrant of the platform is less than that of control group. But the crossing times of treatment group with resveratrol increased compared with the model group. As for the changes of cholinergic neurotransmitters,in AD mice brain ACh content decreased; the Ch AT activity decreased,while the activity of ACh E with the ability to hydrolysis acetylcholine increased. The administration of resveratrol can decrease the activity of ACh enzymes but increase Ch AT activity and the levels of acetylcholine. CONCLUSION Resveratrol nanosuspension loaded in situ gel can ameliorate the declining ability of learning and memory

关键词： resveratrol Intranasal administration Alzheimer disease water maze experiments

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Distribution of nimodipine in brain following Intranasal administration in rats

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Acta Pharmacologica Sinica 2004年第4期25卷 124-129页

作者： Qi-zhi ZHANG, Xin-guo JIANG2, Chun-hua WU Department of Pharmaceutics, School ofPharmacy, Fudan University, Shanghai 200032, China Department of Pharmaceutics School of Pharmacy Fudan University

AIM: To determine whether nasally applied nimodipine (NM) could improve its systemic bioavailability and be transported directly from the nasal cavity to the brain. METHODS: NM was administered nasally, intravenously (iv), and orally to male Sprague-Dawley rats. At different times post dose, blood, cerebrospinal fluid (CSF), and brain tissue samples were collected, and the concentrations of NM in the samples were analyzed byHPLC. RESULTS: Oral systemic bioavailability of NM in rats was 1.17 %, nasal dosing improved bioavailibility to 67.4 %. Following Intranasal administration, NM concentrations in olfactory bulb (OB) within 30 min post dose were found significant higher than in the other brain tissues. However, similar NM levels in different brain regions were observed after iv injection. AUC in CSF and OB from the nasal route was 1.26 and 1.39 fold compared with the iv route, respectively. The brain-to-plasma AUC ratios were significantly higher after nasal administration than after iv administration (P<0.01). CONCLUSION: Nasally administered NM could markedly improve the bioavailability and a fraction of the NM dose could be transported into brain via the olfactory pathway in rats.

关键词： Intranasal administration nimodipine olfactory bulb olfactory pathways

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Drug brain distribution following Intranasal administration of Huperzine A in situ gel in rats

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Acta Pharmacologica Sinica 2007年第2期28卷 273-278页

作者： Yan ZHAO Peng YUE Tao TAO~2 Qing-hua CHEN Shanghai Institute of Pharmaceutical Industry,Shanghai 200040,China ShanghaiInstituteofPharmaceuticalIndustry Shanghai200040China

Aim:To determine the uptake extent of Huperzine A(Hup A)into the brain afterIntranasal administration of Hup A in situ gel to rats,and to compare the pharma-cokinetic parameters between Intranasal administration and iv and po.Methods:Hup A was administered to male Sprague-Dawley rats via nasal,iv and oral routesat the dose of 166.7,166.7,and 500 μg/kg,respectively.Blood and brain tissuesamples including the cerebrum,hippocampus,cerebellum and olfactory bulbwere collected,and the concentrations of Hup A in the samples were assayed byHPLC.The area under the concentration-time curve(AUC0→6 h)and the ratio ofthe AUCbrain to the AUCplasma(drug targeting efficiency,DTE)were calculated toevaluate the brain targeting efficiency of the drug via 3 administration routes.Results:The AUC0→6 h of the drug in the cerebrum,hippocampus,cerebellum,left olfactory bulb and right olfactory bulb after Intranasal administration of theHup A in situ gel were 1.5,1.3,1.0,1.2,and 1.0 times of those after iv administrationof the injection,and 2.7,2.2,1.9,3.1,and 2.6 times of those after administration ofthe oral formulation.The AUCbrain0→6 h/AUCplasma0→6 h of HupAin the cerebrum,hippocampus and left olfactory bulb following the Intranasal administration dosewere significantly higher(Pintranasal deliv-ery showed a viable,non-invasive strategy for delivering the drug into brain.

关键词： Huperzine A in situ gel brain distribution Intranasal administration

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Comparison of pharmacokinetics of Alprazolam after intranasal and intragastric administration in rats

Comparison of pharmacokinetics of Alprazolam after intranasa...

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两岸三地药理学与临床药理学术会议

作者： GAO Yun-sheng FEI Hong-rong LI Ke XIN Xiao-ming QU Xiao-lan QI Yong-xiu (School of Pharmacy, Taishan Medical University, Taian 271016, China)

Objective To compare the pharmacokinetics of Alprazolam after intranasal and intragastic admin- istration in rats and evaluate the practicability of Alprazolam as a nasal drug delivery system.Methods 12 rats were randomly divided into two groups.The fate of drug in the serum of rats was monitered after in- tranasal and intragastic administration of Alprazolam 2 mg·kg.Serum levels of Alprazolam were deter- mined by reversed-phase HPLC with Diode array detectors (DAD).Chromatographic conditions were adopted with ODS column as solid phase,methanaol-0.02 M ammonium acetate (pH=5.0)(60:40) as mo- bile phase at a flow rate of 1.0 mL·min.The detection wavelength was 223 nm.The concentration-time data were analyzed using 3P87 program,and the pharmacokinetic parameters were compared by t-test.Re- suits The pharmacokinetic characteristics were fit to two and one compartment opened model after in- tranasal and intragastic administration of Alprazolam,respectively.The drug absorption was quicker and the serum concentrations of Alprazolam was significantly higher in rats after Intranasal administration group than that intragastic administration group (P0.05).Means of pharmacokinetic parameters in intranasal and intragas- tic groups were:K 37.35±22.98 vs 11.57±12.47 h(P0.05),t(t)2.51±0.99 vs 2.54±0.97 h(P>0.05),t 0.156±0.069 VS 0.618±0.414 h(PIntranasal administration.And the serum concentra- tion and bioavailability can be significantly increased after Intranasal administration,which may be an effec- tive preparation as nasal drug delivery system.

关键词： Alprazolam Intranasal administration pharmacokinetics RP-HPLC

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Influence of the nasal mucociliary system on intranasal drug administration

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Chinese Medical Journal 2000年第7期113卷 71-73页

作者：王静清卜国铉 China 519000 China 130031

To study the influence of the nasal mucociliary system on intranasal drug administration and ways of reducing its influence on nasal absorption Methods Rabbit nasopharynx was closed to stop mucociliary function in one group In the other group, rabbits maintained their mucociliary function Both groups were given a nasal drip of gentamycin and the serum levels were measured from 0 to 180 minutes after drug administration To reduce the undesirable effects of the nasal mucociliary system, acetylcysteine was mixed into the gentamycin drops In addition, nasal nebulization was evaluated in human volunteers as a means of increasing absorption of the drug in the non ciliary area of the nasal cavity Results Nasal mucociliary function reduced intranasal absorption of drug and made the highest absorbing rate and area under the curve (AUC) decrease by 25 1% and 18 2%, respectively Both the nasal drip containing acetylcysteine and the nebulizer could promote drug absorption in the nasal mucosa The former made the highest intranasal absorption and AUC increase by 18 0% and 10 7%, respectively The latter made the absorption increase 1 5-1 6 times Conclusion The mucociliary system can decrease intranasal drug absorption Application of acetylcysteine or the use of nebulizer can increase drug absorption

关键词： Intranasal administration nasal mucociliary system gentamycin

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Polymeric nanocarriers for nose-to-brain drug delivery in neurodegenerative diseases and neurodevelopmental disorders

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Acta Pharmaceutica Sinica B 2023年第5期13卷 1866-1886页

作者： Rania Awad Avi Avital Alejandro Sosnik Laboratory of Pharmaceutical Nanomaterials Science Department of Materials Science and EngineeringTechnion-Israel Institute of TechnologyHaifa 3200003Israel Behavioral Neurobiology Laboratory Department of Occupational TherapyFaculty of Social Welfare and Health SciencesUniversity of HaifaHaifa 3498838Israel

Neurodegenerative diseases are progressive conditions that affect the neurons of the central nervous system(CNS)and result in their damage and death.Neurodevelopmental disorders include intellectual disability,autism spectrum disorder,and attention-deficit/hyperactivity disorder and stem from the disruption of essential neurodevelopmental processes.The treatment of neurodegenerative and neurodevelopmental conditions,together affecting~120 million people worldwide,is challenged by the blood—brain barrier(BBB)and the blood—cerebrospinal fluid barrier that prevent the crossing of drugs from the systemic circulation into the CNS.The nose-to-brain pathway that bypasses the BBB and increases the brain bioavailability of intranasally administered drugs is promising to improve the treatment of CNS conditions.This pathway is more efficient for nanoparticles than for solutions,hence,the research on intranasal nano-drug delivery systems has grown exponentially over the last decade.Polymeric nanoparticles have become key players in the field owing to the high design and synthetic flexibility.This review describes the challenges faced for the treatment of neurodegenerative and neurodevelopmental conditions,the molecular and cellular features of the nasal mucosa and the contribution of intranasal nano-drug delivery to overcome them.Then,a comprehensive overview of polymeric nanocarriers investigated to increase drug bioavailability in the brain is introduced.

关键词： Neurodegenerative diseases Neurodevelopmental disorders Central nervous system Blood—brain barrier Nano-drug delivery systems Nose-to-brain pathway Intranasal administration Polymeric nanoparticles Polymeric micelles Dendrimers

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Human umbilical cord-derived mesenchymal stem cells promote repair of neonatal brain injury caused by hypoxia/ischemia in rats

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Neural Regeneration Research 2022年第11期17卷 2518-2525页

作者： Yang Jiao Yue-Tong Sun Nai-Fei Chen Li-Na Zhou Xin Guan Jia-Yi Wang Wen-Juan Wei Chao Han Xiao-Lei Jiang Ya-Chen Wang Wei Zou Jing Liu Stem Cell Clinical Research Center National Joint Engineering LaboratoryRegenerative Medicine CenterThe First Affiliated Hospital of Dalian Medical UniversityDalianLiaoning ProvinceChina Dalian Innovation Institute of Stem Cells and Precision Medicine DalianLiaoning ProvinceChina Department of Neurology The First Affiliated Hospital of Dalian Medical UniversityDalianLiaoning ProvinceChina College of Life Science Liaoning Normal UniversityDalianLiaoning ProvinceChina

administration of human umbilical cord-derived mesenchymal stem cells(hUC-MSCs)is believed to be an effective method for treating neurodevelopmental disorde rs.In this study,we investigated the possibility of hUC-MSCs treatment of neonatal hypoxic/ischemic brain injury associated with maternal immune activation and the underlying mechanism.We established neonatal rat models of hypoxic/ischemic brain injury by exposing pregnant rats to lipopolysaccharide on day 16 or 17 of pregnancy.Rat offspring were intranasally administe red hUC-MSCs on postnatal day 14.We found that polypyrimidine tract-binding protein-1(PTBP-1)participated in the regulation of lipopolysaccharide-induced maternal immune activation,which led to neonatal hypoxic/ischemic brain injury.intranasal delive ry of hUC-MSCs inhibited PTBP-1 expression,alleviated neonatal brain injury-related inflammation,and regulated the number and function of glial fibrillary acidic protein-positive astrocytes,there by promoting plastic regeneration of neurons and im p roving brain function.These findings suggest that hUC-MSCs can effectively promote the repair of neonatal hypoxic/ischemic brain injury related to maternal immune activation through inhibition of PTBP-1 expression and astrocyte activation.

关键词： developmental brain disease model disease-associated astrocytes Intranasal administration lipopolysaccharide maternal immune activation neonatal brain injury neuroplasticity repair polypyrimidine tract-binding protein-1 stem cell therapy umbilical cord-derived mesenchymal stem cells

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