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Formulation and in vitro characterization of long-acting PLGA injectable microspheres encapsulating a peptide analog of LHRH

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Journal of Materials Science & Technology 2021年第4期63卷 133-144页

作者： Chengqian Zhang Lan Wu Anjin Tao Hriday Bera Xing Tang dongmei cun Mingshi Yang Wuya College of Innovation Shenyang Pharmaceutical UniversityWenhua Road 103110016 ShenyangChina Hybio Pharmaceutical Co. Ltd.Keji C.2nd Road 37518057 ShenzhenChina School of Pharmacy Shenyang Pharmaceutical UniversityWenhua Road 103110016 ShenyangChina Department of Pharmacy Faculty of Health and Medical SciencesUniversity of CopenhagenUniversitetsparken 22100 CopenhagenDenmark

The present study aimed to formulate triptorelin acetate(TA)into poly(D,L-lactic-co-glycolic)acid(PLGA)based injectable sustained-release microspheres(TA-PLGA-MS)by usingdouble emulsion solvent extraction/evaporation(DESE)technique and investigate the effects of various material attributes and process parameters on the quality attributes such as size,shape,surface morphology,encapsulation efficiency(EE)and in vitro release behavior of these *** compositions of the outer water phase,type of the organic solvents,volume ratios of inner water phase to oil phase,PLGA concentrations,and the powers for emulsification in the preparation of the microspheres showed an influence on their quality *** optimal formulation(F-2)obtained from this univariate approach possess an excellent EE value of 63.5%±3.4%and an average volumetric particle size of 35.3±1.8μ*** formulation was further accomplished with different solidification rates assisted by variable incubation temperatures,which exhibited an impact on the shape/surface and inner morphology of the *** resultant microspheres also displayed different in vitro release *** matrices processed with a high incubation temperature conferred the fastest and the most complete drug release profile over the period of 63 ***,the solidification rate could be identified as one of the critical process parameters that affected the quality of the PLGA based injectable microspheres specifically designed for the prolonged delivery of TA.

关键词： sustained release PLGA

Sustained release donepezil loaded PLGA microspheres for injection:Preparation,in vitro and in vivo study

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Asian Journal of Pharmaceutical Sciences 2015年第5期10卷 405-414页

作者： Wenjia Guo Peng Quan Liang Fang dongmei cun Mingshi Yang Department of Pharmaceutics Shenyang Pharmaceutical University110016China Department of Pharmacy Faculty of Health and Medical SciencesUniversity of CopenhagenUniversitetsparken 22100 CopenhagenØDenmark

The purpose of this study was to develop a PLGA microspheres-based donepezil(DP)formulation which was expected to sustain release of DP for one week with high encapsulation efficiency(EE).DP derived from donepezil hydrochloride was encapsulated in PLGA microspheres by the O/W emulsion-solvent evaporation *** optimized formulation which avoided the crushing of microspheres during the preparation process was characterized in terms of particle size,morphology,drug loading and EE,physical state of DP in the matrix and in vitro and in vivo release *** microspheres were prepared successfully with average diameter of 30m,drug loading of 15.92±0.31%and EE up to 78.79±2.56%.Scanning electron microscope image showed it has integrated spherical shape with no drug crystal and porous on its *** scanning calorimetry and X-ray diffraction results suggested DP was in amorphous state or molecularly dispersed in *** Tg of PLGA was increased with the addition of *** release profile in vitro was characterized with slow but continuous release that lasted for about one week and fitted well with first-order model,which suggested the diffusion governing release *** single-dose administration of DP microspheres via subcutaneous injection in rats,the plasma concentration of DP reached peak concentration at 0.50 d,and then declined gradually,but was still detectable at 15 d.A good correlation between in vitro and in vivo data was *** results suggest the potential use of DP microspheres for treatment of Alzheimer’s disease over long periods.

关键词： Donepezil PLGA Sustained release Microspheres In vitro and in vivo correlation

Design and evaluation of a novel transdermal patch containing diclofenac and teriflunomide for rheumatoid arthritis therapy

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Asian Journal of Pharmaceutical Sciences 2014年第5期9卷 251-259页

作者： Yuxiu Zhang dongmei cun Xin Kong Liang Fang Department of Pharmaceutical Science School of PharmacyShenyang Pharmaceutical University103 Wenhua RoadShenyang110016China

The aim of this study was to design a compound transdermal patch containing diclofenac(DA)and teriflunomide(TEF)for the treatment of rheumatoid arthritis(RA).The various organic amines salts of DA were prepared and their forming was confirmed using DSC and *** percutaneous permeation of organic amines salt of DA was investigated in vitro using a two-chamber diffusion cell with excised rabbit skin as transdermal *** formulation of the patch was optimized in terms of the concentration of percutaneous permeation enhancer and the loading dose of *** pharmacokinetic behavior of the optimal formulation was studies in rabbits and the anti-inflammatory and analgesic effects of the optimal patch were evaluated with the adjuvant arthritis model in rats and the pain model in mice,*** result showed that skin penetration of diclofenactriethylamine(DA-TEtA)salt was better than other organic amine *** on previous study of our laboratory,teriflunomide-triethylamine(TEF-TEtA)significantly enhanced the skin permeation of TEF.10%of azone(AZ)was the best enhancer for the two *** optimal patch formulation was composed of 2%of TEF-TEtA,6%of DA-TEtA and 10%of *** cumulative permeated amount of DA-TEtA in vitro was comparable with that of the commercial diclofenac-diethylamine(DA-DEtA)*** absolute bioavailability of TEFTEtA was 42%,which could achieve the therapeutic drug *** animal study,the optimized compound patch containing DA-TEtA and TEF-TEtA displayed significant antiinflammatory and analgesic effect,which indicated the potential of the compound patch.

关键词： Diclofenac(DA) Teriflunomide(TEF) Organic amine salts Patch Rheumatoid arthritis(RA) Pharmacodynamics

Evaluating the pharmacokinetics of intrapulmonary administered ciprofloxacin solution for respiratory infections using in vivo and in silico PBPK rat model studies

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Chinese Chemical Letters 2023年第1期34卷 230-234页

作者： Changzhi Shi Jelisaveta Ignjatovic Junwei Wang Yi Guo Li Zhang Sandra Cvijic dongmei cun Mingshi Yang Wuya College of Innovation Shenyang Pharmaceutical UniversityShenyang 110016China Department of Pharmaceutical Technology and Cosmetology University of Belgrade-Faculty of PharmacyBelgrade 11221Serbia Department of Pharmacy Faculty of Health and Medical SciencesUniversity of CopenhagenCopenhagen DK-2100Denmark

Respiratory antibiotics have been proven clinically beneficial for the treatment of severe lung infections such as Pseudomonas *** a high local concentration of inhaled antibiotics for an extended time in the lung is crucial to ensure an adequate antimicrobial *** this study,we aim to investigate whether an extended exposure of ciprofloxacin(CIP),a model fluoroquinolone drug,in the lung epithelial lining fluid(ELF)could be achieved via a controlled-release formulation *** solutions were intratracheally instilled to the rat lungs at 3 different rates,i.e.,T0h(fast),T2h(medium),and T4h(slow),to mimic different release profiles of inhaled CIP formulations in the ***,the concentration-time profiles of CIP in the plasma and the lung ELF were obtained,respectively,to determine topical exposure index(ELF-Plasma AUC Ratio,EPR).The in silico PBPK model,validated based on the in vivo data,was used to identify the key factors that influence the disposition of CIP in the plasma and *** medium and slow rates groups exhibited much higher EPR than that fast instillation *** ELF AUC of the medium and slow instillation groups were about 200 times higher than their plasma *** contrast,the ELF AUC of the fast instillation group was only about 20 times higher than the plasma *** generated whole-body PBPK rat model,validated by comparison with the in vivo data,revealed that drug pulmonary absorption rate was the key factor that determined pulmonary absorption of *** study suggests that controlled CIP release from inhaled formulations may extend the exposure of CIP in the ELF post pulmonary *** also demonstrates that combining the proposed intratracheal installation model and in silico PBPK model is a useful approach to identify the key factors that influence the absorption and disposition of inhaled medicine.

关键词： Inhalation antibiotics Ciprofloxacin Controlled release PBPK modeling Lung infections

A donepezil/cyclodextrin complexation orodispersible film: Effect of cyclodextrin on taste-masking based on dynamic process and in vivo drug absorption

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Asian Journal of Pharmaceutical Sciences 2019年第2期14卷 183-192页

作者： Tingting Liu Xiaocao Wan Zheng Luo Chao Liu Peng Quan dongmei cun Liang Fang Wuya college of Innovation Shenyang Pharmaceutical University School of Pharmacy Shenyang Pharmaceutical University

The aim of this study was to develop a palatable donepezil(DP) orodispersible film(ODF)to facilitate the swallowing process and investigate the effect of cyclodextrin on tastemasking based on dynamic process and in vivo drug absorption. Complexation of DP with hydroxypropyl-β-cyclodextrin(HP-β-CD) was applied to mask the bitter taste then the prepared complexes were incorporated into ODF using solvent casting method. The tastemasking efficiency was evaluated by e-tongue; meanwhile the pharmacokinetic behavior of DP/HP-β-CD ODF was investigated by in vivo study. Results showed the optimized film was more palatable than donepezil hydrochloride(DH) film and was bioequivalent with DH. The molecular mechanism was revealed by phase solubility study, Fourier-transform infrared spectrometer(FT-IR), Differential scanning calorimeter(DSC), X-ray diffraction(XRD) and molecular modeling. Taste-masking was attributed to the formation of DP/HP-β-CD which was due to moderate interaction between DP and HP-β-CD. The stability of DP/HP-β-CD was decreased because of the acid environment in stomach, which facilitated the absorption of DP. These results extended our understanding about the application of cyclodextrin complexation and provided guidance for the design of ODF especially for drugs with disgusting taste.

关键词： Donepezil Orodispersible film Taste-masking Dynamic process E-tongue Absorption

In vitro - in vivo - in silico approach in the development of inhaled drug products: Nanocrystal-based formulations with budesonide as a model drug

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Asian Journal of Pharmaceutical Sciences 2021年第3期16卷 350-362页

作者： Changzhi Shi Jelisaveta Ignjatovic Tingting Liu Meihua Han dongmei cun JelenaĐuriš Mingshi Yang Sandra Cvijic Wuya College of Innovation Shenyang Pharmaceutical UniversityWenhua Road No.103110016 ShenyangChina Department of Pharmaceutical Technology and Cosmetology University of Belgrade-Faculty of PharmacyVojvode Stepe 45011221 BelgradeSerbia Department of Pharmacy Faculty of Health and Medical SciencesUniversity of CopenhagenUniversitetsparken 2DK-2100 CopenhagenDenmark

This study aims to understand the absorption patterns of three different kinds of inhaled formulations via in silico modeling using budesonide(BUD)as a model *** formulations investigated in this study are:(i)commercially available micronized BUD mixed with lactose(BUD-PT),(ii)BUD nanocrystal suspension(BUD-NC),(iii)BUD nanocrystals embedded hyaluronic acid microparticles(BUD-NEM).The deposition patterns of the three inhaled formulations in the rats’lungs were determined in vivo and in silico predicted,which were used as inputs in GastroPlus TM software to predict drug absorption following aerosolization of the tested *** pharmacokinetics,estimated based on intravenous data in rats,was used to establish a drug-specific in silico absorption *** BUD-specific in silico model revealed that drug pulmonary solubility and absorption rate constant were the key factors affecting pulmonary absorption of BUD-NC and BUD-NEM,*** the case of BUD-PT,the in silico model revealed significant gastrointestinal absorption of BUD,which could be overlooked by traditional in vivo experimental *** study demonstrated that in vitro-in vivo-in silico approach was able to identify the key factors that influence the absorption of different inhaled formulations,which may facilitate the development of orally inhaled formulations with different drug release/absorption rates.

关键词： Pulmonary drug delivery Budesonide Nanocrystal suspension Nanocrystal-embedded microparticles In silico physiologically-based pharmacokinetic modeling

Co-delivery of resveratrol and docetaxel via polymeric micelles to improve the treatment of drug-resistant tumors

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Asian Journal of Pharmaceutical Sciences 2019年第1期14卷 78-85页

作者： Xiong Guo Zhiyue Zhao Dawei Chen Mingxi Qiao Feng Wan dongmei cun Yi Sun Mingshi Yang Wuya College of Innovation Shenyang Pharmaceutical UniversityWenhua Road No.103Shenyang 110016China School of Graduate Liaoning University of Traditional Chinese MedicineChong Shan Road No.79Shenyang 110847China School of Pharmacy Shenyang Pharmaceutical UniversityWenhua Road No.103Shenyang 110016China Department of Pharmacy Faculty of Health and Medical SciencesUniversity of CopenhagenUniversitetsparken 2DK-2100 Copenhagen ODenmark Department of Micro-and Nanotechnology Technical University of Denmarkφsteds PladsKgs.Lyngby 2800Denmark

Co-delivery of anti-cancer drugs is promising to improve the efficacy of cancer *** study was aiming to investigate the potential of concurrent delivery of resveratrol(RES)and docetaxel(DTX)via polymeric nanocarriers to treat breast *** this end,methoxyl poly(ethylene glycol)-poly(D,L-lactide)copolymer(mPEG-PDLA)was prepared and characterized using FTIR and 1H NMR,and their molecular weights were determined by *** analysis and combination index calculation were performed to find the optimal ratio between RES and DTX to against human breast adenocarcinoma cell line(MCF-7 cells).Subsequently,RES and DTX were loaded in the mPEG-PDLA micelles simultaneously,and the morphology,particle size distribution,in vitro release,pharmacokinetic profiles,as well as cytotoxicity to the MCF-7 cells were ***50 of RES and DTX in MCF-7 cells were determined to be 23.0μg/ml and 10.4μg/ml,respectively,while a lower IC50 of 4.8μg/ml of the combination of RES and DTX was *** combination of RES and DTX at a ratio of 1:1(w/w)generated stronger synergistic effect than other ratios in the MCF-7 *** and DTX loaded mPEG-PDLA micelles exhibited prolonged release profiles,and enhanced cytotoxicity in vitro against MCF-7 *** AUC(0→t)of DTX and RES in mPEG-PDLA micelles after *** to rats were 3.0-fold and 1.6-fold higher than that of *** of the individual *** findings indicated that the co-delivery of RES and DTX using mPEG-PDLA micelles could have better treatment of tumors.

关键词： Resveratrol Docetaxel Methoxyl poly(ethylene glycol)-poly(d,l-lactide)copolymer (mPEG-PDLA) Micelles Drug resistance tumor

Pulmonary fibroblast-specific delivery of siRNA exploiting exosomes-based nanoscaffolds for IPF treatment

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Asian Journal of Pharmaceutical Sciences 2024年第4期19卷 175-189页

作者： Haoyu Lu Xulu Liu Mengjun Zhang Hriday Bera Wenwen Xu Huiyang Jiang Xing Zhao Lan Wu dongmei cun Mingshi Yang Wuya College of Innovation Shenyang Pharmaceutical UniversityShenyang 110016China Dr.B.C.Roy College of Pharmacy&Allied Health Sciences West Bengal 713212India Department of Pharmacy Faculty of Health and Medical SciencesUniversity of CopenhagenCopenhagen DK-2100Denmark

Idiopathic pulmonary fibrosis(IPF)is a progressive pulmonary disease that leads to interstitial inflammation,lung damage,and eventually life-threatening *** various pathologic factors,Smad4 is a pivotal molecule involved in the progression and exacerbation of *** mediates nuclear transfer of Smad2/Smad3 complexes and initiates the transcription of fibrosis-promoting ***,the inhibition of Smad4 expression in pulmonary fibroblasts by small interfering RNAs(siRNAs)might be a promising therapeutic strategy for ***,we engineered exosome membranes(EM)by cationic lipid(i.e.,DOTAP)to load siRNAs against Smad4(DOTAP/siSmad4@EM),and investigated their specific delivery to pulmonary fibroblasts for treating IPF in a mouse model via pulmonary *** reference nanoscaffolds,undecorated DOTAP/siSmad4 complexes(lipoplexes,consisting of cationic lipid DOTAP and siRNAs)and siSmad4-loaded lipid nanoparticles(DOTAP/siSmad4@lipo,consisting of lipoplexes fused with DPPC–Chol liposomes)were also *** results showed that DOTAP/siSmad4@EM exhibited a higher cellular uptake and gene silencing efficacies in mouse pulmonary fibroblasts(viz.,MLg2908)as compared to the two reference ***,the outcomes of the in vivo experiments illustrated that DOTAP/siSmad4@EM could significantly down-regulate the Smad4 expression with augmented anti-fibrosis ***,the DOTAP/siSmad4@EM conferred excellent biocompatibility with low cytokine levels in bronchoalveolar lavage fluid and proinflammatory responses in the pulmonary *** together,the outcomes of our investigation imply that specific inhibition of Smad4 expression in pulmonary fibroblasts by pulmonary administrated DOTAP/siSmad4@EM is a promising therapeutic strategy for IPF,which could safely and effectively deliver siRNA drugs to the targeted site of action.

关键词： Idiopathic pulmonary fibrosis siRNA delivery Exosomes Pulmonary administration Pulmonary fibroblasts

Unleashing the healing potential:Exploring next-generation regenerative protein nanoscaffolds for burn wound recovery

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Asian Journal of Pharmaceutical Sciences 2023年第6期18卷 100-112页

作者： Liangwei Si Xiong Guo Hriday Bera Yang Chen Fangfang Xiu Peixin Liu Chunwei Zhao Yasir Faraz Abbasi Xing Tang Vito Foderà dongmei cun Mingshi Yang Wuya College of Innovation Shenyang Pharmaceutical UniversityShenyang 110016China Dr.B.C.Roy College of Pharmacy and Allied Health Sciences Durgapur 713206India Department of Pharmaceutics School of PharmacyShenyang Pharmaceutical UniversityShenyang 110016China Department of Pharmacy Faculty of Health and Medical SciencesUniversity of Copenhagenniversitetsparken 2DK-2100 Copenhagen ODenmark

Burn injury is a serious public health problem and scientists are continuously aiming to develop promising biomimetic dressings for effective burn wound *** this study,a greater efficacy in burn wound healing and the associated mechanisms ofα-lactalbumin(ALA)based electrospun nanofibrous scaffolds(ENs)as compared to other regenerative protein scaffolds were *** serum albumin(BSA),collagen type I(COL),lysozyme(LZM)and ALA were separately blended with poly(ε-caprolactone)(PCL)to fabricate four different composite ENs(LZM/PCL,BSA/PCL,COL/PCL and ALA/PCL ENs).The hydrophilic composite scaffolds exhibited an enhancedwettability and variablemechanical *** ALA/PCL ENs demonstrated higher levels of fibroblast proliferation and adhesion than the other composite *** compared to PCL ENs and other composite scaffolds,the ALA/PCL ENs also promoted a better maturity of the regenerative skin tissues and showed a comparable wound healing effect to Collagen sponge^(■)on third-degree burn *** enhanced wound healing activity of ALA/PCL ENs compared to other ENs could be attributed to their ability to promote serotonin production at wound ***,this investigation demonstrated that ALA is a unique protein with a greater potential for burn wound healing as compared to other regenerative proteins when loaded in the nanofibrous scaffolds.

关键词： Regenerative proteins α-lactalbumin Serotonin Electrospinning Nanofibrous dressing Third-degree burn