Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine(Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine)

概要

基本信息

药物类型

小分子化药

别名

Cholesteryl palmitate/colfosceril palmitate、Colfosceril-palmitate/cholesteryl-palmitate、Dipalmitoylphosphatidylcholine/cholesteryl-palmitate

+ [3]

靶点-

作用机制-

治疗领域

耳鼻咽喉疾病

在研适应症-

非在研适应症

急性中耳炎中耳炎

原研机构

Otodyne, Inc.

在研机构-

非在研机构

Eledon Pharmaceuticals, Inc.

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

关联

4

项与 Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine 相关的临床试验

NCT03818815 / Completed临床2期

A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months

The purpose of this study is to develop a better understanding of the safety, tolerability and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the treatment of Acute Otitis Media (AOM) in infants and children.

开始日期2019-02-21

申办/合作机构

Eledon Pharmaceuticals, Inc.

NCT03828149 / Completed临床1期

Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo

Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults

开始日期2019-02-08

申办/合作机构

Eledon Pharmaceuticals, Inc.

NCT03766373 / Completed临床1期

Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media

The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with Acute Otitis Media.

开始日期2019-01-07

申办/合作机构

Eledon Pharmaceuticals, Inc.

100 项与 Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine 相关的临床结果

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100 项与 Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine 相关的转化医学

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100 项与 Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine 相关的专利（医药）

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78

项与 Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine 相关的文献（医药）

2024-08-01·Journal of Pharmaceutical Sciences

Application of Response Surface Methodology Using Face-centered Central Composite Design for Studying Long-Term Stability of Gliclazide-Loaded Multiparticulate Systems

Article

作者: Elsayed, Ebtesam W ; Emam, Maha F

The appropriate design of experiments (DoE) could support post-approval lean-stability approaches. A three-factor three-level face-centered design was constructed to evaluate the long-term stability of gliclazide (GLZ) alginate-gelatin beads. The formulation variables were GLZ%(X₁), alginate:gelatin ratio(X₂), and glutaraldehyde%(X₃). The studied responses included GLZ release at predefined intervals in 0.1 N HCl (2 h) followed by phosphate buffer (pH 7.4). Model-dependent and independent approaches were utilized for comparison. DoE-model validation and reduction were implemented. All the studied formulations showed non-significant changes in the particle size (p > 0.05) and most of them showed similar release profiles before and after storage. The directions of the relationships between the factors' main effects and the responses (Y₁:Q_0.5_h, Y₂:Q_2h, and Y₃:Q_4h) remained unchanged after storage. The optimal factor settings based on the proposed optimization criteria were defined. The optimized formulations (OP-1 and OP-2) showed non-significant changes in the particle size after storage. The release profiles and kinetics of OP-1 and OP-2 remained unchanged after storage. No chemical change was indicated (FT-IR). DSC-thermograms of OP-1 indicated GLZ conversion to a more stable polymorph after storage. While OP-2 showed a change in GLZ crystallinity. The stored and fresh beads' surfaces after GLZ release were almost similar. DoE could be utilized to evaluate, optimize, and predict the effects of different formulation variables on the long-term stability of GLZ alginate-gelatin beads.

2024-06-14·Science Advances

Realveolarization with inhalable mucus-penetrating lipid nanoparticles for the treatment of pulmonary fibrosis in mice

Article

作者: Jiang, Xinyi ; Chen, Chen ; Liu, Ying ; Yang, Zhenmei ; Yue, Xiao ; Han, Maosen ; Sun, Peng ; Wang, Yan ; Li, Anning ; Han, Kun ; Tang, Chunwei ; Dong, Yuanmin ; Zhang, Jing ; Shi, Chongdeng ; Wang, Zhibin ; Zhang, Yulin ; Kong, Zhichao ; Zhu, Danqing ; Fu, Zhipeng ; Zhao, Xiaotian ; Zhao, Kun

The stemness loss–associated dysregeneration of impaired alveolar type 2 epithelial (AT2) cells abolishes the reversible therapy of idiopathic pulmonary fibrosis (IPF). We here report an inhalable mucus-penetrating lipid nanoparticle (LNP) for codelivering dual mRNAs, promoting realveolarization via restoring AT2 stemness for IPF treatment. Inhalable LNPs were first formulated with dipalmitoylphosphatidylcholine and our in-house–made ionizable lipids for high-efficiency pulmonary mucus penetration and codelivery of dual messenger RNAs (mRNAs), encoding cytochrome b5 reductase 3 and bone morphogenetic protein 4, respectively. After being inhaled in a bleomycin model, LNPs reverses the mitochondrial dysfunction through ameliorating nicotinamide adenine dinucleotide biosynthesis, which inhibits the accelerated senescence of AT2 cells. Concurrently, pathological epithelial remodeling and fibroblast activation induced by impaired AT2 cells are terminated, ultimately prompting alveolar regeneration. Our data demonstrated that the mRNA-LNP system exhibited high protein expression in lung epithelial cells, which markedly extricated the alveolar collapse and prolonged the survival of fibrosis mice, providing a clinically viable strategy against IPF.

2024-04-01·Molecular Pharmaceutics

Nebulization and In Vitro Upper Airway Deposition of Liposomal Carrier Systems

Article

作者: Mravec, Filip ; Bělka, Miloslav ; Malý, Milan ; Kejíková, Jana ; Cejpek, Ondřej ; Lízal, František ; Mišík, Ondrej ; Jugl, Adam

Liposomal carrier systems have emerged as a promising technology for pulmonary drug delivery. This study focuses on two selected liposomal systems, namely, dipalmitoylphosphatidylcholine stabilized by phosphatidic acid and cholesterol (DPPC-PA-Chol) and dipalmitoylphosphatidylcholine stabilized by polyethylene glycol and cholesterol (DPPC-PEG-Chol). First, the research investigates the stability of these liposomal systems during the atomization process using different kinds of nebulizers (air-jet, vibrating mesh, and ultrasonic). The study further explores the aerodynamic particle size distribution of the aerosol generated by the nebulizers. The nebulizer that demonstrated optimal stability and particle size was selected for more detailed investigation, including Andersen cascade impactor measurements, an assessment of the influence of flow rate and breathing profiles on aerosol particle size, and an in vitro deposition study on a realistic replica of the upper airways. The most suitable combination of a nebulizer and liposomal system was DPPC-PA-Chol nebulized by a Pari LC Sprint Star in terms of stability and particle size. The influence of the inspiration flow rate on the particle size was not very strong but was not negligible either (decrease of D_v50 by 1.34 μm with the flow rate increase from 8 to 60 L/min). A similar effect was observed for realistic transient inhalation. According to the in vitro deposition measurement, approximately 90% and 70% of the aerosol penetrated downstream of the trachea using the stationary flow rate and the realistic breathing profile, respectively. These data provide an image of the potential applicability of liposomal carrier systems for nebulizer therapy. Regional lung drug deposition is patient-specific; therefore, deposition results might vary for different airway geometries. However, deposition measurement with realistic boundary conditions (airway geometry, breathing profile) brings a more realistic image of the drug delivery by the selected technology. Our results show how much data from cascade impactor testing or estimates from the fine fraction concept differ from those of a more realistic case.

100 项与 Cholesteryl-palmitate/Dipalmitoylphosphatidylcholine 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性中耳炎	临床2期	美国	Eledon Pharmaceuticals, Inc.	2019-02-21
中耳炎	临床2期	德国	Eledon Pharmaceuticals, Inc.	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03818815 (Pubmed) 人工标引	临床2期	急性中耳炎	103	amoxicillin-clavulanate+OP0201	(顧積廠築網築糧蓋憲選) = No clinically meaningful differences 憲觸膚壓願積願範遞窪 (觸鬱遞鏇襯蓋襯齋構衊 )	不佳	2021-12-01
				amoxicillin-clavulanate+Placebo
NCT03818815 (CTgov)	临床2期	急性中耳炎	103	OP0201+Amoxicillin-clavulanate	膚衊餘壓蓋構襯繭築構(築願餘顧蓋鬱鏇糧鹹繭) = 壓鏇觸築顧構窪糧衊網憲壓餘製憲鹽鏇獵膚衊 (積積鏇醖鹽鹹積繭壓鬱, 範襯糧遞遞顧鹹鹽築簾 ~ 壓觸廠艱膚窪鑰醖積顧) 更多	-	2020-08-11
NCT03828149 (CTgov)	临床1期	-	17	Drug:OP0201 (Drug: OP0201)	願餘構襯鏇醖鑰鑰衊廠(壓艱顧選繭範廠壓築襯) = 窪獵簾築餘構餘構繭築淵鹹鏇鹹膚鑰鬱選製壓 (觸襯膚顧範蓋顧鹽願鹽, 廠築築構蓋齋繭鏇網餘 ~ 顧糧膚鏇繭範廠廠壓範)	-	2019-12-30
				Drug: Placebo (Drug: Placebo)	願餘構襯鏇醖鑰鑰衊廠(壓艱顧選繭範廠壓築襯) = 醖壓衊觸廠顧壓糧鑰觸淵鹹鏇鹹膚鑰鬱選製壓 (觸襯膚顧範蓋顧鹽願鹽, 遞鑰築鏇膚餘遞顧鑰醖 ~ 艱衊醖壓廠築糧淵繭網)
NCT03766373 (CTgov)	临床1期	耳痛 \| 急性中耳炎	24	Drug: OP0201 20mg (Drug: OP0201)	(製選築襯觸鑰選鑰壓鑰) = 襯願襯積壓網齋壓顧鹽願膚窪廠廠窪鏇網選鑰 (夢鹹醖蓋鏇憲鏇窪艱衊, 遞鏇簾襯構糧憲獵艱淵 ~ 遞醖鹹鹽艱構鑰選膚窪) 更多	-	2019-11-21
				Drug: Placebo 0mg (Drug: Placebo)	(製選築襯觸鑰選鑰壓鑰) = 艱醖築網鏇襯鏇餘遞襯願膚窪廠廠窪鏇網選鑰 (夢鹹醖蓋鏇憲鏇窪艱衊, 範夢遞淵鏇夢齋齋築廠 ~ 衊簾廠醖願構積鏇選網) 更多