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Evaluation of the Pharmacokinetics of Hydrocortisone after Administration of Hydrocortisone Acetate 25 mg and 45 mg Suppository in Healthy Adult Volunteers - RA-VP-000-408

开始日期2019-02-25

申办/合作机构

Genus Lifesciences, Inc.

CTRI/2019/02/017469 / CompletedN/A

Relative Bioavailability Study of Hydrocortisone Acetate 25 mg and 45 mg Suppository in Healthy Adult Volunteers - CO180008

开始日期2019-02-25

申办/合作机构

Genus Lifesciences, Inc.

CTRI/2018/01/011386 / Completed临床1期

A randomized, open label, multi-center, two-treatment, two-period, two-sequence, two-waycross-over, multiple dose, steady state Bioequivalence (BE) study of Genus Lifesciences Inc.Nilutamide Tablets 150 mg with NILANDRONÂ® (Nilutamide) Tablets 150 mg from ConcordiaPharmaceuticals Inc. in metastatic prostate cancer patients. - NLM101

开始日期2018-03-01

申办/合作机构

Genus Lifesciences, Inc.

100 项与 Vyteris, Inc. 相关的临床结果

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项与 Vyteris, Inc. 相关的文献（医药）

2021-08-01·Journal of Hazardous Materials1区 · 环境科学与生态学

Mitochondria-targeted dual-channel colorimetric and fluorescence chemosensor for detection of Sn2+ ions in aqueous solution based on aggregation-induced emission and its bioimaging applications

1区 · 环境科学与生态学

Article

作者: Kolandaivel, Ponmalai ; Ramesh, Thiyagarajan ; Ravichandiran, Palanisamy ; Prabakaran, D S ; Kim, Ae Rhan ; Masłyk, Maciej ; Ramalingam, Prakash ; Han, Myung-Kwan ; Yoo, Dong Jin ; Park, Byung-Hyun ; Maroli, Nikhil ; Boguszewska-Czubara, Anna

Several fluorescence and colorimetric chemosensory for Sn²⁺ detection in an aqueous media have been reported, but applications remain limited for discriminative Sn²⁺ detection in live human cells and zebrafish larvae. Herein, a mitochondria-targeted Sn²⁺ "turn-on" colorimetric and fluorescence chemosensor, 2CTA, with an aggregation-induced emission (AIE) response was developed. The sensing of Sn²⁺ was enabled by a reduction-enabled binding pathway, with the conversion of -C˭O groups to -C-OH groups at the naphthoquinone moiety. The color changed from light maroon to milky white in a buffered aqueous solution. The chemosensor 2CTA possessed the excellent characteristics of good water solubility, fast response (less than 10 s), and high sensitivity (79 nM) and selectivity for Sn²⁺ over other metal ions, amino acids, and peptides. The proposed binding mechanism was experimentally verified by means of FT-IR and NMR studies. The chemosensor 2CTA was successfully employed to recognize Sn²⁺ in live human cells and in zebrafish larvae. In addition, a colocalization study proved that the chemosensor had the ability to target mitochondria and overlapped almost completely with MitoTracker Red. Furthermore, a bioimaging study of live cells demonstrated the discriminative detection of Sn²⁺ in human cancer cells and the practical applications of 2CTA in biological systems.

2020-11-01·AAPS PharmSciTech3区 · 医学

Lipid Nanoparticles Improve the Uptake of α-Asarone Into the Brain Parenchyma: Formulation, Characterization, In Vivo Pharmacokinetics, and Brain Delivery

3区 · 医学

Article

作者: Govindarajan, Karthivashan ; Ko, Young Tag ; Jonnalagadda, Sriramakamal ; Ganesan, Palanivel ; Prabakaran, D S ; Vishnu, Revuri ; Choi, Dong-Kug ; Ramalingam, Prakash ; Sodha, Srushti ; Gupta, Pardeep K ; Sivalingam, Kalaiselvi

Treatment of brain-related diseases is one of the most strenuous challenges in drug delivery research due to numerous hurdles, including poor blood-brain barrier penetration, lack of specificity, and severe systemic toxicities. Our research primarily focuses on the delivery of natural therapeutic compound, α-asarone, for the treatment of brain-related diseases. However, α-asarone has poor aqueous solubility, bioavailability, and stability, all of which are critical issues that need to be addressed. This study aims at formulating a lipid nanoparticulate system of α-asarone (A-LNPs) that could be used as a brain drug delivery system. The physicochemical, solid-state properties, stability, and in vitro and in vivo studies of the A-LNPs were characterized. The release of α-asarone from the A-LNPs was prolonged and sustained. After intravenous administration of A-LNPs or free α-asarone, significantly higher levels of α-asarone from the A-LNPs were detected in murine plasma and brain parenchyma fractions, confirming the ability of A-LNPs to not only maintain a therapeutic concentration of α-asarone in the plasma, but also transport α-asarone across the blood-brain barrier. These findings confirm that lipid nanoparticulate systems enable penetration of natural therapeutic compound α-asarone through the blood-brain barrier and may be a candidate for the treatment of brain-related diseases.

2019-08-01·Therapeutic Delivery

Application of Simplex Lattice Design for the Development of Extended Release Tablets of Model Drug Diclofenac Sodium

Article

作者: Parikh, Vaishnavi ; Kanekar, Tanvi ; Phadke, Shivaji ; Gumaste, Suhas

Aim: Simplex lattice design was applied to predict extent of drug release from extended release diclofenac sodium tablets. Methods: The effects of composition on dissolution rate were evaluated by varying the levels of hydroxypropyl methylcellulose, dicalcium phosphate and cornstarch via three component design. Results: The rate of drug release was primarily dictated by the proportion of hydroxypropyl methylcellulose and was also affected by the proportion of dicalcium phosphate and the method of processing (direct compression/wet granulation). Polynomial equations constructed for directly compressed and wet-granulated formulations could successfully predict the extent of drug release at an arbitrary time point of 3 h. Conclusion: Simplex lattice design is a viable tool to predict the drug release patterns of extended release formulations.

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