Cerdulatinib-containing topical skin pharmaceutical compositions and uses thereof
A technology of sadutinib and its composition, applied in the topical skin pharmaceutical composition containing sadutinib and its application field
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Embodiment 1
[0204] Example 1: In vitro potency and selectivity of DMVT-502
[0205] In Vitro Pharmacology Studies The activity and potency of DMVT-502 have been evaluated against a panel of purified kinase assays, followed by specific cellular potency assays against Syk, JAK1, JAK2, JAK3 and Tyrosine Kinase 2 (Tyk2). The efficacy of DMVT-502 was assessed in primary cells and whole blood stimulated with various cytokines to measure JAK / signal transducer and activator of transcription (STAT)-specific pathway responses.
[0206] Efficacy against Syk, JAK1 , JAK2, JAK3, and Tyk2 was tested using the DiscoverRx cell platform and compared to tofacitinib and the JAK1 / 2 selective inhibitor ruloxitinib. Table 1 shows significant potency against Syk, JAK1, and Tyk2, with diminished potency against cellular JAK2 and JAK3.
[0207] Table 1. Potency of DMVT-502 against Syk, JAK1, JAK2, JAK3, and Tyk2 in the DiscoverRx cell platform
[0208]
[0209] Abbreviation: IC 50 , 50% inhibitory concentra...
Embodiment 2
[0212] Example 2: Inhibition of Cytokine Signaling in Peripheral Blood Mononuclear Cell Cultures and Human Whole Blood
[0213] Human primary cells isolated from healthy volunteers were stimulated with various cytokines to measure JAK / STAT-dependent or JAK / STAT-independent signaling and functional responses following exposure to DMVT-502. Peripheral blood mononuclear cells were prepared from human whole blood and incubated with various concentrations of DMVT-502 to elicit JAK / STAT signaling prior to stimulation with appropriate cytokines. Cells were fixed, permeabilized, and subsequently stained with cell-specific lineage and phosphorylated STAT antibodies for intracellular phosphorylation flow cytometry to determine the effect of DMVT-502 on cytokine-mediated STAT phosphorylation. Data from these assays confirmed that DMVT-502 is a potent inhibitor of JAK1 / JAK3-dependent signaling pathways, where IC in T cells and monocytes 50 Values are less than 0.2 μM.
[0214] Cytokin...
Embodiment 3
[0216] Example 3: Skin Penetration Study
[0217] A study was conducted to evaluate the in vitro skin penetration and penetration of sedutinib. The studies included full in vitro skin permeation and permeation experiments for formulations containing sedutinib.
[0218] Freshly excised human skin (cut with a dermatome to a thickness of 500 ± 50 μm) from one skin donor was mounted on the MedFlux-HT TM Between the donor and acceptor compartments of the diffusion cell (~1 cm exposed surface area for each replicate) 2 ). Apply approximately 10 mg of sedutinib formulation to the skin to achieve ~10 mg / cm 2 dosage. Adjust the pump of the MedFlux system to maintain a continuous receiver fluid flow rate of approximately 10 μL / min (600 μL / hr) just below the skin. Receiver fluid was automatically collected into 96-well plates at 2-hour intervals over the course of 24 hours and analyzed using LC-MS / MS analysis.
[0219] After the 24-hour in vitro drug penetration test, the residual ...
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Abstract
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