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Methods and compositions for therapeutic drug monitoring and dosing by point-of-care pharmacokinetic profiling

A technology of pharmacokinetics and curve analysis, applied in the direction of analyzing materials, measuring devices, scientific instruments, etc., can solve the problems of increasing doctor-patient contact time, expensive, error-prone, etc.

Inactive Publication Date: 2014-11-19
奥德特里克有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This approach is error prone, time consuming, expensive, highly subjective and unduly increases physician-patient contact time
In addition, patients risk unnecessary toxicity from exposure to high drug concentrations, or receive suboptimal or ineffective therapeutic concentrations due to insufficient drug concentrations

Method used

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  • Methods and compositions for therapeutic drug monitoring and dosing by point-of-care pharmacokinetic profiling
  • Methods and compositions for therapeutic drug monitoring and dosing by point-of-care pharmacokinetic profiling
  • Methods and compositions for therapeutic drug monitoring and dosing by point-of-care pharmacokinetic profiling

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Example 1. The theoretical PK curve is shown in figure 1 middle. Such as figure 1 As shown in , the PK curve has two principal components, the absorption portion of the curve immediately after administration and the maximum blood concentration (C max ) after the attenuation / clearing portion of the curve. This topic starts with instant C in the case of pill administration max Delay C to case of oral administration max Variety. In between are intravenous infusion, intranasal, intrabuccal, intramuscular, intraperitoneal, etc. The three main features of the PK curve are: C max (maximum blood concentration), mean residence time (MRT) and AUC (area under the curve). AUC is often used to indicate blood exposure. However, two curves with the same AUC, such as figure 1 can have very different curves as depicted in . Intravenous bolus dosing exhibited higher initial blood concentrations, as indicated by C max = defined by dose / blood volume. Oral dosing exhibits longer...

Embodiment 2

[0064] Example 2. To demonstrate that changing drug intake alone would change the PK profile, we studied the PK profile of Taxol dosed at a 3-hour infusion rate and a 24-hour slower infusion rate using Taxol's published pharmacokinetic data ( Ohtsu T, Sasaki Y, Tamura T, Miyata YNakanomyo H, Nishiwaki YSaijo N. (1995) Clinical pharmacokinetics and pharmacodynamics of paclitaxel: a3-hour infusion versus a24-hour infusion. Clin Cancer Res. 1: 599-606.; Wiemik PH , Schwartz EL, Einzig A, Strauman JJ, Lipton RB, Dutcher JP. (1987) Phase I trial of taxol given as a24-hour infusion every21days: responses observed in metastatic melanoma. J Clin Oncol. 5: 1232-9.; Tamura T, Sasaki Y, Eguchi K, Shinkai T, Ohe Y Nishio M, Kunikane H, Arioka H, ​​Karato A, Omatsu H, et al. (1994) Phase I and pharmacokinetic study of paclitaxel by 24-hour intravenous infusion. Jpn J Cancer Res. 85: 1057-62.; Tamura T, Sasaki Y Nishiwaki Y Saijo N. (1995) Phase I study of paclitaxel by three-hour infusion:...

Embodiment 3

[0065] Example 3. To demonstrate that an increased rate of tissue distribution and thus a decreased rate of drug accumulation in the blood alters the PK profile, we investigated the PK profile of Abraxane versus Taxol. Such as image 3 Paclitaxel formulated as Abraxane (ABI-007) exhibited lower AUC compared to paclitaxel formulated as Taxol (Cremophor EL) as shown in . No increase in AUC was observed with faster absorption / infusion (30-minute infusion of Abraxane versus 3-hour infusion of Taxol). FDA approved Abraxane in 2005 (albumin-conjugated paclitaxel, Abraxis BioSciences) for metastatic breast cancer. Abraxane formulations are known to result in faster tissue penetration, a property known to vary among individuals, depending on their levels of paclitaxel-binding proteins, among others. This again demonstrates that PK curve analysis using global PK data is more suitable for therapeutic drug monitoring. We found that such as Genexol ( Figure 4 ) and Nanoxel ( Figu...

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Abstract

Disclosed are methods and kits for pharmacokinetic profiling employing point-of-care or point of service self-sampling and allowing for dosage adjustments based on the pharmacokinetic profiles.

Description

[0001] Cross References to Related Applications [0002] This PCT application claims priority to the following U.S. provisional applications: 61 / 491,268 filed May 30, 2011, 61 / 514,488 filed August 3, 2011, 61 filed August 24, 2011 / 526,950, 61 / 533,250 filed September 11, 2011, 61 / 577,008 filed January 3, 2012, 61 / 606,371 filed March 3, 2012, March 2012 US Provisional Applications No. 61 / 615,312 filed on the 25th and No. 61 / 635,730 filed on April 19, 2012, each of which is incorporated herein by reference in its entirety. Background of the invention [0003] Personalized medicine, when it is used to tailor treatment to an individual patient with a therapeutic agent, has the following components: the pharmacokinetic (PK) component of optimizing the dose of drug administered to that patient and the pharmacodynamics of matching the treatment modality to that patient Academic (PD) component. Therapeutic modalities require an understanding of mechanisms of action and mechanisms of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/543G01N33/00
CPCG01N33/54366Y02A90/10
Inventor 武永·恩戈·特里优
Owner 奥德特里克有限责任公司
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