Use of tigecycline, alone, or in combination with rifampin to treat osteomyelitis and/or septic arthritis

A technology of tigecycline and rifampicin, applied in bone marrow, treatment of bacterial infection of bone, joint and synovial fluid, infection of antibiotic-resistant bacteria, can solve problems such as limitations of oral antibacterial agents

Inactive Publication Date: 2007-01-03
WYETH LLC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Unfortunately, oral antimicrobial options are limited when dealing with multidrug resistant organisms, and treatment of multidrug resistant organisms may require the use of parenteral agents (Tice, Infect Dis Clin North Am 1998; 12:903- 919)

Method used

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  • Use of tigecycline, alone, or in combination with rifampin to treat osteomyelitis and/or septic arthritis
  • Use of tigecycline, alone, or in combination with rifampin to treat osteomyelitis and/or septic arthritis
  • Use of tigecycline, alone, or in combination with rifampin to treat osteomyelitis and/or septic arthritis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Example 1: Treatment of Osteomyelitis Using Tigecycline in Rabbits

[0092] This example demonstrates the use of tigecycline and the combination of tigecycline and rifampicin for the treatment of osteomyelitis in rabbits. Comparative studies using vancomycin and vancomycin plus rifampicin have also been performed. The data demonstrate improved antimicrobial efficacy with tigecycline versus vancomycin and with tigecycline plus rifampicin versus vancomycin plus rifampicin. Furthermore, within the test group, tigecycline plus rifampicin provided complete protection against methicillin-resistant S. aureus.

[0093] Standard curve generated by diffusion bioassay

[0094] Tigecycline (Wyeth-Ayerst Research, Pearl River, New York), vancomycin (Abbott Laboratories, Chicago, Illinois) and rifampin were produced using normal NZW rabbit serum (Fisher Sciontific) and normal, uninfected rabbit tibiae. A standard curve was obtained from Ping (Merrell Pharmaceuticals Inc. Kansas, Mis...

Embodiment 2

[0142] Example 2: Distribution of tigecycline in human tissues after a single intravenous administration of 100 mg.

[0143] This example demonstrates the penetration of selected tissues in human subjects following a single intravenous administration of tigecycline. The data demonstrate a rapid period of distribution with an extended half-life and a high volume of distribution at steady state. Penetration of bone, synovial fluid, lung, gallbladder and colon was further demonstrated in human subjects. Penetration improves the treatment of bone and joint infections.

[0144] Pharmacokinetic studies of intravenous tigecycline in humans have shown a rapid phase of distribution, a prolonged half-life (40-60 hours) and a high volume of distribution at steady state. Animal studies using radiolabeled tigecycline indicate that this rapid distribution phase and high volume of distribution at steady state represent penetration of tigecycline into tissues including lung and bone. Carbo...

Embodiment 3

[0177] Example 3: Tissue Distribution in Rats Treated with Tigecycline

[0178] This study aimed to quantify the organization of [ 14 C]-radioactivity produced by tigecycline in a single 30-minute intravenous infusion of 3 mg / kg in male Sprague-Dawley and Long-Evans rats [ 14 C] - Whole-mount autoradiography using fluorescence imaging after tigecycline.

[0179] Materials and methods

[0180] Tigecycline was provided by the Analytical Department, Wyeth-Ayerst Research, Montreal, Canada. [ 14 C]-Tigecycline was supplied by Amersham (Boston, MA). main body[ 14 C]- The radiochemical purity and specific radioactivity of tigecycline are 98% and 93.6 microCi / mg, respectively.

[0181] Use sterile water to prepare solutions for intravenous administration. The liquid scintillation mixture used to count radioactivity in plasma and urine was Ultima Gold (Packard Instruments Co., Meriden, CT).

[0182] A Model 3078 Tri-Carb Sample Oxidizer equipped with an Oximate-80 Robotic Auto...

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Abstract

The present invention is directed to a method for treating bone or bone marrow infections, joint infection or infection of the tissues surrounding the joint by administration of the antibiotic tigecycline alone or in combination with a rifamycin antibiotic. In a preferred embodiment the bone or bone marrow infection causes osteomyelitis. In another embodiment the joint infection or infection of the tissues surrounding the joint causes septic arthritis. The invention is also directed to manufacture of a medicament for treatment of bone and / or bone marrow infections, or joint infections and / or infections in tissues surrounding the joint with tigecycline alone or in combination with rifampin.

Description

[0001] This application claims priority from US Provisional Application 60 / 500,474, filed September 5, 2003, the entire contents of which are hereby incorporated by reference. field of invention [0002] The present invention relates to novel methods of treating osteomyelitis and septic arthritis caused or caused by bacterial infection. The invention also relates to the treatment of bacterial infections of bone, bone marrow, joints and synovial fluid. The invention also relates to the treatment of these diseases and infections with antibiotic resistant bacteria in tissues. Background of the invention [0003] The second half of the twentieth century saw significant progress in the development of antimicrobial agents. This success has fostered the recognition that bacterial diseases are more treatable than any other major disorder, yet the emergence of multidrug-resistant organisms in the 1990s has resulted in serious public health problems. Resistance has spread to previou...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61P19/02A61P31/04A61K31/65A61K31/4745
CPCA61K31/65A61K31/496A61K31/4745A61P19/00A61P19/02A61P19/08A61P31/00A61P31/04A61P31/14A61P31/16Y02A50/30A61K2300/00
Inventor R·T·特斯塔J·卡尔霍恩J·T·马德尔
Owner WYETH LLC
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