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Medical composition containing dalbavancin

The technology of a pharmaceutical composition and dalbamycin, which is applied in the direction of antibacterial drugs, powder delivery, glycopeptide components, etc.

Inactive Publication Date: 2008-02-27
VICURON PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Although, dosing with fewer doses is a desirable feature of antibiotic dosing regimens, the "pharmaceutical window" (i.e., toxicity profile) of the antibiotic administered must be sufficiently acceptable to allow for larger individual doses to be administered without significant risk in the patient being treated. Hazardous treatments that cause serious adverse reactions in

Method used

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  • Medical composition containing dalbavancin
  • Medical composition containing dalbavancin
  • Medical composition containing dalbavancin

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0158] Example 1. Efficacy and Safety of Weekly Dapamycin in Deep Skin and Soft Tissue Infections

[0159] This randomized controlled study evaluated the safety and efficacy of two dalpamycin dosage regimens. Adult patients with skin and soft tissue infections (SSTI) involving deep skin structures or requiring surgical intervention were randomized into three groups: study arm 1 received 1100 mg dalpamycin by intravenous (IV) injection on day 1; Day 1 received 1 g dapamycin by IV and day 8 received 500 mg dapamycin by IV; study arm 3 received "standard of care". Clinical and microbiological responses and adverse events were assessed.

[0160] groups for analysis

[0161] Sixty-two patients were randomized into the study; all patients received at least one dose of study drug. Safety and efficacy were assessed in 4 study populations and defined as follows: The intent-to-treat (ITT) population included all patients who received at least one dose of study drug (all randomized ...

example 2

[0212] Example 2. Dabamycin Pharmacokinetics and Renal Excretion in Healthy Subjects

[0213] The primary objective of this study was to characterize the pharmacokinetics of dalpamycin and to calculate the extent of renal excretion in healthy subjects receiving therapeutic doses of the drug. This is an open-label, uncontrolled study.

[0214] study drug treatment

[0215] A single 1000 mg IV dose of dalpamycin was infused over 30 minutes into healthy male and female subjects between the ages of 18 and 65.

[0216] All aspects of the study medication received and completed by 6 subjects (1 female and 5 males) were recorded. Three subjects were Caucasian and three subjects were African American. The mean age was 29.8 years (range 22 to 63). The average height is 68.6 inches (from 63 to 75) and the average weight is 179.6 lbs (from 140 to 244).

[0217] Pharmacokinetics

[0218] Blood and urine were collected on study days 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, and 42 (24-hou...

example 3

[0231] Example 3. Measurement of protein binding of dabamycin using isothermal titration microcalorimetry

[0232] Binding of dapamycin to proteins was measured by isothermal titration microcalorimetry (ITC) using a Microcal VP-ITC instrument in 20 mM phosphate, 150 mM NaCl, pH 7.4 at 25 and 37°C. In a standard experiment, 25 x 10 μl of protein (-150 μM) was injected into a calorimeter cell containing a dalpamycin solution (-5 μM). The actual concentration of protein and dalpamycin was determined by measuring the absorbance at 280 nm. Control experiments consisted of injecting the protein into buffer (in the absence of dalpamycin) to account for the heat generated by protein dilution under the same conditions. For control, a similar experiment with some necessary modifications was performed using teicoplanin.

[0233] Dabamycin experiments were performed with the following proteins: human albumin, dog albumin, rat albumin, bovine albumin and human a-glycoprotein. Teicoplani...

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Abstract

The present invention provides a pharmaceutical composition comprising dalbamycin (dalbavancin) and at least one effective stabilizer, wherein the dalbamycin contains approximately less than 3 mole percent MAG, wherein the pH of the composition is about 3 to 5, and wherein said composition is lyophilized.

Description

[0001] This application asserts serial numbers 60 / 427,654 filed November 18, 2002, 60 / 485,694 filed July 8, 2003, 60 / 495,048 filed August 13, 2003, and August 2003 U.S. Provisional Patent Application No. 60 / 496,483, filed on the 19th, the disclosure of which is incorporated herein by reference in its entirety. technical field [0002] This application relates to dalbavancin compositions and methods of using said compositions in methods of treating bacterial infections. Background technique [0003] Hospital bloodstream infections are the leading cause of death in the United States, according to the U.S. Center for Disease Control and Prevention. Approximately 5% of the 7 million central venous catheters (CVCs) inserted each year in the United States are associated with at least one bloodstream infection event (approximately 350,000 per year). Catheter-related bloodstream infections occur when bacteria enter the bloodstream through an intravenous catheter and can be life-thr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/14A61K9/19A61P31/04
Inventor 马尔科·卡瓦莱里蒂莫西·亨克尔达尼埃拉·亚贝斯阿德里亚诺·马拉巴尔巴乔治·莫斯科尼马丁·斯托哥尼理查德·J·怀特
Owner VICURON PHARM INC
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