US2012046281A1PendingUtilityA1

Rifalazil compositions and therapeutic regimens

43
Individually held — no corporate assignee on recordPriority: Sep 23, 2002Filed: Oct 31, 2011Published: Feb 23, 2012
Est. expirySep 23, 2022(expired)· nominal 20-yr term from priority
Inventors:Bernard E. CabanaArthur F. MichaelisGary P. MagnantChalom Sayada
C07D 513/18A61K 47/10A61K 9/0019A61K 31/538A61K 47/14C07D 498/18A61K 9/08A61P 31/04A61K 47/12A61P 31/00A61K 47/34A61K 45/06
43
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Claims

Abstract

The invention features low-dosage rifalazil compositions and therapeutic regimens which are useful for the treatment of bacterial infections.

Claims

exact text as granted — not AI-modified
1 - 5 . (canceled) 
     
     
         6 . A method of treating a bacterial infection in a patient, said method comprising administering rifalazil to said patient in an amount effective to treat said infection, wherein said rifalazil is formulated in unit dosages comprising between 0.1 and 5 mg of rifalazil, and is administered daily for at least a period of two days. 
     
     
         7 . (canceled) 
     
     
         8 . The method of  claim 6 , wherein rifalazil is administered for prophylaxis against an infection resulting from a surgical procedure or implantation of a prosthetic device. 
     
     
         9 - 11 . (canceled) 
     
     
         12 . The method of  claim 6 , wherein said infection is by a drug resistant bacterium selected from the group consisting of  S. aureus, S. epidermidis, S. pneumoniae, S. pyogenes, Enterococcus  spp., and  M. catarrhalis.    
     
     
         13 . The method of  claim 6 , wherein said infection is by multidrug resistant bacteria in said patient. 
     
     
         14 . (canceled) 
     
     
         15 . The method of  claim 13 , wherein said bacteria are selected from the group consisting of  Streptococcus pneumoniae, Staphylococcus aureus, Streptococcus pyogenes , and  Enterococcus  spp. 
     
     
         16 . The method of  claim 6 , wherein said rifalazil is formulated in unit dosages comprising between 0.1 and 3 mg of rifalazil. 
     
     
         17 . The method of  claim 16 , wherein said rifalazil is formulated in unit dosages comprising between 0.1 and 2 mg of rifalazil. 
     
     
         18 . The method of  claim 17 , wherein said rifalazil is formulated in unit dosages comprising between 0.2 and 0.8 mg of rifalazil. 
     
     
         19 . The method of  claim 6 , wherein said rifalazil is formulated as a tablet, pill, capsule, or caplet. 
     
     
         20 . A method of treating a bacterial infection in a patient, said method comprising administering to said patient between 0.1 and 10 mg of rifalazil over a period of four to fourteen days. 
     
     
         21 . The method of  claim 20 , wherein between 0.1 and 5 mg of rifalazil is administered over a period of four to ten days. 
     
     
         22 . (canceled) 
     
     
         23 . The method of  claim 6 , wherein between 0.1 and 3 mg of rifalazil is administered daily for at least a period of five days. 
     
     
         24 . The method of  claim 23 , wherein between 0.1 and 2.6 mg of rifalazil is administered daily for at least a period of ten days. 
     
     
         25 . The method of  claim 24 , wherein between 0.1 and 1.6 mg of rifalazil is administered daily for at least a period of thirty days. 
     
     
         26 . A method of treating a bacterial infection in a patient, said method comprising administering a loading-dose regimen of rifalazil to said patient. 
     
     
         27 . The method of  claim 26 , wherein said loading-dose regimen comprises:
 a) an initial administration of an average daily dose for 4 to 14 days;   b) following said initial administration, administration of less than half said average daily dose for 4 to 14 days.   
     
     
         28 . The method of  claim 26 , wherein said loading-dose regimen comprises an average initial daily dose which is at least 200% of the average daily dose over any of the next two, three, four, or five subsequent dosing days. 
     
     
         29 . The method of  claim 26 , wherein said loading-dose regimen comprises a dose administered on Day  1 , said dose administered on Day  1  being at least 200% of the dose administered on any one of the next four dosing days. 
     
     
         30 - 43 . (canceled) 
     
     
         44 . The method of  claim 6 , wherein the bacterium has a multiplying form and a non-multiplying form, said method further comprising administering to a patient a second antibiotic effective against the multiplying form of said bacterium, wherein said rifalazil is administered in an amount and for a duration effective to treat the non-multiplying form of said bacterium and the second antibiotic is administered in an amount and for a duration effective to treat said multiplying form of said bacterium. 
     
     
         45 . The method of  claim 44 , wherein said antibiotic effective against said multiplying form of said bacterium is administered to said patient in an amount and for a duration to reduce the presence of said bacterium in said patient to less than about 10 6  organisms/mL; and rifalazil is then administered to said patient in an amount and for a duration effective to reduce the presence of said bacterium to or below a level indicative that said infection has been treated. 
     
     
         46 - 51 . (canceled) 
     
     
         52 . The method of  claim 6 , wherein the composition comprising rifalazil in unit dosage form, wherein each dose is in the range of between 0.1 and 5 mg, is accompanied by instructions for administration of the rifalazil on a daily basis for a period of time of at least two consecutive days. 
     
     
         53 . The method of  claim 52 , wherein the instructions are for daily administration for a period of at least 5 days. 
     
     
         54 . The method of  claim 52 , wherein the instructions are for daily administration for a period of at least 10 days. 
     
     
         55 . The method of  claim 52 , wherein the instructions are for daily administration for a period of at least 30 days. 
     
     
         56 . The method of  claim 52 , wherein the instructions are for daily administration for a period of 4 to 14 days.

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