Use of ramoplanin to treat diseases associated with the use of antibiotics

Abstract

The invention features a method of treating or preventing a disease associated with the use of antibiotics in a patient in need thereof by administering to the patient ramoplanin in an amount and for a duration effective to treat said disease. The disease may be caused, for example, by the presence of a bacterium such as enterotoxin producing strains of C. difficile, C. perfringens , or S. aureus.

1 . An immediate release formulation comprising ramoplanin or a pharmaceutically acceptable salt thereof and two or more pharmaceutically acceptable excipients selected from the group consisting of inert diluents, fillers, disintegrating agents, binding agents, antiadhesives, colorants, flavoring agents, plasticizers, humectants, and buffering agents.  
   
   
       2 . The immediate release formulation of  claim 1 , wherein the immediate release formulation is a capsule.  
   
   
       3 . The capsule of  claim 2 , wherein the capsule is a gelatin capsule.  
   
   
       4 . The gelatin capsule of  claim 3 , wherein the disintegrating agents are selected from the group consisting of cellulose, starches, croscarmellose sodium, alginates, and alginic acid.  
   
   
       5 . The gelatin capsule of  claim 3 , wherein the binding agents are selected from the group consisting of sucrose, glucose, mannitol, sorbitol, acacia, alginic acid, sodium alginate, gelatin, starch, pregelatinized starch, microcrystalline cellulose, magnesium aluminum silicate, carboxymethylcellulose sodium, methylcellulose, hydroxypropyl methylcellulose, ethylcellulose, polyvinylpyrrolidone and polyethylene glycol.  
   
   
       6 . The gelatin capsule of  claim 3 , wherein the antiadhesives are selected from the group consisting of magnesium stearate, zinc stearate, stearic acid, silicas, hydrogenated vegetable oils, and talc.  
   
   
       7 . The capsule of  claim 2 , wherein the pharmaceutically acceptable excipients are disintegrating agents, binding agents and antiadhesives.  
   
   
       8 . The capsule of  claim 7 , wherein the disintegrating agents are selected from the group consisting of cellulose, starches, croscarmellose sodium, alginates, and alginic acid.  
   
   
       9 . The capsule of  claim 7 , wherein the binding agents are selected from the group consisting of sucrose, glucose, mannitol, sorbitol, acacia, alginic acid, sodium alginate, gelatin, starch, pregelatinized starch, microcrystalline cellulose, magnesium aluminum silicate, carboxymethylcellulose sodium, methylcellulose, hydroxypropyl methylcellulose, ethylcellulose, polyvinylpyrrolidone and polyethylene glycol.  
   
   
       10 . The capsule of  claim 7 , wherein the antiadhesives are selected from the group consisting of magnesium stearate, zinc stearate, stearic acid, silicas, hydrogenated vegetable oils, and talc.  
   
   
       11 . The capsule of any one of the  claims 2  to  10 , wherein the capsule comprises 100 mg of ramoplanin.  
   
   
       12 . The capsule of any one of the  claims 2  to  10 , wherein the capsule comprises 200 mg of ramoplanin.  
   
   
       13 . The capsule of any one of the  claims 2  to  10 , wherein the capsule comprises 400 mg of ramoplanin.  
   
   
       14 . The immediate release formulation of  claim 1 , wherein the immediate release formulation is a tablet.  
   
   
       15 . The tablet of  claim 14 , wherein the pharmaceutically acceptable excipients are disintegrating agents, binding agents and antiadhesives.  
   
   
       16 . The tablet of  claim 15 , wherein the disintegrating agents are selected from the group consisting of cellulose, starches, croscarmellose sodium, alginates, and alginic acid.  
   
   
       17 . The tablet of  claim 15 , wherein the binding agents are selected from the group consisting of sucrose, glucose, mannitol, sorbitol, acacia, alginic acid, sodium alginate, gelatin, starch, pregelatinized starch, microcrystalline cellulose, magnesium aluminum silicate, carboxymethylcellulose sodium, methylcellulose, hydroxypropyl methylcellulose, ethylcellulose, polyvinylpyrrolidone and polyethylene glycol.  
   
   
       18 . The tablet of  claim 15 , wherein the antiadhesives are selected from the group consisting of magnesium stearate, zinc stearate, stearic acid, silicas, hydrogenated vegetable oils, and talc.  
   
   
       19 . A method of treating a disease associated with the use of antibiotics in a patient in need thereof, comprising administering to the patient the immediate release formulation of  claim 1  in an amount and for a duration effective to treat the disease.  
   
   
       20 . A method of inhibiting or preventing the onset of an antibiotic-associated condition in a patient in need thereof, comprising administering to the patient the immediate release formulation of  claim 1  in an amount and for a duration sufficient to inhibit onset of the antibiotic associated condition.  
   
   
       21 . A method of treating or inhibiting relapse of an antibiotic-associated condition selected from the group consisting of antibiotic-associated diarrhea, colitis, and pseudomembranous colitis in a patient, comprising administering to the patient the immediate release formulation of  claim 1  in an amount and for a duration effective to inhibit relapse of the antibiotic-associated condition  
   
   
       22 . A method for preventing sporulation of  Clostridium difficile  or  Clostridium perfringens  in a patient, comprising administering to the patient the immediate release formulation of  claim 1  in an amount and for a duration effective to prevent sporulation of  Clostridium difficile  or  Clostridium perfringens.