Implantable device for intraperitoneal drug delivery

Abstract

Drug delivery devices, medicaments, and methods are provided for the intraperitoneal treatment of ovarian cancer. An implantable device for drug delivery includes an elongated, flexible device having a housing defining a reservoir that contains a drug in solid or semi-solid form, and configured to be wholly deployed within the peritoneal cavity of a patient and continuously release a therapeutically effective amount of the drug over a period of at least 24 hours. A medicament includes cisplatin for administration into the peritoneal cavity of a patient continuously over a treatment period of at least 24 hours. A method of drug delivery includes implanting within the peritoneal cavity of a patient an elongated, flexible device having a reservoir containing a drug, solubilizing the drug at least in part with peritoneal fluid, and releasing an effective amount of the solubilized drug from the reservoir continuously for a period of at least 24 hours.

We claim: 
     
         1 . An implantable device for intraperitoneal drug delivery comprising:
 an elongated, flexible device which comprises a housing defining a reservoir that contains a drug in solid or semi-solid form,   wherein the device is configured to be wholly deployed within the peritoneal cavity of a patient and continuously release a therapeutically effective amount of the drug over a period of at least 24 hours.   
     
     
         2 . The device of  claim 1 , wherein the housing comprises an elastomeric tube having an outer diameter from about 1 mm to about 5 mm. 
     
     
         3 . The device of  claim 1 , wherein the housing has a length from about 25 mm to about 100 mm. 
     
     
         4 . The device of  claim 1 , wherein the device is sterilized and further comprises at least one suture loop, at least one radio-opaque element, or a combination thereof. 
     
     
         5 . The device of  claim 1 , wherein the drug comprises more than 70 percent of a total volume of the device. 
     
     
         6 . The device of  claim 1 , wherein the housing comprises one or more apertures for releasing the drug in a solubilized form. 
     
     
         7 . The device of  claim 1 , wherein the drug comprises a chemotherapeutic agent. 
     
     
         8 . The device of  claim 1 , wherein the drug comprises cisplatin. 
     
     
         9 . The device of  claim 8 , which is configured to release the cisplatin in vitro at a rate from about 15 mg/day to about 50 mg/day in phosphate buffered saline at 37° C. 
     
     
         10 . The device of  claim 8 , which is configured to release the cisplatin in vivo at a rate from about 0.6 mg/hour to about 2.5 mg/hour. 
     
     
         11 . The device of  claim 8 , which is configured to maintain a concentration of the cisplatin in the peritoneal fluid of the patient of at least about 0.5 μg/mL for at least 7 days, while releasing at an average rate of no more than 5 mg/day. 
     
     
         12 . The device of  claim 11 , which is configured to release cisplatin at an average rate from about 1.5 mg/day to about 3.5 mg/day. 
     
     
         13 . The device of  claim 8 , which contains from 500 mg to 1000 mg cisplatin. 
     
     
         14 . The device of  claim 8 , wherein the housing comprises a first end, a second end, and an annular wall defined between the first and second ends, wherein the reservoir is defined by an inner surface of the annular wall. 
     
     
         15 . The device of  claim 14 , wherein the annular wall comprises silicone and has one or more apertures extending therethrough. 
     
     
         16 . An implantable device for intraperitoneal delivery of cisplatin, the device comprising:
 an elongated housing defining a reservoir that contains cisplatin in a solid or semi-solid form,   wherein the device is configured to be wholly deployed within the peritoneal cavity of a patient and continuously release a therapeutically effective amount of the cisplatin over a period of at least 24 hours.   
     
     
         17 . The device of  claim 16 , which is configured to release the cisplatin in vitro at a rate from about 15 mg/day to about 50 mg/day in phosphate buffered saline at 37° C. 
     
     
         18 . An implantable device for intraperitoneal delivery of cisplatin, the device comprising:
 an elongated housing comprises an elastomeric tube having a first end, a second end, and annular wall between the first and second ends;   a reservoir defined at least in part by an inner surface of the annular wall of the elastomeric tube;   a drug payload disposed in the reservoir and comprising from 500 to 1000 mg of cisplatin;   a radio-opaque element in the housing; and   a suture loop provided at one of the ends,   wherein the device is configured to be wholly deployed within the peritoneal cavity of a patient and continuously release the cisplatin over a period of at least 24 hours.   
     
     
         19 . The device of  claim 18 , which is configured to release the cisplatin in vitro at a rate from about 15 mg/day to about 50 mg/day in phosphate buffered saline at 37° C. 
     
     
         20 . The device of  claim 18 , which is configured to release the cisplatin in vivo at a rate from about 0.6 mg/hour to about 2.5 mg/hour.