Implantable devices for drug delivery with reduced burst release
The invention provides implantable drug delivery devices comprising a core comprising a polymer (or polymer blend) and one or more drugs or pharmaceutical substances, and an outer shell comprising a polymer (or polymer blend) and one or more porogen materials. The invention reduces burst release of drug. Pharmaceuticals such as triiodothyronine (T3) or ropinirole can be delivered by the devices.
1 . A method of delivering a pharmaceutical substance or drug to a patient in need thereof, the method comprising:
implanting a device into the patient, wherein the pharmaceutical substance or drug is released from the device into the patient, and wherein the device, after implantation, comprises:
a core comprising: (i) a polymeric material comprising poly(vinyl alcohol); and (ii) the pharmaceutical substance or drug; and
a porous outer shell comprising poly(vinyl alcohol) and poly-L-lactic acid-co-glycolic acid, wherein the porous outer shell is free of the pharmaceutical substance or drug,
wherein the porous outer shell has a thickness of about 1 micrometer to about 5 micrometers, and
wherein the device is rod-shaped and has a length of about 0.5 cm to 10 cm and a diameter of about 1 mm to about 8 mm, and wherein, after implantation, the pharmaceutical substance or drug diffuses through the porous outer shell.
2 . The method of claim 1 , wherein a period of sustained release of the pharmaceutical substance into the body of the patient is from about 1 month to about 1 year.
3 . The method of claim 1 , wherein a period of sustained release is from 6 months to 1 year.
4 . The method of claim 1 , wherein a period of sustained release is from 6 months to 9 months.
5 . The method of claim 1 , wherein a period of sustained release is about 9 months.
6 . A method of treating a disease in a subject, the method comprising implanting a device into the subject, wherein the device, after implantation, comprises:
a core comprising: (i) a polymeric material comprising poly(vinyl alcohol); and (ii) a pharmaceutical substance or drug; and
a porous outer shell comprising poly(vinyl alcohol) and poly-L-lactic acid-co-glycolic acid, wherein the porous outer shell is free of the pharmaceutical substance or drug,
wherein the porous outer shell has a thickness of about 1 micrometer to about 5 micrometers, and
wherein the implantable device is rod-shaped and has a length of about 0.5 cm to 10 cm and a diameter of about 1 mm to about 8 mm, and wherein, after implantation, the pharmaceutical substance or drug diffuses through the porous outer shell.
7 . The method of claim 6 , wherein the diameter of the implantable device is about 1 mm to about 7 mm.
8 . A method of forming an implantable device, the method comprising:
extruding a first composition to form a core, the first composition comprising: (i) a polymeric material comprising poly(vinyl alcohol); and (ii) a pharmaceutical substance or drug; and
coating the core with a second composition to form an outer shell that is free of the pharmaceutical substance or drug, the second composition comprising poly(vinyl alcohol) and poly-L-lactic acid-co-glycolic acid, wherein the outer shell has a thickness of about 1 micrometer to about 5 micrometers, wherein the implantable device has diameter of about 1 mm to about 8 mm, and wherein, after implantation, the pharmaceutical substance or drug diffuses through pores of the outer shell.
9 . The method of claim 8 , wherein the implantable device is rod-shaped and having a length of about 0.5 cm to 10 cm in length.
10 . The method of claim 8 , wherein the implantable device is rod-shaped and having a diameter of about 1 mm to about 7 mm.
11 . A method of forming an implantable device, the method comprising:
co-extruding a first composition and a second composition, wherein the first composition is extruded to form a core, the first composition comprising (i) a first polymeric material comprising poly(vinyl alcohol); and (ii) a pharmaceutical substance or drug; and the co-extruded second composition forming an outer shell around the core that is free of the pharmaceutical substance or drug, the second composition comprising poly(vinyl alcohol) and poly-L-lactic acid-co-glycolic acid, wherein the outer shell has a thickness of about 1 micrometer to about 5 micrometers, wherein the implantable device has diameter of about 1 mm to about 8 mm, and wherein, after implantation, the pharmaceutical substance or drug diffuses through pores of the outer shell.
12 . The method of claim 11 , wherein the implantable device is rod-shaped and having a length of about 0.5 cm to 10 cm in length.
13 . The method of claim 11 , wherein the implantable device is rod-shaped and having a diameter of about 1 mm to about 7 mm.