Biodegradable drug delivery system
A drug delivery system (DDS) comprised of segmented biodegradable implants sized and suitable for implantation in an ocular region or site and methods for treating ocular conditions. The segmented implants provide an extended release of an active agent at a therapeutically effective amount for a period of time between 50 days and one year, or longer, and permit the DDS to have segments that possess individual and different drug release characteristics.
1. A method of manufacturing a drug delivery system which comprises a segmented bioerodible implant, the method comprising:
a) blending a first active agent with a first bioerodible polymer to form a first active agent polymer mixture;
b) forming the first active agent polymer mixture into a rod shaped first implant segment having a longitudinal axis;
c) blending a second active agent with a second bioerodible polymer to form a second active agent polymer mixture;
d) forming the second active agent polymer mixture into a rod shaped second implant segment having a longitudinal axis;
e) joining the segments at the ends thereof to permit separation from each other in situ into individual segments following implantation into a patient;
wherein each of the segments is formed with at least one end having a cut surface that is at an angle to the longitudinal axis of less than 90° or one end having a beveled shaped surface; wherein at least one of the segments is formed by a double extrusion process; and wherein the segments erode at different rates in situ.
2. The method according to 1 , wherein the first and second bioerodible polymer comprises at least one member selected from the group consisting of poly(lactide) polymers and poly(lactide-co-glycolide) copolymers.
3. The method according to claim 1 , wherein at least one excipient that modifies the erosion characteristics of the bioerodible polymer is blended with the active agent and the bioerodible polymer, and wherein the first and second active agent polymer mixtures comprise different excipients.
4. The method according to claim 3 , wherein the at least one excipient is a member selected from the group consisting of long chain fatty alcohols, cholesterol, and high molecular weight polyethylene glycol polymers.
5. The method according to claim 1 , wherein the first and/or second bioerodible polymer comprises a poly(D,L-lactide-co-glycolide) copolymer with a monomer ratio in the range of 50:50 to 85:15.