Extended release biodegradable ocular implants
Biodegradable implants sized and suitable for implantation in an ocular region or site and methods for treating ocular conditions. The 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.
1. A method for making an extended release bioerodible implant for treating an ocular condition, the method comprising the steps of:
(a) blending an active agent with a first bioerodible polymer;
(b) extruding the blend of step (a) to form a filament;
(c) breaking the extruded filament of step (b) into particles with a size of between about 30 μm and about 50 μm;
(d) blending additional quantities of the active agent with a second bioerodible polymer;
(e) mixing the particles of step (c) with the blend of step (d):
(f) extruding the mixture of step (e) to form a filament;
(g) cutting the filament of step (f) to form an extended release bioerodible implant for insertion into an ocular region for treating an ocular condition.
2. The method of claim 1 , wherein the implant formed in step (g) has as diameter of about 0.05 mm to 3 mm and a length of about 0.5 to about 10 mm.
3. The method of claim 1 , wherein the active agent is a steroidal anti-inflammatory agent.
4. The method of claim 3 , wherein the active agent is dexamethasone.
5. The method of claim 1 , wherein the active agent is dexamethasone,
and wherein the first bioerodible polymer is selected from the group consisting of i) RG755, which is a poly(D,L-lactide-co-glycolide) having a molecular weight of about 40,000 and a lactide:glycolide content of about 75:25 by weight, ii) R203, which is a poly(D,L-lactide) having a molecular weight of about 14,000, iii) RG503, which is a poly(D,L-lactide-co-glycolide) having a molecular weight of about 28,000 and a lactide:glycolide content of about 50:50 by weight, iv) RG502, which is a poly(D,L-lactide-co-glycolide) having a molecular weight of about 11,700 and a lactide:glycolide content of about 50:50 by weight, and v) RG502H, which is a poly(D,L-lactide-co-glycolide) having a molecular weight of about 8,500, a lactide:glycolide content of about 50:50 by weight, and a free acid at the end of the polymer chain,
and wherein the second bioerodible polymer is selected from the group consisting of RG502 and RG502H.