Retinal Drug Delivery System, Phase I
Abstract
The feasibility of fabricating a multi-compartment intravitreal implant for treatment of traction retinal detachment was successfully confirmed. The goal was to design a biodegradable implant capable of pulsatile release of 5-fluorouracil (5-FU) and continuous release of diclofenac. TheriForm technology was used to construct several prototypes; the walls and lids being made with biodegradable polymers of controlled composition and thickness to optimize drug release. Polymer selection was based on film degradation studies and iterative design improvements. All initial prototypes comprised one drug only, but included a placebo structure to mimic the portion that would contain the other drug in the composite commercial dosage form. This tactic simplified product development and demonstrated process capabilities to fabricate implants with therapeutic agents in separate compartments. The 5-FU only implants successfully demonstrated pulsatile release with lag times of 0-18 hours. Ongoing research has provided several leads to increase inter-pulse time delay.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jun 01, 1997
- Accession Number
- ADB227216
Entities
People
- Donald C. Monkhouse
- Esteban R. Bornancini
- Jaedeok Yoo
- Jill K. Sherwood
- Sandeep Kumar