An ocular insert is developed for the controlled systemic delivery of
insulin. Commercially available Gelfoam absorbable gelatin sponge, USP
, is used in the fabrication of the ocular insert in the form of a mat
rix system. Two eyedrop formulations and 13 eye device formulations we
re evaluated. The efficacy of insulin ocular delivery was quantitated
by monitoring the changes in its pharmacological response (i.e., blood
glucose lowering). The in vivo results from devices containing 0.5 or
1.0 mg of insulin with 20 mu g of polyoxyethylene-20-stearyl ether (B
rij-78) give a substantial improvement in insulin activity and a signi
ficant prolongation in its duration compared with the eyedrops. In add
ition, the mean blood glucose concentration returns to nearly normal l
evels within 60 min after the removal of the device. Overall, the appl
ication of the Gelfoam device makes it feasible to obtain a prolonged
systemic delivery of insulin within the desired therapeutic levels wit
hout the risk of hypoglycemia.