Sustained-Release Biodegradable Intracameral Implants Containing Dexamethasone and Moxifloxacin: Development and In...

Area of Science:

• Ophthalmology
• Biomaterials Science
• Drug Delivery Systems

Background:

• Postoperative inflammation and infection (endophthalmitis) are significant risks following cataract surgery.
• Current treatments often require frequent dosing and may have limited efficacy.
• A sustained-release implantable formulation offers a potential solution for improved ocular drug delivery.

Purpose of the Study:

• To develop and characterize a novel intraocular sustained-release implantable pharmaceutical formulation.
• To evaluate the safety and efficacy of the implant for delivering moxifloxacin hydrochloride and dexamethasone.
• To assess the biocompatibility and degradation profile of the implant in an ocular environment.

Main Methods:

• Hot-melt extrusion was used to create implants from polylactide-co-glycolic acid, moxifloxacin hydrochloride (MOX HCl), and dexamethasone (DEX).
• Quality control included drug content, release rate studies, SEM, Raman microscopy, DSC, and XRD.
• In vivo studies in rabbits assessed safety, performance, and biodegradation.

Main Results:

• Implants demonstrated homogeneous drug distribution and met label claims.
• In vitro release showed constant MOX HCl and non-linear DEX release.
• In vivo studies indicated complete biodegradation within ~20 days, with no signs of toxicity or significant intraocular pressure changes.

Conclusions:

• The developed implants function as effective sustained-release depots for MOX HCl and DEX.
• The formulation is biocompatible with ocular structures.
• This novel implantable device shows promise for managing postoperative inflammation and infection after cataract surgery.