Electronic Theses and Dissertations

Date of Award


Document Type


Degree Name

M.S. in Pharmaceutical Science


Pharmaceutics and Drug Delivery

First Advisor

Michael A. Repka

Second Advisor

Eman Ashour

Third Advisor

Soumyajit Majumdar

Relational Format



The objective of the current study was to investigate the processability of Hot Melt Extrusion to formulate Ocular Inserts of Valacyclovir Hydrochloride and Evaluate its drug release in vitro and in vivo. Valacyclovir is the prodrug of Acyclovir, which is used in treatment of ocular keratitis and HSV infections. The bioavailability of the prodrug is better than the acyclovir and it is proved to permeate extensively through the corneal barrier. The polymer of choice was Klucel® Pharm MF and JF grades for the study. To optimize the formulation, different physical mixtures of the polymers and plasticizers (PEG 400 and Propylene glycol) were prepared. The physical mixture was extruded through co – rotating twin-screw Haake MiniLab ThermoFisher ® Scientific extruder. The obtained ocular inserts were cut into dimensions of 4mm×2mm×1mm to have suitable product instillation in the eye. Ocular inserts were evaluated for drug content, weight variation, uniformity of thickness and in vitro and in vivo drug release. The thermal characterization of ocular inserts was observed using Differential Scanning Calorimetry (DSC). Morphology of the ocular inserts was observed using Scanning Electron Microscopy (SEM). The polymer interactions or incompatibilities was assessed using FTIR. Klucel ® Pharm MF exhibited desired results than Klucel ® Pharm JF and was easy to extrude to prepare ocular inserts. The ocular inserts were able to provide sustained drug release compared to eyedrop solution and then dissolve completely in 9 hours.


Emphasis: Pharmaceutics

Available for download on Monday, August 28, 2023