Electronic Theses and Dissertations

Date of Award


Document Type


Degree Name

M.S. in Pharmaceutical Science

First Advisor

Eman Ashour

Second Advisor

Walter G. Chambliss

Third Advisor

Michael A. Repka

Relational Format



The objective of this study was to develop a child-centered metformin hydrochloride (HCL) oral formulation by successfully masking its bitter taste and facilitating ease of administration. Hot-Melt Extrusion (HME) technology was used to extrude filaments containing metformin HCL with varying ratios of Eudragit® Polymers. Eudragit® E PO was used as a main excipient for its pH-dependency. Since it is only soluble in acidic pH up to pH 5.0, it would not release the drug in the saliva environment, which has a pH of approximately 6.8. Eudragit® RL PO and RS PO were added later on in order to further control the release in the saliva environment as well as the food vehicle environment. The HME extrudates were creamy white in color, brittle in texture, 1mm in diameter, and cut into sprinkles measuring less than 2.5 mm in length. In the first stage of the experiment, formulations containing multiple drug loads and Eudragit® E PO were extruded. The 40% drug load formulation attained the best results by releasing less than 10% of its content in pH 6.8 (mimicking saliva pH) and all its content in pH 1.2 (mimicking stomach pH). The next stage tested the effect of adding either Eudragit® RL PO or RS PO in low (5%) or high (10%) concentrations. The formulation containing 10% Eudragit® RL PO was the only formulation that did not release more than 10% of its drug content in pH 6.8. Based on those findings, the formulation containing 40% drug load and only Eudragit® E PO and the formulation containing 10% Eudragit® RL PO were chosen to be testing in different pH environments mimicking the pH of some of the most commonly used pH vehicles for oral drug administration. The taste-masked metformin HCL sprinkles for pediatric oral administration were successfully developed with a drug load of 40%. When administered with food, a neutral to alkaline food vehicle would be a better choice to maintain the taste-masking properties.

Available for download on Thursday, March 05, 2026