(586ad) Effect of Double Layer Formulation On Crystallization of Naproxen/Polyethylene Glycol Dispersion System

Hsu, H. Y., Purdue University

Solid dispersions are an increasingly important formulation approach to improve the dissolution rate and apparent solubility of poorly water soluble compounds. The matrix of hydrophilic polymer confines movement of the drug and depress its crystallization, which decreases the activation energy of dissolution. However, there are still issues of this approach. Two of the main obstacles to its application are difficulty of manufacturing and poor chemical and physical stability.

In this study, molten mixture of naproxen (NAP) and polyethylene glycol (PEG) 3350 was dispensed by a syringe pump, covered by another layer of PEG with different molecular weight (PEG2000, PEG3350, PEG6000, and PEG8000), and stored in environment with different relative humidity (RH). The extent of crystallization of NAP within each sample was assessed and compared. The practicability of combining drop printing technique and multilayer formulation to simplify manufacturing process, increase stability, and even control the releasing behavior of solid dispersion was examined.