Development of a Sustained Release Dosage Form for Phenylephrine Hydrochloride using Solid Lipid Pellets

The purpose of this work was to demonstrate proof-of-concept for a stable sustained release dosage form containing phenylephrine hydrochloride (PE HCI) using Capsugel's Solid Lipid Pellets (SLP) technology.

Phenylephrine is the most common over-the-counter decongestant used in the United States. PE HCI is highly water-soluble and therefore the development of a sustained release dosage form is challenging, moreover, PE HCI exhibits low and variable oral bioavailability due to extensive manoamine oxidase mediated metabolism in the gut and liver.

More specifically the objective was to produce spherical pellets providing a sustained release in-vitro dissolution profile over at least 12 hours and showing acceptable physical and chemical stability on prolonged storage over 18 months.

This poster was presented at the 2014 PBP World Meeting.

Bioavailability Enhancement