This is the first application of Intravail in a solid dosage form. The Intravail formulation is compatible with current tableting processes employed for OTC and prescription drugs and does not alter tablet size or appearance.
Previously published studies have shown that Intravail alkylsaccharide excipients increase oral bioavailability of a number of peptide and nonpeptide drugs in preclinical studies. Examples include exenatide, octreotide, desmopressin, heparin, sumatriptan and a 7kDa antisense (nucleotide analog) drug.
In these latter applications, Intravail was incorporated into aqueous formulations or fast dissolve or chewable formats. The extension of the use of Intravail into solid dosage forms represents a significant expansion of the broad applicability of this technology. Intravail excipients are equally soluble in pharmaceutically accepted oils thus permitting use as oral absorption enhancers in gel caps as well.
Until now, 16 US and foreign patents have issued and notice of allowance has been received on two additional patents that will issue shortly covering various aspects of the Intravail/ProTek alkylsaccharide-based technologies. More than 50 additional patent applications are currently pending.
Aegis licenses its Intravail drug delivery and ProTek protein stabilization technologies to biopharmaceutical companies worldwide and is now seeking licensees for the application of Intravail to a broad range of over-the-counter drugs where increased bioavailability or more rapid onset of action would offer improved performance and significant market differentiation in a crowded field.