Sigmoid is applying these principles to its own pipeline of products but also collaborates with partners either to improve their existing products or to expedite discovery stage compound development. For partners, this approach can rescue a good molecule from being rejected for poor absorption or inadequate pharmacokinetic profile or re-energize an established product’s life cycle by creating a higher performing, second generation formulation. LEDDS® and SmPill® also create the opportunity of developing oral formulations of drugs previously available only by injection.

Other than as a drink, liquid drug formulations for oral administration have previously only been available in large capsules which release their contents immediately at a single site, often in the stomach or small intestine. Further processing, such as coating, of large capsules can be challenging. Moreover, the manufacturing process introduces a seam where the two halves of the capsule are fused and this can lead to variability in dissolution.
 

LEDDS® and SmPill® Technology Overview

To develop a LEDDS® or SmPill®-enabled product, the active pharmaceutical ingredient is:

The result is an encapsulated drug in “pre-solubilised” form which when administered orally provides for predetermined instant or sustained release of the active drug to specific locations and at specific rates along the gastrointestinal tract. In essence, pre-solubilization of the drug enhances the predictability of its kinetic profile while simultaneously enhancing permeability and drug stability.

Because the LEDDS®/SmPill® approach is modular, being comprised of easily-swallowed mini-spheres, it can be presented in a variety of dosage forms in a range of strengths. This makes the technology particularly relevant to formulating drugs for special populations especially children and the elderly where swallowing can be difficult.

Key Clinical benefits of LEDDS® and SmPill®

Patent Portfolio