Sigmoid developed the proprietary SmPill® (single-multiple pill) technology to enhance the safety, efficacy and convenience of orally administered pharmaceuticals. SmPill® is extremely versatile and can be used to formulate drugs independent of inherent physico-chemical characteristics. For difficult-to-formulate molecules, particularly water-insoluble and poorly permeable drugs, SmPill® offers new solutions of particular interest.

SmPill®

SmPill® is the main focus of Sigmoid’s current development work and underpins all product development programmes. CyCol®, Sigmoid’s lead clinical development program, which is advancing into Phase 3 trials for moderate to severe ulcerative colitis, was uniquely enabled using SmPill® drug delivery technology.

SmPill® technology permits the controlled release of a wide range of drugs, including biopharmaceuticals, that are often optimally formulated in liquid or emulsion form for oral delivery.

The industry challenges addressed by SmPill® include, but are not limited to:

  • Poor aqueous drug solubility
  • Poor drug absorption or permeability
  • Unfavourable systemic pharmacokinetics
  • Processing challenges of labile molecules, including vaccines and peptides



The challenges of formulating liquids:

Previously, oral administration of liquid formulations was only possible as large soft gelatine capsules, or as drinks, releasing the drug immediately at a single site, often in the stomach or small intestine

Processing, such as coating, of liquid drug delivery systems, such as soft gel capsules is challenging.


The SmPill® Solution

SmPill® technology produces seamless, solid mini-spheres that are sufficiently robust to allow further processing while preserving the advantages of liquid drug delivery systems.

The process to produce a SmPill®-formulated product involves processing the active pharmaceutical ingredient to:

  • Solubilise as an emulsion, microemulsion or suspension
  • Formulate into solid mini-spheres
  • Apply an outer controlled release coating

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

 
Because the SmPill® approach is modular, being comprised of easily-swallowed mini-spheres, it can be presented in a variety of dosage forms and 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 SmPill® technology

  • Rapid onset of action (if desired)
  • Delivery of liquid/emulsion drug to the optimal site of action (e.g., colon)
  • Delivery of liquid/emulsion drug to maximise absorption
  • Controlled/Sustained release of liquid/emulsion drugs
  • Protection of active ingredient from harsh gastric and intestinal environment
  • Broad intestinal dispersion, (if required) limiting local irritation and increasing absorption

Key Product Development benefits of SmPill® Technology

  • Enhanced stability of active ingredient through protection from light, oxidation and reduction
  • Paediatric and geriatric formulation development facilitated
  • Patent extension to extend product life-cycles
  • Development of single drug formulations for new applications (reprofiling)
  • Development of drug combinations for new uses
  • Developing novel drug combinations to reduce pill burden
  • Inherent taste masking capability
  • Oral formulation of injectable drugs
  • Ease of oral administration arising from mini-sphere format

 

LEDDS® Technology

LEDDS® technology is Sigmoid’s pre-cursor technology to SmPill® technology. With LEDDS® the size of the liquid droplets in the solid, seamless microsphere system tended to be larger. As both LEDDS® and SmPill® are protected by a related patent portfolio and as both technologies confer similar benefits, and the terminology is often used interchangeably, Sigmoid is migrating the nomenclature of its drug delivery technology from LEDDS® to SmPill®

Patent Portfolio

Sigmoid maintains a portfolio of patents and patent applications covering SmPill® as well as new formulations using the platform.

 


Sigmoid Pharma , The Invent Centre
Dublin City University, Dublin 9, Ireland