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
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 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, 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 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