Sigmoid Pharma developed an advanced technology, a single-multiple pill called SmPill aimed to enhance the quality of application of orally administered remedies. It can be used to formulate drugs independent of physicochemical properties. Besides, it offers a brand new strategy when dealing with water-insoluble and low permeable drugs. CyCol lead program with its Phase 3 trials helps to moderate to severe ulcerative colitis in patients. Then, it permits the controlled release of another category of drugs including biopharmaceutical ingredients that are usually formulated in liquid or emulsion formulas for oral delivery.
Moreover, it addresses the next challenges related to the healthcare industry:
Low aqueous remedy solubility;
Low drug absorption or its further permeability;
Unfavorable systemic pharmacokinetics;
Following challenges of labile molecules, including vaccines and peptides.
If concerning the previous experience, oral administration of liquid formulas was only applicable through large and soft gelatine capsules or solutions that released a drug immediately at a single site, in particular, to the stomach or small intestine. However, processing such a coating is quite challenging. That’s why it is worth trying the SmPill Solution.
The SmPill Solution
Developed in a form of seamless and solid spheres, it permits the processing along with preserving the useful substances of liquid drug delivery systems.
The process of initiating this solution product involve also processing the active pharmaceutical ingredient to:
Dissolve as an emulsion, microemulsion or suspension;
Formulate into organic and solid mini-spheres;
Designate an outer controlled release coating.
As a result, a solution is created as an encapsulated drug in the pre-dissolved form that when applied orally provides a patient with the immediate release of the active ingredients to specific sites of the body, again, in particular, stomach or small intestine. Also, it simultaneously enhances permeability and drug stability. As of now, SmPill can be also founded in various dosage forms and a range of strengths. It helps to meet the requirements of both adult and children patients especially when there are difficulties with swallowing in elderly people.
- Rapid absorption;
- Delivery of a drug to the specific site of action (stomach);
- Controlled/Sustained release of liquid/emulsion drugs;
- Protection of active ingredients from bad gastric and intestinal conditions;
- Broad intestinal dispersion, and if needed less irritation.
Development Benefits of SmPill Technology
Improved balance of active ingredient through protection from light, oxidation;
Pediatric and geriatric formulations;
Advanced formulas aimed to extend product life-cycles;
Development of single-drug formulations for new patients;
Development of drug interactions for new uses;
Developing brand new drug combinations to reduce pill burden;
Inherent taste masking;
Ease of oral administration by intaking mini-sphere forms.
LEDDS technology is an integral part of SmPill technology. With LEDDS the size of the liquid droplets in the solid form proved to be efficient and much larger. Both LEDDS and SmPill are protected by a designated patent portfolio. And they together confer similar advantages.
Sigmoid possesses a wide portfolio of patents and patent applications including the main formula of SmPill along with other formulations.