Two CE medical devices based on simethicone, in oil and water formulation, for the control of gastrointestinal gas
When gastrointestinal gas causes discomfort, the problem is almost never the quantity: it’s the form. Gas trapped in foam, bubbles stabilized by endogenous surfactants, which no dietary change can eliminate and which require a chemically designed agent to break them from within.
It is on this mechanism that Rilefast CE Spray and Comil Spray are born: two Class IIb CE medical devices based on simethicone, available in oil-based and water-based formulation, with a documented antifoam profile and formulative safety validated for the most demanding populations, from newborns to adults.
Two distinct platforms to address differentiated use contexts, without compromises on industrial quality.
The underlying problem: gas, foam and gastrointestinal discomfort
Intraluminal gas does not only cause problems due to its quantity, but because of the form in which it accumulates. Gastric and intestinal secretions contain endogenous surfactants that stabilize gas bubbles in a foamy matrix. This foam resists normal transit, increases intraluminal pressure and produces the typical symptoms: distension, cramps, feeling of tension, flatulence, belching.
In newborns and infants, aerophagia during feeding and the immaturity of the digestive system amplify this mechanism. Gaseous colic, bloating and associated diarrheal dysbiosis represent very frequent conditions, often difficult to manage with products that do not respect the safety requirements of the first weeks of life.
In adults, the picture is equally common in contexts of functional dyspepsia, post-prandial bloating and chronic aerophagia. The need for an effective, well-tolerated and fast-acting antifoam agent is documented both in daily clinical practice and in the gastroenterological literature.
Rilefast CE Spray and Comil Spray: two solutions, one single active ingredient
Rilefast CE Spray and Comil Spray are designed around simethicone as the functional active ingredient, with a substantial difference in the delivery vehicle. Rilefast CE Spray uses olive oil as the main excipient, enriched with vitamin E and coenzyme Q10. Comil Spray is the water-based version, designed to meet formulation preferences or use contexts where the oil-based vehicle is not indicated.
Both deliver a unit dose of 40 mg of simethicone through 5 spray doses. The spray system ensures dosing accuracy, ease of administration in pediatric and neonatal settings, and repeatability of delivery regardless of the filling level of the bottle. The 20 ml format with dispenser is designed for practical use in a home setting.
The choice of the oil-based vehicle in Rilefast CE Spray is not incidental. Simethicone is a hydrophobic molecule, and its dispersion in a compatible lipophilic excipient optimizes its distribution in the gastric environment.
Scientific evidence supporting the efficacy of simethicone
The choice of simethicone as the active ingredient of Rilefast CE Spray and Comil Spray is supported by an established clinical literature.
A randomized controlled study published by Sun et al. in Trials (2021) evaluated the effect of simethicone on gastric cleanliness before an esophagogastroduodenoscopy in 311 adult patients, quantifying gastric foam clearance using standardized grades.
The results show that simethicone administered within the optimal time window achieved the maximum gastric cleanliness grade in 79.3% of patients, compared to 17.3% in the control group with administration outside the window (P < 0.001). This data quantitatively confirms the ability of simethicone to eliminate gastric foam effectively and reproducibly.
Use contexts and target populations
Rilefast CE Spray and Comil Spray cover a broad spectrum of indications:
- dyspeptic disorders
- gastroenteric bloating
- aerophagia
- gaseous colic
- diarrheal dysbiosis
They are formulated for use in newborns, infants, children and adults, with age-differentiated dosing.
For newborns and infants, the suggested dose is 1 full dose (5 sprays, 40 mg of simethicone) 1-2 times per day. For children, 1 dose 1-3 times per day.
For adults, half a dose 2-4 times per day. This dosing flexibility, managed with a single product format, simplifies the distribution chain and meets the needs of formulators and companies developing integrated pediatric lines.
Rilefast CE Spray may be particularly suitable in contexts where a formulation with added value compared to classic simethicone in aqueous emulsion is sought: the presence of vitamin E and coenzyme Q10 enriches the formulative profile without adding problematic excipients.
Comil Spray instead meets the demand for a standard aqueous solution, with the same active ingredient and the same safety profile.
Production quality and industrial standards
Rilefast CE Spray and Comil Spray are Class IIb medical devices, MDR certified, with a quality system certified ISO 13485.
Both formulations are free from lactose, gluten, sugars, preservatives, artificial flavors and alcohol. These requirements are not simply commercial labels: they respond to suitability criteria for the neonatal population, where every unnecessary excipient is a potential risk that must be eliminated at the design level.
Comil Spray and Rilefast CE Spray are available in ready-to-market or private label
Source Sun X, Xu Y, Zhang X et al. “Simethicone administration improves gastric cleanness for esophagogastroduodenoscopy: a randomized clinical trial.” Trials (2021) 22:555. https://doi.org/10.1186/s13063-021-05527-8
