Medical device with alginates, hyaluronic acid, and simethicone to protect the gastroesophageal mucosa and counter reflux symptoms
Reflucalm Plus is an oral gel medical device formulated to treat the symptoms of gastroesophageal reflux disease (GERD), particularly in moderate to severe forms and in patients who need prolonged relief.
The formulation combines magnesium alginate, sodium alginate, low molecular weight hyaluronic acid, simethicone, and myrrh extract. The barrier action of the alginates works alongside protective, soothing support for the gastroesophageal mucosa and the action of simethicone on gas-related discomfort. The product is available in a bottle with a measuring cup and dosing syringe.
Gastroesophageal reflux occurs when stomach contents rise into the esophagus, causing symptoms such as retrosternal burning, acid regurgitation, and heartburn. When episodes are frequent or persistent, they can affect daily wellbeing and require medical evaluation. Management of gastroesophageal reflux disease (GERD) depends on symptom severity and may include lifestyle changes, pharmacological treatments, and mechanically acting devices.
Gastroesophageal reflux: symptoms and mucosal protection
Repeated contact with gastric content can irritate the esophageal mucosa and contribute to burning, regurgitation, and retrosternal discomfort. In some patients, extra-esophageal symptoms such as laryngeal irritation may also occur, although these should be properly assessed diagnostically.
Alginates represent a mechanical approach to reflux control: on contact with the gastric environment, they form a gel-like structure that helps hinder the rise of acidic content. This mechanism is distinct from acid secretion suppression and can be useful in the symptomatic control of GERD.
Alginates, hyaluronic acid, and simethicone: the Reflucalm Plus formulation
The Reflucalm Plus formulation combines components with complementary functions:
- Magnesium alginate and sodium alginate: help form a protective barrier over the gastroesophageal tract, countering the rise of gastric content.
- Low molecular weight hyaluronic acid: promotes hydration and protection of the mucosa and supports the repair of damaged epithelium.
- Simethicone: helps reduce gas-related discomfort, such as bloating and abdominal distension.
- Myrrh extract titrated to 30% polysaccharides: has an emollient, soothing action on the laryngeal mucosa irritated by reflux.
The composition also includes gum arabic, xanthan gum, and guar seed flour.
Barrier action and support against reflux-related discomfort
The multi-action system of Reflucalm Plus is designed to address different aspects of the symptoms. Alginates help create a physical barrier, while hyaluronic acid supports hydration and protection of the gastroesophageal mucosa. Simethicone acts on gas-related discomfort, and myrrh contributes to the comfort of irritated mucosa.
This combination makes the product suitable for:
- relief from the symptoms of gastroesophageal reflux disease (GERD)
- protection of the mucosa from acid aggression
- support in cases of esophageal and laryngeal irritation.
Scientific evidence on alginates and mucosal protection
Alginate-based formulations have been studied for the treatment of gastroesophageal reflux symptoms. A systematic review and meta-analysis published in Diseases of the Esophagus analyzed the results of several clinical studies, finding that alginates may offer a benefit in symptom control compared with placebo or antacids. The results support their use as a mechanically acting approach, although there are differences between the formulations and studies considered.
The mechanism of action of alginates has also been investigated through studies evaluating their ability to form a floating barrier on gastric content. This structure helps limit the rise of acidic material toward the esophagus, acting differently from drugs that reduce acid secretion. The barrier formed by alginates therefore helps reduce contact between acidic gastric content and the esophageal mucosa, supporting control of reflux symptoms.
PJ Pharma develops and offers solutions for the gastroenterology sector, with formulation, regulatory, and manufacturing support. Reflucalm Plus is available for B2B and private label projects. Contact us for technical and commercial information and to explore product development opportunities.
The mechanism of action of alginates has also been investigated through studies evaluating their ability to form a floating barrier on gastric content. This structure helps limit the rise of acidic material toward the esophagus, acting differently from drugs that reduce acid secretion. The barrier formed by alginates therefore helps reduce contact between acidic gastric content and the esophageal mucosa, supporting control of reflux symptoms.
Looking for a ready-to-market oral gel for gastroesophageal reflux, or one that can be developed as private label?
We are certified manufacturers of medical devices, food supplements, and cosmetics, and we develop innovative formulations for gastrointestinal wellbeing. Reflucalm Plus is available for B2B and private label projects, with complete formulation, regulatory, and manufacturing support.
Contact us for more information about the product and to explore collaboration opportunities.
References
- Leiman DA, Riff BP, Morgan S, Metz DC, Falk GW, French B, Umscheid CA, Lewis JD. Alginate therapy is effective treatment for GERD symptoms: a systematic review and meta-analysis. Dis Esophagus. 2017 May 1;30(5):1-9. doi: 10.1093/dote/dow020. PMID: 28375448; PMCID: PMC6036656.
- Rohof WO, Bennink RJ, Smout AJ, Thomas E, Boeckxstaens GE. An alginate-antacid formulation localizes to the acid pocket to reduce acid reflux in patients with gastroesophageal reflux disease. Clin Gastroenterol Hepatol. 2013 Dec;11(12):1585-91; quiz e90. doi: 10.1016/j.cgh.2013.04.046. Epub 2013 May 10. PMID: 23669304.
