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Dyspepsia: from Biofarma Group two products to combat digestive difficulties

Data: 29_08_2023
Category: R&D Innovation

Dyspepsia is the medical term used for digestive disease. It is a condition whose prevalence is difficult to establish with certainty due to the different definitions used to describe it and the difficulty for patients to identify its exact symptoms. In fact, according to data from various studies conducted on different populations, the prevalence of dyspepsia varies between 7% and 45%.

Although it is a non-life-threatening condition, for which no association with any increase in mortality has been demonstrated, its impact on patients and health services has proved considerable. In a survey conducted among several European and North American populations, 20% of people with dyspeptic symptoms said they had consulted general practitioners or hospital specialists, more than 50% of dyspeptic sufferers took medication most of the time, and about 30% of dyspeptics reported taking days off work or school because of symptoms. Similar findings have been reported by other leading researchers in this field, who have also highlighted the fact that people with dyspepsia have a significantly reduced quality of life compared to the general population.

Dyspepsia: what it is, causes and symptoms of the disease

 As already mentioned, the term dyspepsia refers to the presence in a subject of digestive problems and, specifically, it means an often-recurring sensation of pain or discomfort in the upper portions of the abdomen.

It is also important to note that the term comprises two different forms of the condition: organic and functional dyspepsia. In the first case, dyspepsia is the consequence of an established cause such as a disease of the digestive tract, drug intake, substance abuse or imbalances resulting from prolonged unbalanced diets. Functional dyspepsia, on the other hand, is when the causes are not identified, and this is the condition that occurs in most cases. It is generally thought that the onset of the condition in this second case is associated with a combination of visceral hypersensitivity, gastric motor dysfunction and psychological factors.

Due to the concomitance of dyspepsia with other diseases, it is not easy to identify the specific symptoms of the condition. In addition to pain and a burning sensation in the stomach, patients sometimes report bloating, nausea, vomiting and belching.

In order to counteract these symptoms, the adoption of a healthy lifestyle and, specifically, a healthy diet is generally recommended. Furthermore, several studies have associated the presence of dyspepsia with mood-related issues, thus making mental well-being an important ally in counteracting the condition.

An important support in combating the symptoms can also be provided by two products developed by Biofarma Group: the food supplement Digestive Gum and the medical device Gas&Bloating.

Ingredients of the product Digestive Gums for dyspepsia

Digestive Gum: a chewable tablet among the remedies for digestive discomfort

 The symptoms of dyspepsia can have a significant impact on the quality of life of people suffering from it. This is why Biofarma Group has formulated  a food supplement to counteract the effects of poor digestion in a practical pharmaceutical form: the chewable tablet.

This innovative technology contains a synergistic mix of active ingredients whose efficacy against dyspepsia is supported by scientific evidence. The food supplement contains ginger extract titrated in gingerols and lemon peel essential oil.

Ginger extract has proven therapeutic efficacy for the stomach as it can stimulate digestion, dissolve fats and above all relieve nausea and vomiting. In fact, this component has been used since antiquity as a traditional remedy for gastrointestinal disorders. An effectiveness made possible in particular by its active ingredients, namely gingerols and shogaols. Several preclinical and clinical studies have evaluated ginger as an effective and safe treatment for nausea and vomiting even in sensitive contexts such as pregnancy and for chemotherapy-induced nausea and vomiting.

For this formulation, encapsulated ginger is used in order to attenuate its generally strong flavour and thus adapt the product to the tastes of a wider audience.

The flavour of the tablet is also enriched by the presence of essential lemon peel oil, which not only provides a very pleasant feeling of lightness, but also aids digestion and helps to combat abdominal bloating.

In addition to the ingredients in the formulation, the form selected for the product also provides important support in facing the symptoms of dyspepsia. Chewable tablet after a meal can in fact stimulate the release of bile, digestive enzymes and acids, all components needed to digest food properly, and can help avoid indigestion after a large meal by also helping to calm acid reflux.

In addition, considering the already emphasised correlation between emotional problems and dyspepsia, it is also important to mention the results of a number of studies showing evidence of the relaxing and calming effect of a chewing gum. This has been analysed in laboratory, in epidemiological studies and in real-life interventions.

If a chewing gum can reduce feelings of stress, it can also alleviate depression, a stress-related disorder. In fact, in a clinical sample of patients with mild-to-moderate depression, this was reduced to a greater extent when chewing gum was administered together with antidepressants, compared to using medication alone.

As in many other areas, there are still several questions that require fundamental research; however, the long-term benefits of chewing on mental wellbeing suggest that it could be a simple and cost-effective way to reduce stress and improve the quality of life and wellbeing of people suffering from it.

The Digestive chewable tablet is therefore a cutting-edge nutraceutical product that combines innovative technology and active ingredients with associated science: a convenient chewable form that provides important health benefits beyond the pleasure of chewing.

Simethicone, key ingredient of the product Gas&Bloating against Dyspepsia

Gas&Bloating: counteracting digestive difficulties with a medical device

Many of the symptoms associated with poor digestion with a major impact on the quality of life of the sufferer (flatulence, meteorism, belching, bloating and abdominal cramps) result from an excessive accumulation of gas in the gastro-intestinal tract.

This is why Biofarma Group has conceived a medical device indicated for the treatment of these exact symptoms: Gas&Bloating.

The product is in the form of an orally-dispersible powder for oral administration, packaged in single-dose sachets of 2 grams each, and its main ingredient is simethicone.

Simethicone is an antifoaming agent that has the ability to lower the surface tension at the interface between liquid and air and to form a thin film that covers the air bubbles retained at the gastrointestinal level. In this way, the bubbles in the tract are broken up, forming free gas that is then easily eliminated.

To the medical device, in some of the available variants, digestive enzymes have been added as secondary ingredients, capable of improving the digestion of food, counteracting the effects of food malabsorption and consequently alleviating the symptoms related to the overproduction of gastrointestinal gas.

The formulation of the Medical Device also includes excipients necessary to obtain an orodispersible powder that is pleasant to the taste and safe to use. Specifically, these are substances with diluting, anti-agglomerating, flavouring and sweetening activities.

The Medical Device is available in two different dosages:

  • Simethicone 75 mg/bag, enzymes (where present) 65 mg/bag

  • Simethicone 125 mg/bag, enzymes (where present) 97.5 mg/bag

In addition, two different flavours are available for each of the formula types: chocolate flavouring and citrus flavouring. The aim is to be able to supply the product to different distributors while taking into account the needs of the different markets for which the product is intended.

The therapeutic efficacy of the medical device was proven through an in vitro test that observed the product's ability to degrade four substrates commonly found in food: starch, lactose, casein and a mixture of triglycerides. The results of the study confirmed the effectiveness of the medical device in supporting the digestion of foods typical of a complete diet.

Gas&Bloating is therefore an important ally for individuals suffering from symptoms caused by digestive difficulties.

Edited by:

  • Antonella Venuti: R&D Development Manager

  • Arianna Vanelli: R&D Scientific and Innovation Manager

  • Stefania Murzilli: R&D Scientific Coordinator

  • Valentina Milite: R&D Scientific Specialist

Bibliography

  • Sanjiv Mahadeva, Khean-Lee Goh, “Epidemiology of functional dyspepsia: A global perspective”, World J Gastroenterol. 2006 May 7; 12(17): 2661–2666.ù

  • Lete I, Allué J. The Effectiveness of Ginger in the Prevention of Nausea and Vomiting during Pregnancy and Chemotherapy. Integr Med Insights. 2016 Mar 31; 11:11-7. doi: 10.4137/IMI.S36273. PMID: 27053918; PMCID: PMC4818021.

  • Hochner H, Tenfelde SM, Abu Ahmad W, Liebergall-Wischnitzer M. Gum chewing and gastrointestinal function following caesarean delivery: a systematic review and meta-analysis. J Clin Nurs. 2015 Jul;24(13-14):1795-804. doi: 10.1111/jocn.12836. Epub 2015 Apr 7. PMID: 25850885.

  • Smith AP. Chewing gum and stress reduction. J Clin Transl Res. 2016 Apr 24;2(2):52-54. PMID: 30873461; PMCID: PMC6410656.

  • Hollingworth HL. CHEWING AS A TECHNIQUE OF RELAXATION. Science. 1939 Oct 27;90(2339):385-7. doi: 10.1126/science.90.2339.385. PMID: 17776097.

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