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Diosmectite
Diosmectite powder
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Formula(Na-Ca)0.33-(Al-Mg)2-Si4-O10-(O-H)2·(H2O)2
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Diosmectite (brand names Smecta, Smecdral) is a natural silicate of aluminium and magnesium used as an intestinal adsorbent in the treatment of several gastrointestinal diseases, including infectious and non-infectious acute and chronic diarrhoea, including irritable bowel syndrome diarrhea subtype. Other uses include: chronic diarrhea caused by radiation-induced, chemotherapy-induced, and HIV/AIDS-associated chronic diarrhea.[1]

It is insoluble in water. It is usually taken orally as a suspension in warm water. In the field of geology, it is more commonly known as montmorillonite. Diosmectite is a contraction of "dioctahedral smectite".

Mechanism of action

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Its effectiveness in improving stool consistency is the result of its alleged ability to absorb bacteria, viruses and toxins as well as strengthening the intestinal mucus barrier to reduce luminal antigens passing through the mucus barrier which in turn helps to reduce inflammation.[1]

Diosmectite may be a useful additive in the treatment of acute childhood diarrhoea. As evidence is of ‘low quality’, future research is needed with higher quality designs before any firm recommendations can be made. [2]

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Diosmectite

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Diosmectite is a natural dioctahedral consisting primarily of aluminum and magnesium silicates, featuring a lamellar, non-fibrous crystalline structure composed of two silica tetrahedral sheets sandwiching a central alumina octahedral sheet. This structure imparts strong adsorbent properties, enabling it to bind , gases, toxins, , and viruses in the . As a pharmaceutical agent, diosmectite is commonly formulated into oral suspensions or powders, such as the brand Smecta, and is indicated for the of acute in adults and children, as well as for related conditions like and peptic ulcers. Clinical trials and meta-analyses have shown that it shortens the duration of by approximately 15 to 24 hours compared to or rehydration alone, while also increasing the likelihood of recovery within three days and reducing stool frequency. Its mechanism involves forming a protective barrier on the intestinal mucosa, restoring permeability, and modulating without altering composition even during long-term use. In , diosmectite belongs to the group of phyllosilicates, known for their swelling capacity due to interlayer and cations, and it is sourced from specific geological deposits, often purified for medical applications to ensure low heavy metal content. Beyond , emerging research explores its potential in for animal , though human therapeutic uses remain its primary application. Diosmectite exhibits minimal systemic absorption with primarily local action in the gastrointestinal tract; the most common side effect is constipation, while hypersensitivity reactions are rare and no systemic side effects have been reported.

Chemical and Physical Properties

Composition and Structure

Diosmectite is classified as a dioctahedral phyllosilicate, a type of with a fundamental 2:1 layer composed of two tetrahedral silica sheets sandwiching a central octahedral sheet dominated by aluminum and magnesium. The general is (Na,Ca)0.33(Al,Mg)2(Si4O10)(OH)2⋅nH2O(\mathrm{Na},\mathrm{Ca})_{0.33}(\mathrm{Al},\mathrm{Mg})_2(\mathrm{Si}_4\mathrm{O}_{10})(\mathrm{OH})_2 \cdot n\mathrm{H}_2\mathrm{O}, where variable interlayer cations such as sodium and calcium balance the negative layer charge arising from isomorphous substitutions in the octahedral and tetrahedral sheets, and nn represents the number of water molecules. The individual layers have a thickness of 9.6–10 , and upon hydration, the basal spacing expands to 12–15 as molecules and exchangeable cations occupy the interlayer , enabling interlayer swelling and . This dioctahedral configuration, with two-thirds of the octahedral sites occupied primarily by Al³⁺ and some Mg²⁺, distinguishes diosmectite from trioctahedral smectites and contributes to its low layer of approximately -0.2 to -0.6 per . Naturally occurring in sedimentary deposits formed through the alteration of or feldspars, pharmaceutical-grade diosmectite is sourced primarily from regions like and , where it is extracted and purified to meet strict impurity standards. The expandable layered architecture allows diosmectite to swell significantly in , generating a high of up to 800 m²/g through the exposure of internal basal surfaces.

Physical Characteristics

Diosmectite appears as a , off-white to with a smooth, non-abrasive texture, making it suitable for oral suspension formulations. The of diosmectite typically ranges from 2 to 7 micrometers, which facilitates its dispersion in liquids without rapid . This contributes to its ability to form stable colloidal suspensions. Diosmectite is insoluble in and organic solvents but disperses readily to form high-viscosity colloidal suspensions upon hydration, owing to the swelling property derived from its layered . The of these suspensions is generally neutral to slightly alkaline, ranging from 7 to 9. Its density is approximately 2.5 g/cm³, and it exhibits thermal stability up to around 500°C before significant occurs.

Medical Uses

Indications

Diosmectite is primarily indicated for the symptomatic treatment of acute watery diarrhea in adults and children over 2 years of age, in addition to oral rehydration therapy, including infectious causes such as viral or bacterial gastroenteritis. It serves as an adjunct therapy to shorten the duration of diarrhea and reduce stool frequency in mild-to-moderate cases. Secondary indications include chronic diarrhea associated with (diarrhea-predominant subtype), where it helps alleviate and . It is approved for chronic functional diarrhea in adults and has been used for diarrhea induced by or . Additionally, diosmectite is used as for HIV/AIDS-related chronic idiopathic enteropathy. Emerging off-label applications involve supportive treatment for associated with , leveraging its adsorption properties to potentially trap viral particles and mitigate symptoms. Diosmectite is not recommended as monotherapy for severe or bloody (dysentery), conditions requiring primary rehydration and targeted antimicrobial therapy.

Dosage and Administration

Diosmectite is administered orally as a powder for suspension, with each containing 3 g of the . The standard adult dose for acute is 3 g (one ) three times daily, totaling 9 g per day, mixed with approximately 50 ml of or incorporated into soft food such as or to form a suspension. For pediatric use, dosing is adjusted by age to ensure safety. In children aged 1–2 years, the recommended dose is 3 g (one ) twice daily, for a total of 6 g per day, while children over 2 years should receive 12 g per day (4 ) for the first 3 days followed by 6 g per day (2 ) for the next 4 days; these doses should also be prepared as an oral suspension in or semi-liquid food like broth or puree. Infants under 1 year should only receive diosmectite under strict medical supervision, typically limited to 3 g once daily if deemed necessary. The suspension should be taken between meals to optimize absorption and , and it must be administered at least 2 hours before or after other medications to prevent potential interactions due to diosmectite's adsorptive properties. Patients are advised to shake or stir the mixture well immediately before use, and the full course should be completed as prescribed. Treatment duration is typically 3–7 days for acute cases such as , with rehydration therapy using oral rehydration solutions mandatory alongside diosmectite to address fluid loss; for chronic conditions, longer use requires ongoing medical supervision to monitor response and prevent complications. If symptoms persist beyond 3 days in children or 7 days in adults, consultation with a healthcare provider is essential.

Mechanism of Action

Adsorption Mechanisms

Diosmectite, a natural aluminomagnesium clay, primarily exerts its therapeutic effects through adsorption mechanisms that involve its high (CEC) and negatively charged layered structure. The CEC of diosmectite is approximately 100 meq/100 g, arising from isomorphic substitutions in its lattice that generate permanent negative charges on the layers. This enables with positively charged species in the , including bacterial toxins, viruses, and , via electrostatic interactions. Additionally, the clay's swelling property in aqueous environments expands its interlayer spaces, facilitating surface adsorption through hydrogen bonding and van der Waals forces. A key aspect of diosmectite's adsorption is the sequestration of enterotoxins, such as cholera toxin from Vibrio cholerae and heat-labile toxin from enterotoxigenic Escherichia coli. These toxins, which are proteins with positive charges at physiological pH, bind to diosmectite via hydrogen bonding and ionic interactions, preventing their attachment to enterocyte receptors and subsequent stimulation of fluid secretion. In vitro studies have demonstrated efficient adsorption of these labile toxins at the pH of intestinal chyme (approximately 6–7), with similar binding observed for E. coli verotoxin in acidic conditions (pH < 5), though adsorption diminishes in alkaline environments. This pH-dependent binding aligns with the varying acidity from the gastric (pH 1–3) to intestinal (pH 6–8) milieu, optimizing toxin capture across the gut. Diosmectite also adsorbs pathogens like and certain through multilayer surface coverage, leveraging its large specific surface area enhanced by hydration-induced swelling. experiments show that diosmectite at concentrations of 100 mg/mL effectively traps rotavirus particles, significantly reducing viral titers and infectivity in cell models by preventing epithelial attachment. Bacterial is similarly inhibited via electrostatic repulsion and physical , with the clay's diffuse negative charges promoting binding of positively charged bacterial surfaces or associated toxins. Overall, these mechanisms contribute to the clay's role in mitigating luminal irritants.

Mucosal Protection

Diosmectite, upon hydration in the , swells to form a colloidal dispersion that adheres to and coats the mucosal surfaces, creating a protective film which shields the from irritants and reduces mucosal permeability and . This film-forming property enhances the by limiting the passage of harmful substances through the layer, thereby supporting mucosal integrity in inflammatory conditions such as . In addition to physical coating, diosmectite stimulates mucus production by upregulating the expression of MUC2, the primary secretory mucin in the intestinal tract, which thickens the layer and bolsters epithelial defense. This effect mimics the protective actions of against mucolysis, and regulation of chloride channels to modulate secretion and maintain mucus viscosity. By preserving and reinforcing the barrier, diosmectite inhibits degradation by enzymes like , further promoting cytoprotection. Diosmectite exerts anti-inflammatory effects by binding pro-inflammatory cytokines such as IL-1β and IL-8, as well as free radicals, thereby mitigating oxidative stress and inflammatory damage to the mucosa from infections or irritants. In vitro studies demonstrate dose-dependent inhibition of cytokine production in stimulated intestinal cells, reducing neutrophil infiltration and expression of inducible nitric oxide synthase. These actions complement its adsorptive role by directly attenuating inflammatory cascades at the mucosal interface. In vivo evidence from animal models supports these protective mechanisms; for instance, in early-weaned piglets exposed to weaning stress—a model of toxin-induced barrier disruption—diosmectite-zinc composite supplementation restored tight proteins like zonula occludens-1 and , improving intestinal and reducing permeability. Similarly, in rat models of trinitrobenzene sulfonic acid-induced , diosmectite administration decreased mucosal by 57%, lowered pro-inflammatory markers, and enhanced overall epithelial repair without altering luminal antigen adsorption details.

Safety Profile

Adverse Effects

Diosmectite is generally well-tolerated, with the most common being , reported in approximately 7% of adults and 1% of children and often attributed to its adsorptive properties that slow intestinal transit, potentially leading to associated and . These effects are typically mild to moderate and transient. Trace amounts of lead are present due to the natural origin of diosmectite; although no cases of have been reported, this led to safety alerts in and ongoing restrictions in use for certain populations as of 2020. Rare adverse effects include , , urticaria, or hypersensitivity reactions such as ; no serious systemic effects have been reported in long-term use, consistent with its lack of absorption from the . In pediatric populations, mild occurs more frequently than other effects, though studies indicate no significant difference from and no reported impact on growth or development with appropriate use. Patients should be monitored for severe constipation or ileus, with discontinuation recommended if these develop; overall, diosmectite exhibits a low incidence of adverse effects, typically under 5% across post-marketing surveillance. Diosmectite acts locally in the gastrointestinal tract with almost no systemic absorption and consequently no systemic side effects. Reliable sources do not report hair loss (alopecia/脱发/掉头发) or facial thinning (脸瘦/脸变瘦) as adverse effects of diosmectite. These symptoms have no evidence of direct causal relation to the medication and may instead result from other factors such as malnutrition or weight changes associated with diarrhea.

Contraindications and Interactions

Diosmectite is contraindicated in patients with to diosmectite or any of the excipients, including in cases of intolerance, glucose-galactose , or sucrase-isomaltase insufficiency due to the presence of glucose and in some formulations. It should not be used in cases of intestinal obstruction or severe chronic , as these conditions may be exacerbated by its adsorbent effects. It is also contraindicated in children under 2 years of age. Not recommended during or . The adsorbent properties of diosmectite may reduce the gastrointestinal absorption of concurrently administered oral medications, including antibiotics such as tetracyclines, vitamins, and thyroxine. To minimize this interaction, other drugs should be taken at least two hours before or after diosmectite administration. Food interactions with diosmectite are minimal, though certain dietary restrictions may apply during treatment for to support recovery.

History and Research

Discovery and Development

Diosmectite, a dioctahedral belonging to the montmorillonite group, originates from natural sub-bentonitic clays, which are sedimentary rocks formed from deposits primarily sourced in . These clays were recognized in geological studies during the mid-20th century for their adsorptive , leading to interest in their potential medical applications as early as the , when specific variants from French sedimentary formations were characterized for pharmaceutical purification. Pharmaceutical development of diosmectite was advanced in the by the French company Beaufour Ipsen (now ), which focused on purifying and standardizing the raw clay to ensure consistent composition and safety for oral use. This process involved extracting the aluminomagnesium from natural deposits, removing impurities, and formulating it into a micronized powder suitable for suspension. The resulting product received its first regulatory approval in on January 1, 1975, for symptomatic treatment of , marking the transition from a geological to a standardized . It was subsequently launched commercially as Smecta in in 1977. In the , Smecta expanded across through national approvals, gaining recognition for its role in managing acute gastrointestinal disorders. By the 2000s, diosmectite had been included on several national lists for pediatric treatment, reflecting its established profile and in resource-limited settings. The brand remains the primary global trademark held by , while generic versions marketed simply as diosmectite are widely available in countries across , , and .

Clinical Studies

Clinical studies on diosmectite, a dioctahedral clay, have primarily focused on its role as an for various forms of , demonstrating reductions in symptom duration and severity across multiple randomized controlled trials (RCTs) and meta-analyses. In children with acute infectious , a 2018 Cochrane of seven RCTs involving 628 participants found low-certainty evidence that , used alongside rehydration therapy, reduces the mean duration of by approximately 24 hours compared to rehydration alone, with no significant increase in adverse events. This effect was more pronounced in rotavirus-positive cases, where stool output decreased significantly after two days of treatment. Similar efficacy has been observed in adults with acute watery . A 2011 multicenter, double-blind, -controlled RCT involving 329 participants (ITT) showed that diosmectite at 6 g three times daily shortened the median time to recovery by 15.2 hours compared to , with 60.8% of treated patients achieving recovery by 72 hours versus 50.0% in the group. The treatment was well-tolerated, with no serious adverse effects reported. For chronic and treatment-induced diarrhea, RCTs indicate diosmectite's utility in specific contexts. A 1999 double-blind, -controlled multicenter study of 98 patients undergoing pelvic or abdominal radiotherapy demonstrated that prophylactic (3 g three times daily) delayed the onset of radiation-induced by a median of 12 days and reduced its incidence during the first two weeks of treatment compared to . In chronic functional , long-term administration (up to 8 weeks) has shown symptom relief without disrupting composition, as evidenced by a 2022 in 20 adults where alpha and remained stable after 56 days of 9 g daily dosing, with no shifts in microbial richness or species abundance. In special populations, diosmectite has demonstrated effectiveness in managing HIV-associated . A Cochrane review of interventions for in HIV-infected individuals included diosmectite among anti-diarrheal agents, noting its role in symptom control, though evidence quality was low due to limited trials. Regarding potential applications in COVID-19-related gastrointestinal symptoms, a 2021 in vitro study reported that diosmectite traps particles, inhibiting viral binding to human enterocytes and reducing activation and secretion; however, clinical data remain limited, with no large-scale trials confirming efficacy . Despite these findings, clinical research on diosmectite has limitations, including few head-to-head comparisons with alternatives like and a reliance on low- to moderate-certainty evidence from smaller RCTs. Additional data are needed for severe cases and broader chronic indications to strengthen recommendations. However, in 2024, the French journal Prescrire recommended avoiding diosmectite for acute , citing insufficient evidence of benefit over rehydration alone.

References

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