Polychitosamine

Other Names

Ascorbate de ChitosaneChitin (deacetylated)ChitosanChitosan AscorbateChitosaneChitosane DéacétyléChitosane Mono-CarboxyméthyléDeacetylated ChitosanEnzymatic Polychitosamine HydrolisatHEP-30Hydrolisat Enzymatique de PolychitosamineMono-Carboxymethylated ChitosanN,O-Sulfated ChitosanN-Carboxybutyl ChitosanN-Carboxybutyl ChitosaneO-Sulfated N-AcetylchitosanPoliglusamPoly-beta-(1-4)-D-glucosaminePoly-[1,4]-beta-D-glucosamineQuitosanoSulfated N-CarboxymethylchitosanSulfated O-CarboxymethylchitosanTrimethyl Chitosan Chloride

Synopsis

Polychitosamine (Chitosan): A Comprehensive Encyclopedic Reference

1. Identity: Names, Chemical Structure, and Natural Sources

1.1 Nomenclature and Synonyms

"Polychitosamine" is an alternate systematic name for the biopolymer more widely known in scientific, regulatory, and commercial literature as chitosan (pronounced /ˈkaɪtəsæn/). The term "polychitosamine" reflects the polymer's structural basis as a chain of chitosamine (glucosamine) units. It appears as a listed synonym in supplement-industry nomenclature alongside other designations such as deacetylated chitin, deacetylchitin, poly-D-glucosamine, polyglucosamine, β-1,4-poly-D-glucosamine, 2-amino-2-deoxy-(1,4)-β-D-glucopyranan, poliglusam, and quitosano. Documented synonyms used in supplement contexts include "enzymatic polychitosamine hydrolisate," "HEP-30," "N-carboxybutyl chitosan," "O-sulfated N-acetylchitosan," and "trimethyl chitosan chloride." The United States Pharmacopeia (USP) and European Pharmacopoeia (EP) both carry formal monographs for the substance under the name "chitosan." Per the USP text, "chitosan is obtained by partial deacetylation of chitin, which is extracted from the shells of edible shrimps and crabs suitable for human use," with a degree of deacetylation of not less than 70.0% and not more than 95.0%; accepted synonyms include deacetylated chitin, deacetylchitin, β-1,4-poly-D-glucosamine, and poly-D-glucosamine.

1.2 Chemical Structure

Chitosan is a linear polysaccharide composed of randomly distributed β-(1→4)-linked D-glucosamine (deacetylated unit) and N-acetyl-D-glucosamine (acetylated unit). It is therefore a copolymer whose ratio of the two monomeric units—expressed as the degree of deacetylation (DDA)—is the primary parameter distinguishing chitosan from its precursor chitin. Chitosan is generally a β(1→4) polyglucosamine that is less than 50% acetylated, while chitin is generally considered to be more than 50% acetylated. Because the proportion of free amino groups relative to acetylated groups governs solubility, charge density, and biological activity, the properties of chitosans can be modified by varying the degree of deacetylation, molecular weight, and other factors during the production process, and it is important to specify parameters like degree of deacetylation, viscosity, and/or molecular weight to achieve consistent properties.

Chitosan is a biopolymer similar in structure and properties to dietary fiber (e.g., vegetable bran, cellulose) but with additional dietary or nutritional advantages derived from its polycationic, or positively charged, structure. This positive charge arises because the free amine groups (–NH₂) of the glucosamine residues become protonated (–NH₃⁺) at acidic pH values, giving the polymer cationic character in gastric conditions.

The chitosan family consists of polymers with different chemico-physical characteristics and activity. Molecular weight ranges used commercially vary from a few thousand daltons (chitosan oligosaccharides, COS) to several hundred thousand daltons. A water-soluble polyglucosamine generally has a molecular weight of less than or equal to about 10,000 kDa and a degree of deacetylation equal to or greater than 80%; in some embodiments, the molecular weight of the soluble polyglucosamine is between 5 and 1,000 kDa.

1.3 Natural Sources

Chitosan, or polyglucosamine, is a natural fibre obtained from chitin, a substance present in the shells of shellfish such as shrimps, crabs, and lobsters, but also inside the cellular walls of mushrooms. More specifically:

Crustacean shells: Because of the large quantities and ready access, waste shells from the shellfish industry are a major source of chitin for manufacturing chitosan, though squid pen and fungi are also potential industrial sources.
Fungal sources: Chitosan, prepared of fungal origin, is initially extracted and purified from reliable and abundant food or biotechnological fungal sources such as Agaricus bisporus or Aspergillus niger.
Other arthropods: Chitin is a white, hard, inelastic, nitrogenous polysaccharide isolated from fungi, mollusks, or from the exoskeletons of arthropods (e.g., crustaceans, insects).
Squid: "Squid pens," waste shell by-products of squid processing, are a renewable and inexpensive source of chitosan.

Chitin can also be extracted from insects or mushrooms, but these types of raw material are not yet used in the pharmaceutical sector due to a lack of information on safety and impurities profiles.

1.4 Manufacturing Process

To obtain chitin, shellfish waste shells are washed, finely crushed, soaked in dilute inorganic acids such as HCl to remove calcium carbonate and other minerals from the shells, and then soaked in strong alkali (e.g., NaOH) to remove proteinaceous components. The major procedure for obtaining chitosan is the alkaline deacetylation of chitin with a strong alkaline solution. Generally, the raw material is crushed, washed with water or detergent, and ground into small pieces; after grinding, the raw material is treated with alkali and acid to isolate the polymer, which is then deacetylated by treatment with alkali. Depending on the specific treatment of chitin, chitosan can vary in the degree of deacetylation.

1.5 Common Commercial Forms and Preparations

Chitosan has great potential for application across several different product groups and can be developed into different formats—from gels, solutions, and liquids to powders, tablets, edible films, and nanoparticles. In the dietary supplement sector specifically, commercial dosage forms include:

Capsules and tablets: the predominant oral supplement form, often combining chitosan with ascorbic acid or tartaric acid to enhance solubility and fat-binding efficacy.
Powders: for mixing into beverages or foods.
Chewing gum: used in oral-health applications.
Topical preparations: also used in mouthwashes, gels, chewing gum, eye drops, and wound dressings.

As a pharmaceutical excipient, chitosans have been used as a binder, disintegrant, coating agent, and matrix material in various dosage forms, such as tablets, capsules, and films.

2. Historical and Traditional Use

2.1 Discovery and Early Scientific History

The scientific investigation of chitin—the direct precursor of polychitosamine/chitosan—dates to the early nineteenth century. Braconnot (1811) discovered chitosan deduced from chitin; subsequently, Hopper-Seiler gave the term "chitosan" for deacetylated chitin in 1894. In 1799, British chemist Charles Hatchett experimented with decalcifying the shells of various crustaceans, finding a soft, yellow, and cartilage-like substance.

2.2 Research Era and Applied Traditional Use

Since its discovery approximately 200 years ago, chitosan, as a cationic natural polymer, has been widely used as a topical dressing in wound management owing to its hemostatic, stimulation of healing, antimicrobial, nontoxic, biocompatible, and biodegradable properties. Use in wound care and hemostasis thus predates formal clinical trial evaluation and constitutes the oldest applied tradition associated with the material.

Researchers in Japan and others started investigating chitosan's applications in the 1960s and 1970s. They discovered that chitosan has several beneficial qualities that make it applicable in many fields such as water purification, agriculture, and medicine; water-absorbing, molecule-binding, and gel-forming are just a few of chitosan's unusual abilities. Japan was particularly active in early research into chitosan as both a food ingredient and a nutraceutical, with Japanese researchers contributing the first peer-reviewed observations of its hypocholesterolaemic properties in rat models in 1980.

Chitin-based materials have a parallel tradition of use in East Asian folk medicine, where substances derived from shellfish exoskeletons were applied topically to wounds and skin lesions, though these historical applications were not formalized under the name "chitosan" or "polychitosamine" until the modern chemical era. Oral use as a dietary supplement for weight management and cholesterol reduction emerged explicitly in the late twentieth century as a commercial supplement category.

3. Key Constituents and Active Compounds

3.1 Primary Structural Component

Chitosan is a polysaccharide comprising copolymers of glucosamine (β(1–4)-linked 2-amino-2-deoxy-D-glucose) and N-acetylglucosamine (2-acetamido-2-deoxy-D-glucose) and can be derived by partial deacetylation of chitin. The two monomers differ only in whether the amine group at carbon-2 is free (glucosamine) or acetylated (N-acetylglucosamine). The relative proportion of free amine groups is the primary determinant of biological activity.

3.2 Physicochemical Properties Governing Activity

Three key physical parameters determine the functional properties of a given chitosan/polychitosamine preparation:

Degree of deacetylation (DDA): determines the density of free amine groups and thus the cationic charge density at low pH.
Molecular weight (MW): influences viscosity, gel-forming ability, and the magnitude of fat-binding and bile acid-binding in the gastrointestinal tract. Any MW chitosan used as a food supplement reduces the absorption of fat and cholesterol. Research comparing MW variants found that intermediate MW preparations may produce the greatest hypolipidemic effects in animal models.
Solubility: From a chemical standpoint, chitosan consists of polymerized D,L-glucosamine which is insoluble in water and in most common organic solvents under neutral to alkaline conditions, but dissolves in dilute acids as the amine groups become protonated.

3.3 Chitosan Oligosaccharides (COS)

A distinct class of active compounds derived from chitosan by enzymatic or chemical depolymerization are the chitosan oligosaccharides (COS), typically defined as low-molecular-weight fragments (approximately 1,000–10,000 Da). Chitosan oligosaccharide (COS), a natural oligomer polysaccharide degraded from chitosan, significantly attenuates ischemia/reperfusion-induced acute kidney injury and maintains glomerular filtration function by inhibiting oxidative stress, mitochondrial damage, and excessive endoplasmic reticulum stress both in vitro and in vivo. COS have been studied independently of high-molecular-weight chitosan, and their differing solubility profile means they may be absorbed to a greater extent than intact chitosan.

4. Mechanisms of Action

4.1 Fat and Bile Acid Binding in the Gastrointestinal Tract

The most extensively studied mechanism of polychitosamine/chitosan is its capacity to bind dietary lipids and bile acids in the gastrointestinal lumen, thereby limiting their absorption. A number of in vitro studies have demonstrated that chitosan can bind fats and bile acids. Although the mechanism is not fully understood, it has been suggested that chitosan dissolves in the stomach, emulsifying fat and forming a gel, which binds with the fat in the intestine, therefore interfering with the absorption of fat in the intestine. This insoluble complex then passes undigested through the large intestine and is naturally excreted.

The mechanism of chitosan action on cholesterol metabolism involves inhibiting the formation of micelles during digestion of lipids in the tract by forming ionic bonds with the bile salts and acids necessary for emulsification of dietary fats and activation of the pancreatic lipase activity, which limits the absorption of fats.

In the small intestine, chitosan interacts with bile salts and acids, forming aggregates which involve substances like cholesterol, triglycerides, and free fatty acids; consequently, an important fraction of these substances can be excreted without being metabolized.

In vitro quantification of these interactions has been undertaken. The bile acid-binding capacities of different chitosan samples were 0.20–0.61, 0.43–1.63, and 0.61–1.61 μmol/g chitosan for cholic, deoxycholic, and chenodeoxycholic acids, respectively, and stronger binding capacity of chitosan against a selected bile acid does not warrant greater binding capacity for other bile acids; fat-binding capacity ranged from 1,077–1,239 g oil/g for the chitosan samples under the experimental conditions.

4.2 Antimicrobial Activity

In common with many cationic polymers, chitosan has pronounced antimicrobial effects due to destabilization of the outer membrane of Gram-negative bacteria and permeabilization of the microbial plasma membrane. Chitosan composites have outstanding antimicrobial activity owing to the electrostatic interactions between the protonated NH₃⁺ chitosan groups and negatively charged cell membranes of microbes.

4.3 Anti-Adipogenic and AMPK-Related Pathways

Beyond simple fat trapping, in animal models, anti-obesity effects may occur through serum leptin and C-reactive protein modulation or AMPK activation and lipogenesis-associated gene inhibition. More recent research has suggested a more complex mode of action for chitosan: a decrease in feed intake was recorded in mice supplemented with chitosan, while exposure of pre-adipocytes to chitooligosaccharide modulated adipokine secretion and inhibited adipogenesis in vitro.

4.4 Antioxidant Properties

Chitosan may increase total plasma antioxidant activity and lower oxidative stress. In an in vitro study, chitosan demonstrated antioxidant effects by reducing albumin carbonyls and hydroperoxides in a time-dependent manner.

4.5 Hemostatic Activity

Chitosan also helps blood clot when applied to wounds. The polycationic surface of chitosan promotes erythrocyte aggregation and platelet adhesion, contributing to its hemostatic action, which has been exploited in wound dressings.

5. Scientific Evidence by Area of Use

5.1 Body Weight and Obesity Management

5.1.1 Background and Proposed Mechanism

Chitosan, a commonly used dietary supplement, is believed to have the potential to decrease body weight by binding to dietary fats and decreasing their absorption. This application has been evaluated in a relatively large number of randomized controlled trials (RCTs) and several systematic reviews and meta-analyses.

5.1.2 Cochrane Review (2008)

The most comprehensive independent assessment of the weight-loss evidence remains the Cochrane Database systematic review. The Cochrane Database of Systematic Review, published concerning the activity of chitosan on body weight control, concluded that "there is some evidence that chitosan is more effective than placebo in the short-term treatment of overweight and obesity; however, many of the included trials to date have been of poor quality; results obtained from high quality trials indicate that the effect of chitosan on body weight is minimal and unlikely to be of clinical significance."

5.1.3 Meta-Analysis of RCTs (2018)

A meta-analysis published in 2018 searching MEDLINE and the Cochrane Library up to December 2017 evaluated RCTs in overweight and obese patients. The usage of chitosan as a dietary supplement up to 52 weeks seems to slightly reduce body weight (–1.01 kg, 95% CI: –1.67 to –0.34). The most significant improvement was observed in systolic blood pressure; the published articles mention as secondary possible benefits the improvement of blood pressure and serum lipids status.

5.1.4 Systematic Review and Meta-Analysis on Obesity Indicators (2024)

A 2024 systematic review and meta-analysis in Food Science & Nutrition included 19 RCTs with 21 effect sizes. The combined analysis showed that chitosan supplementation significantly reduced body weight (WMD = −0.79 kg; 95% CI, −1.30 to −0.29; p = 0.002) and body-fat percentage (BFP) (WMD = −0.41%; 95% CI, −0.50 to −0.32; p < 0.001). Additionally, there was a notable increase in fat-free mass (FFM) (WMD = 0.20 kg; 95% CI, 0.06–0.34; p = 0.005). However, no significant impact of chitosan on body mass index (BMI) (WMD = −0.35 kg/m², 95% CI: −0.71, 0.00; p = 0.054) and waist circumference (WC) (WMD = −0.71 cm, 95% CI: −1.49, 0.05; p = 0.069) was observed. Overall, chitosan supplementation shows promise in improving obesity indicators by reducing body-fat percentage and increasing fat-free mass; however, further well-designed studies with larger sample sizes are needed to confirm these findings.

5.1.5 Evidence Strength Assessment

There is not enough evidence to support the use of chitosan alone without dietary changes or exercise for weight loss. The evidence as a whole across multiple meta-analyses is consistent: statistically significant effects on body weight have been detected, but the absolute magnitudes are small (approximately −0.8 to −1.0 kg compared to placebo), the quality of underlying trials is variable, and the effects are unlikely to be of standalone clinical significance without concurrent dietary modification.

5.2 Blood Lipids (Cholesterol and Triglycerides)

5.2.1 EFSA Scientific Opinion (2011)

The most authoritative regulatory-body assessment is the European Food Safety Authority's 2011 scientific opinion on health claims related to chitosan. In weighing the evidence, a meta-analysis of randomized controlled trials which investigated the effects of chitosan consumption on blood lipids was evaluated by the EFSA Panel and showed a statistically significant reduction in total and LDL-cholesterol concentrations; the Panel concluded that a cause and effect relationship has been established between the consumption of chitosan and maintenance of normal blood LDL-cholesterol concentrations. The Panel also considered that in order to obtain the claimed effect, 3 g of chitosan should be consumed daily.

Based on this opinion, chitosan received EU authorization for a health claim for "maintenance of normal blood LDL-cholesterol concentrations" under Commission Regulation (EU) 432/2012.

5.2.2 Health Canada Monograph

The Natural Health Products Ingredients Database (NHPID) of Health Canada similarly recognizes that chitosan helps lower blood total (and LDL) cholesterol and helps maintain healthy cholesterol levels.

5.2.3 Systematic Review and Meta-Analysis on Serum Lipids (2025)

A comprehensive systematic review and meta-analysis of RCTs examining effects on serum lipid levels reached more conservative conclusions. Chitosan produced clinically insignificant reductions in LDL-C and total cholesterol. Chitosan showed negligible effects on triglycerides, with no clinical relevance. No significant improvement was observed in HDL-C with chitosan use. Certainty of evidence was low to moderate, requiring larger and more robust trials.

5.2.4 Evidence Strength Assessment

The cholesterol evidence is mixed in terms of clinical magnitude. The EFSA Panel recognized a statistically significant reduction sufficient for a regulatory health claim at 3 g/day, yet later systematic reviews characterize the clinical reductions as "statistically significant but clinically negligible." Some clinical trials support the use of chitosan to lower cholesterol, but long-term effectiveness is unknown. The discrepancy likely reflects heterogeneity in product quality (molecular weight, DDA) across the trials included.

5.3 Renal Failure and Hemodialysis

5.3.1 Clinical Evidence

One of the most cited early clinical investigations in this area enrolled eighty patients with renal failure on long-term stable hemodialysis (published in the Journal of Pharmacy and Pharmacology, 1997). The effects of chitosan were investigated in eighty patients with renal failure undergoing long-term stable hemodialysis treatment; the patients were tested after a control treatment period of 1 week; half were fed 30 chitosan tablets (45 mg chitosan/tablet) three times a day. Ingestion of chitosan effectively reduced total serum cholesterol levels (from 10.14 ± 4.40 to 5.82 ± 2.19 mM) and increased serum haemoglobin levels (from 58.2 ± 12.1 to 68 ± 9.0 g L⁻¹). Significant reductions in urea and creatinine levels in serum were observed after 4 weeks of chitosan ingestion. The feeling of physical strength, the appetite, and the sleep of patients in the treatment group had improved significantly after 12 weeks of ingestion, compared with those of patients in the control group. During the treatment period, no clinically problematic symptoms were observed.

A later Japanese study (2014) examined oxidative stress specifically. The study reported the effects of chitosan on oxidative stress and related factors in hemodialysis patients; the ingestion of chitosan over a 12-week period resulted in a significant decrease in serum indoxyl sulfate and phosphate levels compared with the levels prior to the start of the study; the ingestion of chitosan also resulted in a lowered ratio of oxidized to reduced albumin and a decrease in the level of advanced oxidized protein products; in in vitro studies, chitosan solutions were found to bind 38.5% of the indoxyl sulfate and 17.8% of the phosphate, respectively.

5.3.2 Evidence Strength Assessment

Limited clinical data are available regarding efficacy for anemia or chronic renal failure. The 1997 hemodialysis study, while positive, was small and methodologically dated. The uremic toxin-binding mechanism is plausible given chitosan's known ionic binding properties, but the clinical database in this area consists of a small number of studies with limited populations. Evidence must be characterized as preliminary.

5.4 Wound Healing and Antimicrobial Applications

5.4.1 Evidence Base

Chitosan can be used to prevent or treat wound and burn infections not only because of its intrinsic antimicrobial properties, but also by virtue of its ability to deliver extrinsic antimicrobial agents to wounds and burns; it can also be used as a slow-release drug-delivery vehicle for growth factors to improve wound healing.

Chitosan-based dressings have been shown to possess significant potential as wound dressings in wound repair owing to their high porosity, ability to mimic the ECM of the skin, good superficial contact, and excellent antimicrobial properties.

5.4.2 Evidence Strength Assessment

Topically, for improved wound healing, lab studies and a clinical trial support this use. The wound-healing literature is composed predominantly of in vitro and animal studies, with some clinical trial support. This application has led to the development and regulatory clearance of chitosan-based hemostatic wound dressings used in emergency and surgical medicine—an area where application of polychitosamine is more advanced than for any oral indication.

5.5 Blood Pressure

One use noted is high blood pressure: replacing table salt with a product that contains small amounts of chitosan (such as Symbiosal) might help lower blood pressure in people with high blood pressure. The 2018 meta-analysis across overweight and obese patients (described above) found that the most significant secondary improvement observed was in systolic blood pressure. Evidence in this area is limited and largely derived from secondary endpoints in weight-management RCTs, rather than dedicated blood-pressure trials.

5.6 Dental and Oral Health

Some people apply chitosan directly to their gums to treat inflammation that can lead to tooth loss (periodontitis), or chew gum that contains chitosan to prevent cavities (dental caries). The antimicrobial properties of chitosan against oral bacteria underpin these uses. Systematic clinical evidence specifically for oral-health applications in humans is sparse, and this area remains largely investigational.

6. Body Systems and Health Areas Associated with Polychitosamine

Cardiovascular system: LDL-cholesterol reduction, maintenance of normal blood lipid concentrations, potential modest blood pressure effects.
Metabolic/adipose system: Body weight management, body-fat percentage reduction, inhibition of dietary fat absorption.
Renal system: Reduction of uremic toxins (indoxyl sulfate), reduction of serum urea and creatinine, phosphate binding in hemodialysis patients, possible antioxidant protection of albumin.
Integumentary system (topical): Wound healing, hemostasis, burn infection management.
Oral cavity: Dental caries prevention, periodontal inflammation management.
Gastrointestinal system: Reduction of dietary lipid absorption, potential gut-transit modulation.

7. Dosage Forms and Dosages Reported in Studies

Dosages vary substantially across indications and study designs. The following dosages are sourced directly from the cited studies and regulatory documents:

Cholesterol maintenance (EFSA authorized claim): The EFSA NDA Panel concluded that "in order to obtain this effect in adults, 3 g of chitosan should be consumed daily."
Cholesterol and weight management (Health Canada monograph): 0.5–3 grams of chitosan, 2 times per day.
Renal failure / hemodialysis (1997 clinical study): Patients were fed 30 chitosan tablets (45 mg chitosan/tablet) three times a day—equivalent to approximately 4.05 g/day.
Reducing cholesterol and improving anemia / physical strength in hemodialysis patients (as cited by a pharmacological drug reference): 1.35 grams of chitosan three times daily.
Most commonly reported clinical dose range: Chitosan has most often been used by adults in doses of 1–1.35 grams by mouth daily for up to 12 weeks.
Polyglucosamine L112 (a specific chitosan formulation tested in clinical trials for overweight/obese subjects): 750 mg of chitosan per tablet, formulated with ascorbic acid and tartaric acids in the relative proportions of 91:6:3%, with the addition of formulating excipients.

Important note on inter-product variability: In prior Cochrane reviews, the physico-chemical characteristics were not considered, and the different products used in clinical trials were taken as a single chitosan—a methodological limitation that complicates cross-study dose comparisons, since products differ substantially in molecular weight, degree of deacetylation, and co-formulation.

8. Safety Considerations and Drug Interactions

8.1 General Tolerability

Clinical trials report few adverse events, generally limited to flatulence and constipation; chitosan's toxicity profile is relatively low. Chitosan is a non-toxic nutritional supplement generally regarded as a safe compound. It has been described as biodegradable, nontoxic, non-immunogenic, and biocompatible, with properties similar to cellulose.

8.2 Gastrointestinal Side Effects

Common side effects of chitosan include constipation, flatulence (gas), bloating, nausea, and abdominal cramping. Mild gastrointestinal symptoms, mainly constipation, were most commonly reported across clinical trials in the lipid meta-analysis. One disadvantage of using chitosan is that it induces constipation, an undesirable condition that includes difficult and often painful elimination.

8.3 Shellfish Allergy

Chitosan is taken from the outer skeleton of shellfish; people with allergies to shellfish might also be allergic to chitosan. However, the mechanistic picture is nuanced: there is a concern that people with allergies to shellfish might also be allergic to chitosan; however, people who are allergic to shellfish are allergic to the meat, not the shell; so some experts believe that chitosan may not be a problem for people with shellfish allergy. This uncertainty nonetheless warrants caution. Reported adverse events include constipation and gastrointestinal distress; patients allergic to shellfish or mushrooms should use related supplements with caution.

8.4 Interaction with Warfarin (Anticoagulant)

The most clinically documented drug interaction involves warfarin. Potentiation of the anticoagulant effect of warfarin was reported in a patient receiving chitosan 2.4 g/day. Warfarin is a blood thinner; there is some concern that taking chitosan might increase the blood-thinning effects of warfarin (Coumadin); taking chitosan with warfarin could increase the chance of bruising or bleeding; if you take warfarin, avoid taking chitosan. A case report indicates that chitosan may increase the blood-thinning effects of warfarin.

8.5 Interaction with Antiviral Agents

Taking chitosan with acyclovir might reduce the amount of acyclovir the body absorbs. Chitosan might also interfere with the way some other antiviral agents work.

8.6 Nutrient Absorption (Fat-Soluble Vitamins and Minerals)

Chitosan may also prevent the body from absorbing fat-soluble vitamins such as vitamins A, D, E, and K; magnesium may also not be absorbed. However, no effect on vitamins A, D, or E was observed in one clinical trial. The theoretical concern exists because of chitosan's mechanism as a fat-binder, but clinical evidence of significant nutrient depletion is limited.

8.7 Pregnancy and Lactation

There isn't enough reliable information to know if chitosan is safe to use when pregnant or breast-feeding; staying on the safe side and avoiding use is recommended.

8.8 Duration of Safe Use

Chitosan is likely safe for most adults if taken orally in recommended doses for up to three months. Long-term safety data beyond three months are limited.

8.9 Anticoagulant Drug Class Interactions

Care should be taken if taking drugs to thin the blood—these include drugs like warfarin, heparin, or enoxaparin.

9. Regulatory and Pharmacopoeial Status

The USP-NF and EP monographs provide two different types of chitosans as a pharmaceutical excipient. The European Pharmacopoeia (EP) monograph was prepared for the hydrochloride salt of chitosan (European Pharmacopoeia, 2019). As polymers for human use, both chitosan hydrochloride and chitosan-valeric acid-hydrocolloid are reported in IRIS, the online platform of the European Medicines Agency (EMA).

In the European Union, the health claim for chitosan and "maintenance of normal blood LDL-cholesterol concentrations" was authorized under Commission Regulation (EU) 432/2012 following the 2011 EFSA positive scientific opinion, with a specified condition of use of 3 g/day. The EFSA Panel explicitly did not authorize health claims for "reduction in body weight," "reduction of intestinal transit time," or "reduction of inflammation" on the basis of insufficient evidence from the trials reviewed at the time.

Vegetable (fungal-derived) chitosan has received GRAS (Generally Recognized As Safe) status from the U.S. Food and Drug Administration for use as a beverage ingredient.

References

Health Conditions

Health conditions that Polychitosamine may help support.

No conditions available.

Body Systems

Body systems that Polychitosamine may help support.

No body systems available.